(272 days)
Gammex PI Breach Detect Powder Free Surgical Gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. When used as an underglove, the glove is intended to promote visibility of a fluid that breaches/enters the glove via an increased spreading rate.
Gammex Pl Breach Detect Powder Free Surgical Glove is a sterile, green in color, single use disposable powder free surgical glove. The glove is made of synthetic polyisoprene rubber. A polymer is applied to the inner surface of the glove to make donning easy. The glove's outer surface is coated with a surface-active agent and when used as an under-glove, this coating and the glove's green color can improve visibility of a glove breach by promoting wetting of the glove surface and spreading of bodily fluid penetrating the breach.
This document describes a 510(k) premarket notification for a medical device called "Gammex PI Breach Detect Powder Free Surgical Glove" (K171375). However, the document does not contain the kind of detailed information about acceptance criteria and performance study results that would typically be found for an AI/ML-driven medical device, such as a diagnostic algorithm.
The device in question is a surgical glove, which is a Class I device. The FDA's review for Class I devices generally focuses on demonstrating substantial equivalence to a predicate device based on defined physical, material, and biocompatibility characteristics, rather than extensive clinical performance studies or AI model validation.
Therefore, many of the specific questions you've asked (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, ground truth for training sets) are not applicable to this device and the information provided in this 510(k) summary.
Here's a breakdown based on the provided text, addressing what is available and explaining why other aspects are absent:
1. A table of acceptance criteria and the reported device performance
The document provides a table outlining "Technological Characteristics" compared to ASTM or equivalent standards. These function as the acceptance criteria for a surgical glove.
| Characteristics | Standard/Test/FDA Guidance | Acceptance Criteria (Implied by Standard) | Reported Device Performance (Result Summary) |
|---|---|---|---|
| Physical Characteristics: | |||
| Dimensions: Length | ASTM D3577-09 | Minimum 265mm | Average value: Minimum 297 mm (Meets) |
| Dimensions: Palm Width (mm) | ASTM D3577-09 | Size 5.5: $70 \pm 6$ | |
| Size 6.0: $76 \pm 6$ | |||
| Size 6.5: $83 \pm 6$ | |||
| Size 7.0: $89 \pm 6$ | |||
| Size 7.5: $95 \pm 6$ | |||
| Size 8.0: $102 \pm 6$ | |||
| Size 8.5: $108 \pm 6$ | |||
| Size 9.0: $114 \pm 6$ | Size 5.5: 76 | ||
| Size 6.0: 82 | |||
| Size 6.5: 86 | |||
| Size 7.0: 91 | |||
| Size 7.5: 98 | |||
| Size 8.0: 100 | |||
| Size 8.5: 112 | |||
| Size 9.0: 120 (Meets) | |||
| Dimensions: Thickness (mm) – single wall (Finger, Palm, Cuff) | ASTM D3577-09 | Minimum 0.10 for Finger, Palm, Cuff | Finger: 0.25 |
| Palm: 0.21 | |||
| Cuff: 0.17 (Meets) | |||
| Physical Properties: | ASTM D3577-09 | Requirements for tensile strength, ultimate elongation, and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves. | Meets ASTM D3577-09 requirements (Meets) |
| Freedom from holes | ASTM D3577-09, ASTM D5151-06 | AQL 1.5 | Meets ASTM D3577-09 and ASTM D5151-06 requirements of AQL 1.5 (Meets) |
| Powder Residual | ASTM D3577-09, ASTM D6124-06 | ≤ 2 mg per glove | Meets applicable requirement for powder free; ≤ 2 mg per glove (Meets) |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 | $10^{-6}$ SAL (Sterility Assurance Level) | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of $10^{-6}$ SAL. (Meets) |
| Biocompatibility: | |||
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009 | Undiluted and 1:2 dilution not cytotoxic. | Under the conditions of the study, undiluted and 1:2 dilution were cytotoxic. 1:4, 1:8, 1:16, 1:32 and 1:64 are not cytotoxic. (Note: This result is reported rather than a pass/fail against typical acceptance of "not cytotoxic at all concentrations". However, the overall conclusion for substantial equivalence indicates this was acceptable.) |
| ISO Skin Irritation Study | ISO10993-10:2010 | Not an irritant | Under the conditions of the study, not an irritant (Meets) |
| ISO Maximization Sensitization Study | ISO 10993-10:2010 | Not a sensitizer | Under the conditions of the study, not a sensitizer (Meets) |
| ISO acute systemic toxicity | ISO 10993-11: 2006 | No evidence of systemic toxicity | Under the conditions of the study, no evidence of systemic toxicity (Meets) |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML algorithm. The performance data refers to standard compliance tests (e.g., ASTM standards for glove characteristics). These tests involve sampling plans as defined within the respective standards, but the specific number of gloves tested for each characteristic is not provided in this summary.
- Data Provenance: Not applicable. These are laboratory test results based on manufactured glove samples. The data is not patient-derived from specific countries or retrospective/prospective studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical product (surgical glove), not an AI/ML diagnostic device requiring expert interpretation of medical images or data for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable.
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 not an AI-assisted diagnostic device. The document explicitly states: "A clinical study was not conducted on the subject or predicate devices."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground truth for this device is based on established engineering standards and material science properties (e.g., ASTM standards for dimensions, tensile strength, freedom from holes, powder residue; ISO standards for biocompatibility and sterility). The "truth" is whether the glove meets the specified physical and biological performance characteristics.
8. The sample size for the training set:
- Not Applicable. There is no AI/ML model for which to define a training set.
9. How the ground truth for the training set was established:
- Not Applicable.
§ 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).