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The Phospholin ES Activated Partial Thromboplastin Time reagent is a liquid activated reagent with phospholipids derived from soybean lecithin for use in the determination of Activated Partial Thromboplastin Time (APTT) and related coagulation procedures. Phospholin ES is to be used as an APTT reagent (qualitative assay) on patient plasma for the routine screening in the general patient population for deficiencies involving the intrinsic pathway of coagulation. Phospholin ES is sensitive to lupus-like inhibitors.

R2 Diagnostics Phospholin ES is a liquid reagent containing ellagic acid as the activator and phospholipids derived from soybean lecithin. The reagent also contains buffer and preservatives. Phospholin ES is an in vitro diagnostic reagent intended for use for the performance of the activated partial thromboplastin time two-stage test (APTT) and related coagulation factor assays. Phospholin ES is sensitive to lupus anticoagulants. Phospholin ES as with any APTT test requires the addition on 0.02-0.025M Calcium Chloride to perform the assay.

Here's a breakdown of the acceptance criteria and study information for the R2 Diagnostics Phospholin ES device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document frames its "acceptance criteria" and "device performance" in terms of substantial equivalence to a predicate device. The performance criteria are primarily correlation coefficients and precision for various sample types.

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

• Sample Size: The document does not explicitly state the exact number of samples used in the correlation studies. It mentions "normal and abnormal patients, as well as samples from patients positive for lupus anticoagulants."
• Data Provenance: Not specified, but likely retrospective convenience sampling given the nature of the study as a comparison to an existing predicate device. The country of origin is not mentioned.

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

This information is not provided. For an in vitro diagnostic device like Phospholin ES, the "ground truth" for the test set would typically be the results obtained from the predicate device itself, which is already an accepted diagnostic method. The document relies on a comparison between the new device and the predicate device, rather than an independent "expert ground truth" as might be seen in imaging or pathology studies.

4. Adjudication Method for the Test Set

Not applicable. The study is a direct comparison of results between two in vitro diagnostic reagents rather than human interpretation with potential for disagreement requiring adjudication.

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

No. This is an in vitro diagnostic reagent study, not an imaging or interpretation study involving multiple human readers.

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

Yes, this is an in vitro diagnostic reagent. Its performance is evaluated on its own, producing a quantitative result (APTT time) from a biological sample. Human interpretation is subsequent to the reagent's performance in the laboratory instrument.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance of the predicate device (Dade Actin FSL and Stago Calcium Chloride). The study aimed to show that Phospholin ES's results correlate highly with and are interchangeable with those obtained from the predicate device.

8. The Sample Size for the Training Set

Not applicable. This type of in vitro diagnostic reagent development does not typically involve a "training set" in the machine learning sense. The formulation of the reagent is based on chemical and biological principles, and its performance is validated against established methods.

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

Not applicable. As noted above, there isn't a "training set" in the conventional sense for this type of device.

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