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CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.

CRYOcheck Hex LA is comprised of three reagents supplied in a frozen format as follows:

LA Start: Pooled normal plasma with buffer and a heparin neutralizer.

LA Correct: Pooled normal plasma with buffer, a heparin neutralizer, and inverted hexagonal phase phospholipid.

LA APTT: Silica-based lupus sensitive APTT reagent with stabilizer.

1. Acceptance Criteria and Device Performance:

2. Sample Sizes and Data Provenance:

• Precision Study:
  • 3 control plasmas and 5 plasmas with varying LA positivity.
  • Tested in duplicate, twice a day for 20 days per lot of reagent (3 lots used).
• Reproducibility Study:
  • 3 control plasmas and 5 plasmas with varying LA positivity.
  • Each sample tested in triplicate, twice a day for 5 days for each of the 3 lots of reagent.
• Normal Range and Assay Cut-off Study:
  • Normal samples: 137 on Analyzer A, 126 on Analyzer B.
  • Each sample tested using 3 lots of CRYOcheck Hex LA.
• Shelf Life Stability Study:
  • 3 lots of CRYOcheck Hex LA.
  • 10 replicates of 3 controls tested at time = 0 and regular intervals up to 37 months.
  • One additional plasma sample close to the cut-off for one lot.
• In-Use Stability Study:
  • 3 lots of CRYOcheck Hex LA.
  • 5 replicates of 3 control plasmas and 4 test plasmas with varying levels of LA.
  • Tested at 0, 2, 4, 6, 7, 8, and 9 hours.
• Interference Studies:
  • Patient plasma samples spiked with possible interferents.
  • 20 replicates of spiked samples tested alongside 20 replicates of corresponding blank matrix control.
  • Single lot of CRYOcheck Hex LA used.
• Method Comparison Studies (Test Set):
  • Total samples: 446
    • 124 known (previously characterized) LA positive samples.
    • 75 normal (presumed LA negative) samples from individuals with other medical conditions including autoimmune disorders.
    • 220 LA target screening population samples.
  • Data Provenance: The document does not explicitly state the country of origin for the patient samples. The study involved one internal site and three external sites, suggesting a multi-center study. It is a retrospective study since samples were "known (previously characterized) LA positive" or "presumed LA negative."
• Sample Integrity Study:
  • 64 samples.

3. Number of Experts and Qualifications for Ground Truth:

• This device is an in vitro diagnostic (IVD) test, not an AI/imaging device requiring expert interpretation for ground truth.
• The ground truth for the method comparison study was established by comparing the CRYOcheck Hex LA results against a legally marketed predicate device, Staclot® LA (K923731).
• The determination of "known (previously characterized)" LA positive samples and "presumed LA negative" samples would implicitly rely on established clinical or laboratory diagnostic procedures, which are performed by qualified laboratory personnel, not typically "experts" in the sense of a radiology reader study.

4. Adjudication Method for the Test Set:

• Not applicable as this is a comparison study against a predicate device's results, not a human reader study needing adjudication. The "ground truth" for the test set was the result obtained from the predicate device (Staclot® LA).

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

• No, an MRMC comparative effectiveness study was not done. This is an IVD device measuring a biomarker, not an imaging AI device assisting human readers. Therefore, the concept of "effect size" of how human readers improve with AI vs. without AI assistance is not relevant here.

6. Standalone Performance:

• Yes, the performance data presented (Precision, Reproducibility, Normal Range, Stability, Interferences) are essentially standalone (algorithm-only) performance characteristics of the CRYOcheck Hex LA device in a laboratory setting.
• The method comparison study also evaluated the device's performance independently against a predicate, effectively demonstrating its standalone performance in identifying LA status.

7. Type of Ground Truth Used:

• For the method comparison study (test set), the ground truth was comparison to a legally marketed predicate device (Staclot® LA).
• For the known LA positive/negative samples, the ground truth was "previously characterized" LA status, likely established through a combination of clinical diagnosis and existing laboratory methods.

