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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.

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.

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 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.

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.

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.

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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).

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.

For professional use only.

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.

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

• 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.

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The Haemonetics® Cell Saver® Elite®+ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping the processed red blood cells to a product bag. The intended use of the Sequestration Protocol is to collect an autologous, preoperative, plasma product for reinfusion to the same patient within the recommended time of the American Association of Blood Banks (AABB), 9th Edition.

The subject of this Traditional 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System 7.3 (AQ) software update which allows users the ability to manually control the cell salvage procedure through manual mode, quick transfer and decreased minimum wash volume. The Cell Saver Elite/Elite+ System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite/Elite+ System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines. The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient. The Elite+ System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

The provided text is a 510(k) Summary for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) software update. It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain information about the acceptance criteria and study design for proving the device meets those criteria from an AI/ML perspective.

The changes in this 510(k) are related to a software update (version 7.3 AQ) for an autotransfusion system, specifically adding "manual mode, quick transfer and decreased minimum wash volume" features. This device processes blood (concentrating and washing red blood cells) rather than interpreting medical images or data using AI/ML algorithms.

Therefore, many of the requested items (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, type of ground truth for AI, how ground truth for training set was established) are not applicable to this type of device and submission.

The document focuses on:

• Software Verification: To verify the new software revision.
• Functional Testing: To validate washout performance (a physical function of the blood processing).
• Usability Testing: To validate operational needs and usability.

These tests are standard for a medical device software update and functional changes, but they do not involve AI/ML performance evaluation as typically understood in the context of diagnostic or prognostic AI systems that require ground truth, expert readers, and rigorous statistical analysis of AI model performance.

In summary, this document is for a medical device software update, not an AI/ML device. Therefore, it does not provide the information requested about AI/ML acceptance criteria and study paradigms.

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The TEG® 6s Hemostasis System consists of the TEG 6s Hemostasis Analyzer and TEG 6s Citrated: K, RT, FF Assay Cartridge. 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 TEG 6s Hemostasis System records the kinetic changes in a sample of 3.2% citrated whole blood as the sample clots.

The Citrated: K, RT, FF Assay Cartridge contains three independent assays (CK, CRT and CFF) and the system output consists of a table of numerical values for parameters R, LY30, and MA.

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 L Y 30 (fibrinolysis after 30 minutes of reaching maximum clot strength).

The CRT assay monitors the hemostasis process via both the intrinsic pathways in 3.2% citrated whole blood specimens on the TEG 6s Hemostasis System. Clotting characteristics are described by the functional parameter MA (maximum clot strength).

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

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 65 Hemostasis System use is with adult patients (18 years and older) where an evaluation of their blood hemostasis properties is desired. Hemostasis evaluation with the TEG 6s Hemostasis System using the Citrated: K, RT, FF Assay Cartridge is used to assess clinical conditions in a trauma setting to assess hemorrhage or thrombosis conditions.

For professional use only.

The TEG® 6s Hemostasis System (TEG® Hemostasis analyzer and TEG® 6s Assay Cartridges) is intended for in vitro diagnostic use to provide semi-quantitations 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 resulting from the hemostasis process over time. This information can be used by clinicians to aid in determining if a 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.

This document describes the TEG® 6s Hemostasis System, an in vitro diagnostic device used to provide semi-quantitative indications of the hemostasis state of a venous blood sample.

Here’s an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for performance in a pass/fail format with exact numerical thresholds for all evaluated aspects. Instead, it details various performance characteristics and states that the data "supports a substantial equivalence determination." However, based on the performance testing presented, we can infer the implicit acceptance criteria by observing the reported results and the conclusions drawn.

