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The BCS™ System is an automated coagulation analyzer for in vitro diagnostic use in clinical laboratories. The instrument performs the following parameters: Activated Partial Thromboplastin Time (APTT), Antithrombin Illa, Batroxobin, D-dimer, Deficient Plasmas, Derived Fibrinogen, Factor V Leiden, Fibrinogen, Heparin, Lupus Anticoagulants, Prothrombin Time (PT), Plasminogen, Protein C-clotting, Protein C-chromogenic, Thrombin Time, von Willebrand factor.

Device Description

The current BCS™ System was originally determined to be substantially equivalent as a fully automated photometric coagulation analyzer in 510(k) Premarket Notification 14.1 Subsequent to its clearance, the indications for use of the instrument was modified under 510(k) Premarket Notifications, K992959, K000973 and K002080 for the modified under 510(R) I Temarket Nothlouisms, Roseson, I s cleared to perform coagulometric, chromogenic, and immunochemical tests, such as the routine tests: orothrombin time, partial thromboplastin time, heparin, and fibrinogen, as well as the special tests: single factor determination, antithrombin IIIa, batroxobin, plasminogen, protein C, and D-dimer.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the BCS™ System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., "The coefficient of correlation must be >= 0.95"). Instead, it presents the "Device Performance Characteristics" as the results of a correlation study against a predicate device. The implied acceptance is that the correlation values are high enough to demonstrate substantial equivalence.

Assay	Implied Acceptance Criteria (Based on Submitted Data)	Reported Device Performance (Coefficient of Correlation, r)
LA1 Screening Reagent (seconds)	High correlation (e.g., r >= 0.95 for substantial equivalence to predicate)	0.967
LA1 Screening Reagent (normalized)	High correlation (e.g., r >= 0.95 for substantial equivalence to predicate)	0.967
LA2 Confirmation Reagent (seconds)	High correlation (e.g., r >= 0.95 for substantial equivalence to predicate)	0.956
LA2 Confirmation Reagent (normalized)	High correlation (e.g., r >= 0.95 for substantial equivalence to predicate)	0.956
LA1/LA2 Ratio	High correlation (e.g., r >= 0.95 for substantial equivalence to predicate)	0.964
LA1/LA2 Ratio (normalized)	High correlation (e.g., r >= 0.95 for substantial equivalence to predicate)	0.964

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the implied acceptance criteria is a method comparison study evaluating plasma samples on the modified BCS™ System against the predicate device, the Sysmex® CA-6000 System.

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

Sample Size (Test Set):
- LA1 Screening Reagent (seconds & normalized): 202 samples
- LA2 Confirmation Reagent (seconds & normalized): 196 samples
- LA1/LA2 Ratio (raw & normalized): 194 samples
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission for a medical device modification, it's highly likely to be prospective data collected specifically for this submission to demonstrate performance in a controlled environment. The manufacturer, Dade Behring Inc., has locations in Germany and the USA, but the specific origin of the samples is not provided.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of consensus interpretation. The study is a method comparison against a legally marketed predicate device (Sysmex® CA-6000 System). The results from the predicate device serve as the reference for comparison, not an expert-derived ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was a method comparison study between two automated systems, not a study involving human interpretation that would require 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

No. This document describes an automated coagulation analyzer (BCS™ System). It does not involve human readers or AI assistance in the interpretation of results. It compares the performance of one automated device against another.

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

Yes, this was a standalone performance study of the BCS™ System. The device itself is an automated system; there is no human-in-the-loop performance component described in the context of generating the quantitative results being evaluated. The comparison is between two fully automated systems.

7. The Type of Ground Truth Used

The "ground truth" for this study was the results obtained from the legally marketed predicate device, the Sysmex® CA-6000 System. This is a common approach in 510(k) submissions for demonstrating substantial equivalence of in vitro diagnostic devices.

8. The Sample Size for the Training Set

The document does not provide information on a training set. This type of 510(k) submission for a device modification typically focuses on verification and validation studies of the modified device's performance, often through method comparison or clinical validity studies. Development and training data for the device's algorithms (if any, though this is a photometric coagulation analyzer rather than a complex AI system) are usually not detailed in 510(k) summaries unless they specifically pertain to a new algorithm or AI component.

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

Not applicable, as no training set information is provided in the document.

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