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A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex. The glove is coated with hydrogel polymer coating. The glove is manufactured using molds that feature anti-slip finish, independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile.

The provided document describes a 510(k) premarket notification for "Sterile Latex Powder-Free Surgical Gloves with Hydrogel Coating." This is a medical device, and the evaluation focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy or a new clinical benefit through extensive clinical studies. Therefore, many of the typical elements of AI/software device studies (like MRMC studies, training set details, or complex ground truth establishment) are not applicable here.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on compliance with ASTM standards and regulatory requirements for surgical gloves. The "reported device performance" refers to the results of tests conducted to demonstrate this compliance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the granular sample sizes (e.g., number of gloves tested) for each specific test (e.g., how many gloves for a freedom from holes test, or how many guinea pigs for sensitization). However, it indicates that the tests met the requirements of the specified ASTM standards. These standards themselves define appropriate sampling plans and methodologies.

• Sample Size: Not explicitly given numerically, but implied to be sufficient to meet the statistical requirements of the cited ASTM standards and 21 CFR 800.20.
• Data Provenance: The tests were conducted by the applicant, Cardinal Health, Inc. Implicitly, these are prospective tests performed specifically for this 510(k) submission, likely performed at their own facilities or accredited contract labs. The country of origin of the data is the USA (applicant address in McGaw Park, IL).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

For this type of device (surgical gloves), "ground truth" is established through standardized laboratory testing and chemical analysis, not through expert clinical interpretation in the same way an AI diagnostic device would.

• Number of Experts: Not applicable in the context of clinical expert review. The "experts" are the lab technicians, chemists, and quality engineers performing and interpreting the results of the ASTM and biocompatibility tests.
• Qualifications of Experts: Not specified, but assumed to be appropriately qualified personnel trained in performing the specific ASTM and ISO (for biocompatibility) test methods.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers interpret medical images or data. This is not applicable to the performance testing of surgical gloves. The results of the tests are based on objective measures and adherence to established protocols.

• Adjudication Method: Not applicable. Performance is determined by objective laboratory measurements against acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is used to compare the performance of human readers, often with and without AI assistance, especially in radiology and pathology. This type of study is not relevant for the regulatory clearance of surgical gloves.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not an AI/algorithm device. The "device" is a physical product (surgical glove). Performance is measured directly through physical, chemical, and biological testing, not through an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance claims is based on:

• Standardized Laboratory Test Results: Objective measurements obtained through recognized and validated ASTM (American Society for Testing and Materials) methods for physical properties, powder residue, and protein content.
• Biocompatibility Test Results: Objective results from tests like Primary Skin Irritation and Guinea Pig Maximization, often following ISO standards for medical device biocompatibility.
• Regulatory Standards: Compliance with specific sections of the Code of Federal Regulations (e.g., 21 CFR 800.20 for freedom from holes).

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/machine learning device, there is no "training set." The device is manufactured using a defined process, and its performance is verified through testing samples, not by training a model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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