(88 days)
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Elite™ Powder Free Polyurethane Synthetic Surgical Gloves are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies for the Elite™ Powder Free Polyurethane Synthetic Surgical Gloves:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | Meets ASTM D 3577, Type 2 | Meets ASTM D 3577, Type 2 |
| Freedom from holes | Meets ASTM D 5151 | Passes |
| Powder-Free | Meets ASTM D 6124 and not more than 2 mg residue by mass | Meets described test in Attachment VI, Not more than 2 mg residue by mass. |
| Biocompatibility - Primary Skin Irritation | Passes described test in Attachment VI | Passes |
| Biocompatibility - Guinea Pig Sensitization | Passes described test in Attachment VI | Passes |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not explicitly state the sample sizes used for the tests outlined (e.g., for freedom from holes, physical properties, biocompatibility). It only references that the device "meets" or "passes" the specified ASTM standards or internal tests. The data provenance is also not specified; it is implied to be from internal testing by Ansell Perry, Inc., in the United States, but no specific country of origin for the data is mentioned. The studies are assumed to be prospective, as they are part of a submission for market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish a "ground truth" for the test set in the way one might for diagnostic AI. The acceptance criteria are based on established ASTM standards for surgical gloves. The compliance with these standards would typically be assessed by internal quality control personnel and verified by a regulatory body like the FDA, rather than clinical experts establishing a ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring adjudication of expert opinions for a diagnostic outcome. The tests involve objective measurements against predefined standards (e.g., dimensions, physical properties, hole detection).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical glove, not a diagnostic or decision-support AI tool where human reader performance would be a relevant metric.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The performance evaluation presented is a standalone assessment of the device (the surgical glove) against established physical and chemical standards. There is no "human-in-the-loop" component in the testing of the glove's basic physical properties, freedom from holes, or biocompatibility.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established industry standards (ASTM) and defined test methods. For example:
- Dimensions and Physical Properties: Assessed against the specifications outlined in ASTM D 3577.
- Freedom from Holes: Assessed against the specifications in ASTM D 5151.
- Powder-Free: Assessed against ASTM D 6124 and a quantitative limit of 2mg residue by mass.
- Biocompatibility: Assessed against defined primary skin irritation and guinea pig sensitization tests.
8. The Sample Size for the Training Set
Not applicable. This document describes the testing and clearance of a medical device (surgical gloves), not an artificial intelligence algorithm or model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device submission.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).