(92 days)
The FlexGard® Cut-Resistant Glove Liners are single use glove liners intended to help with protection against cuts when used with an inner and outer surgical glove. The glove liner must be worn between two surgical gloves.
The FlexGard Cut Resistant Glove Liners provide an optional method of providing cut resistance to surgical gloves. The FlexGard Cut Resistant Glove Liners are applied between layers of surgical gloves. The FlexGard Cut Resistant Glove Liners are placed over a surgical glove and subsequently covered by a surgical glove.
The FlexGard Cut Resistant Glove Liners are ambidextrous, there is no left or right handed Glove Liner variations.
The FlexGard Cut Resistant Glove Liners are provided to the user terminally sterilized by a validated ethylene oxide process. The FlexGard Cut Resistant Glove Liners are labeled for single use.
The FlexGard Cut Resistant Glove Liners provide protection against cuts and slashes. The FlexGard Cut Resistant Glove Liners are not puncture resistant or cut proof.
The provided document is a 510(k) Premarket Notification for the FlexGard® Cut-Resistant Glove Liners. It details the device's characteristics, intended use, and comparative analysis with a predicate device.
However, the request asks for information related to a study that proves a device meets acceptance criteria, specifically focusing on AI/machine learning models in medical imaging, as indicated by questions 2-9 (sample size for test/training sets, data provenance, expert ground truth, MRMC study, standalone performance, etc.).
The FlexGard® Cut-Resistant Glove Liners are a physical medical device (glove liners) and not an AI/machine learning software device. Therefore, the detailed questions about AI model testing (like the number of experts, adjudication methods, MRMC studies, training/test set ground truth establishment, or standalone algorithm performance) are not applicable to the information provided in this 510(k) submission.
The document describes non-clinical performance tests for a physical product, addressing aspects like cut protection, sterility, biocompatibility, and shelf life.
Here's the information extracted that is applicable to the prompt, focusing on the acceptance criteria and the study (non-clinical testing) that proves the device meets these criteria:
Acceptance Criteria and Reported Device Performance
The document presents a table summarizing non-clinical performance tests conducted to demonstrate the device met its acceptance criteria.
Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cut Protection | Meet requirements for ANSI/ISEA 105-2011, Level 2 cut resistance. | Pass |
| Sterility | Sterility assurance level (SAL) of 10-6. | Pass |
| Sterile Barrier Package Integrity | The sterile barrier Tyvek pouch must have a seal strength $\geq$ 1 lbf and not leak. | Pass |
| Biocompatibility (Cytotoxicity) | Cytotoxicity passes for a Grade of $\leq$ 2. | Pass (Grade = 1) |
| Biocompatibility (Sensitization) | Sensitization passes for a Grade = 0. | Pass (Grade = 0) |
| Biocompatibility (Irritation) | Irritation passes for a Primary Irritation Index $\leq$ 0.4. | Pass (Primary Irritation Index = 0) |
| Shelf Life (2 years) | Cut Protection: Meet requirements for ANSI/ISEA 105-2011, Level 2 cut resistance. | |
| Sterile Barrier Package Integrity: The sterile barrier Tyvek pouch must have a seal strength $\geq$ 1 lbf and not leak. | Pass |
Inapplicability of AI/ML Specific Questions:
The following questions regarding AI/ML study design are not applicable to this submission for a physical medical device:
- Sample sized used for the test set and the data provenance: Not applicable. This is a physical product, not an AI model. Testing involved physical samples of gloves for performance (e.g., cut resistance, sterility, biocompatibility).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is established by standardized test methods (e.g., ASTM standards for cut resistance, ISO standards for sterility, biocompatibility).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This concept applies to human reader consensus for AI model ground truth, not physical device testing.
- 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. MRMC studies are for evaluating clinical performance of AI systems in diagnostic tasks, not for physical devices like glove liners.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical devices, ground truth is based on physical measurements and standardized test results (e.g., force required to cut, microbial presence, biocompatibility assays). These are derived from established scientific and engineering principles, not expert consensus in image interpretation.
- The sample size for the training set: Not applicable. This refers to training data for AI models.
- How the ground truth for the training set was established: Not applicable. This refers to ground truth for AI models.
In summary, the provided document outlines the non-clinical testing and acceptance criteria for a physical medical device (cut-resistant glove liners) and successfully demonstrates that the device passes those criteria. The questions posed in the prompt are designed for the evaluation of AI/Machine Learning medical devices and are therefore not relevant to this specific premarket notification.
§ 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).