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HemosIL ProS is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.

This in vitro diagnostic test determines the functional activity of free Protein S by measuring the degree of prolongation of a prothrombin time in the presence of the tissue factor, phospholipids, calcium ions and activated Protein C. The Protein S activity is proportional to the prolongation of the clotting time of a Protein S deficient plasma to which the diluted sample was added.

HemosIL ProS is a functional assay for the quantitative determination of free Protein S in human citrated plasma on IL coagulation systems as an aid in the diagnosis of hereditary and acquired Protein S deficiency.

The reconstituted and onboard stability claims for HemosIL ProS on the ACL Futura (K951891) and ACL Advance (K002400) are being revised as a precautionary measure based on indications from internal QC release data on multiple product lots.

Here's an analysis of the provided text regarding the HemosIL ProS device, focusing on the requested information for acceptance criteria and the supporting study:

Disclaimer: The provided document is a 510(k) summary for a modification to a previously cleared device. It primarily focuses on changes to stability claims. Therefore, the depth of information on all requested points might be limited compared to an initial 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for the stability testing. The summary refers to "internal QC release data on multiple product lots."
• Data Provenance: "Internal QC release data," implying it's from the manufacturer (Instrumentation Laboratory Company) and likely refers to testing conducted in their facilities. The country of origin is implicitly the US (Lexington, MA).
• Retrospective/Prospective: Not specified, but generally, QC release data would be a form of prospective testing during manufacturing. The "additional stability testing" for the revised claims would also be prospective.

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

• Not Applicable. This document pertains to an in-vitro diagnostic (IVD) assay for measuring Protein S. The "ground truth" for such assays typically relies on established analytical methods and reference materials, not expert interpretation of images or patient data. The "ground truth" for stability would be the actual measured stability performance over time.

4. Adjudication Method for the Test Set:

• Not Applicable. As mentioned above, this is an IVD assay, not a diagnostic imaging or clinical interpretation device that would require adjudication of expert opinions. The assessment of stability would be based on predefined analytical specifications and statistical analysis of quantitative measurements.

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 a standalone in-vitro diagnostic assay and does not involve human "readers" in the context of interpreting results in combination with AI. It measures a specific biochemical marker.

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

• Yes, effectively. The HemosIL ProS is a standalone in-vitro diagnostic assay. Its performance is evaluated intrinsically through laboratory testing (e.g., stability, accuracy, precision) without human interpretation in the loop of the primary measurement. The "algorithm" here refers to the chemical reactions and optical detection methods of the assay itself, rather than a separate AI algorithm processing data.

7. The Type of Ground Truth Used:

• For the core functionality of the device (quantitative determination of free Protein S), the ground truth would be established through a combination of:
  • Reference materials/calibrators: Samples with known concentrations of Protein S.
  • Reference methods: Established, often more laborious, analytical methods for Protein S measurement.
  • Clinical correlation: (Though not extensively detailed in this summary, an initial 510(k) for such a device would likely correlate results with patient diagnostic status, potentially against a "gold standard" clinical diagnosis or another validated Protein S assay.)
• For the stability claims (the focus of this K053499 submission), the ground truth is the actual measured concentration of Protein S in control samples over time, compared to initial measurements, to determine if the device's accuracy remains within acceptable limits.

8. The Sample Size for the Training Set:

• Not Applicable/Not Provided. This is not an AI/machine learning device that typically has "training sets." The "training" for such an assay involves method development and optimization, which utilizes various reagent lots and samples, but not in the sense of a dedicated training set for an algorithm. The stability testing itself relies on a number of control samples and product lots (as mentioned, "multiple product lots").

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

• Not Applicable/Not Provided. As it's not an AI/ML device with a training set in the conventional sense, this question does not apply. The "ground truth" in the context of stability testing is the direct analytical measurement against a specified initial value or an established range.

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