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510(k) Data Aggregation
(27 days)
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a nonsterile disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. It is also tested to be used against Chemotherapy Drugs and Fentanyl Citrate.
Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) is a disposable single-use, non- sterile, blue-colored and powder-free examination glove made from nitrile latex. Gloves meet the specification of ASTM D6319-19 and have been tested for resistance to permeation by chemotherapy drugs and fentanyl citrate as per ASTM D6978-05(2019).
The provided text is a 510(k) Premarket Notification from the FDA for a medical device: "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)".
This document does not describe the acceptance criteria or a study related to an AI/ML powered device. Instead, it details the testing and comparison of a physical medical device (gloves) against a predicate device, focusing on material properties, performance standards (like resistance to permeation by chemotherapy drugs and fentanyl citrate), and biocompatibility.
Therefore, I cannot extract the requested information regarding AI/ML device acceptance criteria or related studies from this document. The questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets are not applicable to the type of device described in this FDA submission.
However, I can extract the acceptance criteria and performance data for the physical device as described:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary performance criterion for the "Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)" is its resistance to permeation by chemotherapy drugs and fentanyl citrate. The acceptance criterion is a minimum breakthrough detection time for each substance.
| Chemotherapy Drug and Concentration | Acceptance Criteria (Minimum Breakthrough Detection Time in Minutes) | Reported Device Performance (Minimum Breakthrough Detection Time in Minutes) |
|---|---|---|
| Carmustine, 3.3 mg/ml | N/A (Tested to determine time) | 10.2 |
| Cisplatin, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Cyclophosphamide, 20.0 mg/ml | N/A (Tested to determine time) | >240 |
| Dacarbazine, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Doxorubicin Hydrochloride, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Etoposide, 20.0 mg/ml | N/A (Tested to determine time) | >240 |
| Fluorouracil, 50.0 mg/ml | N/A (Tested to determine time) | >240 |
| Methotrexate, 25.0 mg/ml | N/A (Tested to determine time) | >240 |
| Mitomycin C, 0.5 mg/ml | N/A (Tested to determine time) | >240 |
| Paclitaxel, 6.0 mg/ml | N/A (Tested to determine time) | >240 |
| Thiotepa, 10.0 mg/ml | N/A (Tested to determine time) | 30.2 |
| Vincristine Sulfate, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Bleomycin Sulfate, 15.0 mg/ml | N/A (Tested to determine time) | >240 |
| Bortezomib, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Busulfan, 6.0 mg/ml | N/A (Tested to determine time) | >240 |
| Carboplatin, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Chloroquine, 50.0 mg/ml | N/A (Tested to determine time) | >240 |
| Cyclosporin A, 100.0 mg/ml | N/A (Tested to determine time) | >240 |
| Cytarabine, 100.0 mg/ml | N/A (Tested to determine time) | >240 |
| Daunorubicin, 5.0 mg/ml | N/A (Tested to determine time) | >240 |
| Docetaxel, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Epirubicin, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Fludarabine, 25.0 mg/ml | N/A (Tested to determine time) | >240 |
| Gemcitabine, 38.0 mg/ml | N/A (Tested to determine time) | >240 |
| Idarubicin, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Ifosfamide, 50.0 mg/ml | N/A (Tested to determine time) | >240 |
| Irinotecan, 20.0 mg/ml | N/A (Tested to determine time) | >240 |
| Mechlorethamine HCI, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Melphalan, 5.0 mg/ml | N/A (Tested to determine time) | >240 |
| Mitoxantrone, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Oxaliplatin, 2.0 mg/ml | N/A (Tested to determine time) | >240 |
| Paraplatin, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Retrovir, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Rituximab, 10.0 mg/ml | N/A (Tested to determine time) | >240 |
| Topotecan, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Trisenox, 1.0 mg/ml | N/A (Tested to determine time) | >240 |
| Fentanyl Citrate Injection, 100mcg/2ml | N/A (Tested to determine time) | >240 |
Additional Acceptance Criteria and Performance Data (already met by similar predicate device or physical properties):
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Freedom from holes | AQL 1.5% (Meets ASTM D5151-19 and ASTM D6319-19) | Pass |
| Residual Powder | Average < 2 mg/glove (Meets ASTM D6319-19 & ASTM D6124-06 (2017)) | Pass |
| Dimensional Conformance | Conforms to ASTM D6319 width, thickness, and length requirements for XS, S, M, L, and XL; AQL 4% | Pass |
| Tensile Performance | Tensile Strength Before Aging: $\ge$ 14 MPa; Ultimate Elongation Before Aging: $\ge$ 500 %; Tensile Strength After Aging: $\ge$ 14 MPa; Ultimate Elongation After Aging: $\ge$ 400 % (Meets ASTM D6319-19); AQL 4% | Pass |
| Biocompatibility: Skin Irritation | Not an irritant (Under the conditions of the study, per ISO 10993-10) | Pass |
| Biocompatibility: Skin Sensitization | Not a sensitizer (Under the conditions of the study, per ISO 10993-10) | Pass |
| Biocompatibility: Acute Toxicity | No acute toxicity (Under the conditions of the study, per ISO 10993-11) | Pass |
2. Sample size used for the test set and the data provenance:
The document mentions that "Fentanyl citrate permeation testing was performed on the subject glove using the ASTM D6978 method." While it confirms the test was done, it does not specify the sample size for the test set used for the permeation testing.
The data provenance is from Malaysia, where the manufacturer (Hartalega NGC Sdn. Bhd.) is located. The study appears to be prospective testing conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for this device is established through physical and chemical testing against industry standards (ASTM D6978, D6319, D5151, D6124, ISO 10993) rather than expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this involves standardized physical and chemical laboratory testing, not human expert 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 is a medical glove, not an AI/ML-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical glove, not an AI/ML-powered device.
7. The type of ground truth used:
The ground truth is established through standardized laboratory testing protocols (ASTM D6978-05, D6319-19, D5151-19, D6124-06(R17), ISO 10993-10, ISO 10993-11) and the measured chemical permeation times and physical properties of the gloves.
8. The sample size for the training set:
Not applicable. This is a medical glove, not an AI/ML-powered device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device.
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