• CK R (minutes): 4.6 - 9.1 (n=157)
• CK LY30 (percent): 0.0 - 2.6 (n=132)
• CRT MA (mm): 52 - 70 (n=152)
• CFF MA (mm): 15 - 32 (n=151) |
  | Analytical Precision: Demonstrated across different coagulation levels (hypo, normal, hyper) and sample types (natural, contrived, patient-derived), using CLSI EP5-A2 guidance with acceptable Standard Deviations (SD) and Coefficients of Variation (%CV). | Three precision studies were conducted. Results (SD and %CV) were reported across reagent lots, operators, instruments, and days for various parameters and sample types (Hypo, Normal, Hyper donors; Contrived samples with Dabigatran/Cytochalasin D/ReoPro, Kaolin/RiaStap; Patient-derived samples with Dabigatran/Warfarin; and low/high/no tPA for LY30). The values are presented in Tables 5, 6, 7, and 8, indicating the device maintains precision across these conditions. (Specific numeric thresholds for "acceptable" are not given, but the presentation implies the results are within acceptable industry limits for such a device). |
  | Interference: Identifies interfering factors and limits for CRT and CFF assays. | For CK assay, no interfering factors were found among: Absence of a Discard Tube, Short Draw, Hemolysis, Hemodilution, Direct Oral Anticoagulants (FXa and direct thrombin inhibitors), Antiplatelet Drug (P2Y12 inhibitor).
  For CRT assay, Hemolysis and Hemodilution above 30% were found to be interfering factors.
  For CFF assay, Hemodilution above 40% was found to be an interfering factor. |
  | Method Comparison (Equivalency to Predicate Device): Slopes of linear regression lines close to 1.0 (with 95% CI containing 1.0), acceptable predictive bias relative to acceptance criteria, and high Pearson linear correlation (>0.9 for identical parameters, 0.86 for CRT MA vs CK MA). | The linear regression slope estimates for all between-device comparisons were close to 1.0, with their respective 95% confidence intervals all containing 1.0 (range 0.99 to 1.06).
  The assessment of predictive bias and its 95% confidence interval relative to the bias acceptance criteria supports equivalency according to CLSI EP09-A3.
  Predicted biases at AMR limits were consistent with reference range limits.
  Pearson linear correlation estimates were above 0.9 for all identical parameters. The correlation for CRT MA (TEG® 6s) and CK MA (TEG® 5000) was 0.86.
  Conclusion: The method comparison data strongly supports the correlation between TEG® 6s and the TEG® 5000. |

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

• Reference Ranges:

  • CK R: 157 samples
  • CK LY30: 132 samples
  • CRT MA: 152 samples
  • CFF MA: 151 samples
  • Provenance: 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. (Implies prospective collection for range establishment).

• Analytical Precision (First Study):

  • Sample Size: Blood from 4 donors (2 Hypo, 1 Normal, 1 Hyper). Run in duplicate for 5 non-consecutive days, across 3 reagent lots, by 2 operators, using 12 analyzers. Each data point in Table 5 represents n=120 replicates.
  • Provenance: Donors with natural coagulation levels (Hypo, Normal, Hyper). (Implies prospective collection from specific donor profiles).

• Analytical Precision (Second Study - Contrived/Patient-Derived):

  • Sample Size:
    • 3 contrived samples (Hypo, Hyper types)
    • 4 patient-derived dabigatran samples
    • 2 patient-derived warfarin samples
    • Each run in duplicate for 5 non-consecutive days, by 3 operators, using up to 12 analyzers. Each data point in Tables 6 and 7 represents N=12 replicates per parameter/sample/patient ID.
  • Provenance: Contrived samples (blood from normal donors spiked with drugs/reagents). Patient-derived samples (blood from clinical patients being treated with therapeutic levels of anticoagulants). (Combination of prospective collection for spiking and retrospective/prospective from clinical patients).

• Analytical Precision (Third Study - CK LY30):

  • Sample Size: 3 sample types (no tPA, low tPA, high tPA). 12 replicates per sample type, by 3 operators, using 3 reagent lots for 5 days. Each data point in Table 8 represents N=58 to N=60 replicates.
  • Provenance: Normal donors (for no tPA) and normal donor blood spiked to create low/high tPA samples. (Implies prospective collection for spiking).

