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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non-Sterile, powder-free latex examination gloves with protein claim (50 micrograms or less).

This looks like a 510(k) premarket notification for non-sterile, powder-free latex examination gloves, which typically doesn't involve complex algorithms or AI. The acceptance criteria and "study" described here refer to conformance with established performance standards for medical gloves, rather than a clinical trial or AI model validation.

Therefore, many of the typical AI/ML study components (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.

Here's a breakdown of the available information relating to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of a numerical count of individual gloves tested. The submission refers to meeting standards like "AQL 2.5" for pinholes, which implies a sampling plan defined by ASTM D3578. However, the specific number of gloves sampled for each test is not provided in this summary.
• Data Provenance: The testing was performed by "Siam Sempermed Laboratories in Thailand" for physical properties and "Consumer Product Testing" in Fairfield, New Jersey, USA for biocompatibility. This suggests a combination of in-house (Thailand) and third-party (USA) testing. The data is prospective in the sense that the manufacturer tested their actual product to demonstrate compliance.

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

• This is not applicable. The "ground truth" for glove performance is defined by the objective, quantifiable metrics within the referenced ASTM and ISO consensus standards (e.g., specific dimensions, tensile strength, protein limits, pinhole AQL). There are no "experts" establishing ground truth in the way a clinical study would for medical imaging.

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

• Not applicable. Adjudication methods are relevant for subjective interpretations, whereas these tests involve objective measurements against predefined thresholds in standards.

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 a physical medical glove, not an AI or imaging device that uses "human readers" or "AI assistance."

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

• Not applicable. This is not an algorithmic or AI device. The performance tests are for the physical properties of the glove itself.

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

• The "ground truth" is established by consensus standards (ASTM D3578-05, ISO 10993-10/2002) which specify measurable physical, chemical, and biological properties that the gloves must meet for their intended use. These standards are developed through a consensus process involving experts in the field.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable.

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