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A patient examination Nitrile Blue Powder Free Glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.

Nitrile Blue Powder Free Examination Glove

Here's an analysis of the provided FDA document regarding the acceptance criteria and study details for the Nitrile Blue Powder Free Examination Glove:

This document is a 510(k) clearance letter for a medical device (Nitrile Blue Powder Free Examination Glove). It does not contain the acceptance criteria or results of a study designed to prove the device meets specific performance criteria, especially not in the context of an AI/ML powered device.

Instead, this document is a regulatory approval letter stating that the device is "substantially equivalent" to a legally marketed predicate device. This means the manufacturer demonstrated that their device performs similarly to an existing device for its intended use, rather than conducting a de novo study against a set of predefined acceptance criteria for novel performance claims.

Therefore, I cannot provide the requested information from the provided text. The questions you've asked are typically relevant for AI/ML device submissions, which involve rigorous testing against performance metrics. This document pertains to a Class I medical device for which the primary regulatory pathway is demonstrating substantial equivalence.

However, to illustrate what specific elements are missing and why the provided document does not fulfill the request, let's address each point as if this were an AI/ML device submission, explaining why the information is absent:

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

• Missing: This document does not specify any quantitative performance metrics (e.g., sensitivity, specificity, accuracy, F1 score, AUC) or corresponding acceptance criteria needed for an AI/ML device. For a glove, the "performance" would relate to barrier integrity, tensile strength, and freedom from holes, but these types of metrics are not detailed here.

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

• Missing: No test set is described, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm.

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)

• Missing: Not applicable for this type of device and submission.

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

• Missing: Not applicable.

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

• Missing: Not applicable. This device is not an AI algorithm intended to assist human readers.

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

• Missing: Not applicable. This is a physical product, not an algorithm.

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

• Missing: Not applicable. For a glove, "ground truth" might relate to physical properties meeting standards, but this is not detailed.

8. The sample size for the training set

• Missing: Not applicable. There is no training set for a physical device like a glove.

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

• Missing: Not applicable.

Conclusion:

The provided FDA letter (K071208) is a clearance for a Nitrile Blue Powder Free Examination Glove based on substantial equivalence. It does not contain the detailed performance metrics, study designs, or data provenance information that would be requested for an AI/ML device's acceptance criteria and validation study. The letter confirms market clearance, but not specific test results or acceptance criteria in the manner you've outlined for software/algorithm performance.

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