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A Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D35 77 -09(2015), Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes. All variants share the same natural color (No color additive is added). The proposed device is sterilized using Gamma and ETO method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 5years.

The provided document is a 510(k) premarket notification for a medical device: "Sterile Latex Surgical Gloves Powder Free." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness. As such, the information you've requested regarding acceptance criteria and study details for an AI/ML-based device is not entirely applicable to this document.

However, I can extract the closest equivalent information from the given text, focusing on the performance criteria by which the device's substantial equivalence was established.

Here's the breakdown based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document provides a detailed comparison of the subject device (Nulife / Sterile Latex Surgical Gloves Powder Free) against the predicate device (JR Medic Latex Surgeon's Gloves Sterile Powder Free) and references relevant ASTM and ISO standards for acceptance criteria.

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

The document does not explicitly state the sample sizes for each of the non-clinical tests. It refers to compliance with standards like ASTM D3577-09, which would typically define the sample sizes required for such tests.
The data provenance is from bench tests conducted to verify design specifications. The manufacturer "MRK Healthcare Pvt Ltd" is located in Gujarat, India, suggesting the testing was performed there or coordinated by them. The document does not specify if the testing involved retrospective or prospective data collection; these are standard material property tests where samples are tested according to defined protocols.

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

This question is not applicable to the evaluation of surgical gloves. The "ground truth" for these tests is established by adhering to widely accepted and standardized test methods (e.g., ASTM, ISO) which define objective, measurable physical, chemical, and biological properties. This does not involve expert consensus in the way an AI/ML diagnostic device's performance is often evaluated against expert-annotated ground truth.

4. Adjudication method for the test set

Not applicable. The tests performed are objective measurements per standard protocols, not subjective assessments requiring expert 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

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

7. The type of ground truth used

The "ground truth" for the performance evaluation of these surgical gloves is based on:

• Standard Specifications: Requirements defined by recognized standards (e.g., ASTM D3577-09 for physical properties, ASTM D5151-06 for pinholes, ASTM D6124-06 for powder residue, ASTM D5712-15 and ASTM D6499-18 for protein content).
• Biocompatibility Standards: Requirements from ISO 10993 series and USP tests for biological safety (e.g., irritation, sensitization, cytotoxicity, pyrogenicity, bacterial endotoxin).

8. The sample size for the training set

Not applicable. This is not an AI/ML medical device, so there is no training set in that context.

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

Not applicable. There is no training set in the context of an AI/ML device.

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