Search Results

Regulation Number

Type

Panel

TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge

Reference & Predicate Devices

K243858

Intended Use

The TEG 6s Hemostasis System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a 3.2% citrated whole blood sample. The Citrated: K, KH, RT, FF Assay Cartridge, to be used with the TEG 6s analyzer, contains four independent assays (CK, CKH, CRT, and CFF), described below.

The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameters Clotting Time (R), Speed of Clot Formation (K and Alpha angle) and Maximum Clot Strength (MA).

The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests.

The CRT assay monitors the hemostasis process via both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s System. Clotting characteristics are described by the functional parameter Maximum Clot Strength (MA). The CRT MA parameter is equivalent to the CK MA parameter but the final MA value is reached more quickly using the CRT assay.

The CFF assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s System after blocking platelet contributions to clot strength. Clotting characteristics are described by the functional parameters Maximum Clot Strength (MA) and the Estimated Functional Fibrinogen Level (FLEV).

Results from the TEG 6s analysis should not be the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests. The indication for TEG 6s System use is with adult patients where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluations are commonly used to assess clinical conditions in cardiovascular surgery and cardiology procedures to assess hemorrhage or thrombosis conditions before, during and following the procedure. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care.

Device Description

The TEG® 6s Hemostasis System (TEG® Hemostasis analyzer and TEG® 6s Assay Cartridges) is intended for in vitro diagnostic use to provide semi-quantitative indications of a blood sample's ability to form and maintain a clot. The TEG® 6s Hemostasis System records the kinetic changes in a sample of whole blood as the sample clots, retracts and/or lyses. The system output consists of a table of numerical values and graphs resulting from the hemostasis process over time. This information can be used by clinicians to aid in determining if a clotting dysfunction or coagulopathy is present.

To perform a test, a disposable TEG® 6s Assay Cartridge is inserted into the TEG® 6s Hemostasis analyzer. The instrument reads the bar code on the cartridge and identifies the type of cartridge for operator confirmation. Blood (collected in a 3.2% sodium citrate tube) or Quality Control (QC) material is added to the entry port on the cartridge and drawn into the cartridge under the TEG® 6s Hemostasis analyzer control. The amount of the sample drawn into the cartridge is determined by the pre-set volume of the blood chambers in the cartridge. Once in the cartridge, the sample is metered into as many as 4 separate analysis channels, depending upon the assays being performed. Reconstitution of reagents dried within the cartridge is accomplished by moving the sample back and forth through reagent chambers, under the control of microfluidic valves and bellows (pumps) within the cartridge. After each sample has been mixed with reagent, it is delivered to a test cell where it is monitored for viscoelastic changes due to coagulation. Excess sample material is moved under microfluidic control into an enclosed waste chamber within the cartridge.

The TEG® 6s technology is based on a disposable cartridge containing up to 4 independent measurement cells. Each cell consists of a short vertically-oriented injection molded tube (ring). Detection of clotting in the TEG® 6s Hemostasis System is performed optically. A piezoelectric actuator vibrates the measurement cell(s) through a motion profile composed of summed sinusoids at different frequencies. The movement of the measurement cells will induce motion in the sample meniscus, which will be detected by a photodiode. The resulting motion of the meniscus is monitored optically and analyzed by the instrument to calculate the resonant frequency and modulus of elasticity (stiffness) of the sample. By performing a Fast Fourier Transform (FFT) on meniscus motion data, the resonant frequencies can be determined. The analyzer monitors the harmonic motion of a hanging drop of blood in response to external vibration. As the sample transitions from a liquid state to a gel-like state during clotting, the modulus of elasticity (stiffness) and therefore resonant frequency increase. The TEG® 6s Hemostasis analyzer measures these variations in resonant frequency during clotting and lysis.

Resonance is the tendency of a material or structure to oscillate with greater amplitude at some frequencies than others. The exact frequencies at which resonance occurs will depend on the stiffness and mass of the sample. Stiffness, in turn, is a function of a material's modulus of elasticity and the boundary conditions to which the material is exposed, such as the geometry and materials of a test cell. By holding these boundary conditions and sample mass constant from sample to sample, the TEG® 6s Hemostasis System allows direct comparison of elasticity between samples. The output measurements are displayed in a table and on a graphical tracing that reflects the hemostasis profile of the clot formation.

In a typical test, blood that has been delivered to the measurement cell will not clot for several minutes. During this time the sample has no inherent stiffness except that provided by surface tension, and since this remains constant the measured resonant frequencies will not change. Once clotting begins, however, the elastic modulus and thus the resonant frequencies increase rapidly. During fibrinolysis, the process is reversed, with elastic modulus and resonant frequencies decreasing. In tests where clotting does not occur, the resonant frequency of the sample will not change. During coagulation, however, a clot will bind to the ring contained in the cartridge and the resonant frequency will rise with increasing firmness of the clot. The TEG® 6s Hemostasis Analyzer collects meniscus motion data, tracks changing resonant frequencies and analyzes the frequency data to provide semi-quantitative parameters describing the clot.

The TEG® 6s Hemostasis System monitors the interaction of platelets within the fibrin mesh of the clot during clot formation and lysis, all in a whole-blood setting. The TEG® 6s Hemostasis System uses thromboelastography to provide continuous measurement of clot elasticity.

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the TEG 6s Hemostasis System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed acceptance criteria and study data often found in novel device approvals or publications on algorithmic performance.

Therefore, the document does not contain the level of detail requested for many of the points, especially those related to AI algorithm performance (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for training). The device described is an in vitro diagnostic (IVD) system that measures blood coagulation properties, suggesting a direct measurement rather than an AI-driven interpretation of complex data like images.

Below is an attempt to extract and infer information based on the provided text, while also clearly indicating what information is not available in this document.

Acceptance Criteria and Device Performance Study

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria for a novel device or an AI algorithm. The core of the study described is a comparison of the modified device's performance against its predicate and within different sample matrices.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter Category	Acceptance Criteria (Inferred from "met clinically acceptable bias limits")	Reported Device Performance
Sample Matrix Equivalence	No statistical difference in agreement between TEG 6s and TEG 5000 by blood source.	Demonstrated.
Predicate Bias (Comparison between new and predicate cartridge types)	Bias met clinically acceptable bias limits across all parameters for TEG 6s Citrated: K, KH, RT, FF vs. TEG 6s Citrated: K, KH, RTH, FFH.	Demonstrated.

Note: Specific numerical acceptance criteria (e.g., ±X% bias) are not provided in this document. The document states that the bias "met clinically acceptable bias limits," but the limits themselves are not specified.

2. Sample Sizes and Data Provenance for the Test Set

Sample Size for Test Set: Not specified in the document.
Data Provenance: The document mentions "an observational study" for the agreement analysis between TEG 6s and TEG 5000 by blood source. It does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable/not provided for this type of IVD device clearance. The device measures physical properties of blood, and the "ground truth" for its performance would typically involve comparison to established laboratory methods or accepted clinical standards rather than expert consensus on subjective interpretations.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are typically used in studies involving subjective interpretations (e.g., image reading) where multiple experts might disagree. This device measures quantifiable physiological parameters.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not performed/not applicable. An MRMC study is relevant to subjective interpretation tasks, often in medical imaging, where human readers interact with AI. This device directly measures blood coagulation parameters, so there is no "human reader" in the AI sense, nor is there an "AI assistance" component described.

6. Standalone Performance Study (Algorithm Only)

Not performed/not applicable. The TEG 6s Hemostasis System, as described, is a physical instrument that performs direct measurements. It is not an "algorithm only" device or an AI system in the typical sense that would have a standalone performance study independent of human interaction. The "algorithm" here refers to the internal processing of sensor data to derive hemostasis parameters. Its performance is intrinsically linked to the physical measurement system.

7. Type of Ground Truth Used

The ground truth used for this device would be the quantitative measurements of hemostatic parameters from established, validated laboratory methods or from the predicate device itself. The document mentions:

Agreement analysis with TEG 5000 (a prior generation or related device).
Comparison with predicate TEG 6s Citrated: K, KH, RT, FF (K243858).

8. Sample Size for the Training Set

The concept of a "training set" in the context of machine learning is not applicable to this device as described in the provided document. The device performs direct physical measurements rather than learning from a dataset via an AI algorithm. Therefore, no training set size is reported.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" or AI algorithm in the described context.

Ask a Question

Ask a specific question about this device

K Number

K243858

Device Name

Manufacturer

Haemonetics Corporation

Date Cleared

2025-01-15

(30 days)

Product Code

Regulation Number

Type

Panel

Citrated: K, KH, RTH, FFH

Reference & Predicate Devices

K150041

Intended Use

The TEG 6s Hemostasis System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a venous blood sample. The Citrated: K, KH, RT, FF Assay Cartridge, to be used with the TEG 6s analyzer, contains four independent assays (CK, CKH, CRT, and CFF), described below.

