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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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