(20 days)
A powderfree patient examination glove is a disposable device made of natural rubber latex or synthetic material that is intended to be worn on the hand or fingers for medical purposes to provide a barrier against poetentially infectious and other contaminants.
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This document is a 510(k) premarket notification FDA letter for examination gloves. As such, it does not contain the detailed information required to describe the acceptance criteria and the study proving a device meets those criteria in the way envisioned by the prompt (which is more typical for AI/software as a medical device).
However, I can extract the information that is present and explain why other requested information is not available in this type of document.
Here's an analysis based on the provided text, addressing the points you requested:
Acceptance Criteria and Device Performance for Shanghai Huamao Powder-Free Yellow Vinyl Examination Gloves (K024154)
This 510(k) premarket notification primarily focuses on establishing "substantial equivalence" of the Shanghai Huamao Powder-Free Yellow Vinyl Examination Gloves to predicate devices. For medical devices like gloves, "acceptance criteria" and "device performance" in a 510(k) context generally refer to meeting recognized standards (e.g., ASTM standards for physical properties, biocompatibility, etc.) and demonstrating that the new device is as safe and effective as a legally marketed predicate. The provided text does not include a table of specific acceptance criteria or detailed performance data from testing. The FDA letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This implies that the manufacturer provided data in their full submission that demonstrated compliance with relevant performance standards, but this detailed data is not part of this summary FDA letter.
Here's what can be inferred or stated about the requested points:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Inferred): For examination gloves, acceptance criteria typically involve meeting established ASTM standards for properties such as tensile strength, elongation, puncture resistance, barrier integrity (freedom from holes), and biocompatibility. The specific thresholds for these would be defined in those standards. The document does not explicitly list these criteria or values.
- Reported Device Performance: The document states that the device was found "substantially equivalent" to predicate devices. This implies that the submitted performance data met the necessary standards, but the actual performance values are not reported in this letter.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not available in the provided FDA letter. The 510(k) summary (or full submission) would contain details on test methods, sample sizes, and data provenance.
- The manufacturer is "Shanghai Huamao Gloves Company Limited" in "Shanghai, China," implying the manufacturing origin, but not necessarily the origin of the performance test data.
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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):
- This concept is typically relevant for interpretative devices (e.g., AI for medical imaging) where human expert consensus defines the "ground truth." For a physical device like an examination glove, "ground truth" is established through objective, standardized physical and chemical testing (e.g., tensile testing, leak testing, biocompatibility assays). Therefore, the concept of "experts establishing ground truth" in the sense of clinical interpretation does not apply here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Similar to point 3, adjudication methods are used to resolve discrepancies in expert interpretations. Since "ground truth" for gloves is based on objective measurements against standards, adjudication methods are not applicable in this context.
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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:
- MRMC studies are specific to evaluating interpretive devices, often AI-powered, by comparing human reader performance with and without AI assistance. This device is a physical examination glove, not an interpretive device or AI. Therefore, an MRMC study was not performed and is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This refers to the performance of an algorithm without human intervention, again relevant for AI/software devices. Since this is a physical medical glove and not an algorithm, a standalone performance study in this sense was not done and is not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For examination gloves, the "ground truth" for performance is based on objective measurements against recognized national and international standards for physical properties (e.g., strength, durability, barrier integrity), biocompatibility (e.g., cytotoxicity, irritation, sensitization), and other relevant properties. There is no "pathology" or "outcomes data" in the typical clinical sense for establishing the fundamental performance of the glove itself.
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The sample size for the training set:
- This concept is relevant for machine learning algorithms that require large datasets for training. As this is a physical examination glove, and not an AI/ML device, there is no "training set" in this context.
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How the ground truth for the training set was established:
- As there is no training set for a physical device like an examination glove, this question is not applicable.
Summary of what the document implies about the study for these gloves:
The FDA's determination of "substantial equivalence" means that Shanghai Huamao Gloves Company Limited provided data (in their full 510(k) submission, not shown here) demonstrating that their Powder-Free Yellow Vinyl Examination Gloves meet the same safety and effectiveness criteria as existing, legally marketed predicate gloves. This typically involves:
- Physical testing (e.g., tensile properties, freedom from holes) to relevant ASTM or ISO standards.
- Biocompatibility testing to ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization).
- Labeling compliance.
- Material composition comparison with predicate devices.
The FDA letter itself is a regulatory confirmation, not a detailed scientific study report.
§ 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.