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DuraCLEAN® with LYCRA® Medical Examination Glove is a disposable device made of synthetic LYCRA® polymer that is intended for medical purposes to be worn on the examiner's hand to provide a barrier against potentially infectious materials and other contaminants.

The subject device is an ambidextrous, powder-free patient examination glove composed of 100% DuPont LYCRA® polymer. It is offered non-sterile, in a range of sizes from Extra Small to Extra Large.

The device meets the requirements of applicable recognized standards, including those specified by ASTM D3578, ASTM D6124, ASTM D5151, and the agency's June, 1999 draft Medical Glove Guidance Mamual.

The device has been demonstrated biocompatible through dermal irritation, dermal sensitization, and cytotoxicity testing in accordance with EN ISO 10993.

The provided text is a 510(k) summary for a medical examination glove, not a device that uses AI or machine learning. Therefore, many of the requested categories for describing an AI/ML device's acceptance criteria and study information are not applicable.

However, I can extract the relevant information regarding the acceptance criteria and how the device meets them based on the provided text for this medical glove.

Acceptance Criteria and Device Performance for DuraCLEAN® with LYCRA® Medical Examination Glove

Regarding the study that proves the device meets the acceptance criteria (and the AI/ML specific questions):

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

  • The document does not specify sample sizes for the testing of the glove (e.g., how many gloves were tested for pinholes, physical properties, or biocompatibility). It only states that the device "conforms to" specific ASTM standards and "has been demonstrated biocompatible through" various tests.
  • Data provenance is not mentioned.

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

  • Not applicable. This is a physical medical device (glove), not an AI/ML diagnostic or assistive device that requires expert ground truth establishment in the traditional sense. The "ground truth" for a glove is its adherence to mechanical and biological safety standards.

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

  • Not applicable for a physical medical glove. The testing involves standardized laboratory methods (ASTM, EN ISO 10993) rather than human interpretation requiring adjudication.

• 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 as this is not an AI/ML device.

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

  • Not applicable as this is not an AI/ML device.

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

  • The "ground truth" for this device is established by adherence to recognized national and international standards for medical gloves: ASTM D3578, ASTM D6124, ASTM D5151 (implied, as D3578 covers many aspects but D5151 is specifically for pinholes), and EN ISO 10993 for biocompatibility. The FDA's June 1999 draft Medical Glove Guidance Manual also serves as a benchmark. These standards define the acceptable performance characteristics.

• 8. The sample size for the training set:

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

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

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

Summary of Non-Clinical Tests (from the document):

• "In vivo and in vitro testing conducted to assess dermal irritation, dermal sensitization, and cytotoxicity, establish that the subject device is biocompatible within the limits of those test."

Summary of Clinical Tests (from the document):

• "(Not applicable)" - This explicitly states that no clinical tests were performed or were deemed necessary for this 510(k) submission, relying instead on non-clinical (laboratory) testing and substantial equivalence to predicate devices.

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