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510(k) Data Aggregation
(230 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, White, Tested for Use with Chemotherapy Drugs
This document is an FDA 510(k) clearance letter for "Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs" (K182176). It does not describe a study that uses artificial intelligence (AI) or machine learning, nor does it contain the specific types of information requested in your prompt regarding AI/ML device performance.
The document focuses on the device performance of surgical gloves in terms of their resistance to chemotherapy drug permeation. Based on the provided text, here’s an attempt to extract relevant information, but please note it does not align with the requested structure for AI/ML device studies:
1. A table of acceptance criteria and the reported device performance
The document presents the "Breakthrough Detection Time (Minutes)" for various chemotherapy drugs, which can be interpreted as the device's reported performance against a specified test. There isn't an explicit "acceptance criteria" listed in the way one might find for an AI algorithm's metric thresholds. However, regulatory bodies like the FDA typically have guidance or standards for what constitutes acceptable barrier protection for medical gloves against hazardous chemicals. For the purpose of this response, the reported breakthrough times are the "device performance."
| Test Chemotherapy Drug and Concentration | Reported Device Performance (Breakthrough Detection Time - Minutes) |
|---|---|
| Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) | 37.5 (47.8, 38.3, 37.5) |
| Cisplatin 1.0 mg/ml (1,000ppm) | >240 min |
| Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) | >240 min |
| Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) | >240 min |
| Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) | >240 min |
| Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) | >240 min |
| Fluorouracil 50.0 mg/ml (50,000 ppm) | >240 min |
| Ifosfamide 50.0 mg/ml (50,000 ppm) | >240 min |
| Methotrexate 25 mg/ml (25, 000 ppm) | >240 min |
| Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) | >240 min |
| Melphalan 5 mg/ml (5,000 ppm) | >240 min |
| Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) | >240 min |
| Thiotepa 10.0 mg/ml (10,000 ppm) | 58.3 (69.8, 68.6, 58.3) |
| Vincristine Sulfate 1.0 mg/ml (1,000 ppm) | >240 min |
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, nor the data provenance in terms of country of origin or retrospective/prospective nature. This information would typically be in a detailed test report, not the summary 510(k) clearance letter.
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 is not applicable to the type of device and testing described. The "ground truth" for glove permeation testing is established through standardized laboratory methods as defined by organizations like ASTM, not by expert human interpretation in the way AI/ML ground truth is established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept relates to human consensus in medical image interpretation, which is not relevant to chemical permeation testing of 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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" here is the measured breakthrough time of the chemotherapy drugs through the glove material, determined by quantitative laboratory testing using established standards (e.g., ASTM D6978, which is a common standard for this type of testing). This is a direct physical measurement.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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