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510(k) Data Aggregation
(223 days)
Powder free vinyl patient examination glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06.
Here's a breakdown of the acceptance criteria and study information based on the provided text, structured to answer your questions:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM standard D 5250-06 | Meets |
| Physical Properties | ASTM standard D 5250-06 | Meets |
| Freedom from pinholes | 21 CFR 800.20 | Meets |
| Powder Residual | ASTM standard D 5250-06 and D6124-06 | <2mg/glove |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in rabbits | Passes (Not a Primary Skin Irritation) |
| Biocompatibility (Dermal Sensitization) | Dermal sensitization in the guinea pig | Passes (Not a Dermal Sensitization) |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective) in the context of device performance or clinical studies. The performance is reported against established standards without detailing the specific methodology or a separate test dataset used to achieve these "Meets" or "Passes" statements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document does not describe the use of experts to establish ground truth for a test set in the context of this device's performance evaluation. The evaluation relies on meeting established ASTM and CFR standards, which are objective measurements.
4. Adjudication method for the test set
Not applicable. There is no mention of a test set requiring adjudication in the context of this submission. The device's performance is gauged against pre-defined, objective standards.
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 device is a patient examination glove, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a patient examination glove and does not involve any algorithm or AI component.
7. The type of ground truth used
The "ground truth" for the device's performance is based on established industry standards and regulatory requirements. Specifically:
- ASTM standard D 5250-06 for dimensions and physical properties.
- 21 CFR 800.20 for freedom from pinholes.
- ASTM standard D 5250-06 and D6124-06 for powder residual.
- ISO10993-10 for biocompatibility (Primary Skin Irritation and Dermal Sensitization).
These are objective, measurable criteria, not expert consensus, pathology, or outcomes data in the typical sense of a clinical study for complex medical devices.
8. The sample size for the training set
Not applicable. The document does not describe any "training set" as this is a medical device (patient examination glove) and not an AI or machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no training set involved with this device.
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