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Life49C is sterile, non-pyrogenic, advanced buffered corneal preservation medium which is supplemented with chondroitin sulfate (membrane stabilizer), recombinant human insulin (cell metabolism enhancer), Dextran (osmotic agent), glutathione (antioxidant, free-radical scavenger, enzyme cofactor), stabilized L-glutamine , ATP precursors, nutrient cell supplements, amino acids, vitamins, trace elements, gentamycin, streptomycin and phenol red (pH indicator).

AI/ML Overview

The provided text is a 510(k) summary for a medical device called Life4°C, a sterile medium for hypothermic corneal storage. The document focuses on establishing substantial equivalence to a predicate device, Optisol GS Corneal Storage Media (K924165), rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, much of the requested information regarding acceptance criteria, performance, sample sizes for test and training sets, ground truth establishment, expert involvement, and MRMC studies is not available in the provided document.

Here's a breakdown of what can be extracted and what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Explicit Acceptance Criteria: Not explicitly stated in terms of quantifiable thresholds for performance metrics. The submission relies on demonstrating substantial equivalence to a predicate device.	Long-term Stability: Tests were performed, but no specific performance metrics (e.g., maximum allowable degradation, acceptable deviation from baseline) or actual results are reported.
	Safety Testing: Tests were performed, but no specific safety endpoints or results are reported.
	Performance Characteristics: Tests were performed, but no specific performance characteristics or results are reported.
	Sterilization Validation: Tests were performed, but no specific criteria or validation results are reported.
	Comparison with Predicate Device: Tests were performed (implicitly to show equivalence in performance), but no direct comparison data or specific metrics are provided.
Intended Use: Storage of human corneas suitable for keratoplasty up to 14 days under refrigeration (2-8°C).	Implied Performance: The device performs equivalently to the predicate, which is approved for the same intended use. No specific "success rate" or "retention of viability" metrics are provided for Life4°C itself.

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

The document mentions "Non-clinical tests" including "Long-term Stability," "Safety Testing," "Performance Characteristics," "Sterilization Validation," and "Comparison with Predicate Device."
However, it does not provide any details on the sample sizes used for these tests.
Data Provenance: Not specified. It's implied these are internal company tests conducted by Numedis, Inc., but no country of origin or whether they were retrospective or prospective is mentioned.

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

Not applicable / Not provided. The nature of the tests (stability, sterility, safety, performance characteristics of a storage medium) typically does not involve human experts establishing "ground truth" in the same way an AI diagnostic device would. These tests would involve laboratory measurements against established standards or predicate device performance.
The document explicitly states "(b) Clinical tests - Not required," which further indicates no human expert-based ground truth establishment as would be present in a clinical trial.

4. Adjudication method for the test set

Not applicable / Not provided. Since there's no mention of human expert assessment or ground truth establishment in a diagnostic sense, there is no adjudication method described.

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, an MRMC comparative effectiveness study was not done.
The device is a corneal storage medium, not an AI diagnostic device that assists human readers.

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

Not applicable. The device is a corneal storage medium, not an algorithm or AI system. Its performance is evaluated through non-clinical laboratory tests, not standalone algorithm performance.

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

Not explicitly stated in terms of "ground truth" as a diagnostic reference. For tests like long-term stability and sterilization validation, the "ground truth" would be established acceptance limits based on scientific principles and regulatory standards (e.g., cell viability thresholds, sterility assurance levels).
For the "Comparison with Predicate Device," the predicate's established performance serves as a reference.

8. The sample size for the training set

Not applicable / Not provided. The device is a physical sterile medium, not an AI model requiring a training set.

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

Not applicable / Not provided. As there is no AI model or training set, this information is irrelevant to the described device.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Life4°C corneal storage medium to a predicate device (Optisol GS) through non-clinical laboratory tests. It explicitly states that clinical tests were "Not required." Therefore, the detailed information typically requested for AI/diagnostic device performance studies (like expert involvement, ground truth, sample sizes for training/test sets, and MRMC studies) is not present in this document. The "acceptance criteria" are implicitly met by demonstrating performance comparable to the predicate for parameters like stability, safety, and general performance characteristics, though the specific quantifiable criteria and results are not detailed.

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