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

The subject device is Powder-Free Vinyl Patient Examination Gloves that is worn upon the examiner's hands or finger. As a barrier, the subject device prevents contamination between patient and examiner. The subject device meets all of the requirements of ASTM standards D5250-06 for Physical and performance characteristics, D5151-06 for barrier properties and D6124-06 for residual powder.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder-Free Clear Vinyl Patient Examination Gloves (K142892).

It's important to note that this document is a 510(k) summary for a Class I medical device (patient examination glove). For such devices, the FDA typically relies on performance standards and substantial equivalence to a predicate device rather than extensive clinical trials for approval.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Test Set Sample Size: The document specifies that "The dimensions and physical properties tests followed ASTM D5250-06 and met AQL 2.5, inspection level S-2." and "The barrier test followed ASTM D5151-06 and met AQL 2.5, inspection level S-1." These AQL (Acceptable Quality Limit) levels refer to a sampling plan for inspection.
     • For physical properties (ASTM D5250-06) with AQL 2.5, inspection level S-2, the sample size would be determined by the specific batch size being tested according to the ASTM standard. For example, for a batch size of 50,001 to 150,000, inspection level S-2 uses a sample size of 80.
     • For barrier test (ASTM D5151-06) with AQL 2.5, inspection level S-1, the sample size would also be determined by the batch size. For a batch size of 50,001 to 150,000, inspection level S-1 uses a sample size of 50.
   • Data Provenance: The tests were conducted internally by the manufacturer or a contracted lab. The document does not specify the country of origin of the data beyond the manufacturer being in China. The tests are prospective in nature, as they are performed on the newly manufactured device to ensure it meets the specified standards.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is Not Applicable in the context of this device and study type. The "ground truth" for these tests are objective, measurable physical, chemical, and biological properties evaluated against established industry standards (ASTM, ISO). There is no "expert consensus" on classifications or interpretations of images, for example. The tests are performed by technicians following standard protocols.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This is Not Applicable. The tests performed are objective measurements against defined pass/fail criteria from the ASTM and ISO standards. There is no subjective interpretation requiring adjudication among experts.

4. 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 is Not Applicable. This document is for a medical glove, not an AI or diagnostic imaging device. Therefore, no MRMC study was conducted or is relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is Not Applicable. This is a physical medical device, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the non-clinical tests is based on objective measurements against established industry standards.

   • For physical properties (tensile strength, elongation, dimensions), the ground truth is the values obtained from standardized mechanical tests.
   • For barrier properties (pinholes), the ground truth is the number of defects found in a sample based on a standardized liquid integrity test.
   • For residual powder, the ground truth is the measured mass of powder per glove.
   • For biocompatibility (irritation, sensitization), the ground truth is the observable biological response in a standardized animal or in-vitro test model, assessed against predefined criteria for irritation/sensitization.

7. The sample size for the training set: This is Not Applicable. As this is not an AI/machine learning device, there is no "training set." The device is manufactured and tested against pre-defined specifications.

8. How the ground truth for the training set was established: This is Not Applicable for the reasons stated above.

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