(58 days)
A device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim), meet all of the requirements of ASTM D 3577, Type 1. Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves. Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
The provided document is a 510(k) premarket notification for "Encore Orthopaedic Powder Free Surgical Gloves (Protein Labeling Claim)." The document outlines the device's characteristics and its compliance with established standards, but it does not describe a study in the traditional sense of a clinical trial or a formal performance study with a test set, ground truth experts, or multi-reader multi-case analysis.
Instead, the "study" demonstrating the device meets acceptance criteria is primarily an assertion of compliance with existing ASTM standards and FDA requirements for surgical gloves.
Here's a breakdown based on the provided input:
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 1 | Meets ASTM D 3577, Type 1 |
| Freedom from holes | Meets ASTM D 3577 & ASTM D 5151 | Meets ASTM D 3577 & ASTM D 5151 |
| Powder-Free | Meets described test in Attachment VI | Not more than 2 mg residue by mass |
| Protein Label Claim | Meets ASTM D 6124 | 50 micrograms or less of total water extractable protein per gram |
| Biocompatibility: Primary Skin Irritation in Rabbits | Passes | Passes |
| Biocompatibility: Guinea Pig Sensitization | Passes | Passes |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" for a research study. The performance is based on the inherent manufacturing and testing procedures required for compliance with ASTM standards. These standards typically involve sampling from production lots. The document implies that samples from the manufactured gloves were tested to ensure compliance.
- Data Provenance: Not explicitly stated. Likely refers to internal quality control and testing conducted by Ansell Perry during the manufacturing process. Retrospective, in that the samples were already produced, and data collected on them.
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" here is the established ASTM standards and FDA regulations for surgical gloves. Compliance is determined by direct measurement and testing against these predefined criteria, not by expert consensus on individual cases.
4. Adjudication method for the test set
- Not Applicable. As there's no "test set" requiring expert interpretation or consensus, no adjudication method was used. Performance is based on objective measurements against 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 medical device (surgical gloves), not an AI-powered diagnostic or assistive tool. No MRMC study was performed, and there is no AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device (surgical gloves). There is no "algorithm only" performance to evaluate. The device itself is the physical product.
7. The type of ground truth used
- Established Standards and Regulations: The ground truth used is objective; it's the specific numerical and qualitative requirements outlined in:
- ASTM D 3577 (Standard Specification for Rubber Surgical Gloves)
- ASTM D 5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D 6124 (Standard Test Method for Residual Powder on Medical Gloves)
- FDA hole requirements
- Specific thresholds for protein labeling claim (50 micrograms or less)
- Biocompatibility testing protocols (Primary Skin Irritation in Rabbits, Guinea Pig Sensitization).
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of this device. This is a manufactured product subject to quality control and compliance testing, not a machine learning model that requires training data.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, there is no ground truth established for one.
§ 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).