8. Sample Size for the Training Set:

• This document describes a 510(k) submission for an in vitro diagnostic (IVD) device, not an AI/machine learning device that typically involves a "training set" in the same computational sense.
• The development and optimization of such an IVD assay would involve internal development samples and studies, but these are not referred to as "training sets" in the context of this regulatory filing. The provided information focuses on analytical and clinical performance validation.

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

• Not applicable due to the nature of the device as explained in point 8. The device's "training" or development would involve laboratory optimization and calibration using reference materials and characterized samples, but not "ground truth" in the AI sense for a dedicated "training set."

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HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies. For in vitro diagnostic use.

The HemoIL SCT assay, consisting of SCT Screen and SCT Confirm, is intended to simplify and standardize the detection of Lupus Anticoagulants (LA) in clinical evaluations. SCT Screen is poor in phospholipid making it sensitive to LA. The additional amount of phospholipid in SCT Confirm neutralizes LA to give shorter clotting times. Silica Clotting Time in the presence of calcium, directly activates the intrinsic pathway of coagulation. SCT Screen and SCT Confirm are therefore unaffected by factor VII deficiencies or inhibitors.

This document is not structured as a typical study report, but rather as a 510(k) summary for a Special 510(k) submission. A Special 510(k) is used when a modification is made to a legally marketed device, and the modification does not affect the device's indications for use or its fundamental scientific technology. In this case, the modification is to the device's labeling (specifically, clarifying heparin interference information) based on updated guidance (CLSI Guideline H60-A).

Therefore, the primary "study" proving the device meets acceptance criteria in this context is the demonstration that the changes are only to the labeling and do not impact the assay's performance compared to the predicate device. This type of submission relies heavily on the predicate's prior clearance and the assertion that the core device technology and performance remain unchanged.

Given this, I will describe the "acceptance criteria" and "device performance" in terms of substantiating that the change in labeling does not alter the device's substantial equivalence to its predicate.

Here's the breakdown of information, addressing your points where applicable based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document describes a Special 510(k) submission. This type of submission is based on the premise that there are no actual changes to the device's performance, but rather to its labeling or minor design aspects.
Therefore, no new "test set" data from patient samples is typically required or provided for a Special 510(k) for a labeling change. The claim of substantial equivalence rests on the device being unchanged and performing as cleared under its predicate (K050221). The "study" here is the comparison demonstrating no change to the device itself.

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)
Not applicable. No new clinical or analytical performance study requiring a ground truth determination from experts on a new test set was conducted for this Special 510(k) submission. The changes are to informational labeling based on a published guideline (CLSI H60-A).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no new test set requiring expert adjudication was utilized for this type of submission.

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 device is an in vitro diagnostic (IVD) reagent for a laboratory test (detection of Lupus Anticoagulants), not an imaging device or an AI-powered diagnostic system designed for human reader assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is an IVD reagent, not an algorithm. Its performance is measured directly by clinical laboratory methods.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable to this Special 510(k) based on a labeling change. The original predicate device (K050221) would have established its performance against appropriate reference methods or clinical outcomes during its initial clearance process. For this submission, the "ground truth" is that the device itself has not changed and therefore its previously established performance holds. The update to the labeling regarding heparin interference aligns with an industry-accepted guideline (CLSI Guideline H60-A).

8. The sample size for the training set
Not applicable. No training set was used for this Special 510(k) submission.

9. How the ground truth for the training set was established
Not applicable. No training set was used for this Special 510(k) submission.

In summary of the "study":

The "study" in this Special 510(k) is a comparison study that demonstrates the "modified device" is identical in all functional aspects to the "predicate device," with the only changes being to the instructional labeling regarding heparin interference. The acceptance criterion is that no functional or performance changes were introduced, and therefore the device remains substantially equivalent to the previously cleared predicate (K050221). The proof is in the documentation confirming no changes to formulation, operating principle, indications for use, stability, specimen requirements, software, or test parameters.

