(157 days)
The Nittile Powder Free Examination Glove with Low Dermatitis Claim and Tested for Use with Chemotherapy Drugs (Blue) is a non- sterile disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs. The list of Chemotherapy Drugs (tested with breakthrough times) as per attached table.
Nitrile Powder Free Examination Glove with Low Dernatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
This is a 510(k) clearance letter for a medical device, specifically a Nitrile Powder Free Examination Glove. The document states that the device is "substantially equivalent" to legally marketed predicate devices. However, it does not contain the detailed information typically found in a study report regarding acceptance criteria and performance data in the structured format requested.
The document primarily focuses on the regulatory clearance for the glove, including its intended use, a list of chemotherapy drugs it has been tested against, and associated breakthrough times. It does not describe a study in the sense of an algorithm's performance, human reader studies, or training/test set details.
Therefore, I cannot provide the requested information in the structured format because it is not present in the provided text. The document refers to "tested for use with Chemotherapy Drugs" and "the list of Chemotherapy Drugs tested (with breakthrough times)", but this is a performance claim for the glove's barrier properties, not a study evaluating an AI device's performance or a diagnostic accuracy study.
Here's a breakdown of why each requested point cannot be addressed from the given text:
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A table of acceptance criteria and the reported device performance: While there's a table of chemotherapy drugs and their breakthrough times, these are performance characteristics of the glove's barrier function, not "acceptance criteria" and "reported device performance" in the context of a diagnostic or AI study. There's no mention of a particular acceptance threshold for these breakthrough times.
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Sample sized used for the test set and the data provenance: Not applicable as this is not a study comparing diagnostic accuracy or AI performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here would relate to the chemical testing of the glove's permeation, which is a materials science test, not a diagnostic one.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
The document focuses on:
- Device Name: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
- Intended Use: Non-sterile disposable device for medical purposes, worn on examiner's hand to prevent contamination, and tested for use against chemotherapy drugs.
- Performance Data: Breakthrough times for various chemotherapy drugs, ranging from 10.1 minutes (Carmustine) to >240 minutes for most others.
§ 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.