(340 days)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Polychloroprene Powder-Free Surgical Glove (White) Tested For Use With Chemotherapy Drugs; Polychloroprene Powder-Free Surgical Glove (Green) Tested For Use With Chemotherapy Drugs
This document is a 510(k) premarket notification for surgical gloves, specifically Polychloroprene Powder-Free Surgical Gloves (White and Green) tested for use with chemotherapy drugs. It is not related to an AI/ML medical device, and therefore does not contain any of the requested information regarding AI/ML study design, such as acceptance criteria, sample sizes for test/training sets, expert ground truth establishment, or multi-reader multi-case studies.
The document primarily focuses on establishing substantial equivalence for the surgical gloves and their performance against chemotherapy drugs. The tables presented show the minimum breakthrough detection time for various chemotherapy drugs when tested with the gloves. This is a performance characteristic of the physical device (gloves), not an AI algorithm.
To explicitly address the numbered points in your request:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: While not explicitly stated as such, the implicit acceptance criteria for these surgical gloves for chemotherapy use would be that they provide a barrier to chemotherapy drugs for a reasonable period. The "minimum breakthrough detection time" is the metric measured.
- Reported Device Performance (Polychloroprene Powder-Free Surgical Glove (White)):
Test Chemotherapy Drug Concentration (mg/ml) Minimum Breakthrough Detection Time (minutes) Carmustine 3.3 mg/ml 31.1 Cisplatin 1.0 mg/ml > 240 min Cyclophosphamide 20.0 mg/ml > 240 min Dacarbazine 10.0 mg/ml > 240 min Doxorubicin Hydrochloride 2.0 mg/ml > 240 min Etoposide 20.0 mg/ml > 240 min Fluorouracil 50.0 mg/ml > 240 min Ifosfamide 50.0 mg/ml > 240 min Mechloroethamine HCl 1.0 mg/ml > 240 min Melphalan 5.0 mg/ml > 240 min Methotrexate 25.0 mg/ml > 240 min Paclitaxel 6.0 mg/ml > 240 min Thiotepa 10.0 mg/ml 30.4 Vincristine Sulfate 1.0 mg/ml > 240 min - Reported Device Performance (Polychloroprene Powder-Free Surgical Glove (Green)):
Test Chemotherapy Drug Concentration (mg/ml) Minimum Breakthrough Detection Time (minutes) Carmustine 3.3mg/ml 0.20 Cisplatin 1.0mg/ml > 240 min Cyclophosphamide 20.0 mg/ml > 240 min Dacarbazine 10.0 mg/ml > 240 min Doxorubicin Hydrochloride 2.0mg/ml > 240 min Etoposide 20.0 mg/ml > 240 min Fluorouracil 50.0 mg/ml > 240 min Ifosfamide 50.0 mg/ml > 240 min Mechlorethamine HCl 1.0mg/ml > 240 min Melphalan 5.0mg/ml > 240 min Methotrexate 25.0 mg/ml > 240 min Paclitaxel 6.0mg/ml > 240 min Thiotepa 10.0 mg/ml 15.4 Vincristine Sulfate 1.0mg/ml > 240 min
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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 provided as it's a physical device test, not an AI model.
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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): Not applicable for a physical device test. The "ground truth" would be the direct measurement of chemical permeation.
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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; this is not an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable; this is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth here is the measured permeation time of chemotherapy drugs through the glove material, determined through validated laboratory testing methods (likely following ASTM standards for chemical permeation).
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The sample size for the training set: Not applicable; this is not an AI device.
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How the ground truth for the training set was established: Not applicable; this is not an AI device.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).