(148 days)
A powdered surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
A powder-free surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The Surgical Glove is made of all natural rubber, sterile, and powdered with USP absorbable dusting powder and contains less than 50 micrograms or less of protein content.
The provided text describes a 510(k) summary for surgical gloves, which are medical devices and not typically subject to the same kind of "AI model performance" studies as software algorithms. The request asks for details that are common for AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance), but these are not relevant for the described device (surgical gloves).
Therefore, I will extract the available acceptance criteria and device performance based on the provided document. I will also explicitly state that the other requested information (sample size for test set, experts for ground truth, adjudication, MRMC, standalone performance, training set details) is not applicable or not provided for this type of device submission.
Here's the breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standards (Acceptance Criteria) | Device Performance |
|---|---|---|
| Dimensions | ASTM D 3577-09e1 | Meets |
| Physical Properties | ASTM D 3577-09e1 | Meets |
| Freedom from pinholes | ASTM D 3577-09e1 | Meets |
| Powder Residual | ASTM D 6124-06 | Meets |
| Protein Level | ASTM D 5712-10 | Meets |
| Biocompatibility: Primary Skin Irritation in Rabbits | (Implied standard for "Passes") | Passes (Not a primary skin irritant) |
| Biocompatibility: Dermal Sensitization | (Implied standard for "Passes") | Passes (Not a primary skin irritant) |
| Sterilization Validation | ISO 11137-2:2006 | Meets |
Additionally, the conclusion states the device meets "FDA requirements for water leak test on pinhole AQL" and "glove performance standards."
2. Sample size used for the test set and the data provenance
This information is not applicable or not provided for this type of medical device (surgical gloves). Device performance is typically evaluated against established ASTM and ISO standards, which define testing methodologies and sample sizes within those standard documents, rather than through independent "test sets" in the context of an AI/ML algorithm. The data provenance would refer to the materials and manufacturing process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or not provided. The "ground truth" for surgical glove performance is established by the specified ASTM and ISO standards and their associated test methods, not by expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided. Adjudication methods are relevant for subjective interpretations, often in image analysis or clinical diagnosis. Surgical glove testing involves objective physical, chemical, and biological tests.
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
This information is not applicable or not provided. MRMC studies are used for evaluating the impact of diagnostic aids (often AI) on human reader performance. This submission is for a physical medical device (surgical gloves).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable or not provided. This concept applies to standalone software algorithms or AI models, not to physical devices like surgical gloves.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective measurements defined by international and national standards (ASTM D 3577-09e1, ASTM D 6124-06, ASTM D 5712-10, ISO 11137-2:2006) and established biocompatibility tests (Primary Skin Irritation in Rabbits, Dermal Sensitization). For instance, freedom from pinholes is measured by a water leak test, and protein level via a standard chemical assay.
8. The sample size for the training set
This information is not applicable or not provided. "Training set" refers to data used to train an AI/ML model, which is not relevant for surgical gloves.
9. How the ground truth for the training set was established
This information is not applicable or not provided.
§ 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).