• Method Comparison:

  • Sample Size:
    • CFF MA: 450 samples
    • CK R: 405 samples
    • CK LY30: 86 samples
    • CRT MA vs. CK MA: 336 samples
  • Provenance: Conducted at 12 US clinical sites, enrolling adult patients (18+ years) who met full or limited trauma team criteria of the American College of Surgeons or similar institutional guidelines. (This indicates prospective, multi-center, real-world clinical data collection).

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

For this device, the "ground truth" is typically established by the inherent physical properties of the blood samples (clotting characteristics) and comparison to an established predicate device (TEG® 5000), not by human expert interpretation of results in the traditional sense of image analysis or diagnostic decision-making.

• Reference Ranges: Established using samples from "normal donors" with "no known coagulopathies." The determination of "normal" is likely based on standard medical criteria, possibly verified by physicians or lab personnel, but not explicitly stated as "expert consensus" in the document.
• Precision Studies: Ground truth is the measured value of the parameters (R, MA, LY30) from the samples themselves, along with their known characteristics (e.g., "hypo," "hyper," spiked with certain drugs). This is measured intrinsically by the device itself, not by external human experts.
• Method Comparison: The predicate device, TEG® 5000, serves as the "ground truth" or reference for comparison. The study assesses how closely the TEG® 6s results correlate with the TEG® 5000, rather than comparing to a diagnostic expert's opinion. Clinical experts (physicians) would ultimately interpret both TEG® 5000 and TEG® 6s results to make patient diagnoses, but they are not directly establishing the "ground truth" for the device's functional performance in this context.

Therefore, the document does not mention human experts establishing ground truth for the test sets in the way AI/ML studies often describe.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense. The studies described are performance evaluations of an in vitro diagnostic device, involving quantitative measurements. There is no mention of an adjudication process (e.g., 2+1, 3+1 consensus) because the "ground truth" for the performance tests (precision, method comparison) is based on instrumental measurements and comparison to a predicate, not subjective human interpretations that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic tool that provides numerical parameters describing blood hemostasis. It is not an AI-assisted diagnostic imaging device or a tool designed to directly improve human reader performance for tasks like lesion detection in images. The output is a graphical tracing and a table of numerical values for R, LY30, and MA, which clinicians then interpret.

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

The performance studies described are standalone (algorithm/device only) in nature. The TEG® 6s Hemostasis System automatically measures and outputs parameters without human-in-the-loop diagnostic assistance within the measurement process itself. The interpretation of these results for patient diagnosis is then performed by a professional. The studies evaluate the device's ability to accurately and precisely perform these measurements.

7. The Type of Ground Truth Used

The types of "ground truth" used are:

• Defined Reference Ranges: Established from "normal donors" (i.e., empirically derived from a healthy population).
• Known Sample Characteristics: For precision and interference studies, samples were classified as Hypo, Normal, Hyper, or specifically manipulated (spiked with drugs/reagents like Dabigatran, Warfarin, Kaolin, RiaStap, tPA) to represent known coagulation states.
• Predicate Device Measurements: For method comparison, the measured values from the legally marketed Thrombelastograph® Coagulation Analyzer (TEG®) – 5000 served as the reference for determining substantial equivalence.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" in the context of machine learning. The TEG® 6s Hemostasis System is described as a measurement device based on physical principles (resonant frequency, modulus of elasticity) rather than a machine learning algorithm that is "trained" on data. Therefore, the concept of a separate training set, as typically defined in AI/ML, is not applicable or discussed here. The reference ranges and performance characteristics are established via analytical studies on various sample types.

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

As explained in point 8, there is no explicit "training set" in the AI/ML sense. The device's operational characteristics and parameter calculations are based on established biophysical principles of coagulation, not on machine learning from a labeled training dataset.

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The TEG 6s System is intended for in vitro diagnostic use to provide semi-quantitative indications of the hemostasis state of a blood sample. The TEG 6s System records the kinetic changes in a venous sample of 3.2% citrated whole blood as the sample clots, and retracts in real time. The system output consists of a table of numerical values for parameters R, K, Angle, MA, and FLEV. The TEG 6s System provides specific blood modifiers, in the form of reagents dried-in-place within TEG 6s cartridges.

