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A Patient Examination Glove is a disposable device intended to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Pouderfree Blue Nitrile Examination Gloves Polymer Coated

This document is a 510(k) clearance letter from the FDA for "Powderfree Blue Nitrile Examination Gloves (Polymer Coated)". It states that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as requested in your prompt. This type of regulatory clearance letter typically confirms substantial equivalence based on comparisons to existing devices, and often refers to supporting data previously submitted, but does not present the study details itself.

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A Patient Examination Glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Powderfree Nitrile Examination Gloves (Polymer Coated)

Here's an analysis of the provided text in relation to acceptance criteria and device study, based on the information available:

The provided document is a 510(k) clearance letter from the FDA for "Powderfree Nitrile Examination Gloves." It certifies that the device is "substantially equivalent" to legally marketed predicate devices.

Critical Point: The concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" as typically understood in the context of AI/ML medical devices, or even complex non-AI medical devices with performance claims, is not directly applicable to this document.

This document pertains to a 510(k) submission for a Class I medical device (gloves), which is subject to "general controls provisions" and substantial equivalence to a predicate device. For such devices, the primary "study" is often demonstrating that the new device is as safe and effective as (i.e., substantially equivalent to) existing devices on the market, usually through a comparison of physical properties, materials, and intended use, rather than complex clinical studies or AI performance metrics.

Therefore, many of the requested fields about AI-specific studies, test sets, ground truth establishment, and expert adjudication are not present or relevant in this type of FDA clearance document for a simple Class I device.

However, I can extract what is available or inferable from the document in relation to your request, albeit with many "Not Applicable" entries.

Acceptance Criteria and Device Performance

Since this is a substantial equivalence determination for examination gloves, the "acceptance criteria" are implied to be that the gloves perform comparably to predicate devices in preventing contamination and are safe for their intended use. There are no explicit quantitative performance metrics or a detailed "study" described in the provided FDA letter itself. Instead, the FDA reviewed the manufacturer's 510(k) submission (which is not provided here) that would have contained data supporting substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not explicitly stated in the FDA letter. For a Class I device like gloves, the "test set" would typically refer to the samples of gloves tested for physical properties (e.g., tensile strength, barrier integrity) and biocompatibility, as compared to predicate devices. The 510(k) submission (not provided) would contain this information.
• Data Provenance: Not specified.

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

• Not Applicable. This device is not an AI/ML device, nor does it typically involve expert review for "ground truth" in the way clinical diagnostic devices do. The FDA staff (e.g., those in the Division of Dental, Infection Control and General Hospital Devices) are the experts who reviewed the technical documentation for substantial equivalence.

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

• Not Applicable. See point 3. The 510(k) review process is an internal FDA regulatory review, not a clinical trial adjudication of medical cases.

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 a non-AI device.

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

• Not Applicable. This is a non-AI device.

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

• Not Applicable. For this type of device, "ground truth" would relate to accepted industry standards for glove properties, material safety, and performance characteristics, typically established through laboratory testing rather than clinical "ground truth" labels.

8. The sample size for the training set:

• Not Applicable. This is a non-AI device.

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

• Not Applicable. This is a non-AI device.

Summary regarding the provided document:

The provided FDA letter is a regulatory clearance document based on "substantial equivalence" for a simple medical device (gloves). It does not contain the detailed performance study information, acceptance criteria, or ground truth establishment relevant to complex medical devices, especially AI-driven ones. The "study" here refers to the manufacturer's submission demonstrating that their gloves are comparable to existing, legally marketed gloves, and thus are safe and effective for their intended use.

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