(77 days)
The Original Perry Style 42 Surgeon's Glove intended use is to be worn by operating room personnel to protect a surgical wound from contamination.
The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all of the requirements of ASTM D 3577-99, Type 1. The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-99 Rubber Surgical Gloves. The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination.
The provided text describes a 510(k) summary for medical gloves and does not contain information about a device that uses AI or requires a study involving ground truth, expert consensus, or training sets as outlined in the request.
The device in question, "The Original Perry Style 42 Powdered Surgeon's Gloves (Protein Label Claim)," is a medical glove. The acceptance criteria and "study" described are based on compliance with existing ASTM (American Society for Testing and Materials) standards for surgical gloves and FDA hole requirements.
Therefore, many of the requested fields cannot be filled as they are not applicable to the type of device and submission described.
Here's a breakdown of the available information based on your request, highlighting what is not applicable:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577-99 | Meets ASTM D 3577-99 |
| Physical Properties | Meets ASTM D 3577-99, Type 1 | Meets ASTM D 3577-99, Type 1 |
| Freedom from holes | Meets ASTM D 3577-99 | Meets ASTM D 3577-99 |
| Meets ASTM D 5151-92 | Meets ASTM D 5151-92 | |
| Protein Label Claim | 60 micrograms or less of total water extractable protein per gram. Meets ASTM D 5712-95 Standard Test Method for Analysis of Protein in Natural Rubber and Its Products | This latex glove contains 60 micrograms or less of total water extractable protein per gram. Meets ASTM D 5712-95 Standard Test Method for Analysis of Protein in Natural Rubber and Its Products |
| Primary Skin Irritation | Passes | Passes |
| Guinea Pig Sensitization | Passes | Passes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text. Compliance with ASTM standards typically involves specified sample sizes for testing, but these are not explicitly detailed here.
- Data Provenance: Not specified. The testing is described as "performance test data of the non clinical tests," implying laboratory testing rather than data from a specific country or clinical setting. It's prospective testing against a standard.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This device is a physical product (medical glove) and its performance is evaluated against defined physical and chemical standards, not through "ground truth" established by human experts in the context of diagnostic or interpretive tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective evaluations, typically in clinical studies or expert reviews. The testing described here is objective and based on established ASTM test methods.
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 glove, not an AI-powered diagnostic device. No human reader or AI assistance is involved in its evaluation as described.
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 (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device's performance is adherence to defined physical and chemical properties and biocompatibility tests as specified in ASTM standards.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm; there is no training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI algorithm; there is no training set or associated ground truth establishment process.
In summary: The provided document describes a medical glove's compliance with established industry standards through non-clinical performance testing. It does not involve AI, human expert evaluation for "ground truth," or clinical studies of the type typically associated with AI-powered diagnostic devices.
§ 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).