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 use for the TEG 6s System 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 TEG6s analyzer is a four-channel in vitro diagnostic instrument with an integrated computer module, a display touch screen for operator interaction, and a slot for inserting one TEG 6s cartridge. The TEG 6s analyzer is for use in laboratories and near patient use. It consists of an assembly of controllers, sensors, and displays, all managed and sequenced by a central processor. The embedded programming in the processor provides the necessary information for the automation of hemostasis testing. The program sequences the instrument hardware through the appropriate cycles to perform the test. Using a compressor, pressure and vacuum sensors, and a series of valves, actuators and controls, blood samples are introduced into the microfluidics of a disposable cartridge.

To perform a test, a disposable cartridge is inserted into the instrument. The instrument reads the bar code on the cartridge, identifies the type of cartridge for operator confirmation. Then, the operator adds a blood sample to the entry port on the cartridge and uses the touch screen to issue the command to the instrument to proceed with the test. The sample is then drawn into the cartridge under instrument control. The amount of the sample drawn into the cartridge is automatically determined by the volume of the reagent chambers in the cartridge.

The TEG 6s analyzer firmware provides features for and manages all functions of the instrument, including user interface (via the touch display screen) and external communications for service and installation via Service Maintenance Software (SMS). SMS is run on a separate computer connected to one or more TEG 6s analyzer(s) via the Ethernet port and a router. Its purpose is to allow additional control of analyzer functions by authorized remote users, such as administrative and service personnel.

The TEG Manager 2.0.0 is an optional accessory to Haemonetics TEG 6s Hemostasis System. TEG Manager 2.0.0 is an application that provides remote viewing of current and historical patient tracing and test results created by the TEG 6s analyzers, and administration of all connected TEG 6s devices. TEG Manager interfaces with the TEG analyzers to obtain clinical data and retrieves patient information from external Hospital Information System (HIS). Users cannot manipulate the data that is stored and displayed within TEG Manager or input any additional clinical data in the software.

The provided document is a 510(k) summary for the Haemonetics TEG® 6s Hemostasis System and TEG Manager 2.0.0. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, specifically the TEG 6s Hemostasis System (K140893 and K150041), with the addition of TEG Manager 2.0.0 as an optional accessory.

Here's the breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for the TEG Manager 2.0.0. Instead, the acceptance criterion for the software is described in a more general sense:

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

The document does not specify a "test set" in the context of clinical data for a direct performance evaluation of the TEG Manager 2.0.0 as an AI/ML device. The testing described is primarily software verification and validation (V&V). Therefore, there are no details on clinical sample size or data provenance (country of origin, retrospective/prospective) for a performance study. The focus is on ensuring the software functions as intended and accurately displays data from the TEG 6s Analyzer.

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

Since the "test set" refers to software V&V rather than clinical performance data requiring expert adjudication, there is no mention of experts establishing ground truth or their qualifications. Software testing typically relies on predefined requirements and expected outputs rather than expert consensus on clinical findings.

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned because the V&V of the TEG Manager 2.0.0 does not involve clinical interpretation or a "ground truth" that would require expert consensus. The software's function is to accurately display data generated by the TEG 6s Analyzer.

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

No MRMC comparative effectiveness study is described. The TEG Manager 2.0.0 is an auxiliary viewing and management tool for data already generated by the TEG 6s Analyzer. It does not involve human readers interpreting images or data with and without AI assistance to assess an effect size.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The TEG Manager 2.0.0 is described as an "optional accessory" that provides "remote viewing of current and historical patient tracing and test results created by the TEG 6s analyzers, and administration of all connected TEG 6s devices." It "does not provide any additional analytical or interpretive data outside of the TEG analyzer capabilities." Therefore, its performance is intrinsically tied to the TEG 6s Analyzer, and it does not operate as a standalone diagnostic algorithm in the way an AI/ML device typically would. Its "performance" would be related to its ability to accurately reflect the analyzer's output and manage devices, which is covered by the software V&V.

