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A patient examination gloves is a disposable device intended for medical purposes that is worn A pattent examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250)

Powder Free Butadiene Exam Gloves with Aloe, Green Color

This document is a 510(k) clearance letter for "Powder Free Butadiene Exam Gloves with Aloe, Green Color." It indicates that the device is substantially equivalent to legally marketed predicate devices. The document does not contain acceptance criteria or a study proving that the device meets acceptance criteria in the way typically expected for a medical imaging AI device.

This clearance is for a Class I medical device (patient examination glove), which is a low-risk device. For such devices, the "acceptance criteria" and "study" are typically much simpler and focus on material properties, safety, and functionality, rather than complex performance metrics like those needed for AI algorithms.

Therefore, many of the requested points are not applicable to this type of device clearance and the information provided.

However, based on the context of a 510(k) clearance for patient examination gloves, we can infer some "acceptance criteria" related to general controls and FDA regulations.

Here's an attempt to answer the questions based on the provided document and general understanding of 510(k) for this type of device, highlighting where information is not present:

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

The document does not explicitly present a table of acceptance criteria or reported device performance in the manner requested for an AI device. For patient examination gloves, the acceptance criteria are generally related to:

• Substantial Equivalence: The primary acceptance criterion for 510(k) clearance is that the device is substantially equivalent to a legally marketed predicate device.
• Conformity to General Controls: The device must comply with general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice (GMP), labeling, and prohibitions against misbranding and adulteration.
• Intended Use: The device must meet the intended use for "a disposable device intended for medical purposes that is worn on an examiner's hands or finger to prevent contamination between patient and examiner." (21CFR 880.6250)

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

This information is not present in the document. For patient examination gloves, testing would typically involve evaluating material properties (e.g., tensile strength, elongation, barrier integrity, biocompatibility) and potentially clinical performance (e.g., fit, dexterity), but details on sample sizes and provenance for such tests are not part of this clearance letter.

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/present. The concept of "ground truth" established by experts for a test set is relevant for diagnostic devices or AI algorithms. For examination gloves, performance is assessed through standardized material and biological safety tests, not expert consensus on diagnostic interpretations.

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

This information is not applicable/present. Adjudication methods are used to resolve disagreements in expert interpretations, which is not relevant for the testing of examination 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

This information is not applicable/present. MRMC studies are for evaluating the performance of diagnostic imaging systems or AI devices with human readers. This device is an examination glove.

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

This information is not applicable/present. This device is not an algorithm.

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

This information is not applicable/present in the context of diagnostic "ground truth." For examination gloves, the "ground truth" would equate to established physical, chemical, and biological standards and test methods. For example:

• Physical properties (e.g., ASTM D3577 for tensile strength).
• Barrier integrity (e.g., ASTM D5151 for water leak test).
• Biocompatibility (e.g., ISO 10993 for irritation, sensitization).

8. The sample size for the training set

This information is not applicable/present. This is not an AI device that requires a training set.

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

This information is not applicable/present. This is not an AI device that requires a training set.

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