Device Description

Once clotting begins, however, the elastic modulus and thus the resonant frequencies increase rapidly. During fibrinolysis, the process is reversed, with elastic modulus and resonant frequencies decreasing. In tests where clotting does not occur, the resonant frequency of the sample will not change. During coagulation, however, a clot will bind to the ring contained in the cartridge and the resonant frequency will rise with increasing firmness of the Clot. The TEC® 6s Hemostasis Analyzer collects meniscus motion data, tracks changing resonant frequencies and analyzes the frequency data to provide semi-quantitative parameters describing the clot.

AI/ML Overview

The provided document is a 510(k) Summary for the Haemonetics TEG® 6s Hemostasis System, specifically for the Citrated: K, KH, RT, FF Assay Cartridge. Its primary purpose is to demonstrate substantial equivalence to a predicate device (K150041). As such, it focuses on comparing the proposed device to the predicate rather than detailing a study that establishes novel acceptance criteria or proves performance against new, distinct benchmarks requiring extensive clinical trials with human-in-the-loop or standalone AI performance.

The document states: "There is no change to the technology, design of the device, reported parameters, or mechanics of how the cartridge is run on the TEG® 6s analyzer. No additional product development of the TEG® 6s system was required." The only change mentioned is an expansion of the "Use Location" from "clinical laboratory" to "clinical laboratory or at the point-of-care."

Therefore, the document does not contain the detailed information necessary to answer the prompt's request for:

A table of acceptance criteria and reported device performance for a new device or significant modification requiring such a study. Instead, it relies on the predicate's established performance.
Sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details as these are typically required for demonstrating efficacy or superiority of a new or substantially modified device, especially AI/ML-driven ones.

The document is a submission for substantial equivalence for a minor modification (expanded use location) of an already cleared device, not a submission for a novel device or a device with a new AI/ML component that requires extensive performance validation against a defined ground truth.

Therefore, based solely on the provided text, I cannot extract the information required by your prompt, as the study described is a demonstration of substantial equivalence via comparison to a predicate, not an independent performance study of a novel device against predefined acceptance criteria for its core functionality.

The "study" described is a regulatory comparison. The "acceptance criteria" are effectively that the modified device performs equivalently to the predicate device, especially in the expanded use environment. No specific performance metrics or detailed study results are presented because the core technology and measured parameters are unchanged from the predicate.

Ask a Question

Ask a specific question about this device

K Number

K232018

Device Name

Manufacturer

Haemonetics Corporation

Date Cleared

2024-03-29

(266 days)

Product Code

Regulation Number

Type

Panel

Instrumentation Laboratory

Reference & Predicate Devices

K150041

Intended Use

The TEG 6s Hemostasis System consists of the TEG 6s Hemostasis Analyzer and the Citrated: K, KH, RTH, FFH assay cartridge. The TEG 6s Hemostasis System is intended for in vitro diagnostic use with adult patients where an evaluation of their blood hemostasis properties is desired. The TEG 6s Hemostasis System records the kinetic changes in a sample of 3.2% citrated whole blood as the sample clots and provides semi-quantitative results. The TEG 6s Hemostasis System can be used in the laboratory or at the point-of-care.

The Citrated: K, KH, RTH, FFH assay cartridge is intended to be used in patients where heparin/heparinoids may be present and who are at an increased risk of coagulopathy. Hemostasis evaluations are indicated to assess clinical conditions in cardiovascular surgery, cardiovascular procedures (e.g. minimally invasive valve replacement or repairs) and liver transplantation to assess hemorrhage or thrombosis conditions before, during and following the procedure.

The Citrated: K, KH, RTH, FFH assay cartridge contains four independent assays (CK, CKH, CRTH and CFFH) and the system output consists of a table of numerical values for parameters R, MA, and LY30.

The CK assay monitors the hemostasis process via the intrinsic pathway in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. Clotting characteristics are described by the functional parameters R (clotting time) and MA (maximum clot strength).

The CKH assay monitors the effects of heparin in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. CKH is used in conjunction with CK, and heparin influence is determined by comparing Clotting Times (R) between the two tests. LY30 describes fibrinolysis 30 minutes after reaching maximum clot strength.

The CRTH assay monitors the hemostasis process after stimulation of both the intrinsic and extrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System, neutralizing the effect of heparin in the sample. Clotting characteristics are described by the functional parameter MA (maximum clot strength with contributions of both platelets and fibrin).

The CFFH assay monitors hemostasis of 3.2% citrated whole blood specimens in the TEG 6s Hemostasis System after blocking platelet contributions to clot strength, neutralizing the effect of heparin in the sample. Clotting characteristics are described by the functional parameter MA (fibrinogen contribution to maximum clot strength).

For professional use only.

Device Description

The TEG® 6s Hemostasis System (TEG® hemostasis analyzer and TEG® 6s assay cartridges) is intended for in vitro diagnostic use to provide semi-quantitative indications of a blood sample's ability to form and maintain a clot. The TEG® 6s Hemostasis System records the kinetic changes in a sample of whole blood as the sample clots, retracts and/or lyses. The system output consists of a table of numerical values and graphs resulting from the hemostasis process over time. This information can be used by clinicians to aid in determining if a clotting dysfunction or coagulopathy is present.

To perform a test, a disposable TEG® 6s assay cartridge is inserted into the TEG® 6s hemostasis analyzer. The instrument reads the bar code on the cartridge and identifies the type of cartridge for operator confirmation. Blood (collected in a 3.2% sodium citrate tube) or Quality Control (QC) material is added to the entry port on the cartridge and drawn into the cartridge under the TEG® 6s hemostasis analyzer control. The amount of the sample drawn into the cartridge is determined by the pre-set volume of the blood chambers in the cartridge. Once in the cartridge, the sample is metered into as many as 4 separate analysis channels, depending upon the assays being performed. Reconstitution of reagents dried within the cartridge is accomplished by moving the sample back and forth through reagent chambers, under the control of microfluidic valves and bellows (pumps) within the cartridge. After each sample has been mixed with reagent, it is delivered to a test cell where it is monitored for viscoelastic changes due to coagulation. Excess sample material is moved under microfluidic control into an enclosed waste chamber within the cartridge.

The TEG® 6s technology is based on a disposable cartridge containing up to 4 independent measurement cells. Each cell consists of a short vertically-oriented injection molded tube (ring). Detection of clotting in the TEG® 6s Hemostasis System is performed optically. A piezoelectric actuator vibrates the measurement cell(s) through a motion profile composed of summed sinusoids at different frequencies. The movement of the measurement cells will induce motion in the sample meniscus, which will be detected by a photodiode. The resulting motion of the meniscus is monitored optically and analyzed by the instrument to calculate the resonant frequency and modulus of elasticity (stiffness) of the sample. By performing a Fast Fourier Transform (FFT) on meniscus motion data, the resonant frequencies can be determined. The analyzer monitors the harmonic motion of a hanging drop of blood in response to external vibration. As the sample transitions from a liquid state to a gel-like state during clotting, the modulus of elasticity (stiffness) and therefore resonant frequency increase. The TEG® 6s hemostasis analyzer measures these variations in resonant frequency during clotting and lysis.

Once clotting begins, however, the elastic modulus and thus the resonant frequencies increase rapidly. During fibrinolysis, the process is reversed, with elastic modulus and resonant frequencies decreasing. In tests where clotting does not occur, the resonant frequency of the sample will not change. During coagulation, however, a clot will bind to the ring contained in the cartridge and the resonant frequency will rise with increasing firmness of the clot. The TEG® 6s hemostasis analyzer collects meniscus motion data, tracks changing resonant frequencies and analyzes the frequency data to provide semi-quantitative parameters describing the clot.

