(50 days)
Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloyes were tested for use with cherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The document describes the acceptance criteria and performance of a "Sterile Powder Free Nitrile Surgical Glove, White Colored, Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim." This is a medical device, not an AI/ML device, and thus the acceptance criteria and study data provided are for a physical product, not an algorithm's performance.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, and how ground truth for training set was established) are not applicable to this type of device and are not provided in the document.
1. A table of acceptance criteria and the reported device performance:
| Chemotherapy Drug and Concentration | Acceptance Criterion: Minimum Breakthrough Detection Time (minutes) | Reported Device Performance: Minimum Breakthrough Detection Time (minutes) |
|---|---|---|
| Carmustine (BCNU) (3.3 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | 78.4 |
| Cisplatin (1.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Cytarabine(100 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Etoposide (20.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Fluorouracil (50.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Ifosfamide (50.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Methotrexate (25.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Mitomycin C (0.5 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Mitoxantrone (2.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
| Thiotepa (10.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | 118.8 |
| Vincristine Sulfate (1.0 mg/ml) | Not explicitly stated as an "acceptance criterion" in this document, but implies a desired performance level based on ASTM D6978-05. | >240 |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the performance criteria is described as follows:
- Methodology: "These gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2013) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs." This standard practice outlines the procedure for testing the resistance of medical gloves to permeation by chemotherapy drugs.
Details specific to AI/ML device studies (as requested in the prompt but not applicable here):
- Sample size used for the test set and the data provenance: Not applicable. For this physical glove, the "test set" would be the number of gloves tested and the specific conditions per the ASTM standard. This information is not provided beyond the reference to the standard.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical glove's chemical resistance is established by laboratory measurements according to a standard.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance of the chemotherapy drug permeation is established through laboratory testing following the specific protocols of ASTM D6978-05 (Reapproved 2013). This involves precise measurement of breakthrough detection time.
- The sample size for the training set: Not applicable. This is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
§ 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).