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510(k) Data Aggregation
(30 days)
A powder-free, nitrile examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
These gloves were tested for use with chemotherapy drugs, as per ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
| Drug Name | Concentration Tested | Minimum Breakthrough Detection Time (Minutes) |
|---|---|---|
| Cyclophosphamide (Cytoxan) | 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 |
| Doxorubicin Hydrochloride | 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 |
| Etoposide (Toposar) | 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 |
| Fluorouracil | 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 |
| Paclitaxel (Taxol) | 6.0 mg/ml (6,000 ppm) | No breakthrough up to 240 |
| Cisplatin | 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 |
| Dacarbazine (DTIC) | 10.0 mg/ml (10,000 ppm) | No breakthrough up to 240 |
| Ifosfamide | 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 |
| Mitoxantrone | 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 |
| Vincristine Sulfate | 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 |
| Carmustine (BCNU) | 3.3 mg/ml (3,300 ppm) | No breakthrough up to 14.3 * |
| Thiotepa | 10.0 mg/ml (10,000 ppm) | No breakthrough up to 48.2 * |
*Please note that Carmustine and Thiotepa have low permeation times. Do not use with Carmustine and/or Thiotepa.
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The provided document is an FDA 510(k) clearance letter for Nitrile Exam Gloves, including an "Indications for Use" section that details chemotherapy drug testing results. This document does not contain information relevant to an AI/ML powered medical device, and therefore, does not provide the information requested in the prompt regarding acceptance criteria and a study proving a device meets those criteria.
Specifically, the document discusses:
- The review of a 510(k) premarket notification for Nitrile Exam Gloves.
- The device's classification as Class I, reserved.
- General controls provisions and other regulatory requirements for the device.
- The "Indications for Use," which states the gloves are disposable devices intended for medical purposes to prevent contamination.
- Crucially, it includes testing results for chemotherapy drug permeation according to ASTM D6978-05 (2019) demonstrating "No breakthrough up to 240 minutes" for most listed drugs, and specific lower breakthrough times for Carmustine and Thiotepa, with a cautionary note not to use the gloves with these two drugs.
The prompt, however, asks for details typically associated with the validation of an AI/ML-powered medical device, such as:
- Acceptance criteria and device performance for an AI/ML algorithm.
- Sample sizes for test sets (implying data like images or patient records).
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- MRMC studies and human reader improvement with AI assistance.
- Standalone algorithm performance.
- Type of ground truth (e.g., pathology, outcomes data).
- Training set sample size and ground truth establishment method.
Since the provided text pertains to regulatory clearance for physical medical devices (nitrile gloves) and their performance against chemical permeation, it does not offer any of the data points needed to answer the prompt's specific questions about AI/ML device validation.
Therefore, I cannot fulfill the request using only the provided input.
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