AI/ML Overview

The provided text describes the acceptance criteria and study proving that the "Citrated: K, KH, RTH, FFH" assay cartridge for the TEG 6s Hemostasis System meets these criteria.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Reference Ranges	Expected values within established Reference Ranges (CLSI EP28-A3c) for a normal population.	CK-R (min): 4.6-9.1 (N=157)
CK-MA (mm): 52-69 (N=151)
CKH-R (min): 4.3-8.3 (N=155)
CKH-LY30 (%): 0-3.2 (N=148)
CRTH-MA (mm): 53-69 (N=162)
CFFH-MA (mm): 15-34 (N=162)	Pass
Analytical Precision (Repeatability and Reproducibility)	CV for all precision tests:

CK-R: 0.82 (CK-R: 0.90, CK-MA: 0.95, CKH-R: 0.82, CKH-LY30: 0.99, CRTH-MA: 0.97).
Type 3 Parameter (CFFH-MA vs. Clauss Fibrinogen):
Spearman correlation coefficient: 0.79 (95% CI: 0.757; 0.814). | Pass |
| Electrical Safety & EMC | Compliance with IEC 61010-1, IEC 61010-2-010, IEC 61010-2-101 for safety; and IEC 60601-1-2, IEC/EN61326-1, IEC/EN61326-2-6 for EMC. | "The system complies with the IEC 61010-1, IEC 61010-2-010, IEC 61010-2-101, standards for safety and the IEC 60601-1-2, IEC/ EN61326-1, IEC/ EN61326-2-6, standards for EMC." | Pass |
| Software Verification & Validation | Documentation as recommended by FDA guidance for "moderate" level of concern. | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." | Pass |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Sizes (Clinical Performance - Method Comparison):
- CK-R: 617 samples
- CK-MA: 539 samples
- CKH-R: 829 samples
- CKH-LY30: 828 samples
- CRTH-MA: 870 samples
- CFFH-MA: 883 samples
Data Provenance:
- Country of Origin: United States ("All studies were performed in the United States.")
- Retrospective or Prospective: Prospective clinical trials (indicated by "patients undergoing liver transplantation, cardiovascular surgery, or cardiology procedures. Blood samples were drawn before, during, and after the procedures"). These samples were collected at eight clinical trial sites.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The comparability study uses predicate devices (TEG 6s with Citrated Multichannel Cartridge and Clauss Fibrinogen) as comparators, not expert consensus on ground truth conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. The study uses comparison to predicate devices/methods rather than a ground truth established by an adjudication process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Was an MRMC study done? No.
Effect size of human readers improvement with/without AI: Not applicable, as this is an in-vitro diagnostic device for blood hemostasis properties, not an AI-assisted diagnostic tool for human readers interpreting images or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device operates in a standalone manner, providing semi-quantitative results for blood hemostasis properties. The clinical performance testing is a method comparison study, where the device's results are compared to those of predicate devices/established methods, without explicit human interpretation as part of the primary performance metric. The results are numerical values and graphs. The device's output is "not the sole basis for a patient diagnosis, but should be evaluated together with the patient's medical history, the clinical picture and, if necessary, further hemostasis tests," indicating that a human interprets the device's standalone results, rather than the human being part of the measurement process itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical performance study (method comparison) was primarily based on:

Comparison to legally marketed predicate devices (TEG 6s with the Citrated Multichannel Cartridge) for most parameters (CK-R, CK-MA, CKH-R, CKH-LY30, CRTH-MA using CKH-MA from the predicate as an equivalent channel).
Comparison to Clauss Fibrinogen plasma concentration for CFFH-MA, as an established method for measuring fibrinogen contribution to clot formation.

8. The sample size for the training set

This information is not explicitly provided as a "training set" in the context of machine learning. However, reference ranges were established using 148-162 samples from "normal donors" (see section 14.A. Reference Ranges), and various precision studies involved hundreds of measurements using QC materials and normal/contrived whole blood samples. This constitutes data used for establishing operational parameters and validating performance characteristics, which is analogous to a training or development set for IVDs.

9. How the ground truth for the training set was established

For the establishment of reference ranges, "Citrated whole blood from normal donors (representative of normal population distributions - age, gender, race) with no known coagulopathies and not taking any drugs that would potentially affect patient hemostasis was used." A non-parametric method for analysis was used to determine the reference range for each assay parameter. For precision studies, QC materials with known values and contrived blood samples simulating various hemostatic states (hypo-coagulable, hyper-coagulable, hyper-fibrinolytic) were used. The "ground truth" for these samples refers to their classification as normal or contrived states and the expected behavior based on the additives.

Ask a Question

Ask a specific question about this device

K Number

K233790

Device Name

ACL TOP 970 CL

Manufacturer

Date Cleared

2023-12-29

(31 days)

Product Code

Regulation Number

Type

Panel

ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM

Reference & Predicate Devices

K231031,K221359,K172903,K034007,K070005,K213464,K150877

Intended Use

The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis.

The system provides results for both direct measurements and calculated parameters.

Device Description

The ACL TOP 970 CL is an additional member of the ACL TOP Family 70 Series previously FDA cleared under K231031. This family member consists of two side-by-side test modules:

. Main Module (ACL TOP 550 CTS, K150877) the subject of this submission
Chemiluminescent (CL) Module previously FDA cleared under K221359 .

The Main Module to the ACL TOP 970 CL instrument performs the following types of tests, using the same optical measuring wavelengths and test parameters as the predicate (ACL TOP Family 50 Series):

. Coagulometric (Turbidimetric) Measurements
. Chromogenic (Absorbance) Measurements
. Immunological Measurements

The ACL TOP 970 CL is an additional member of the ACL TOP Family 70 Series (K231031) and utilizes the same consumables, reagents, calibrators, and controls, and provides the same analytical methodology for routine and specialty assay result reporting as the predicate (ACL TOP Family 50 Series).

The ACL TOP 970 CL also offers the same pre-analytical features available on the ACL TOP Family 50 Series. These features alert the instrument operator to a potential HIL (Hemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "ACL TOP 970 CL" device. This device is a Multipurpose System For In Vitro Coagulation Studies. Based on the content, it does not appear to be an AI/ML-driven device that would involve the complex ground truthing, expert reads, MRMC studies, or training/test set definitions typically associated with such technologies.

Instead, this submission is for a new hardware configuration (the ACL TOP 970 CL Main Module) that is substantially equivalent to a previously cleared device (ACL TOP Family 50 Series, K150877). The "studies" mentioned are analytical studies (precision and method comparison) to demonstrate that the new configuration performs equivalently to the predicate device for various coagulation assays.

Therefore, many of the requested points related to AI/ML device studies (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of device submission and are not found in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantified, pre-defined table format for each test. Instead, it refers to industry-standard guidelines (CLSI EP05-A3, CLSI EP09c, 3rd Ed) and states that "all analytical studies were performed in accordance to established plans and protocols and design control procedures. Testing verified that all acceptance criteria were met and results equivalent to the predicate device."

However, we can infer the performance metrics from the results presented:

Performance Metric	Acceptance Criteria (Inferred - based on "results equivalent to the predicate device" and meeting CLSI guidelines)	Reported Device Performance (ACL TOP 970 CL Main Module)
Precision	Meeting CLSI EP05-A3 guidelines for within-run and total %CV and comparability to predicate device performance.	(See "Precision" tables below for specific values per assay and material. All deemed acceptable.)
Method Comparison	Demonstrated equivalence (slope near 1, intercept near 0, high correlation 'r') when compared to predicate device (ACL TOP 550 CTS) across the analytical measuring range. Meeting CLSI EP09c, 3rd Ed guidelines.	(See "Method Comparison" tables below for specific values per assay. All deemed acceptable.)
Thermal Verification	No impact on analytical results from structural changes.	Confirmed no impact.
Optical Stray Light Verification	No impact on analytical results from new back wall design.	Confirmed no impact.
Environmental Verification	No impact on analytical results from changes to skin/air intake.	Confirmed no impact.

Reported Device Performance Tables (from the document):

HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU - Precision

Material	Mean	Within Run %CV	Total %CV
Low Control	733	4.3	4.5
High Control	2664	2.5	2.8
Cut-off Plasma Pool	532	5.2	6.0
High Plasma Pool	2435	2.4	2.4

HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity - Precision

Material	Mean	Within Run %CV	Total %CV
Normal Control	93.3	3.7	4.6
Abnormal Control	26.5	3.7	6.5
Plasma Pool 1	41.5	6.3	7.3
Plasma Pool 2	5.8	4.4	5.4

HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds - Precision

Material	Mean	Within Run %CV	Total %CV
Normal Control	11.5	0.5	1.2
Abnormal Pool	26.3	0.8	2.3
Low Abn Control	22.9	1.6	2.1
High Abn Control	38.7	1.1	2.6

HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL - Precision

Material	Mean	Within Run %CV	Total %CV
Normal Control	387	0.9	1.4
Low Fibrinogen Control	178	6.1	6.3
Normal Pool	392	1.3	2.0
Abnormal Pool	109	1.8	2.4

HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL - Precision

Material	Mean	Within Run %CV	Total %CV
UF Low Control	0.35	1.82	2.81
UF High Control	0.65	1.43	2.36
UF Pool	0.55	1.69	2.27
LMW High Control	1.57	1.18	2.15
LMW Low Control	0.64	2.55	2.81
LMW Pool	0.71	1.49	2.05

Method Comparison Results (ACL TOP 970 CL vs. ACL TOP 550 CTS):

HemosIL D-Dimer HS 500 (K172903) – D-dimer ng/mL FEU
N: 136, Slope: 0.939, Intercept: 27.0, r: 0.996

HemosIL Factor VIII deficient plasma (K034007) – Factor VIII % Activity
N: 105, Slope: 1.045, Intercept: 0.0, r: 0.993