7. Type of Ground Truth Used

For the TEG Manager 2.0.0, the "ground truth" for the software validation would be the expected output values and display capabilities based on the data directly produced by the TEG 6s Analyzer and the specified software requirements. It's not clinical ground truth in the sense of pathology, outcomes data, or expert consensus on a diagnosis.

8. Sample Size for the Training Set

The document does not describe any training set as would be relevant for an AI/ML model. The TEG Manager 2.0.0 is a software application for data display and management, not a learning algorithm that undergoes training.

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

As there is no training set for an AI/ML model, there is no discussion of how ground truth was established for such a set.

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The Haemonetics Cell Saver® Elite®+ Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

The Cell Saver Elite/Elite+ System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intra-operative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.

The Cell Saver Elite/Elite+ System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intra-operative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.

The Cell Saver Elite/Elite+ System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite/Elite+ System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines.

The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient.

The Elite/Elite+ System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

The subject of this Special 510(k) is the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System software and hardware to enable use of wired and wireless connectivity.

This document describes the regulatory approval (K162423) for the Haemonetics Cell Saver Elite/Elite+ Autotransfusion System with added wired and wireless connectivity features. The approval is based on demonstrating substantial equivalence to a predicate device (K160197).

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on the safety and performance of the added connectivity features and modifications to the user interface hardware. The acceptance criteria essentially revolve around demonstrating that these changes do not compromise the existing performance requirements of the autotransfusion system and comply with relevant standards.

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

The document does not explicitly state the "sample size" in terms of number of devices or number of test cases run for each test. The non-clinical testing summary simply lists the tests conducted.

The data provenance is from non-clinical testing performed by the manufacturer, Haemonetics Corporation, as part of their 510(k) submission. This is internal testing, not patient data, and is thus prospective in the sense that it was performed specifically for this submission. The country of origin for the data generation would be where Haemonetics conducted their internal R&D and testing.

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

This information is not applicable in the context of this 510(k) submission for device modifications. No "ground truth" based on expert medical opinion (like clinical diagnosis) was established or used for the technical performance tests (EMC, electrical safety, wireless coexistence, software validation). These tests rely on engineering standards and functional verification.

4. Adjudication Method for the Test Set

This is not applicable. The tests performed (EMC, electrical safety, wireless coexistence, software validation) are objective engineering and software verification tests, not subjective interpretations requiring adjudication.

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

This is not applicable. This submission is for modifications to an autotransfusion system, a medical device that processes blood. It does not involve "human readers" or "AI assistance" in the context of interpreting medical images or making diagnostic decisions, which is typically where MRMC studies are conducted.

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

This is not applicable. The device is an autotransfusion system, not an algorithm performing a standalone diagnostic or interpretive function. The "software validation" was for the embedded software controlling the device's functionality and connectivity, which operates as part of the overall system with human operators.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance tests was based on engineering specifications, regulatory standards (e.g., IEC 60601-1-2, IEC 60601-1), and the defined functional requirements of the device. For example, for EMC, the ground truth is compliance with the specified limits in the standard. For wireless coexistence, the ground truth is the device operating without unacceptable interference. For software, the ground truth is the software performing as designed according to its requirements.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML system that undergoes a "training phase" with a training set of data in the typical sense (e.g., for image recognition or predictive models). The software validation refers to the testing of the developed software against its requirements.

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

This is not applicable for the reasons stated in point 8. The device's software is developed through standard software engineering practices and validated against pre-defined functional and performance requirements.

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The Haemonetics Cell Saver® Elite® Autotransfusion System and its related accessory components are intended for use to recover blood shed during or subsequent to an operation or as a result of trauma, processing the blood by a centrifugation and washing procedure, and pumping this processed red cell product to either a bag for gravity reinfusion into the patient or to the arterial line of an extracorporeal circuit for reinfusion into the patient.