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The STA® - Cephascreen® kits provide reagents for the determination of the activated partial thromboplastin time (APTT) in citrated plasma on the STA® line of analyzers suitable to these reagents.

The STA®-Cephascreen kits provide reagents for the determination of the activated partial thromboplastin time (APTT) according to Langdell R.D. et al. (1) and Larrieu M. J., Weilland C. (2) by analyzers of the STA® line suitable to these reagents.
STA®-Cephascreen ®: reagent containing cephalin (platelet substitute), prepared from rabbit cerebral tissues (2) and a polyphenolic activator (patent pending) in a buffered medium.
The STA®-Cephascreen ® is available in two different kit sizes:

• STA®-Cephascreen®©(REF00308) containing 12x4 mL vials ready for . use reagent
• STA®-Cephascreen®쓰(REF 00310) containing 12x10 mL vials of ready . for use reagent
  The STA®-Cephascreen® reagents are provided in liquid form, ready for use after stabilization and mixing when a vial is opened.

Here's an analysis of the provided text regarding the STA®-Cephascreen Kit, focusing on acceptance criteria and the supporting study:

The document describes a 510(k) summary for the STA®-Cephascreen Kit, which is a reagent for determining activated partial thromboplastin time (APTT). The primary purpose of this submission is to demonstrate substantial equivalence to a predicate device, the STA®-C.K.Prest® kit.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the STA®-Cephascreen Kit in the traditional sense of numerical thresholds for sensitivity, specificity, or accuracy compared to a gold standard. Instead, the study aimed to demonstrate substantial equivalence to the predicate device.

The reported performance is based on the correlation between the new device and the predicate device.

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

• Sample Size: 125 plasma samples.
  • 40 plasmas from presumed normal individuals
  • 20 plasmas from patients receiving unfractionated heparin (UFH) therapy
  • 20 plasmas from patients receiving low molecular weight heparin (LMWH) therapy
  • 15 plasmas from patients receiving oral anticoagulant (AVK) therapy
  • 10 LA positive plasma samples
  • 10 plasmas from patients with factor VIII deficiency (F. VIII Def.)
  • 10 plasmas from patients with factor IX deficiency (F. IX Def.)
• Data Provenance: Not explicitly stated regarding country of origin. The manufacturer is French (Diagnostica Stago, France), but the distributor is in the US (Diagnostica Stago, Inc., Parsippany, NJ). The plasma types suggest clinical samples, but whether they were collected retrospectively or prospectively, or from what geographic region, is not specified. It's common for such studies to use retrospectively collected samples from a clinical lab specializing in coagulation.

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

This type of study does not involve "experts" establishing a ground truth in the sense of image interpretation or diagnostic classification. Instead, the "ground truth" for the test set is established by the measurement value provided by the predicate device (STA®-C.K.Prest® kit). The study compares the new device's readings to those of the predicate. Therefore, information about the number and qualifications of experts is not applicable here.

4. Adjudication Method for the Test Set:

Not applicable. There is no adjudication method described as this is a comparative analytical performance study, not a diagnostic accuracy study relying on human interpretation.

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

No, an MRMC comparative effectiveness study was not done. This is an in-vitro diagnostic (IVD) device for laboratory testing, not an AI-powered diagnostic tool for human readers. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply.

6. Standalone Performance Study:

Yes, a standalone performance study was done implicitly. The STA®-Cephascreen Kit was used "exactly as described by their respective package inserts" to determine APTT values. The study then compared these standalone results to those obtained from the predicate device. The correlation data (r, a, b values) represent the analytical performance of the new device when used independently and compared to an established method.

7. Type of Ground Truth Used:

The "ground truth" for this study is the measurements obtained from the legally marketed predicate device, STA®-C.K.Prest® kit. The goal was to show that the new device produces results comparable to the predicate when measuring the same plasma samples. This is a common approach for demonstrating substantial equivalence for new IVD devices that perform the same function as existing ones.

