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The Powder-Free, Polychloroprene Surgical Gloves with Vera and Vitamin E, Sterile is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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This appears to be a 510(k) clearance letter from the FDA for a surgical glove. The provided text does not contain any information about acceptance criteria, study details, or device performance data.

The document primarily focuses on:

• Device Identification: Trade/Device Name, Regulation Number, Regulatory Class, Product Code.
• FDA Clearance: Confirmation of substantial equivalence to a predicate device.
• Regulatory Information: General controls provisions, potential additional controls, contact information for regulatory guidance.
• Indications for Use: Stating the purpose of the surgical gloves (protection of a surgical wound from contamination).

Therefore, I cannot provide the requested table and study details based on the given input. To answer your request, I would need a document that includes performance data for the device, such as a summary of safety and effectiveness (SSE) report or a clinical study report that details the testing performed to demonstrate the device meets certain criteria.

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A surgical glove is a disposable device made from Natural or Synthetic rubber intended to be worn by operating room personnel to protect the surgical wound from contamination.

Not Found

This appears to be a 510(k) clearance letter for Powder Free Polychloroprene Sterile Surgical Gloves. These letters typically document the FDA's decision regarding substantial equivalence to a predicate device, rather than providing detailed acceptance criteria or a study proving device performance in the way a clinical trial for a novel AI/software medical device might.

Regarding the specific questions you asked:

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

The document provided does not contain a table of acceptance criteria or reported device performance for an AI/software device. This letter is for a physical medical device (surgical gloves). For surgical gloves, performance is typically assessed against recognized consensus standards (e.g., ASTM standards for barrier integrity, physical properties). The letter itself does not detail these standards or test results.

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

This information is not available in the provided document. The 510(k) letter confirms clearance based on substantial equivalence, but it doesn't detail the testing performed on the device or the characteristics of the data used for any such testing.

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)

This information is not applicable and not available in the provided document. Surgical gloves do not typically involve expert ground truth establishment in the way an AI diagnostic tool would.

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

This information is not applicable and not available in the provided document for the reasons stated above.

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

This information is not applicable and not available in the provided document, as it is not an AI/software device.

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

This information is not applicable and not available in the provided document, as it is not an AI/software device.

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

This information is not applicable and not available in the provided document for the reasons stated above.

8. The sample size for the training set

This information is not applicable and not available in the provided document, as it is not an AI/software device.

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

This information is not applicable and not available in the provided document for the reasons stated above.

Summary based on the provided document:

The document is an FDA 510(k) clearance letter for "Powder Free Polychloroprene Sterile Surgical Gloves" (K030228). It states that the device is substantially equivalent to legally marketed predicate devices. The letter itself does not include specific acceptance criteria or detailed study results for performance relative to those criteria. For surgical gloves, performance is generally demonstrated through adherence to recognized consensus standards (e.g., for barrier integrity, biocompatibility, dimensions, physical properties), which would be part of the 510(k) submission but are not detailed in the clearance letter itself.

Ask a specific question about this device