HemosIL RecombiPlasTin 2G (K070005) – Prothrombin Time Seconds
N: 118, Slope: 1.000, Intercept: 0.25, r: 0.998

HemosIL RecombiPlasTin 2G (K070005) – Fibrinogen mg/dL
N: 123, Slope: 0.991, Intercept: 5.1, r: 0.998

HemosIL Liquid Anti-Xa (K213464) – Heparin IU/mL
N: 139, Slope: 0.989, Intercept: 0.015, r: 0.997

2. Sample size used for the test set and the data provenance

Precision Test Set Sample Size: For precision studies, samples for each material were run for 20 days, two runs per day, 2 replicates per run (n=80). This applies to each of the multiple materials tested for each assay (e.g., Low Control, High Control, etc.).
Method Comparison Test Set Sample Size:
- HemosIL D-Dimer HS 500: N=136 clinical samples
- HemosIL Factor VIII deficient plasma: N=105 clinical samples
- HemosIL RecombiPlasTin 2G (Prothrombin Time): N=118 clinical samples
- HemosIL RecombiPlasTin 2G (Fibrinogen): N=123 clinical samples
- HemosIL Liquid Anti-Xa: N=139 clinical samples
Data Provenance: The document does not specify the country of origin for the data or explicitly state whether the samples were retrospective or prospective. It mentions "clinical samples" for method comparison and "material" (controls/plasma pools) for precision. Typically, such studies for IVD devices are conducted in a controlled laboratory setting (prospective testing) using a mix of manufactured controls/calibrators and patient samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. This is not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" for this in-vitro diagnostic device is the actual measurement of analytes, established by reference methods or validated predicate devices. Proficiency of technical staff operating the instruments would be presumed as per standard laboratory practices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. Not applicable to a measurement device; no human interpretation or adjudication beyond standard laboratory quality control and data review.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This is not an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is a standalone instrument for in-vitro diagnostic testing, not an algorithm. Its performance is based on its ability to accurately and precisely measure analytes. The "performance" tables provided are essentially the standalone performance of the device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The ground truth for an in-vitro diagnostic coagulation system like this is based on:

Reference Materials: For precision, known concentration control materials and plasma pools with established values are used.
Comparative Measurements: For method comparison, results from the subject device are compared against a legally marketed predicate device (ACL TOP 550 CTS) which serves as the established reference. The assumption is that the predicate device's measurements are equivalent to the "ground truth" for the test.

8. The sample size for the training set

N/A. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is a hardware instrument with validated analytical capabilities.

9. How the ground truth for the training set was established

N/A. See point 8.

Ask a Question

Ask a specific question about this device

K Number

K221359

Device Name

Manufacturer

Instrumentation Laboratory Co.

Date Cleared

2023-09-29

(506 days)

Product Code

JPA,MID,MSV

Regulation Number

Type

Panel

STA R Max 3, STA Compact Max 3

Reference & Predicate Devices

K083518,K092181,K091556

Intended Use

ACL TOP 970 CL: The ACL TOP 970 CL is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic use by health care professionals in a clinical laboratory. The system provides results for both direct measurements and calculated parameters.
HemosIL CL Anti-Cardiolipin IgM: HemosIL CL Anti-Cardiolipin IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. For use with adult population. For prescription use only.
HemosIL CL Anti-ß2 Glycoprotein-I IgM: HemosIL CL Anti-B2 Glycoprotein-I IgM is a fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 Glycoprotein-I (anti-B2GPI) IgM antibodies in human 3.2% or 3.8% citrated plasma on the ACL TOP 970 CL in the laboratory setting by a healthcare professional, as an aid in the diagnosis of Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. For use with adult population. For prescription use only.

Device Description

ACL TOP 970 CL Instrument: The ACL TOP 970 CL is an instrument that integrates new chemiluminescent test capability similar to the ACL AcuStar, K083518.
HemosIL CL Anti-Cardiolipin IgM: HemosIL CL Anti-Cardiolipin IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with cardiolipin and human purified ß2GPI, which capture, if present, the aCL antibodies from the sample. After incubation, magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgM antibody is added and may bind with the captured aCL IgM on the particles. After a second incubation, magnetic separation, and wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLU) by the ACL TOP 970 CL optical system. RLUs are directly proportional to the aCL IgM concentration in the sample.
HemosIL CL Anti-ß2 Glycoprotein-I IgM: HemosIL CL Anti-ß2 Glycoprotein-I IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with human purified ß2GPI, which capture, if present, the aß2GPI antibodies from the sample. After incubation, magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgM antibody is added and may bind with the captured aß2GPI IgM on the particles. After a second incubation, magnetic separation, and wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLUs) by the ACL TOP 970 CL optical system. RLUs are directly proportional to the aß2GPI IgM concentration in the sample.

AI/ML Overview

The provided text describes the 510(k) summary for the ACL TOP 970 CL instrument and two associated immunoassays, HemosIL CL Anti-Cardiolipin IgM and HemosIL CL Anti-β2 Glycoprotein-I IgM. The studies presented focus on analytical performance and comparability to predicate devices, rather than AI model performance or human-in-the-loop studies. Therefore, many of the requested elements pertaining to AI-driven diagnostic devices (such as expert adjudication, MRMC studies, or training set details for AI) are not applicable or cannot be extracted from this document.

However, I can extract information related to the acceptance criteria for the analytical performance of the assays and how that performance was demonstrated.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for these in vitro diagnostic devices are demonstrated through various analytical performance studies, focusing on precision, linearity, analytical sensitivity (LoD/LoQ), analytical specificity, and method comparison to predicate devices. The document does not explicitly state pre-defined acceptance thresholds for each parameter (e.g., minimum CV for precision, minimum slope for linearity). Instead, it presents the results of these studies, implying that the observed performance met internal or regulatory acceptance.

HemosIL CL Anti-Cardiolipin IgM

Acceptance Criteria (Implied)	Reported Device Performance
Precision (Low Lot-to-Lot Variability)	Lot-to-Lot Variability (% CV):

Low Multi-Ab Control: 1.6%
High Multi-Ab Control: 1.2%
Plasma Samples A-E: 1.6% - 9.6% |
| Reproducibility (Low CV across sites/runs)| Reproducibility (% CV):
Low Multi-Ab Control: 7.0%
High Multi-Ab Control: 7.4%
Clinical Samples 1-4: 4.5% - 9.5% |
| Analytical Sensitivity (LoD/LoQ) | LoD: 1.0 U/mL
LoQ: 1.0 U/mL |
| Linearity Range | 2.7 - 500.0 U/mL |
| Analytical Specificity (No interference) | No interference for: Hemoglobin, Bilirubin, Triglycerides, Heparin (LMW/UF), Rheumatoid Factor, Acetylsalicylic acid, Atorvastatin, Warfarin, Prednisone, Acid Citric Dextrose, Hydroxychloroquine, Rituximab at specified concentrations. |
| Method Comparison (Strong correlation to predicate) | Slope (95% CI): 1.00 (0.98 - 1.01)
r: 1.00 |
| Diagnostic Performance (Sensitivity/Specificity vs. APS Classification - provided for context, not a direct "acceptance criterion" in the same way as analytical measures) | Sensitivity: 40.5% (33.8% - 47.6%)
Specificity: 91.9% (88.4% - 94.5%) |

HemosIL CL Anti-β2 Glycoprotein-I IgM

Acceptance Criteria (Implied)	Reported Device Performance
Precision (Low Lot-to-Lot Variability)	Lot-to-Lot Variability (% CV):

Low Multi-Ab Control: 12.8%
High Multi-Ab Control: 11.5%
Plasma Samples A-E: 3.6% - 7.2% |
| Reproducibility (Low CV across sites/runs)| Reproducibility (% CV):
Low Multi-Ab Control: 8.3%
High Multi-Ab Control: 7.7%
Clinical Samples 1-4: 4.8% - 8.3% |
| Analytical Sensitivity (LoD/LoQ) | LoD: 2.0 U/mL
LoQ: 2.0 U/mL |
| Linearity Range | 1.9 - 400.0 U/mL |
| Analytical Specificity (No interference) | No interference for: Hemoglobin, Bilirubin, Triglycerides, Heparin (LMW/UF), Rheumatoid Factor, Acetylsalicylic acid, Atorvastatin, Warfarin, Prednisone, Acid Citric Dextrose, Hydroxychloroquine, Rituximab at specified concentrations. |
| Method Comparison (Strong correlation to predicate) | Slope (95% CI): 0.94 (0.92 – 0.96)
r: 0.99 |
| Diagnostic Performance (Sensitivity/Specificity vs. APS Classification - provided for context, not a direct "acceptance criterion" in the same way as analytical measures) | Sensitivity: 33.0% (26.7% - 39.9%)
Specificity: 94.6% (91.4% - 96.6%) |

