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INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION

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The provided text is a 510(k) premarket notification approval letter for "Sterile Operating Room Towels, Blue" (K981823) from the FDA to Baldur Systems Corporation. This document is a regulatory approval and does not contain information about acceptance criteria or a study proving device performance as it pertains to AI/ML or diagnostic devices.

The information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are characteristic of the data typically provided in submissions for AI/ML-powered medical devices or diagnostic devices that require performance evaluation studies.

Since the device in question is "Sterile Operating Room Towels," a low-risk product, the FDA approval is based on substantial equivalence to a predicate device rather than on detailed performance metrics from a clinical study as would be required for more complex devices or AI/ML technologies.

Therefore, I cannot provide the requested information based on the input document. The document simply states the intended use as: "XXE INTENDED BE USED P COUERIN ﺮ INCISIO A SITE SURGICAL From AND other MICROBIAN CONTAMINATION" (intended to be used for covering an incision site during surgery from microbial contamination).

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A gauze is used to wipe off blood and fluids from a patient's mouth or skin.

Class I gauze sponge 79EFQ

The provided text describes a 510(k) summary for the "Baldur" Non-Sterile Cotton Sponges. However, it does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a study proving device performance in the context of an AI/ML device.

This document is for a Class I manual medical device (cotton gauze) and its performance data refers to meeting USP/BP standards for the physical properties of the gauze itself, not a digital device's diagnostic performance. Therefore, many of your questions, especially those related to AI/ML specific studies (MRMC, standalone algorithm performance, ground truth for training/test sets, expert qualifications, etc.), are not applicable to the provided information.

Based only on the provided text, here's what can be extracted:

1. Table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Compliance with USP/BP standards (for gauze sponges)	"Baldur" gauze sponges meet the USP/BP standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not specified. The document only states "The performance data is shown in Table 1," but Table 1 itself is not provided, nor are details about how the compliance with USP/BP standards was tested (e.g., sample size, test methods).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This device is a cotton gauze, not an AI/ML diagnostic tool. Ground truth in the context of expert diagnosis is not relevant here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable.

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 is not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

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

   • For a cotton gauze, "ground truth" would likely refer to the physical and chemical properties determined by standard laboratory tests (e.g., absorbency, sterility if applicable, fiber content, etc.) as defined by USP/BP standards. The document only states compliance with these standards, not the specific methods or "ground truth" establishment.

8. The sample size for the training set:

   • Not applicable. This is not an AI/ML device.

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

   • Not applicable. This is not an AI/ML device.

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