Search Results
Found 1 results
510(k) Data Aggregation
(51 days)
A PATIENT EXAMINATION GLOVES IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80LYZ, and meets all requirements of ASTM Standard D5250-06
The provided text describes a 510(k) submission for "Disposable Vinyl Examination Glove, Powdered" and does not contain information about a study proving a device meets acceptance criteria using AI or machine learning. The submission is for a medical glove, which is a physical product, not a software or AI-based device.
Therefore, the requested information fields related to AI/ML device studies (such as sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.
However, I can extract the acceptance criteria and performance related to the physical glove as described in the 510(k) summary.
Acceptance Criteria and Device Performance for Xuzhou Full Sun Medical Products Ltd.'s Disposable Vinyl Examination Glove, Powdered
The device is a physical product (medical glove), and its acceptance criteria and performance are based on established ASTM standards and FDA requirements for such devices. The document does not describe AI/ML performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Performance Metric | Reported Device Performance |
|---|---|---|
| ASTM D5250-06 | Physical and Dimensions Testing | Meets all requirements, Inspection level S-2, AQL 4.0 |
| FDA 1000 ml Watertight Test (based on ASTM D-5151-06) | Pinhole Rate | Meets requirements, AQL 2.5, Inspection level I |
| Biocompatibility (Primary Skin Irritation) | Skin Irritation | No primary skin irritant reactions |
| Biocompatibility (Skin Sensitization) | Skin Sensitization | No sensitization reactions (allergic contact dermatitis) |
2. Sample size used for the test set and the data provenance
- Physical and Dimensions Testing: Inspection level S-2, AQL 4.0. The exact sample size (number of gloves tested) is not specified but is implied by the AQL (Acceptance Quality Limit) and inspection level, which are standard statistical sampling plans.
- FDA 1000 ml Watertight Test: AQL 2.5, Inspection level I. The exact sample size is not specified but is implied by the AQL and inspection level.
- Biocompatibility Testing: The number of subjects or samples used for primary skin irritation and sensitization testing is not specified in this summary.
- Data Provenance: The tests were performed by the manufacturer, Xuzhou Full Sun Medical Products Ltd. (China). The data is presented retrospectively as part of the 510(k) submission for marketing clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for a medical glove involves physical properties and biological reactions, which are determined by standardized laboratory tests and assessments, not expert consensus on interpretations like with AI/imaging.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of interpretations. Test results are objective measurements against predefined 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 is a physical product (glove), not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical product, not an algorithm.
7. The type of ground truth used
- Physical and Dimensions: The truth is defined by the specifications and tolerances outlined in ASTM D5250-06.
- Pinhole Detection: The truth is defined by the absence of leaks as per the FDA 1000 ml Watertight Test based on ASTM D-5151-06.
- Biocompatibility: The truth is defined by the absence of observable adverse reactions (irritation, sensitization) in standard biological tests.
8. The sample size for the training set
Not applicable. This is a manufactured product, referring to "training set" doesn't apply in the context of AI/ML. Manufacturing processes are "trained" through quality control and process adjustments, but not in the AI sense.
9. How the ground truth for the training set was established
Not applicable. Again, this refers to AI/ML context, which is not relevant here. Manufacturing quality is maintained through adherence to Good Manufacturing Practices (GMP) and ongoing quality control, referencing the same ASTM standards.
Ask a specific question about this device
Page 1 of 1