(259 days)
This device is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The tested chemotherapy drugs are as follows: Carmustine (BCNU) 3.3 mg/mL, 23 minutes Cisplatin 1.0 mg/mL. >240 minutes Cyclophosphamide (Cytoxan) 20 mg/mL, >240 minutes Dacarbazine (DTIC) 10.0 mg/mL, >240 minutes Doxorubicin 2.0 mg/mL. >240 minutes Etoposide (Toposar) 20.0 mg/mL, >240 minutes Fluorouracil 50.0 mg/mL, >240 minutes Methotrexate 25 mg/mL, >240 minutes Paclitaxel (Taxol) 6.0 mg/mL, >240 minutes Thiotepa 10.0 mg/mL, 68.2 minutes Vincristine Sulfate 1.0 mg/mL, >240 minutes
WARNING: Not for use with Carmustine and Thiotepa.
Fentanyl tested as follows: Fentanyl citrate 100 mcg/2mL, >240 minutes
Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Violet Blue)
The document provided is an FDA clearance letter for a medical device: "Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl".
This document does not contain information about acceptance criteria or a study proving the performance of a device that uses AI/ML or requires ground truth establishment by experts.
The product being cleared is a nitrile examination glove, which is a physical medical device. The 'testing' referred to in the document is chemical resistance testing against specific chemotherapy drugs and fentanyl, not performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance (for an AI/ML device)
- Sample size for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method for the test set
- MRMC comparative effectiveness study or effect size
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document is a standard FDA 510(k) clearance letter confirming substantial equivalence to a predicate device, based on the testing of the glove's resistance to certain chemicals, and general device characteristics (e.g., non-sterile, powder-free). It does not involve complex data analysis, expert reads, or AI/ML algorithm validation as would be the case for an AI/ML-driven medical device.
§ 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.