(252 days)
A powder-free sterile surgeon's glove is a disposable device made of synthetic rubber intended to be worn on the hands of healthcare personnel as a barrier for protection against cross-contamination between the healthcare personnel and patient.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Chemotherapy Drug | Concentration | Average Breakthrough Detection Time (Minutes) |
|---|---|---|
| * Carmustine (BCNU) (3.3 mg/ml) | 27.3 | |
| Cisplatin (1.0 mg/ml) | > 240 | |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | > 240 | |
| Dacarbazine (10.0 mg/ml) | > 240 | |
| Doxorubicin Hydrochloride (2.0 mg/ml) | > 240 | |
| Etoposide (20.0 mg/ml) | > 240 | |
| Fluorouracil (50.0 mg/ml) | > 240 | |
| Ifosfamide (50.0 mg/ml) | > 240 | |
| Methotrexate (25.0 mg/ml) | > 240 | |
| Mitomycin C (0.5 mg/ml) | > 240 | |
| Mitoxantrone (2.0 mg/ml) | > 240 | |
| Paclitaxel (6.0 mg/ml) | > 240 | |
| * ThioTepa (10.0 mg/ml) | 26.9 | |
| Vincristine Sulfate (1.0 mg/ml) | > 240 |
*WARNING: Do not use Carmustine and ThioTepa.
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This document is a 510(k) premarket notification for a medical device, specifically Powder Free Nitrile Surgical Glove, Sterile, Tested For Use With Chemotherapy Drugs. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present a study proving the device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, many of the requested details about acceptance criteria, test sets, experts, and ground truth are not directly applicable to a 510(k) submission for a non-AI/ML medical device like a surgical glove.
However, based on the provided text, we can extract information regarding the device's performance against specific standards:
1. A table of acceptance criteria and the reported device performance.
The acceptance criteria here are implicitly defined by the ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The reported device performance is presented in the table provided in the "Indications for Use" section. For most drugs, the performance exceeds 240 minutes, with the notable exception of Carmustine and ThioTepa.
| Chemotherapy Drug | Concentration | Acceptance Criteria (Implied by standard and "good" performance for others) | Reported Device Performance (Average Breakthrough Detection Time (Minutes)) | Comments |
|---|---|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | --- | > 240 minutes (ideal, based on other drugs) | 27.3 | WARNING: Do not use |
| Cisplatin (1.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Dacarbazine (10.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Doxorubicin Hydrochloride (2.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Etoposide (20.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Fluorouracil (50.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Ifosfamide (50.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Methotrexate (25.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Mitomycin C (0.5 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Mitoxantrone (2.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| Paclitaxel (6.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
| ThioTepa (10.0 mg/ml) | --- | > 240 minutes (ideal, based on other drugs) | 26.9 | WARNING: Do not use |
| Vincristine Sulfate (1.0 mg/ml) | --- | > 240 minutes | > 240 | Acceptable performance |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the testing of the chemotherapy drug permeation. It is a standard test defined by ASTM D6978, which would outline the appropriate sample size. The provenance of the data (country of origin, retrospective/prospective) is not mentioned. This testing is typically prospective, performed on newly manufactured batches of gloves.
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)
This question is not applicable. The "ground truth" here is the measured breakthrough time of chemotherapy drugs through the glove material, determined by laboratory testing according to ASTM D6978. It does not involve expert medical opinion or consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used when human judgment is involved in establishing a ground truth, such as in clinical studies with expert readers. Here, the "truth" is an objective measurement from a standardized test.
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
This question is not applicable. This document is for a physical medical device (surgical gloves) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This document is for a physical medical device (surgical gloves) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used is objective measurement based on a standardized laboratory test (ASTM D6978). The breakthrough detection time is a direct measurement of how long it takes for a chemotherapy drug to permeate through the glove material.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of testing the performance of a physical device like a surgical glove against a standardized permeation test.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set mentioned in this context.
§ 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).