(114 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination in between patient and examiner. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Glove to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
| Chemotherapy Drug and Concentration | Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (BCNU), 3.3mg/ml | 27.8 |
| Cisplatin, 1.0mg/ml | >240 |
| Cyclophosphamide (Cytoxan), 20mg/ml | >240 |
| Cyclosporin A, 100 mg/ml | >240 |
| Dacarbazine (DTIC) 10g mg/ml | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | >240 |
| Etoposide (Toposar), 20mg/ml | >240 |
| Fluorouracil 50mg/ml | >240 |
| Paclitaxel (Taxol), 6.0mg/ml | >240 |
| Thiotepa, 10mg/ml | 77.9 |
| Vincristine Sulfate, 1.0mg/ml | >240 |
Please note that the following drug has extremely low permeation times: Carmustine (BCNU): 27.8 minutes.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a medical glove. It contains information about the device, its classification, and its intended use, particularly its resistance to chemotherapy drugs.
However, the document does not contain the kind of information needed to answer your questions about acceptance criteria for a device performance study, nor does it describe a study that proves the device meets acceptance criteria in terms of AI model performance, human reader improvement with AI, or ground truth establishment.
Specifically, the document lists specifications for the glove's resistance to various chemotherapy drugs (breakthrough detection time), which could be considered "acceptance criteria" for that specific characteristic. However, your detailed questions (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, etc.) are characteristic of the evaluation of an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. This document describes a traditional, non-AI medical device (a glove).
Therefore, I cannot provide the requested information from this document. The information you are asking for is typically found in clinical study reports or detailed technical documentation for AI/ML medical devices, not in a 510(k) clearance letter for a patient examination glove.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination 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). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.