2. Sample Sizes Used for the Test Set and Data Provenance

Precision Study (Test Set):
- HemosIL CL Anti-Cardiolipin IgM & Anti-β2 Glycoprotein-I IgM: 5 plasma samples (3 positive, 2 negative) and 2 levels of controls. Each material was run in duplicate, twice per day over 20 days.
Reproducibility Study (Test Set):
- HemosIL CL Anti-Cardiolipin IgM & Anti-β2 Glycoprotein-I IgM: 4 plasma samples (3 positive, 1 negative for Anti-Cardiolipin IgM; 3 positive for Anti-β2 Glycoprotein-I IgM) and 2 levels of controls. Each material tested in triplicate, twice a day for 5 days, totaling 30 replicates per level.
Analytical Sensitivity (LoD/LoQ):
- Specific sample numbers for LoD/LoQ for new reagent lots are not detailed, but samples prepared by combining Ab-positive and normal donor plasma were used.
Linearity:
- For each assay, samples were prepared by diluting a high antibody plasma sample with a negative antibody plasma sample to create required concentrations. Each level was measured in seven replicates.
Normal Reference Range:
- 100 citrated plasma normal donor samples.
Method Comparison:
- HemosIL CL Anti-Cardiolipin IgM: N = 131 samples.
- HemosIL CL Anti-β2 Glycoprotein-I IgM: N = 123 samples.
APS Outcome Study (Diagnostic Performance):
- HemosIL CL Anti-Cardiolipin IgM: N = 500 samples.
- HemosIL CL Anti-β2 Glycoprotein-I IgM: N = 503 samples (indicated by the sum of Positive/Negative categories: 63+17+128+295=503).

Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective, though typical clinical performance studies for diagnostic devices are usually prospective or utilize carefully curated samples. Reproducibility studies were conducted at "3 external sites."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. For these in vitro diagnostic immunoassays, the "ground truth" for the analytical performance studies (precision, linearity, etc.) is the quantitative measurement itself, validated against established laboratory methods or reference materials. For the "APS Outcome Study," the ground truth is "APS disease classification per 2006 International Consensus Statement from Miyakis et al." This classification is typically based on a combination of clinical and laboratory findings, interpreted by clinicians, but the specific number and qualifications of experts involved in this classification for the study samples are not detailed.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable, as this is an in vitro diagnostic device measuring analyte concentrations, not an imaging AI relying on expert interpretations or adjudications. The diagnostic performance (sensitivity/specificity) is compared against pre-defined clinical classification criteria (Miyakis et al. 2006).

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes an in vitro diagnostic device (immunoassay and analyzer), not an AI-driven imaging diagnostic device. There is no mention of human readers or AI assistance in diagnostic interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance data provided (precision, linearity, sensitivity, specificity, method comparison) is the standalone performance of the device (instrument + assay). The device provides a semi-quantitative measurement of antibodies, which then aids in diagnosis when used "in conjunction with other laboratory and clinical findings." There is no "human-in-the-loop" component in the assay's direct operation or result generation as described beyond the healthcare professional performing the test.

7. The Type of Ground Truth Used

Analytical Studies (Precision, Linearity, LoD/LoQ, Specificity): The ground truth is inherent to the nature of these highly controlled analytical tests. For example, for linearity, serially diluted samples with known concentrations are used. For interference, samples spiked with known interferents are used.
Method Comparison: The ground truth is established by the measurements obtained from the predicate (reference) devices: HemosIL AcuStar Anti-Cardiolipin IgM (K092181) and HemosIL AcuStar Anti-β2 Glycoprotein-I IgM (K091556) on the ACL AcuStar (K083518).
Normal Reference Range: Established by testing 100 samples from "normal donors."
APS Outcome Study: "APS disease classification per 2006 International Consensus Statement from Miyakis et al." This is a consensus-based clinical classification criteria.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device that requires a distinct training set. The "development" of the assays would involve internal R&D, but not a "training set" in the context of AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned for an AI model. For the development/validation of the immunoassay itself, the "ground truth" for calibrators and controls would be established through careful analytical procedures, often traceable to international standards or reference materials, under strict quality control.

Ask a Question

Ask a specific question about this device

K Number

K212183

Device Name

Manufacturer

Diagnostica Stago SAS

Date Cleared

2023-06-07

(694 days)

Product Code

Regulation Number

Type

Panel

ROTEM sigma Thromboelastometry System

Reference & Predicate Devices

K983460,K082675,K093001,K151867,K130090,K961579,K093167

Intended Use

Device Description

The STA R Max 3® and STA Compact Max 3® are fully automatic clinical analyzers designed to be used by professional laboratory personnel and to perform tests on human venous plasmas (in 3.2% trisodium citrate tubes) the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.
The technological characteristics are the same for all STA R Max® Family and STA Compact Max® family analyzers, including STA R Max 30 and STA Compact Max 30, which is based on two measurement principles: Chronometric measurement principle and Photometry measurement principle.
The analyzers use Diagnostica Stago reagents in addition to open adaptation of other available reagents. The instrument performs multiple test methodologies in random access, as selected by the user. These include clotting time or clot-based tests (i.e. chronometric measures) and photometric assays on plasma samples.
Changes include a redesigned PSR module to replace the Hamilton syringes and Valcor pump of the fluidic circuit and the addition of the HIL module for estimating interferences (Hemoglobin, Icterus, Lipemia).

AI/ML Overview

The provided text describes the performance data for laboratory instruments (STA R Max 3® and STA Compact Max 3®) used for in vitro coagulation studies, not for an AI/ML-driven medical device for which the acceptance criteria would typically focus on diagnostic accuracy metrics like sensitivity, specificity, or AUC as evaluated by expert readers.

Therefore, the requested information regarding acceptance criteria and study design elements specific to AI/ML devices (e.g., sample size for test set with provenance, number of experts for ground truth, adjudication methods, MRMC study, standalone performance, training set details) is largely not applicable to the content of this FDA 510(k) summary, as it pertains to traditional in vitro diagnostic instruments and their analytical performance.

The document focuses on:

Method Comparison: Comparing the new devices' measurements against predicate devices using standard regression analysis (Passing & Bablok, Deming) and correlation coefficients (Spearman's r).
Precision/Reproducibility: Assessing the variability of measurements within a run, between runs, between days, and between instruments/sites using standard deviation (SD) and coefficient of variation (CV%).
Interference Testing (HIL): Testing the impact of hemoglobin, icterus, and lipemia on results.

Below is a reinterpretation of the request based on the provided document, focusing on the analytical performance acceptance criteria and study details for these in vitro diagnostic instruments.

Acceptance Criteria and Device Performance for Coagulation Analyzers (STA R Max 3® and STA Compact Max 3®)

The provided document details the analytical performance of the STA R Max 3® and STA Compact Max 3® coagulation analyzers, demonstrating their substantial equivalence to predicate devices (STA R Max® and STA Compact Max®). The acceptance criteria are implicit in the presented method comparison and precision data, aiming to show comparable performance to the legally marketed predicates.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an in vitro diagnostic (IVD) device (a laboratory instrument) and not an AI/ML-driven diagnostic algorithm, the "acceptance criteria" are defined differently than for radiological AI tools. Here, they relate to statistical comparability (method comparison) and measurement reproducibility (precision). The specific quantitative "acceptance criteria" values (e.g., maximum allowable bias, maximum CV%) are not explicitly stated as discrete numbers in the document's summary tables, but rather are implied by the presentation of regression analysis results (slopes, intercepts, correlation coefficients) and precision statistics (SD, CV%). The expectation is that these values demonstrate strong agreement with the predicate devices and sufficient reproducibility for clinical use.