8. Sample Size for the Training Set:

The document does not mention a "training set." This type of comparative analytical performance study for an IVD device does not typically involve machine learning or AI models requiring a training set in the conventional sense. The device is a reagent kit, not an algorithm that learns from data.

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

Not applicable, as no training set is mentioned or implied for this type of IVD device study.

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HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems.

The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.

This document describes the performance data for the HemosIL SynthASil device after optimization of its APTT parameter settings on the ACL Futura and ACL Advance systems. The stated purpose of this submission is to demonstrate substantial equivalence to the predicate device (K953981 HemosIL SynthASil) and to the HemosIL SynthASil reagent run on the ACL TOP system (K033414).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly uses the performance of the predicate device (K953981 HemosIL SynthASil) and the HemosIL SynthASil on the ACL TOP (K033414) as the acceptance criteria for achieving "improved correlation" and "substantial equivalence." While explicit numerical acceptance criteria are not presented in a table format, the performance data provided aims to demonstrate this correlation.

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

• Precision Test Set: The sample size for the precision study is not explicitly stated as a number of individual samples. It mentions "three levels of control plasma" and "assessed over multiple runs." This implies multiple measurements were taken for each of these three control levels.
• Method Comparison Test Set: For each of the four SynthASil lots, n=93 or n=92 citrated plasma samples were used.
• Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective in nature, performed to optimize and validate the device settings for regulatory submission. The samples are referred to as "human citrated plasma."

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

This type of in-vitro diagnostic device (reagent for APTT determination) does not typically involve human expert interpretation for establishing ground truth in the same way an imaging AI device would. The "ground truth" for the method comparison is the measurement obtained from the predicate device or the ACL TOP system, which are themselves validated instruments. Therefore, there were no human experts establishing ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is an objective measurement study comparing an optimized device's performance to established methods, not subjective human interpretation requiring adjudication.

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

• No MRMC study was done. This study concerns the performance of an in-vitro diagnostic reagent and instrument settings, not a device that involves human interpretation of results requiring a comparison of human reader performance with and without AI assistance.

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

• Yes, this is effectively a standalone performance study. The document describes the performance of the HemosIL SynthASil reagent and its optimized settings on the ACL Futura and ACL Advance instruments. The results reported (precision, slope, intercept, r) are direct measurements from the device system without requiring human-in-the-loop analysis. The "algorithm" here refers to the optimized parameter settings and the reagent's performance characteristics.

7. Type of Ground Truth Used

• The ground truth used for the method comparison study was the measurements obtained from a legally marketed predicate device (K953981 HemosIL SynthASil) or an equivalent, legally marketed device (HemosIL SynthASil on the ACL TOP system - K033414). This is a form of "reference standard" or "comparative standard" established by existing, validated medical devices.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI models. Instead, it refers to the "optimization" of APTT parameter settings. While this optimization process would have involved testing and refining these settings on various samples, the specific sample size, type, and method used for this optimization are not detailed in this summary. It's implied that the "optimization" process served a similar purpose to training, but no specific dataset is identified as a training set.

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

Since there is no explicitly defined "training set" in the context of an AI/ML model, the concept of establishing ground truth for it is not directly applicable here. The "optimization" likely involved iterative adjustments of the parameter settings and testing them against known reference values or comparative measurements (similar to the method comparison's ground truth, but likely a larger or different set of samples used during development) to achieve the desired performance, particularly for correlation with the ACL TOP and predicate devices.

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HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies. For in vitro diagnostic use.

HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.

Here's a summary of the acceptance criteria and study details for the HemosIL Silica Clotting Time device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document explicitly states that the device "is substantially equivalent to the commercially available predicate devices (HemosIL LAC Screen and HemosIL LAC Confirm) in performance and intended use." This implies that the acceptance criteria were based on demonstrating comparable performance to these predicate devices rather than pre-defined absolute thresholds, for the correlation and clinical performance metrics. For precision, the reported %CVs fall within generally acceptable ranges for diagnostic assays.

