(30 days)
A patient examination gloves is a disposabledevice intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder Free Vinyl Synthetic Examination Gloves, White color(Sensi-Pro)
This document is a 510(k) clearance letter from the FDA for "Sensi-Pro Disposable Powder Free Vinyl Synthetic Examination Gloves". It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/software-as-a-medical-device (SaMD) products.
The information requested in your prompt (acceptance criteria, device performance, sample size, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) is highly specific to the evaluation of AI/SaMD devices, which are assessed for their diagnostic or predictive accuracy.
This document is for a physical medical device (examination gloves), which are evaluated based on physical and mechanical properties, barrier integrity, and biocompatibility, not AI performance metrics. Therefore, the requested information is not relevant to this type of device and is not present in the provided text.
To answer your prompt directly based on the provided text, I must state:
- A table of acceptance criteria and the reported device performance: Not applicable. The document is for examination gloves, not an AI/SaMD. Criteria would relate to physical properties, not diagnostic accuracy.
- Sample size used for the test set and the data provenance: Not applicable. No test set for AI performance is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for AI performance is mentioned.
- Adjudication method for the test set: Not applicable. No test set for AI performance is mentioned.
- 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 document pertains to physical examination gloves, not an AI system that assists human readers.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This document pertains to physical examination gloves, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth for AI performance is mentioned.
- The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set.
- How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.
In summary, the provided FDA 510(k) letter is for a medical device (gloves) that does not involve artificial intelligence or software-as-a-medical-device. Consequently, none of the specific details requested about AI/SaMD performance evaluation are present or applicable.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.