(79 days)
This surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs and its permeation time is listed as below.
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatius Potential and Tested for Use with Chemotherapy Drugs
This document is a 510(k) clearance letter from the FDA for Polychloroprene Powder Free Sterile Surgical Gloves and does not contain information about an AI/ML device. Therefore, it does not provide acceptance criteria or a study proving device performance as typically expected for AI/ML medical devices.
The document focuses on the regulatory clearance of a physical medical device (surgical gloves) and confirms its substantial equivalence to previously marketed devices. The "Indications for Use" section lists the device's intended purpose and data on the glove's permeation time for various chemotherapy drugs, which are essential for its specific indication as "Tested for Use with Chemotherapy Drugs."
To address your request, I will explain why your questions cannot be answered by the provided text.
Based on the provided document, the device in question is Polychloroprene Powder Free Sterile Surgical Gloves, which is a physical medical device, not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, do not apply to this document.
The document focuses on the FDA's 510(k) clearance for this type of medical glove, specifically highlighting its "Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs."
Here's an analysis based on the information provided, tailored to what can be extracted for a physical device:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria for the chemotherapy drug permeation would be that the breakthrough detection time meets or exceeds certain standards for safe handling. The reported performance is directly presented in the table within the "Indications for Use" section.
| Test Chemotherapy Drug and Concentration | Acceptance Criteria (Implied: High Breakthrough Time) | Reported Breakthrough Detection Time (Minutes) |
|---|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | (Specific threshold not explicitly stated by FDA, but should allow reasonable handling time) | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | >240 min | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | >240 min | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 min | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 min | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | >240 min | >240 min |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | >240 min | >240 min |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | >240 min | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | >240 min | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 min | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | >240 min | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 min | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | (Specific threshold not explicitly stated by FDA, but should allow reasonable handling time) | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 min | >240 min |
Note: The implied acceptance criterion for most drugs is ">240 min", as the glove met this for the majority. For Carmustine and Thiotepa, the values are lower, and the document explicitly cautions about these drugs having "much lower permeation times." This suggests that even these lower times were deemed acceptable within the context of their use, with the caveat for users.
2. 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 in the document. For a physical device like gloves, the "test set" would refer to the number of gloves or samples tested for permeation. The document does not specify this, nor does it provide details on data provenance (e.g., retrospective or prospective) as that's more relevant to clinical studies for performance claims, rather than material properties.
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 as the ground truth for glove permeation is established through laboratory testing (e.g., using ASTM standards), not by human experts interpreting clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, which are not relevant to the chemical permeation testing of the surgical gloves.
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 as the device is a physical surgical glove, not an AI-assisted diagnostic or predictive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a physical surgical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the glove's performance related to chemotherapy drug permeation would be established through laboratory testing using standardized methods, likely following ASTM guidelines (e.g., ASTM F739), which measure the breakthrough time of specific chemicals through a barrier material. This is a direct measurement, not subject to expert consensus or pathology in this context.
8. The sample size for the training set
This question is not applicable as the device is a physical product and does not involve AI/ML models that require a training set.
9. How the ground truth for the training set was established
This question is not applicable for the same reason as point 8.
§ 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).