(199 days)
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below.
Powder Free Blue Nitrile Examination Gloves - Tested for Use with 32 Chemotherapy Drugs and Fentanyl Citrate
The provided document is an FDA 510(k) clearance letter for "Powder Free Blue Nitrile Examination Gloves - Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate." This document primarily focuses on the substantial equivalence determination for a medical device (gloves) and its performance against chemical permeation for certain drugs.
The request asks for information typically found in the clinical validation of AI/ML-based medical devices or diagnostic tools. The provided document does not contain any information related to AI/ML device performance, test sets, ground truth establishment, expert adjudication, or MRMC studies. It is a regulatory clearance for a physical medical device (gloves) based on chemical permeation testing, not an AI system.
Therefore, I cannot provide the requested information. The document details chemical resistance and breakthrough times, not AI algorithm performance.
However, if we were to interpret the document's content as "acceptance criteria" and "device performance" in the context of the gloves' chemical resistance, the information could be presented as follows:
Acceptance Criteria and Device Performance (Based on Chemical Permeation Testing for Gloves)
Given the nature of the device (examination gloves) and the provided data, the "Acceptance Criteria" are implicitly derived from the testing standards for medical gloves' resistance to chemotherapy drugs and fentanyl citrate. The "Device Performance" refers to the measured breakthrough times. For regulated medical gloves, the expectation is generally to demonstrate sufficient resistance (i.e., a "breakthrough detection time" that meets or exceeds a certain threshold, often >240 minutes, indicating prolonged protection).
1. Table of Acceptance Criteria and Reported Device Performance
| Chemotherapy Drugs: | Acceptance Criteria (e.g., Target Breakthrough Time) | Reported Device Performance (Breakthrough Detection Time in Minutes) |
|---|---|---|
| 1. Carmustine (BCNU)3.3 mg/ml(3,300 ppm) | To be defined by standard (e.g., >x min) | 54.8 min |
| 2. Cisplatin 1.0 mg/ml (1,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 3. Cyclophosphamide (Cytoxan) 20mg/ml(20,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 4. Dacarbazine (DTIC)10.0 mg/ml(10,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 7. Fluorouracil 50.0 mg/ml (50,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 8. Ifosfamide 50.0 mg/ml (50,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 9. Methotrexate 25 mg/ml (25,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 10.Mitomycin C 0.5 mg/ml (500ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 11. Mitoxantrone 2.0 mg/ml (2,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 13. Thio-Tepa 10.0 mg/ml (10,000ppm) | To be defined by standard (e.g., >x min) | 46.9 min |
| 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 15. Amethopterin (Methotrexate) 25 mg/ml, (25,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 16. Bleomycin 15 mg/ml (15,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 17. Busulfan 6 mg/ml (6,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 18. Carboplatin 10 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 19. Cytarabine 100 mg/ml (100.000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 20. Daunorubicin 5 mg/ml (5,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 21. Doxetacel 10.0 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 22. Ellence 2 mg/ml (2,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 23. Fludarabine 25 mg/ml (25,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 24. Gemcitabine (Gemzar) 38 mg/ml (38,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 25. Idarubicin 1 mg/ml (1,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 26. Irinotecan 20.0 mg/ml (20,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 27. Mechloretamine HCL 1.0 mg/ml (1,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 28. Melphalan 5 mg/ml (5,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 29. Oxaliplatin 2.0 mg/ml (2,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 30. Rituximab 10 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 31. Trisonex 0.1 mg/ml (100 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| 32. Vinorelbin 10 mg/ml (10,000 ppm) | To be defined by standard (e.g., >x min) | >240 min |
| Fentanyl Citrate Injection 100 mcg/2ml | To be defined by standard (e.g., >x min) | >240min |
Note: The document highlights "Please Note that the following Drugs have extremely low permeation times : Carmustine : 54,8 minutes and Thio-Tepa: 46.9 minutes," indicating these may be areas where performance is lower relative to other tested drugs, but still acceptable under relevant standards for their intended use and risk mitigation strategies.
For the remainder of the questions, as stated, the provided document does not contain this information as it pertains to AI/ML device validation, not the direct chemical permeation testing of physical gloves.
- 2. Sample size used for the test set and the data provenance: Not applicable. This refers to the number of gloves tested for chemical resistance, not a dataset for an AI model. The document does not specify the exact number of gloves or samples, nor their country of origin for testing purposes. The testing is laboratory-based chemical permeation.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for chemical permeation is established by analytical chemistry methods (e.g., spectroscopy) that detect the breakthrough of a chemical through the glove material over time, not by human expert opinion.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Chemical permeation testing uses objective measurement, not human adjudication.
- 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 applies to diagnostic AI, not chemical resistance of gloves.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This applies to diagnostic AI, not chemical resistance of gloves.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for glove performance is the precise measurement of chemical permeation/breakthrough time under controlled laboratory conditions, typically following standards like ASTM D6978.
- 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML 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.