Study Details

1. Sample size used for the test set and the data provenance:

   • Method Comparison Study: 210 citrated plasma samples (120 normals/90 abnormals)
   • Clinical Study: 206 citrated plasma samples (121 normals/85 abnormals)
   • Data Provenance: "in-house study" and "clinical study." The document does not specify the country of origin, but given the manufacturer (Lexington, MA, USA) and the 510(k) submission to the FDA, it is highly probable the studies were conducted within the US or followed US regulatory guidelines. The studies appear to be retrospective as they involved analyzing collected plasma samples.

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

   • The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set. The ground truth appears to be based on the results from the predicate devices (HemosIL LAC Screen and HemosIL LAC Confirm) for comparison. The classification of samples as "normals" and "abnormals" for Lupus Anticoagulants would have been based on established clinical diagnostic criteria, likely involving expert interpretation of multiple tests, but this detail is not provided.

3. Adjudication method for the test set:

   • The document does not describe a specific adjudication method. As the primary comparison is against predicate devices, the "ground truth" for the test set is established by the results of those predicate devices.

4. 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:

   • No. This device is an in-vitro diagnostic (IVD) assay, not an AI-assisted imaging or diagnostic tool that requires human reader interpretation. Therefore, an MRMC study is not applicable.

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

   • Yes. The reported performance metrics (slope, intercept, r, sensitivity, specificity, precision) are for the HemosIL Silica Clotting Time device running on an IL Coagulation System, indicating a standalone (algorithm/device only) performance evaluation. There is no mention of human-in-the-loop performance.

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

   • The ground truth for the test sets (both method comparison and clinical) appears to be established by the results obtained from the predicate devices (HemosIL LAC Screen and HemosIL LAC Confirm). Additionally, for the clinical study, it's mentioned that "All known Lupus Anticoagulant samples (n=48) tested as part of this study gave SCT normalized ratios > 1.24," suggesting that a subset of the abnormal samples had a pre-established clinical diagnosis of Lupus Anticoagulant, likely based on a combination of tests and expert consensus.

7. The sample size for the training set:

   • The document does not specify a separate "training set" in the context of machine learning. This is an IVD device, and the development process would involve formulation, optimization, and characterization rather than AI model training. The "in-house study" and "clinical study" are performance validation studies.

8. How the ground truth for the training set was established:

   • Not applicable as there is no mention of a separate training set in the context of an AI/ML model for this IVD device. The development of such a device focuses on reagent formulation and instrument calibration, typically using well-characterized samples and reference methods.

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The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.

The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.

Here's a breakdown of the acceptance criteria and study information for the Vital Scientific APTT device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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For in vitro diagnostic use with the CARESIDE Analyzer to measure activated partial thromboplastin time from citrated whole blood or citrated plasma as an aid in the diagnosis of patients with clotting disorders and to monitor patients receiving heparin anticoagulation therapy.

CARESIDE APTT cartridges are used with the CARESIDE Analyzer to measure activated partial thromboplastin time from citrated whole blood or plasma as the applied sample. The CARESIDE APTT cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma to a cartridge cuvette to initiate the measurement of an activated partial thromboplastin time. The patented cartridge contains all reagents necessary to measure an activated partial thromboplastin time.

Here's a breakdown of the acceptance criteria and study information for the CARESIDE APTT device, based on the provided text:

Acceptance Criteria and Device Performance

Note on Acceptance Criteria: The document primarily focuses on demonstrating substantial equivalence to a predicate device (Dade Actin on Electra 900C). Therefore, the "acceptance criteria" are generally derived from the established performance characteristics of that predicate device. The CARESIDE APTT aims to meet or improve upon these characteristics.

Study Information

Due to the nature of the provided 510(k) summary for an in vitro diagnostic device (APTT test), the study information is structured differently than for a typical AI/software device. Many of the requested categories (e.g., expert ground truth, MRMC, training set details) are not directly applicable or are not explicitly detailed in this type of submission.

