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

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

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

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

System Software V3.0.0 is being introduced on the ACL TOP family (instrument available with and without the feature of closed tube sampling) to support the conversion from the Windows 2000 Operating System to the Windows XP Operating System. This software also includes additional features and ease-of-use enhancements.

This 510(k) summary is for a software update (System Software V3.0.0) for an existing device, the ACL TOP coagulation analyzer. The purpose of the submission is to support the conversion from Windows 2000 to Windows XP operating system and to introduce additional features and ease-of-use enhancements.

Therefore, the study described here is focused on demonstrating that the updated software does not negatively impact the performance of the device and that it remains substantially equivalent to the predicate device. It is not a study to establish new performance metrics or efficacy.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain a table of specific acceptance criteria or reported device performance metrics in the way you might expect for a new device's clinical study. The submission focuses on demonstrating substantial equivalence, meaning the updated software does not alter the existing performance and indications for use.

Instead of quantitative performance metrics, the "acceptance criteria" here are implicitly met by showing that:

• There are no changes in ACL TOP test parameters.
• There are no changes to the labeled indications for use/intended use.
• There are no changes to the performance claims of the instrument or its reagents.

The "reported device performance" is the statement: "The performance of the ACL TOP family with System Software V3.0.0 is substantially equivalent to the performance of the current legally marketed ACL TOP (K063679)."

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

The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). This is because the submission is for a software update to an existing, cleared device. The focus is on demonstrating that the software change itself doesn't affect the established performance, rather than re-evaluating the device's original performance with a new clinical study.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This submission is not evaluating a diagnostic algorithm where expert ground truth is established for images or clinical cases. It's a software update for a clinical laboratory instrument.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of diagnostic interpretation that would require adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study assesses how AI impacts human reader performance, which is not relevant for a software update to a laboratory instrument that performs automated assays.

6. Standalone (Algorithm Only) Performance Study

No, a standalone performance study in the context of an algorithm interpreting data (like imaging or patient characteristics) was not explicitly described or performed. The device itself (ACL TOP) is a standalone automated analyzer, but the submission is about its operating software update, not a new diagnostic algorithm.

7. Type of Ground Truth Used

Not applicable/Implicit. For an automated coagulation instrument, the "ground truth" for its measurements would typically come from reference methods or established gold standards for coagulation testing. However, the software update submission focuses on ensuring the new software maintains the accuracy and reliability already established for the device. Therefore, no new "ground truth" was established for this specific submission; it relies on the predicate device's established performance.

8. Sample Size for the Training Set

Not applicable. This submission is not about an AI/machine learning algorithm that requires a training set of data. It's about an operating system and feature update for an existing instrument.

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

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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