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INTENDED FOR MEDICAL PURPOSES WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.

PVC SYNTHETIC EXAMINATION GLOVES, POWDERED DISPOSABLE

This document is a 510(k) clearance letter from the FDA for "PVC (Polyvinyl Chloride) Synthetic Examination Gloves, Powdered." It is not a study report for a novel medical device like AI software or an implant, but rather a clearance for a relatively simple disposable medical examination glove. Therefore, most of the questions regarding acceptance criteria, study design, and performance metrics (like sample size, ground truth, expert qualifications, MRMC studies, etc.) are not applicable in the typical sense for a 510(k) clearance of this type of device.

For a device like examination gloves, the "acceptance criteria" are generally related to manufacturing standards, material safety, and performance characteristics such as barrier integrity and strength, rather than diagnostic accuracy or clinical outcomes in the same way an AI algorithm would be evaluated. The "study" proving the device meets a criteria would typically involve laboratory testing rather than a clinical trial with human subjects for efficacy.

Here's an attempt to answer the questions based on the provided document and general understanding of 510(k) clearances for examination gloves:

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

The provided document (a 510(k) clearance letter) does not contain a table of acceptance criteria or reported device performance in the same manner as a clinical study report for an AI device. For examination gloves, acceptance criteria are typically derived from recognized consensus standards (e.g., ASTM standards for medical gloves) related to:

• Physical Properties: Tensile strength, elongation at break.
• Barrier Integrity: Freedom from holes (e.g., Water Leak Test, Air Leak Test).
• Dimensions: Length, width, thickness.
• Biocompatibility: Absence of irritation, sensitization, or cytotoxicity (usually tested according to ISO 10993 series).
• Level of Powder (if powdered).

The 510(k) process for examination gloves relies on demonstrating substantial equivalence to a predicate device. This implies that the new device meets the same performance standards as legally marketed predicate devices. The specific quantitative acceptance criteria and the Shanghai Palomar Mountain Industries, Incorporated glove's performance against these criteria are not detailed in this FDA clearance letter. These details would be in the applicant's 510(k) submission.

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 directly from the provided document. For physical and barrier integrity testing of gloves, sample sizes are typically determined by statistical sampling plans (e.g., AQL levels for attributes data) from manufacturing batches. The country of origin for the data would be China (where the manufacturer is located), and such testing is generally prospective, occurring during or after manufacturing.

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. For examination gloves, "ground truth" is established through standardized laboratory tests (e.g., observing for leaks, measuring tensile strength) by trained technicians or quality control personnel, not subjective expert opinion.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers/experts, which isn't relevant for objective laboratory testing of gloves.

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. MRMC studies are for evaluating diagnostic accuracy with and without AI assistance, which is irrelevant for examination gloves.

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

Not applicable. "Standalone" performance is a concept for AI or automated diagnostic devices. This device is a physical barrier protection device.

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

For examination gloves, the "ground truth" for performance is established by objective, standardized laboratory test methods (e.g., ASTM D6319 for PVC gloves, which specifies tests for physical dimensions, ultimate tensile strength, elongation, and watertight integrity via visual inspection for leaks).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of examination glove evaluation as it's not a machine learning or AI device. Manufacturing processes are honed over time, but this isn't a "training set" in the computational sense.

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

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

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