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The MVR 1200 PC is intended for use as a storage reservoir for blood in an extracorporeal bypass circuit for periods up to six hours.

Sorin Monolyth Venous Reservoir 1200 PC with Phosphorilcholine coating (hereafter referred to as the MVR 1200 PC) is a soft, flexible polyviny chloride plastic bag designed for use during extracorporeal bypass surgery as in-line venous bag reservoir. Blood contact surfaces of the MVR 1200 PC have been coated with phosphorylcholine (PC) coating improves blood compatibility, resulting in reduced platelet adhesion on the coated surfaces.

The provided text describes the submission of a 510(k) premarket notification for the "MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with phosphorylcholine coating". This is a medical device, and the information focuses on demonstrating its substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and performance against those criteria in the way one might for a diagnostic AI/ML device.

Therefore, many of the requested categories for AI/ML device studies (like expert-established ground truth, MRMC studies, sample sizes for training/test sets, adjudication methods, and effect sizes) are not applicable to this type of device submission.

However, I can extract the relevant "acceptance criteria" and "device performance" in the context of this traditional medical device submission, which primarily revolves around biocompatibility, functional equivalence, and safety.

Here's a breakdown of the available information structured to best answer your query given the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of clinical trials or AI/ML datasets. The testing involved various in vitro and biocompatibility tests on the device itself.
• Data Provenance: The device tested was the MVR 1200 PC, which was subjected to accelerated aging up to three years. The data provenance is from tests conducted on this manufactured device. There is no mention of "country of origin of the data" in terms of patient data, nor is it retrospective or prospective in the clinical trial sense. The studies were laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a physical medical device. "Ground truth" in this context refers to the defined specifications and standards (e.g., ISO 10993-1995, FDA guidance documents) against which the device's physical and biological performance is measured. It does not involve expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

• Not Applicable. As above, the tests are laboratory-based measurements against established technical and biological specifications, not qualitative assessments requiring 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 is not an AI/ML device involving human readers or comparative effectiveness studies of that nature.

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

• No. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for this device's performance is established by well-defined international standards (ISO 10993-1995) and FDA guidance documents for biocompatibility and in vitro functional testing of blood-contacting medical devices. The device's performance is assessed against these established specifications and against the performance of predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established

• Not Applicable. No training set was used.

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