Here's an attempt to answer the questions based on the available text:

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

   • Sample Size: Not explicitly stated for the "test set" in terms of number of patient samples. The "Accuracy via Method Comparison" likely involved a set of samples compared against the predicate device, but the exact number isn't provided.
   • Data Provenance: Not specified. It's common for such studies to be conducted by the manufacturer or their contract research organizations, but the location or whether it was retrospective/prospective is not mentioned.

2. 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 is an in vitro diagnostic device for measuring Activated Partial Thromboplastin Time (APTT). The "ground truth" for APTT measurements is typically established by laboratory testing using a reference method or predicate device, not by human experts adjudicating images or clinical cases. The predicate device (Dade Actin on Electra 900C) serves as the de-facto "ground truth" for comparison in the method comparison study. Therefore, this question is not directly applicable in the context of this device.

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

   • Not applicable. As this is an in vitro diagnostic device, "adjudication" in the sense of clinical expert consensus for interpreting results is not typically part of the regulatory submission for establishing performance. Performance is determined by quantitative comparison to a reference method.

4. 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:

   • No. This is an in vitro diagnostic device, not an AI-powered diagnostic imaging tool for human interpretation. Therefore, an MRMC study is not relevant or performed for this type of device.

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

   • Yes, the performance data presented (accuracy, precision, interference) would be considered standalone performance of the device itself (CARESIDE APTT + CARESIDE Analyzer) measuring the APTT parameter. While a human initiates the test and interprets the final numerical result, the "performance" data refers to the accuracy and reliability of the device's measurement process.

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

   • The "ground truth" for evaluating the CARESIDE APTT device's performance is the measurement obtained from the legally marketed predicate device, Dade Actin on the Electra 900C. The study aims to show that the CARESIDE APTT measurements correlate highly and are substantially equivalent to those from the predicate.

7. The sample size for the training set:

   • This document describes a premarket notification for an in vitro diagnostic assay, not a machine learning or AI algorithm in the contemporary sense that would involve explicit training data in the way an AI model is trained. Therefore, a "training set" as defined for AI is not applicable or mentioned. Device development involves calibration and validation, but not typically a "training set" for an algorithm in this context.

8. How the ground truth for the training set was established:

   • Not applicable, as a "training set" for an AI algorithm is not implied by the provided text. The device is a diagnostic instrument and reagent system.

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The Hemochron Jr. Citrate APTT is a unitized microcoagulation test intended to be used in performing a quantitative one-stage Activated Partial Thromboplastin Time (APTT for monitoring low doses of heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the Hemochron Jr. microcoagulation instruments. The test is intended for use in point of care settings. For In Vitro Diagnostic Use Only

The Hemochron Jr.Citrate APTT test is a self-contained disposable test cuvette, pre-filled with dried reagents required to perform an Activated Partial Thromboplastin Time (APTT) using citrated whole blood in the Hemochron Jr. Whole Blood Microcoagulation Analyzers. The preparation consists of kaolin, phospholipid, stabilizers and buffers. These same components are used in the previous formulation of the citrate APTT. The citrate APTT test can be performed on both the Hemochron Jr. II and Hemochron Jr. Signature Series instruments. The test is intended for point of care use. The instrument draws a precise volume of blood into the test channel of the cuvette. The cuvette contains the APTT reagent formulation. An array of LED's detects the motion of the blood sample/reagent mixtures as it moves through the precision channel. The blood is pumped back and forth until a clot begins to form, obstructing the channel and slowing the flow of the blood sample. The instrument detects a clot when the blood movement decreases below a predetermined rate.

This document describes the Hemochron® Jr. Citrate Activate Partial Thromboplastin Time (APTT) Cuvette, a medical device for monitoring heparin anticoagulation.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a modification of a predicate device, and the primary acceptance criterion appears to be an improved correlation with laboratory APTT plasma results.

Cuvette Lot 2 - Normal: Day 1: Mean 94 sec, SD 1.0 sec, CV 1.1%; Day 2: Mean 99 sec, SD 5.9 sec, CV 5.9%; Day 3: Mean 90 sec, SD 6.1 sec, CV 6.8%. Total: Mean 95 sec, SD 5.8 sec, CV 6.1%.