The intended use of the Sequestration Protocol is to collect an autologous, preoperative, platelet rich plasma product for reinfusion to the same patient within 6 hours of collection.

The Cell Saver Elite System is intended to be used by trained physicians, operating room nurses or floor nurses, anesthesia technicians and autotransfusion service providers to provide intraoperative and post-operative blood salvage for surgical procedures with medium to high blood loss including, but not limited to CABG, AAA, joint replacement, spinal, trauma and transplant surgeries.

The subject of this Special 510(k) is the Haemonetics Cell Saver Elite Autotransfusion System fat washing protocol and modified 70mL bowl algorithm.

The Cell Saver Elite System consists of a single use disposable set and reusable equipment. One disposable set is used throughout an individual patient's surgical procedure and then discarded. The Cell Saver Elite System utilizes a unique bowl processing kit, but is compatible with Haemonetics standard reservoirs and A&A lines.

The collected blood is processed through a centrifugal separation chamber (bowl) where RBCs are concentrated and then washed, removing unwanted substances such as hemolized cells, anticoagulant and irrigating fluids. The washed RBC product is available for return via a product bag to the patient.

The Elite System is designed to perform plasma sequestration using the autotransfusion disposable in conjunction with an ancillary sequestration set prior to performing autotransfusion.

Here's a breakdown of the acceptance criteria and study information for the Haemonetics Cell Saver Elite Autotransfusion System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance (for Fat Washing Protocol):

Note: (**) refers to data from the reference device Sorin Xtra, cited as "Fat removal during cell salvage - An optimized program in the XTRA® autotransfusion device" by Timo Seyfried, MD, Michael Gruber, MD; Lilith Haas; Emil Hansen, PhD, MD 13th ECOPEAT Vienna - Austria 2013.*
Note: () for the subject device indicates "depending on bowl size used".*

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

• Sample Size: The document does not explicitly state the sample size used for the performance tests (functional testing and software validation). It lists several test reports by number (e.g., TR-SOF-100562, TR-OTH-100649), but these reports themselves are not included in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "non-clinical performance testing was submitted."

3. Number of Experts and Qualifications for Ground Truth:

• This information is not provided in the document. The testing described appears to be primarily technical and functional validation against predefined performance metrics for a medical device rather than studies requiring expert human interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

• This information is not applicable and not provided. The testing described is against established performance requirements and is not a clinical study requiring adjudication of expert interpretations.

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

• No MRMC comparative effectiveness study is mentioned. The submission is for a modification to an existing autotransfusion system, focused on technical performance improvements rather than reader interpretation.

6. Standalone Performance Study (Algorithm Only):

• The document implies standalone performance studies were conducted for the device's functionality. Table 1 "Summary of Performance Studies" lists "Software Validation" and "Functional Testing" with corresponding report numbers and "Test Intent" that demonstrate the device (or its software components and new features like fat washing protocol and modified 70mL bowl algorithm) met performance requirements. The results are simply "Passed," indicating the algorithm's performance in achieving the specified criteria.

7. Type of Ground Truth Used:

• The ground truth used for the performance studies appears to be based on objective, quantitative measurements related to blood processing parameters. For example:
  • Hematocrit (HCT%)
  • Red Blood Cell (RBC) Recovery
  • Plasma Hemoglobin (HgB) Washout
  • Heparin Washout
  • Albumin Washout
  • Fat Removal
• These are physical and chemical properties of blood that can be measured directly by laboratory methods, establishing a clear objective ground truth for the device's performance in processing blood.

8. Sample Size for the Training Set:

• The document does not provide details about a "training set" as this device is not an AI/ML algorithm that typically requires a large training dataset in the same way. The mentioned "Software Validation" and "Functional Testing" refer to verification and validation activities for the device's software and hardware, where "training" in the context of machine learning is not directly applicable.

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

• As mentioned above, the concept of a "training set" and its associated ground truth establishment is not relevant to this type of device submission based on the provided information. The validation focuses on ensuring the device meets pre-defined performance specifications for blood processing.

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