(13 days)
Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect surgical wounds from contamination.
Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.
The provided text describes the acceptance criteria and a study for the "Micro-Touch® Powder Free Latex Surgical Gloves (Protein Label Claim)". However, it's important to note that this is a 510(k) submission from 2001 for a physical medical device (surgical gloves), not an AI/ML software device. Therefore, many of the requested fields (like sample size for test/training set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this type of submission.
Here's a breakdown of the information that can be extracted or inferred from the document based on the provided categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Reference) |
|---|---|
| Dimensions (ASTM D 3577-00) | Meets ASTM D 3577-00 (Non-clinical test data) |
| Physical Properties (ASTM D 3577-00) | Meets ASTM D 3577-00 (Non-clinical test data) |
| Freedom from holes (ASTM D 3577-00) | Meets ASTM D 3577-00 (Non-clinical test data) |
| Freedom from holes (ASTM D 5151-99) | Meets ASTM D 5151-99 (Non-clinical test data) |
| Biocompatability (Primary Skin Irritation in Rabbits Test) | Passes Primary Skin Irritation in Rabbits Test (Non-clinical test data) |
| Biocompatability (Guinea Pig Sensitization Test) | Passes Guinea Pig Sensitization Test (Non-clinical test data) |
| Protein Label Claim (≤ 50 micrograms total water extractable protein per gram) | Meets ASTM D 5712-99 (specifically, "contains 50 micrograms or less of total water extractable protein per gram") (Non-clinical test data) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable for this type of medical device submission. The "tests" refer to standardized physical and chemical property tests, not a "test set" in the context of an AI/ML algorithm. The ASTM standards specify testing methodologies and sample sizes for quality control, but this document summarizes the results of meeting those standards.
- Data Provenance: Not applicable in the AI/ML sense. The non-clinical test data was generated by Ansell Healthcare Products Inc. to demonstrate adherence to established ASTM standards. The specific country of origin for the test execution is not mentioned, and it's not "retrospective or prospective" data in the way a clinical study would be.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of physical device, ground truth is established by objective measurements against recognized industry standards (ASTM). No human expert consensus for "ground truth" (in the AI/ML sense) is involved.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations, often in clinical imaging or diagnostics. The tests for surgical gloves are objective, laboratory-based measurements against defined 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
- No. An MRMC study is not relevant for this physical medical device. This type of study assesses the impact of AI on human reader performance, which doesn't apply to surgical gloves.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical product (surgical gloves), not an algorithm. Therefore, "standalone performance" of an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is defined by established objective measurements and performance criteria specified in the referenced ASTM standards (ASTM D 3577-00 for dimensions, physical properties, freedom from holes; ASTM D 5151-99 for freedom from holes; ASTM D 5712-99 for protein analysis) and biocompatibility tests (Primary Skin Irritation in Rabbits Test, Guinea Pig Sensitization Test). This is a form of objective standard compliance.
8. The sample size for the training set
- Not applicable. There is no "training set" for physical medical devices of this nature. This concept is specific to machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is irrelevant.
§ 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).