(Note: The table provided for "PRECISION DATA" in the document only includes data for "Normal" levels, not "Level II" for heparinized samples, despite mentioning Level II in the descriptive text.) |
| Substantial equivalence to the predicate device | "The technology employed and intended use of the modified Hemochron Jr.Citrate APTT cuvette is substantially equivalent to the Predicate Hemochron Jr. Citrate APTT." |

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

• Sample Size for Test Set: 210 fresh citrated blood samples.
• Data Provenance: The samples were collected from patients undergoing catheterization and angioplasty. While the document doesn't explicitly state the country of origin, the company is based in Edison, NJ, USA, and the FDA review process suggests the data is likely from the United States. The study appears to be prospective in nature, as samples were collected "at the patient bedside" and then analyzed.

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

• This information is not provided in the document. The ground truth for the correlation study was established by a laboratory APTT test performed on an Electra 900 MLA instrument using Dade Actin FSL* APTT reagent. This is a reference method, not an expert consensus.

4. Adjudication Method for the Test Set

• This information is not applicable/provided. The ground truth was established by a laboratory reference method, not by human experts requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. The primary study was a correlation study comparing the device's performance to a laboratory reference method. The device is for coagulation testing, which typically does not involve human readers interpreting results in the same way imaging devices might.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

• Yes, a standalone study was done. The described "Summary of Performance Data and Precision" specifically evaluates the performance of the Hemochron Jr. Citrate APTT device itself, comparing its results to a laboratory standard (correlation) and evaluating its consistency (precision) independently. The device provides a quantitative measurement, so human interpretation after the device provides the result is inherent to its use, but the analytical performance of the device was tested in a standalone manner.

7. The Type of Ground Truth Used

• Reference Laboratory Method: The ground truth for the correlation study was established by performing an APTT test on plasma samples using the Dade Actin FSL* APTT reagent on an Electra 900 MLA instrument. This acts as the "gold standard" laboratory method.

8. The Sample Size for the Training Set

• This information is not provided. The document describes a "modified" reagent formulation, implying that development and potentially internal "training" or optimization occurred, but details on a specific training set size for the algorithms or formulation are absent.

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

• This information is not provided. As the specific training set and its use are not detailed, neither is the method for establishing its ground truth.

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Sigma Diagnostics ALEXIN™ HS is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Sigma Diagnostics ALEXIN 14 HS contains purified rabbit brain and soy phospholipids with an ellagic acid activator for the determination of the activated partial thromboplastin time and related coagulation procedures in citrated plasma.

Sigma Diagnostics ALEXIN™ HS is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway. The study aimed to demonstrate its substantial equivalence to Dade Actin-FS.

1. Table of acceptance criteria and reported device performance:

The document doesn't explicitly state "acceptance criteria" in a numerical sense, but rather demonstrates substantial equivalence through correlation and regression with a predicate device, and provides precision data. For the purpose of this analysis, we will infer the acceptance criteria from the reported performance, implying that the achieved correlation and precision were considered acceptable for substantial equivalence.

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Sigma Diagnostics ALEXIN™ LS is a device used for primary screening for coagulation Shina Diagnest of evaluation of the effect of therapy on procoagulant disorders, and as able mail.com factor deficiencies of the intrinsic coagulation pathway.

Sigma Diagnostics ALEXIN™ LS contains purified rabbit brain and sov phospholipids with an ellagic acid activator for the determination of the activated partial thromboplastin time and related coagulation procedures in citrated plasma. This reagent has increased sensitivity to lupus anticoagulants.

The provided document describes the safety and effectiveness study for the Sigma Diagnostics ALEXIN™ LS device, demonstrating its substantial equivalence to the Dade Actin-FSL device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for this device appear to be a strong correlation and agreement with a legally marketed predicate device (Dade Actin-FSL). The precision data also represents performance within expected ranges for such assays.

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