Performance Data Summary (Representing "Met Acceptance Criteria")

Test/Characteristic	Acceptance Criteria (Implicit from comparability with predicate and clinical utility based on CLSI guidelines)	Reported Device Performance (Summary)
Method Comparison STA R Max 3® vs. STA R Max®	Slope near 1.00, Intercept near 0, High Spearman's r (close to 1.00) indicating strong correlation and minimal bias.	STA - Neoplastine CI Plus: Slope: 0.98, Intercept: 0.20 sec, rSpearman: 0.997
STA - PTTA: Slope: 1.00, Intercept: -0.32, rSpearman: 0.997
STA - Fibrinogen: Slope: 1.01, Intercept: 4.26 mg/dL, rSpearman: 0.996
STA - Stachrom® ATIII: Slope: 1.03, Intercept: -1.03%, rSpearman: 0.980
STA - Liatest D-Di: Slope: 1.02, Intercept: -0.02 µg/mL, rSpearman: 0.998
Method Comparison STA Compact Max 3® vs. STA Compact Max®	Slope near 1.00, Intercept near 0, High Spearman's r (close to 1.00) indicating strong correlation and minimal bias.	STA - Neoplastine CI Plus: Slope: 0.99, Intercept: 0.20 sec, rSpearman: 0.994
STA - PTTA: Slope: 0.99, Intercept: 0.06 sec, rSpearman: 0.996
STA - Fibrinogen: Slope: 1.01, Intercept: 4.94 mg/dL, rSpearman: 0.995
STA - Stachrom® ATIII: Slope: 1.00, Intercept: 0.00%, rSpearman: 0.981
STA - Liatest D-Di: Slope: 1.02, Intercept: -0.01 µg/mL, rSpearman: 0.997
Method Comparison HIL vs. Reference (cobas® 8000/spectrophotometer)	Strong correlation coefficients (r or rSpearman) and acceptable slopes/intercepts.	Hemolysis: Slope: 1.12 (with outliers), 1.11 (without outliers), rSpearman: 0.954 (with outliers), 0.948 (without outliers)
Icterus: Slope: 0.99, Intercept: 0.26 mg/dL, rSpearman: 0.956
Lipemia: Linear Regression (vs. Spectrophotometer) r = 0.91; (vs. cobas® 8000) r = 0.97.
Precision/Reproducibility	Low CV% for within-run, between-run, between-day, between-instrument/site, and total precision. Specific acceptable CV% ranges are not explicitly stated, but the values provided are generally low indicating high precision. The summary states: "The acceptance criteria were met for all samples in the studies."	Detailed tables are provided for 5 different assays (PT, APTT, FIB, AT, D-Dimer) across up to 5 samples per assay, showing SD and CV% for various precision components. For example, for STA R Max 3, combined total precision CV% ranges from 1.1% (PT) to 10.6% (D-Dimer). For STA Compact Max 3, combined total precision CV% ranges from 1.5% (PT) to 9.2% (AT).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Method Comparison: For each assay and each instrument (STA R Max 3 and STA Compact Max 3), samples were "selected in order to cover the entire measuring range." The exact number of samples (patients) for each method comparison is not explicitly stated as a single number but would be consistent with CLSI EP09c recommendations. For example, the precision data tables indicate 80 replicates per sample per analyzer for single-site precision (e.g., 240 N for "All instruments combined" across 3 analyzers), and 90 N per sample for multi-site precision (across 3 sites) for a total of 270 replicates per sample per parameter across all sites and analyzers.
- HIL Method Comparison: Not explicitly stated, but samples were "spiked plasma" to create various concentrations across designated indices.
Data Provenance: The method comparison studies were conducted at "three external sites." Precision studies were conducted at "one external site" (single-site precision) and "three external sites" (multi-site precision). The country of origin is not specified but is implicitly within a region where FDA regulatory standards are applicable.
Retrospective or Prospective: Not explicitly stated, but given the nature of instrument validation studies, they are typically purpose-generated (prospective) for the study rather than utilizing historical patient data. Spiked plasma for HIL analysis indicates prospective sample preparation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable in the context of this IVD device. For an in vitro diagnostic instrument like a coagulation analyzer, "ground truth" is established by the analytical method itself, often by comparison to a well-established reference method or the predicate device that has established analytical accuracy. There are no human "experts" establishing a diagnostic ground truth from images or clinical data in the way an AI/ML diagnostic device would require. The "truth" is the measured concentration or clotting time.

4. Adjudication Method for the Test Set

Not applicable. As there are no human interpretations or classifications that require adjudication for this type of IVD instrument validation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This study pertains to the analytical performance of a laboratory instrument, not an AI-assisted diagnostic tool that aids human readers.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, in the context of an IVD analyzer. The "standalone" performance here refers to the analytical performance of the instrument itself when measuring samples. The entire document describes this "standalone" performance through method comparison and precision studies. The device measures various coagulation parameters directly from plasma samples.

7. The Type of Ground Truth Used

Analytical Ground Truth: The ground truth for this device's performance is established by:
- Comparison to a Legally Marketed Predicate Device: The performance of the new devices (STA R Max 3 and STA Compact Max 3) is compared directly to the established performance of their previous versions (STA R Max and STA Compact Max) using patient samples. This is the primary method for demonstrating substantial equivalence.
- Reference Methods (for HIL): For the HIL interferences, the device's readings were compared against "reference methods, cobas® 8000 modular analyzer (Hemolysis, Icterus, and Lipemia) and spectrophotometer (Lipemia)."
- Theoretical/Expected Values (for HIL spiking): For HIL, "spiked plasmas were prepared" to provide known concentrations of interfering substances, and the results "matched the index determination for the subject devices and the theoretical index."
- Repeated Measurements (for Precision): For precision, repeated measurements demonstrating low variability around a mean value for different samples serve as the internal "ground truth" for reproducibility.

8. The Sample Size for the Training Set

Not applicable for this type of conventional IVD instrument. These are not AI/ML devices that undergo "training" on a data set. Their "training" or calibration involves standard laboratory procedures and calibration materials according to manufacturer protocols.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no "training set" in the AI/ML sense for this traditional laboratory instrument.

Ask a Question

Ask a specific question about this device

K Number

K201440

Device Name

Manufacturer

Tem Innovations GmbH

Date Cleared

2022-07-08

(767 days)

Product Code

Regulation Number

Type

Panel

GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2

Reference & Predicate Devices

K083842,K101533

Intended Use

The ROTEM sigma thromboelastometry system is a fully integrated and automated in vitro diagnostic system designed to monitor and analyze a patient's coagulation status by measuring the viscoelastic properties of a 3.2% citrated venous or arterial whole blood sample. The ROTEM sigma system is indicated for use with adult patients 21 years and older where a semi-quantitative evaluation of their blood coagulation properties is desired, in the point of care and laboratory settings. Coagulation evaluations on the ROTEM sigma instrument, together with the ROTEM sigma complete + hep cartridge, are used to assess peri-operative hemorrhage and/or thrombosis in cardiovascular surgery and liver transplantation. The single use, multichannel cartridge ROTEM sigma complete + hep contains the following assays:

INTEM C is a semi-quantitative assay used to monitor coagulation via the intrinsic pathway in citrated whole blood samples.

EXTEM C is a semi-quantitative assay used to monitor coagulation via the extrinsic pathway in citrated whole blood samples.

FIBTEM C is a semi-quantitative assay used to monitor coagulation via the extrinsic pathway in citrated whole blood samples, after blocking platelet contribution to clot firmness.

HEPTEM C is a semi-quantitative assay used to monitor coagulation via the intrinsic pathway in citrated whole blood samples, after inactivating heparin.

Results from the ROTEM sigma should not be the sole basis for a patient diagnosis; ROTEM sigma results should be considered along with a clinical assessment of the patient's condition and other laboratory tests.

For in vitro Diagnostic Use.

For professional use only.

Device Description

The ROTEM sigma is an in vitro diagnostic (IVD) whole blood hemostasis system intended for use in the evaluation of coagulopathies in Point of Care (POC) or laboratory settings. It uses rotational thromboelastometry to provide semiquantitative information about the coagulation state of a blood sample. The ROTEM sigma system records the kinetic changes in a sample of 3.2% citrated whole blood during clot formation, as well as when the sample clot retracts and/or lyses.

Several parameters are measured and reported for this purpose. The graphical presentation reflects the various physiological results, which describe the interaction between coagulation factors and inhibitors, fibrinogen, platelets, and the fibrinolysis system. Additionally, the effect of certain drugs influencing hemostasis, in particular some anticoagulants (e.g. heparin), can be detected.

The ROTEM sigma technology uses rotational thromboelastometry that is based on a fixed cylindrical cup and an oscillating vertical axis. The axis is supported by a high precision ball bearing and oscillates through an angle of 4.75°. The oscillation of the axis is driven by a motor that is connected to the axis via a spring. For the measurement, the channel's measurement axis engages the plastic pin in the cup of the disposable heated cartridge holding the blood sample. The oscillation is detected optically via a mirror plate at the upper end of the axis, which reflects the light from a diode light source onto a light sensitive sensor. If no clotting takes place, the pin movement is not restricted. As a clot forms and attaches itself between the pin and cup surfaces, the pin movement becomes increasingly restricted. The result is a balance between the spring tension and the tension of the clot. As the clot becomes firmer, the oscillation amplitude of the axis is reduced.

The ROTEM sigma assays are based on the principle of either

intrinsic coagulation activation with or without the presence of heparin, or
extrinsic coagulation activation with or without the presence of platelet inhibitors.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them.

It's important to note that this document is a 510(k) summary for an In Vitro Diagnostic (IVD) device, specifically a Thromboelastometry System (ROTEM sigma). The "acceptance criteria" here refer to performance specifications (e.g., precision, reproducibility, method comparison) for the device's measurements, not typical "acceptance criteria" for an AI/ML model's diagnostic accuracy (like sensitivity/specificity against a ground truth). Similarly, "expert consensus" or "adjudication" in the context of IVDs refers to establishing the accepted values of controls or comparing to a reference method, not to human image interpretation.

