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A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded. (21 CFR 878.4460)

FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves, FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.

This document is a 510(k) clearance letter from the FDA for two types of surgical gloves: FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves and FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.

The letter explicitly states that the FDA "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

This means the device has been cleared based on substantial equivalence to existing predicate devices, not through a study involving acceptance criteria and performance metrics specifically for this device in the way a new, novel AI or diagnostic device would.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not applicable to this type of regulatory submission and clearance.

Here's why and what can be deduced:

1. A table of acceptance criteria and the reported device performance: Not applicable. The FDA's 510(k) process for devices like surgical gloves primarily involves demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves performance testing against recognized standards (e.g., ASTM standards for glove integrity, tensile strength, etc.) that the predicate device also met, rather than setting new, specific acceptance criteria for this device's clinical performance in the way an AI diagnostic would. The document does not contain these specific performance details.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. There is no "test set" in the context of a clinical study for this device as would be seen for an AI diagnostic. Performance testing for gloves typically involves laboratory testing (e.g., for pinholes, physical properties) rather than a clinical trial with a "test set" of patients/cases. The document does not provide details of 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): Not applicable. No "ground truth" establishment in a clinical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.

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 device is surgical gloves, not an AI diagnostic algorithm for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is surgical gloves, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for surgical gloves typically relates to meeting physical and biological performance standards (e.g., sterility, barrier integrity, biocompatibility), which are measured objectively, not through human expert consensus on diagnostic images or outcomes data.

8. The sample size for the training set: Not applicable. No "training set" in the context of machine learning or AI is involved.

9. How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

• Device Name: FINESSIS VIOLET Intense Polyisoprene Powderfree Sterile Surgical Gloves, FINESSIS GREEN Corium Polyisoprene Powderfree Sterile Undergloves.
• Regulation Number: 21 CFR 878.4460
• Regulation Name: Surgeon's Glove
• Regulatory Class: I
• Product Code: KGO
• Indications for Use: "A surgeon's glove is a device made of natural rubber or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination."
• Clearance Type: 510(k) - Substantial Equivalence to legally marketed predicate devices.
• No specific acceptance criteria or performance study results for the device itself are detailed in this regulatory letter. The letter confirms that based on the submitted information (which would include performance data against established standards), the device is substantially equivalent to existing market devices.

To obtain the specific "acceptance criteria" (likely referring to the performance standards met) and the detailed "study" (likely referring to laboratory performance testing) that led to this clearance, one would need to refer to the actual 510(k) submission document (K123629) itself, which is not provided here. The letter only summarizes the outcome of the FDA's review.

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