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510(k) Data Aggregation
(99 days)
The Halyard® Black-Orange Powder-Free Nitrile Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Halyard® Black-Orange Powder-Free Nitrile Exam Gloves are disposable, black-colored on the grip side and orange colored on the donning side, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are chlorinated on the donning side and are packed in a cardboard dispenser box.
The document describes the testing performed for the Halyard® Black-Orange Powder-Free Nitrile Exam Glove to demonstrate its substantial equivalence to a predicate device. This is not a study about an AI-powered device, but rather a medical device (exam glove) being evaluated against established standards. Therefore, some of the requested information regarding AI-specific studies (e.g., sample size for training set, number of experts for ground truth, MRMC study, standalone performance) is not applicable.
Here's the information that can be extracted from the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves | Meets the 2.5 AQL requirement in the standards for leakage. | "Testing of the subject device shows it meets the 2.5 AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard. PASS" |
| ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Applications | Holes: AQL 2.5% Length: ≥230 mm Width: 85-105mm Finger thickness: ≥0.050mm Palm thickness: ≥0.050mm Unaged Tensile: ≥14 MPa Unaged Elongation: ≥500% Aged Tensile: ≥14 MPa Aged Elongation: ≥400% Powder: ≤2mg/glove | Holes: AQL 1.0% Length: 230-258 mm Width: 85-105mm Finger thickness: 0.06-0.09mm Palm thickness: 0.05-0.07mm Unaged Tensile: ≥16 MPa Unaged Elongation: ≥500% Aged Tensile: ≥15 MPa Aged Elongation: ≥450% Powder: ≤2mg/glove "The physical dimensions of the subject device are within the limits of the standard and the physical properties of the subject device meet the requirements for tensile strength and elongation in the standard. Therefore the device meets the acceptance criteria of the standard. PASS" |
| ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves | < 2 mg maximum powder per glove (powder-free limit). | "Residual powder on the subject device is within the powder-free limit of < 2 mg maximum powder per glove and meets the acceptance criteria for powder-free. PASS" |
| ISO 10993-10 Biological evaluation of medical devices - Tests for Irritation | No erythema/edema up to 72 hours post exposure. | "Erythema/edema was negligible. Meets acceptance criteria. PASS" |
| ISO 10993-10 Biological evaluation of medical devices - Tests for Skin Sensitization | No evidence of delayed dermal contact sensitivity at 24 and 48 hours post injection. | "Not a sensitizer under conditions of the study. Meets acceptance criteria. PASS" |
| ISO 10993-11 Biological evaluation of medical devices - Tests for Systemic Toxicity | No signs of systemic toxicity up to 72 hours post injection. | "No systemic toxicity observed. Meets acceptance criteria. PASS" |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document does not explicitly state the specific sample sizes used for each test. Standards like ASTM and ISO often specify minimum sample sizes for material testing, but these are not enumerated in this summary.
- Data Provenance: The tests were conducted on the "subject device" (Halyard® Black-Orange Powder-Free Nitrile Exam Glove), implicitly meaning the data is prospective, generated from the manufacturing and testing of this specific product. The country of origin of the data is not specified but would typically be where the manufacturer (Halyard Health, Alpharetta, GA, USA) conducts its testing or outsources it.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI/diagnostic device where expert establishment of ground truth is relevant. The "ground truth" for the performance of the exam glove is defined by the objective physical and chemical properties and biological responses measured against established medical device standards (ASTM, ISO).
4. Adjudication method for the test set
- Not Applicable. As this is not an AI/diagnostic device, an adjudication method for a test set (e.g., 2+1, 3+1) is not relevant. The results are obtained through standardized laboratory testing procedures.
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
- No. This is not an AI-powered device, so an MRMC comparative effectiveness study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not an AI-powered device, so standalone algorithm performance is not applicable.
7. The type of ground truth used
- The "ground truth" is based on established regulatory standards and scientifically validated test methods (ASTM D5151, ASTM D6319, ASTM D6124, ISO 10993-10, ISO 10993-11) for medical exam gloves. These standards define the acceptable physical properties, barrier integrity, and biocompatibility.
8. The sample size for the training set
- Not Applicable. This is not an AI-powered device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI-powered device that requires a training set or ground truth for such.
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