Acceptance Criteria and Device Performance for ROTEM sigma Thromboelastometry System

The ROTEM sigma Thromboelastometry System is an in vitro diagnostic device for assessing blood coagulation. Its performance is demonstrated through various analytical studies. The acceptance criteria are implicit in the presentation of the study results, where the variability and agreement with reference methods are shown to be within acceptable ranges for an IVD.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an IVD device, the "acceptance criteria" are typically defined by ranges of acceptable precision (CV%), reproducibility (SD/CV%), and correlation with a predicate device (slope, intercept, R-value). The document presents the results of these studies, and the implicit acceptance criteria are met if these results fall within expected performance ranges for such devices.

Summary of Key Performance Parameters (Implicit Acceptance Criteria and Reported Performance)

Performance Study	Parameter	Acceptance Criteria (Implicit)	Reported Device Performance (Worst Case/Overall)
Precision	%CV (Within-Laboratory)	Should be low, indicating consistent results for identical samples.	Highest %CV observed:
(Whole Blood)	INTEM C: CT, A5, A10, A20, MCF	Generally 240 replicates per control type).

*   **Whole Blood (Normal, Contrived Hypocoagulable, Contrived Hypercoagulable):** Run in triplicate, in one (1) day, on five (5) instruments, resulting in 15 replicates per sample type per lot (3 lots => 45 replicates per sample type).
*   **Lysis Precision (Normal Whole Blood & Hyperfibrinolysis Blood):** Fifteen (15) replicates per sample type per cartridge lot (3 lots => 45 reps per type).
*   **Lot-to-Lot Variability (Normal Donor Whole Blood):** Thirty (30) replicates per cartridge lot (3 lots => 90 replicates).

Reproducibility (External Clinical Sites):
- Three (3) external clinical sites.
- Four (4) ROTEM sigma instruments per site.
- Three (3) lots of controls (ROTEM sigma ROTROL N and P).
- Run in triplicate, twice a day for five (5) days, resulting in thirty (30) replicates per control per site (90 replicates per control across all sites).
Interference:
- Various Interferents (Heparins, Acids, Ticagrelor): Eight (8) replicates at three (3) interferent levels for normal and hypocoagulable whole blood samples.
- Lupus Anticoagulant: Eleven (11) donors, each run on three (3) instruments with one (1) replicate per instrument.
Reference Intervals: One hundred twenty (120) whole blood samples from healthy donors.
Method Comparison:
- Number of samples for each assay parameter: INTEM C (144-148), EXTEM C (183-187), FIBTEM C (183), HEPTEM C (182).
- Data provenance: Patient samples from the "intended use populations and contrived samples." Conducted at four (4) clinical sites. No specific country of origin is mentioned beyond "internal precision study" and "external clinical sites" (implicitly within the regulatory region/country this submission applies to). The studies are prospective in the sense that they involve planned laboratory testing and data collection.
Arterial vs. Venous Study: Seventy-four (74) matched venous and arterial citrated whole blood samples. Performed at two (2) external clinical sites.

Data Provenance (Summary):
The studies include data from internal testing and multiple external clinical sites. The samples include healthy donors, patient samples (intended use populations), and contrived samples (e.g., hypocoagulable, hypercoagulable). The studies are analytical performance studies, not clinical outcome studies. These are prospective laboratory studies designed to evaluate technical performance. No specific countries are listed, but the context of an FDA 510(k) submission suggests either U.S. or international data accepted by the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For an IVD device like the ROTEM sigma, "ground truth" is established by controlled laboratory methods and comparison to existing, cleared predicate devices, rather than human interpretation or expert consensus in the typical sense for image-based AI.

Precision and Reproducibility: Ground truth is inherent in the preparation of controlled samples (normal, contrived hypocoagulable, contrived hypercoagulable, control materials) with known characteristics. The goal is to demonstrate the device's ability to consistently measure these known or expected characteristics. No external human experts are involved in creating this "ground truth" beyond standard laboratory practices and quality control.
Method Comparison: The "ground truth" or reference standard for comparison is the predicate device, the ROTEM delta (K083842, K101533). The performance is assessed by correlating the ROTEM sigma's measurements with those of the legally marketed predicate device. This is a comparative study, not one establishing an absolute "ground truth" with human experts.

There is no mention of experts establishing ground truth in the way one would for an AI in medical imaging (e.g., radiologists annotating images).

4. Adjudication Method for the Test Set

For IVD analytical performance studies, traditional "adjudication" (e.g., 2+1, 3+1 for discordant reads) is not applicable. The measurements are quantitative. For method comparison, if there were significant discrepancies between the new device and the predicate, further investigation would occur to understand the cause, but it's not an adjudication process of human interpretation. The consistency across multiple instruments and sites is shown in the reproducibility studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is typically for evaluating the diagnostic performance of software, often AI, sometimes with and without human assistance (e.g., radiologists reading images). This document describes the analytical performance of an in vitro diagnostic instrument that measures blood coagulation properties. It does not involve human readers interpreting "cases" in a diagnostic context. Therefore, there's no "effect size of how much human readers improve with AI vs without AI assistance" to report here, as AI is not assisting human interpretation in this context; it is the measurement device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The ROTEM sigma is inherently a "standalone" device in its primary function. It's an automated system that measures coagulation parameters. The performance studies (precision, reproducibility, method comparison) are all "algorithm only" in the sense that they evaluate the device's ability to produce consistent and accurate measurements on its own. Human intervention during operation involves sample loading and system maintenance, but the measurement process itself is automated ("fully integrated and automated").

7. The Type of Ground Truth Used

The "ground truth" in this context refers to established values or reference methods:

Established Reference Materials/Controls: For precision, reproducibility, and lot-to-lot variability, the "ground truth" is based on the known or expected values of the control materials and the stability of the whole blood samples used.
Predicate Device (ROTEM delta): For method comparison, the ROTEM delta serves as the reference standard or "ground truth" for evaluating the clinical equivalence of the ROTEM sigma's measurements.
Healthy Donor Samples: For reference interval establishment, samples from healthy individuals are used to define the typical range of values, which then serve as a clinical "ground truth" for normalcy.
Contrived Samples: For some studies (precision, method comparison), samples are artificially manipulated (e.g., hypocoagulable, hypercoagulable) to represent different physiological states. The "ground truth" for these is the known manipulation.

There is no "pathology" or "outcomes data" ground truth in the direct sense of a diagnostic accuracy study. The device provides semi-quantitative measurements that aid in diagnosis, but it does not provide a definitive diagnosis itself.

8. The Sample Size for the Training Set

This document describes the validation of a medical device, not the training of an AI/ML model. Therefore, there is no "training set" in the context of machine learning. The device determines coagulation parameters based on a physical principle (rotational thromboelastometry) and built-in algorithms, not from a data-driven training process in the AI sense.

9. How the Ground Truth for the Training Set Was Established

Since there is no "training set" for an AI/ML model, this question is not applicable.

Ask a Question

Ask a specific question about this device

K Number

K202101

Device Name

Manufacturer

Accriva Diagnostics, Inc.

Date Cleared

2021-12-29

(518 days)

Product Code

JPA,GGN,JBP

Regulation Number

Type

Panel

K193041,K941007,K960749,K120977

Reference & Predicate Devices

Intended Use

The GEM® Hemochron™ 100 System is a battery-operated portable instrument that performs individual in vitro quantitative coagulation tests on fresh whole blood. The system is intended to be used with test cartridges available from the manufacturer and include tests for Activated Clotting Time (ACT+) and Low Range Activated Clotting Time (ACT-LR). The system is intended for use only in point-of-care settings for patients aged 18 years and above.

The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is mended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL.

The GEM® Hemochron™ 100 ACT-LR (Low Range Activated Clotting Time) test is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures. The GEM® Hemochron™ 100 ACT-LR test demonstrates linear correlation to the anticoagulation effects of UFH concentrations up to 2.5 units/mL.

For in vitro diagnostic use. For Professional Use, Rx Only ..

GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+):

The GEM® Hemochron™ 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring . anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® Hemochron™ 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL.

The GEM® Hemochron™ 100 ACT+ test can be performed on the GEM® Hemochron™ 100 System and any model of Hemochron™ Signature Series device. Each instrument is portable, which allows testing at the point-of-care. For in vitro diagnostic use.

For Professional Use, Rx Only

GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR):

The GEM Hemochron 100 ACT-LR test can be performed on the GEM® Hemochron™ 100 system and any model of Hemochron™ Signature Series device. Instruments are portable, which allows testing at the point-of-care. For in vitto diagnostic use.

