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510(k) Data Aggregation
(52 days)
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This device also provides protection against exposure to certain chemotherapy drugs.
Powder Free Nitrile Examination Gloves, Tested For Use With Chemotherapy Drugs (Blue)
The provided document describes the FDA clearance (K101293) for "Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue)". This document is a 510(k) clearance letter and an accompanying "Indications for Use" form. It is not a study report for an AI device.
Therefore, most of the requested information regarding acceptance criteria and studies for an "AI device" cannot be extracted from this document, as it pertains to a physical medical device (examination gloves) and not software or an AI algorithm.
However, I can extract the "performance" data that was submitted to support the claim that the gloves provide "protection against exposure to certain chemotherapy drugs." This is presented as "Breakthrough detection time in minutes" for various chemotherapy drugs.
Here's the closest representation of the requested information based on the provided document:
Acceptance Criteria and Device Performance (for Nitrile Examination Gloves)
This document does not specify "acceptance criteria" in a typical numerical threshold format as would be expected for an AI algorithm. Instead, it presents the "Breakthrough detection time" as the performance metric for each listed chemotherapy drug. While the specific acceptance criterion is not explicitly stated as a minimal breakthrough time, the implication is that longer breakthrough times are better, and certain drugs exceeded 240 minutes, indicating strong protection. The critical warning for Carmustine indicates that its breakthrough time of 1.21 minutes is unacceptable for protection against that specific drug.
| Acceptance Criterion (Implicit) | Reported Device Performance (Breakthrough detection time in minutes) |
|---|---|
| Sufficient protection against chemotherapy drugs (longer time is better, > 240 min appears desirable, 240 | |
| Etoposide (Toposar) (20.0 mg / ml) | > 240 |
| Cyclophosphamide (Cytoxan) (20.0 mg / ml) | > 240 |
| Mitomycin C (0.5 mg / ml) | > 240 |
| Methotrexate (25.0 mg / ml) | > 240 |
| Paclitaxel (Taxol) (6.0 mg / ml) | > 240 |
| Doxorubicin Hydrochloride (2.0 mg / ml) | > 240 |
| Dacarbazine (DTIC) (10.0 mg / ml) | > 240 |
| Cisplatin (1.0 mg / ml) | > 240 |
| Mitoxantrone (2.0 mg / ml) | > 240 |
| Ifosfamide (50.0 mg / ml) | > 240 |
| Vincristine Sulfate (1.0mg / ml) | > 240 |
| Warning: Do Not Use with Carmustine | Indicates failure to meet protective needs |
Information Not Applicable or Not Provided in the Document (as it's not an AI device study):
- Sample sized used for the test set and the data provenance: Not applicable to a physical glove. The testing methodology for chemotherapy drug permeation is not detailed beyond the results.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemotherapy permeation is established through laboratory testing (e.g., using a permeation cell, as per ASTM standards).
- Adjudication method for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI. For the gloves, the "ground truth" is the empirically measured breakthrough time of the drug through the glove material in a controlled laboratory setting.
- The sample size for the training set: Not applicable (no AI training set).
- How the ground truth for the training set was established: Not applicable (no AI training set).
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