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510(k) Data Aggregation
(102 days)
The nitrile powder free patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition to routine examination glove's intended use, the gloves are Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid.
KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are 245mm in length and dark magenta in color, and are single use only, non-sterile, disposable gloves. The powder-free gloves are made of synthetic copolymers of acrylonitrile and butadiene. The product will be sold as a disposable and non-sterile product in extrasmall, small, medium, large, and extra-large sizes.
The provided document describes the safety and performance testing of KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves. However, this is a 510(k) premarket notification for a medical glove, not an AI/ML medical device. Therefore, the information required to answer the specific questions about acceptance criteria for an AI/ML device, such as sample sizes for test/training sets, data provenance, expert ground truth establishment, or clinical study design (MRMC), is not present in this document.
The document focuses on non-clinical performance tests of the physical and chemical properties of the gloves.
Here's an attempt to extract relevant "acceptance criteria" and "reported performance" based on the provided document, framed as close as possible to the request, while highlighting the limitations for an AI/ML context.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is for a physical medical device (gloves), the "acceptance criteria" are defined by recognized standards (e.g., ASTM, ISO) for physical properties, chemical resistance, and biocompatibility.
| Test Category | Acceptance Criteria (from Standards) | Reported Device Performance (KIMTECH™ Polaris™ Nitrile Gloves) |
|---|---|---|
| Dimensions | Length: ≥ 230 mmWidth (mean): ≥ 70 mmFinger/Palm Thickness: ≥ 0.05 mm | Meets requirements (All sizes comply with length, width, and thickness dimensions) |
| Physical Properties | Before Aging:Tensile Strength: ≥ 14 MPaUltimate Elongation: ≥ 500%After Aging:Tensile Strength: ≥ 14 MPaUltimate Elongation: ≥ 400% | Meets requirements (Complies both before and after accelerated aging) |
| Freedom from Pinholes | ASTM D6319 G1, AQL 2.5 (7 Accept, 8 Reject)No leakage | Pass (AQL 0.65) - Note: Subject glove AQL is tighter than the standard, indicating better performance. |
| Powder-Free | ≤ 2 mg / glove | Passed at < 2mg / glove in accordance with the standard |
| Biocompatibility - Irritation | Primary Irritation Index ≤ 0.4 (ISO 10993, Part 23) | Under the conditions of the study, the device is not an irritant (Passed) |
| Biocompatibility - Systemic Toxicity | No animals treated with test extracts exhibit greater reaction than control animals (ISO 10993, Part 11) | No evidence of Acute systemic toxicity (Passed) |
| Biocompatibility - Skin Sensitization | Grade < 1 (ISO 10993, Part 10) | Under the conditions of the study, the device is not a sensitizer (Passed) |
| Chemotherapy Drug Permeation | No signs of breakthrough up to 240 minutes for most drugs (ASTM D6978-05). Drugs with lower permeation times must be specified. | Breakthrough measured for up to 240 minutes for most of the 24 chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl in Simulated Gastric Acid. Exceptions: - Carmustine: 76.6 minutes - ThioTEPA: 78.5 minutes (both less than 240 min, and subject to caution statements) |
The following information typically required for an AI/ML device is NOT found in this document because it describes a physical medical glove:
- Sample size used for the test set and the data provenance: Not applicable. For gloves, testing involves physical samples tested according to standards. The document lists the ASTM and ISO standards used for testing the gloves. There's no "test set" of data in the AI/ML sense. Data provenance would refer to the origin of the physical glove samples tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties and chemical resistance is established by laboratory measurements against defined standards, not human expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept pertains to human interpretation/labeling of data in AI/ML studies.
- 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 strictly for AI/ML performance studies involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" equates to the results of standardized, objective laboratory tests for physical and chemical properties (e.g., tensile strength, resistance to permeation, absence of pinholes, etc.) and biocompatibility studies.
- The sample size for the training set: Not applicable. This device does not use an AI/ML model that requires training data.
- How the ground truth for the training set was established: Not applicable. No training set is used.
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