For Professional Use, Rx Only.

directCHECK Whole Blood Controls:

The directCHECK™ Whole Blood Quality Controls are dried whole blood preparations which have been assayed and are intended to be used to perform quality control assays using the Hemochron™ test cartridges

For in vitro Diagnostic Use. For Professional Use, Rx Only.

Device Description

The GEM® Hemochron™ 100 system is a battery-operated, point-of-care coagulation analyzer that represents the next generation platform of the predicate Hemochron™ Signature Elite microcoagulation system. The analyzer employs the same fundamental opto-mechanical clot detection technology and the same analytical algorithms used by the predicate device for calculating test results. The single-use test cartridges for Activated Whole Blood Clotting Time Plus (ACT+) or Low Range ACT (ACT-LR) assays are identical to the cartridges used by the predicate analyzer. Whole Blood Controls used on the GEM® Hemochron™ 100 system are identical to those used on the Hemochron™ Signature Elite. The system is intended for use only in clinical settings requiring point of care testing. ACT results for patient blood samples or liquid control material are displayed as ACT Celite-equivalent values (CEV) in seconds.

The analyzer contains a test chamber which warms a test cartridge to the required temperature, and it performs all operations to measure the clotting time of a whole blood sample after it is placed in the test cartridge and the test is started by the operator. The user interface includes a color touch screen that displays various action keys and an external barcode scanner for reading Operator identification number (OID), Patient identification (PID) number and lot numbers and expiry dates of liquid quality controls (QC). The operator uses the touch screen to select a command, set software configurations or enter information. The GEM® Hemochron™ 100 system is POCT1-A2 compliant and has Wi-Fi and Ethernet networking capability. It has increased storage for 10,000 patient and QC records. ACT+ and ACT-LR cartridge labels are modified to include a 2D barcode that identifies test type, lot number and expiry date, which is readable by the internal camera. Quality control features such as designation of QC levels, tagging of test results with date and time, and entry of OID and PID numbers are included and are similar to the predicate device.

The GEM® Hemochron™ 100 system is intended for use at the point of care professional healthcare environments such as the Cardiovascular Operating Room and Catheterization lab and is designed to perform its essential tasks of performing in-vitro diagnostic blood coagulation-time tests without the use of a network connection. The device contains an 802.11 interface which supports WPA2 encryption as well as EAP authentication framework. The device is able to connect to a Wireless Local Area Network (WLAN) via 802.11 b/g/n connections at 2.4 and 5 GHz. The communications interfaces supported by the device are utilized to configure or update the device software by supervisory staff before deployment to the intended use environment and in the reporting of test results to the Laboratory or Hospital Information Systems (LIS/HIS) by the clinical operators at the point of care. Test results are used directly at the point of care in aiding medical decision making, and the device's intended use is not reliant on the device's ability to transmit the information to the LIS/HIS.

GEM® Hemochron™ 100 ACT+ cartridges are single-use disposable test devices with a well for application of liquid QC and whole blood samples. When a liquid QC or patient test is requested, the instrument prompts the Operator to insert a cartridge into the instrument. After the instrument warms the cartridge, it prompts the Operator to apply the sample into the sample well of the cartridge. The ACT+ test cartridge is a self-contained disposable test chamber preloaded with a dried preparation of silica, kaolin, phospholipid, stabilizers, and buffers that provide maximum activation as defined by clinical practice guidelines. Each cartridge is sealed in a foil pouch labeled with lot number and expiry date. Reagents in GEM® Hemochron™ 100 ACT+ cartridges (000GACT+) are identical in composition to those in the predicate Hemochron™ ACT+ cuvettes (JACT-LR). A 2D barcode added to the cartridge label identifies the test type, lot number and expiry date. This information is automatically read by the internal camera. Each box of GEM® Hemochron™ 100 ACT+ cartridges contain 45 pouches, each pouch containing one GEM® Hemochron™ 100 ACT+ cartridge and one desiccant packet.

GEM® Hemochron™ cartridges are single-use disposable test devices with wells for application of samples. When a patient test or an LQC test is requested, the instrument prompts the Operator to insert a cartridge into the instrument. After the instrument warms the cartridge, it prompts the Operator to apply the sample into the sample well of the cartridge. Each GEM® Hemochron™ 100 ACT-LR cartridge is sealed in a foil pouch labeled with lot number and expiry date. The cartridge is a self-contained disposable test chamber preloaded with a dried preparation of Celite and silicon dioxide activators, potato dextrin, stabilizers, and buffers to provide maximum activation as defined by clinical practice guidelines. Reagents in GEM® Hemochron™ 100 ACT-LR cartridges (000GACT-LR) are identical in composition to those in the predicate Hemochron™ ACT-LR cuvettes (JACT-LR). A 2D barcode added to the cartridge label identifies the test type, lot number and expiry date. This information is automatically read by a new internal camera. Each box of GEM® Hemochron™ 100 ACT-LR cartridges contain 45 pouches, each pouch containing one GEM® Hemochron™ 100 ACT-LR cartridge and one desiccant.

Blood coagulation instruments and assays should be quality controlled prior to and during routine use. Performance ranges are provided with each control product against which users should compare results. Quality assurance programs include instrument service, quality control and complete performance records. directCHECK™ Quality Control products are to be used with Hemochron Systems (GEM® Hemochron™ 100 and Hemochron™ Signature Series). Level 1 and Level 2 QC products are provided in separate packaging. These preparations consist of dried fixed bovine red blood cells, rabbit cephalin, buffered sheep and horse plasma. Assayed clotting time values are provided with each lot of material. Each control preparation is provided in a dropper vial. Each dropper vial also contains diluent used to rehydrate the dried whole blood control. Diluent preparations consist of distilled water, sodium chloride, Tween® 20, ProClin®, and anticoagulant.

AI/ML Overview

The provided text details the 510(k) summary for the Accriva Diagnostics, Inc. GEM Hemochron 100 System and associated tests and controls. This document aims to demonstrate the substantial equivalence of the new device to existing legally marketed predicate devices. The study described focuses on the comparison between the new GEM Hemochron 100 system and the predicate Hemochron Signature Elite, rather than proving the device meets acceptance criteria in a traditional sense of a clinical trial with predefined success/failure thresholds against a ground truth.

Instead, the provided text describes performance data collected to demonstrate substantial equivalence to an already cleared predicate device. This is a common pathway for FDA 510(k) clearance, where a new device is compared to a legally marketed predicate to show it is as safe and effective.

Here's an attempt to answer your questions based on the provided text, reinterpreting "acceptance criteria" as the performance metrics and comparability demonstrated for substantial equivalence:

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, "acceptance criteria" for performance studies are typically framed as demonstrating equivalence or non-inferiority to the predicate device within acceptable statistical bounds. The reported performance is then compared to that of the predicate. The document doesn't explicitly state quantitative acceptance criteria in a "pass/fail" table format, but rather presents the results of equivalence studies.

Here's a summary of the performance data presented, emphasizing the comparison to the predicate:

Performance Metric	Acceptance Criteria (Demonstration of Equivalence to Predicate)	Reported Device Performance (GEM Hemochron 100)
Precision (LQC) - ACT+	Within-run CV comparable to established performance for similar devices.	Level 1: Mean 157.7s, SD 11.4s, CV 7.2%
Level 2: Mean 419.0s, SD 9.7s, CV 2.3%
Precision (LQC) - ACT-LR	Within-run CV comparable to established performance for similar devices.	Level 1: Mean 117.1s, SD 10.5s, CV 9.0%
Level 2: Mean 272.3s, SD 19.1s, CV 7.0%
Precision (Whole Blood) - ACT+	Within-instrument CV comparable to established performance for similar devices across target ranges.	Target 68-180s: Mean 105.9s, SD 5.6s, CV 5.3%
Target 181-360s: Mean 235.6s, SD 22.3s, CV 9.5%
Target 361-540s: Mean 375.7s, SD 6.6s, CV 1.8%
Target 541-720s: Mean 708.3s, SD 41.3s, CV 5.8%
Target >=721s: Mean 760.1s, SD 69.3s, CV 9.1%
Precision (Whole Blood) - ACT-LR	Within-instrument CV comparable to established performance for similar devices across target ranges.	Target 65-145s: Mean 117.5s, SD 5.9s, CV 5.0%
Target 146-226s: Mean 209.8s, SD 10.9s, CV 5.2%
Target 227-307s: Mean 266.8s, SD 12.5s, CV 4.7%
Target >=308s: Mean 351.2s, SD 21.6s, CV 6.1%
Method Comparison (ACT+)	Linear correlation and low bias (e.g.,

Ask a Question

Ask a specific question about this device

K Number

K193041

Device Name

Hemochron Signature Elite

Manufacturer

Accriva Diagnostics, Inc.

Date Cleared

2019-11-22

(22 days)

Product Code

Regulation Number

Type

Panel