(260 days)
Gammex PI Hybrid Surgical Glove is intended to be worn by operating room personnel to protect a surgical wound from contamination.
The subject device is single-use disposable powder-free surgical glove that is supplied sterile and made of synthetic rubber blend of polyisoprene and neoprene.
The provided document describes a 510(k) premarket notification for a surgical glove, the Gammex PI Hybrid Surgical Glove. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a new device meets specific acceptance criteria through a clinical study.
Therefore, many of the typical acceptance criteria and study details requested in the prompt related to AI/medical imaging device performance metrics (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document. The document focuses on showing that the new glove is as safe and effective as a previously approved glove by meeting established material and performance standards for surgical gloves.
Here's an attempt to answer the questions based on the information provided, highlighting where it is not applicable or different for a surgical glove compared to an AI diagnostic device:
1. A table of acceptance criteria and the reported device performance
For a surgical glove, "acceptance criteria" are typically defined by recognized standards (like ASTM or ISO) for physical characteristics, integrity, and biocompatibility. The "reported device performance" indicates whether the device met these standards.
| Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Result Summary) |
|---|---|
| Dimensions (ASTM D3577-09) | Meets ASTM D3577-09 requirements for length, width, and thickness |
| Length (Minimum 265mm) | Average 305mm |
| Palm Width (size 5.5: 70±6mm) | 73mm |
| Palm Width (size 6.0: 76±6mm) | 80mm |
| Palm Width (size 6.5: 83±6mm) | 86mm |
| Palm Width (size 7.0: 89±6mm) | 91mm |
| Palm Width (size 7.5: 95±6mm) | 97mm |
| Palm Width (size 8.0: 102±6mm) | 103mm |
| Palm Width (size 8.5: 108±6mm) | 110mm |
| Palm Width (size 9.0: 114±6mm) | 117mm |
| Thickness Finger (Minimum 0.10mm) | 0.22mm |
| Thickness Palm (Minimum 0.10mm) | 0.20mm |
| Thickness Cuff (Minimum 0.10mm) | 0.17mm |
| Physical Properties (ASTM D3577-09) | Meets ASTM D3577-09 requirements for tensile strength and elongation at break before and after accelerated aging |
| Freedom from holes (ASTM D3577-09, ASTM D5151-06) | Meets ASTM D3577-09 and ASTM D5151-06 requirements of AQL 1.5 |
| Powder-Free (ASTM D3577-09, ASTM D6124-06) | Meets Applicable requirement for Powder Free; ≤ 2 mg per glove |
| Sterility (ANSI/AAMI/ISO 11137-1:2006) | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL |
| Biocompatibility: | |
| ISO Skin Irritation Study (ISO 10993-10:2010) | Under the conditions of the study, not an irritant |
| ISO Maximization Sensitization Study (ISO 10993-10:2010) | Under the conditions of the study, not a sensitizer |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable in the context of the provided document, as it describes a clearance for a physical medical device (surgical glove) based on conformance to established standards for manufacturing and materials, not an AI or diagnostic device that relies on a "test set" of patient data. The tests are typically performed on samples from manufacturing lots.
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)
This is not applicable. The ground truth for a surgical glove is derived from standardized physical, chemical, and biological tests, not expert interpretation of images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically used for expert consensus on diagnostic imaging or clinical outcomes, which is not relevant here.
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
An MRMC study is not applicable. This type of study is for evaluating observer performance with AI assistance for diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. This question refers to the performance of an algorithm without human intervention, which is irrelevant for a surgical glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the surgical glove is based on objective measurements and assessments against established industry standards:
- Physical dimensions: Measured values (e.g., length, width, thickness).
- Physical properties (tensile strength, elongation): Measured values to ASTM D3577-09.
- Freedom from holes: Water leak test to ASTM D5151-06, meeting AQL 1.5.
- Powder-Free: Measurement of powder residue to ASTM D6124-06, meeting ≤ 2 mg per glove.
- Sterility: Sterilization validation to ANSI/AAMI/ISO 11137-1:2006, achieving 10-6 SAL.
- Biocompatibility: In-vivo animal studies for skin irritation and sensitization according to ISO 10993-10:2010.
8. The sample size for the training set
This is not applicable, as there is no "training set" for a surgical glove in the context of an AI/machine learning device. The manufacturing process is controlled and tested to meet specifications.
9. How the ground truth for the training set was established
This is not applicable. As there is no training set. The "ground truth" for the device's characteristics is established by widely accepted and published national and international standards (ASTM and ISO).
§ 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).