(150 days)
This surgeon's glove is a disposable device made of synthetic polychloroprene intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination. These gloves are tested for use with chemotherapy drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
This surgeon's glove is a disposable device made of synthetic polychloroprene.
The provided text describes the regulatory clearance for a surgical glove and its testing against chemotherapy drugs. It does not describe an AI medical device or a study involving human or AI readers. Therefore, I cannot fulfill the request for information on acceptance criteria and study details related to an AI device.
The document is a 510(k) clearance letter for a medical device: "SensiCare® Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)". The "acceptance criteria" and "device performance" in this context refer to the glove's resistance to permeation by chemotherapy drugs, as outlined in ASTM D6978-05.
Here's the relevant information extracted from the provided text, formatted to match parts of your request where applicable, noting that much of your requested AI-specific information is not present:
1. Table of acceptance criteria and the reported device performance
| Chemotherapy Drug | Concentration | Acceptance Criteria (Permeation Breakthrough Detection Time) | Reported Device Performance (Breakthrough Detection Time) |
|---|---|---|---|
| Bleomycin | 15 mg/ml | >240 minutes | >240 minutes |
| Busulfan | 6 mg/ml | >240 minutes | >240 minutes |
| Carboplatin | 10.0 mg/ml | >240 minutes | >240 minutes |
| Carmustine (BCNU) | 3.3 mg/ml | A minimum acceptable breakthrough time (not explicitly stated, but implied by the reported value) | 36.3 (36.3, 37.4, 38.4) minutes |
| Cisplatin | 1.0 mg/ml | >240 minutes | >240 minutes |
| Cyclophosphamide (Cytoxan) | 20 mg/ml | >240 minutes | >240 minutes |
| Dacarbazine (DTIC) | 10.0 mg/ml | >240 minutes | >240 minutes |
| Doxorubicin Hydrochloride | 2.0 mg/ml | >240 minutes | >240 minutes |
| Epirubicin (Ellence) | 2 mg/ml | >240 minutes | >240 minutes |
| Etoposide (Toposar) | 20.0 mg/ml | >240 minutes | >240 minutes |
| Fludarabine | 25.0 mg/ml | >240 minutes | >240 minutes |
| Fluorouracil | 50.0 mg/ml | >240 minutes | >240 minutes |
| Idarubicin | 1.0 mg/ml | >240 minutes | >240 minutes |
| Ifosfamide | 50.0 mg/ml | >240 minutes | >240 minutes |
| Mechlorethamine HCl | 1.0 mg/ml | >240 minutes | >240 minutes |
| Melphalan | 5 mg/ml | >240 minutes | >240 minutes |
| Methotrexate | 25 mg/ml | >240 minutes | >240 minutes |
| Mitomycin C | 0.5 mg/ml | >240 minutes | >240 minutes |
| Mitoxantrone | 2.0 mg/ml | >240 minutes | >240 minutes |
| Paclitaxel (Taxol) | 6.0 mg/ml | >240 minutes | >240 minutes |
| Paraplatin | 10 mg/ml | >240 minutes | >240 minutes |
| Rituximab | 10 mg/ml | >240 minutes | >240 minutes |
| Thiotepa | 10.0 mg/ml | A minimum acceptable breakthrough time (not explicitly stated, but implied by the reported value) | 49.2 (56.0, 49.2, 78.5) minutes |
| Vincristine Sulfate | 1.0 mg/ml | >240 minutes | >240 minutes |
CAUTION: The document specifically highlights: "Testing showed a minimum breakthrough time of 36.3 minutes with Carmustine and 49.2 minutes for Thiotepa." This suggests these values met an implicit acceptance criterion for these specific drugs, as they did not achieve the ">240 minutes" seen with most other drugs.
Regarding the AI-specific questions (2-9), the provided text does not contain any information as it pertains to a physical medical device (surgical gloves) and not an AI/software device:
- 2. Sample size used for the test set and the data provenance: Not applicable. The testing is for physical properties of a glove, following ASTM D6978-05.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth is established by laboratory testing procedures as per ASTM D6978-05.
- 4. Adjudication method for the test set: Not applicable.
- 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: Not applicable. This device is not an AI algorithm for reading medical cases.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: For this device, the "ground truth" would be the experimentally determined breakthrough times by a recognized standard (ASTM D6978-05).
- 8. The sample size for the training set: Not applicable. This is not a machine learning model.
- 9. 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).