(255 days)
The Biogel® PI Indicator® Underglove is a disposable device made of polyisoprene, blue in color, that is intended to be worn on the hands, usually in a surgical setting, to provide a barrier against potentially infectious material and other contaminants.
The proposed device, the Biogel PI Indicator Underglove is manufactured of polyisoprene colored with blue pigmentation. The Biogel PI Indicator Underglove is manufactured of the exact same material and coated with the Biogel® Coating which is used on the currently cleared device that has been legally marketed by Molnlycke Health Care for many years with the addition of a surfactant.
This describes the Biogel® PI Indicator® Underglove, a surgical glove. As a Class I device, it is subject to general controls and does not require extensive clinical studies or complex acceptance criteria typically seen with higher-risk medical devices or AI-powered diagnostics.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D3577 | Meets ASTM D3577 |
| Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 |
| Freedom from Holes | Meets ASTM D3577 | Meets ASTM D3577 |
| Biocompatibility | Meets ISO 10993-1 | Meets ISO 10993-1 |
| LAL Test Results | Meets ASTM D7102 | Meets ASTM D7102 |
Note: The document explicitly states, "No clinical data was required." This indicates that the device's performance was evaluated against established standards for surgical gloves, rather than through
comparative clinical trials with human subjects.
1. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample size used for each test (Dimensions, Physical Properties, Freedom from Holes, Biocompatibility, LAL Test). It only states that the device "Meets" the respective ASTM and ISO standards. These standards themselves specify sampling plans and test methodologies.
- Data Provenance: Not specified. The testing was likely conducted in a lab setting by the manufacturer or a contracted lab to confirm compliance with the standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the evaluation is based on objective physical and chemical testing against established engineering standards (ASTM, ISO), not on expert subjective assessment or medical diagnosis.
3. Adjudication method for the test set:
This is not applicable. The assessment is based on objective measurements against pass/fail criteria defined by the ASTM and ISO standards. There is no subjective interpretation requiring adjudication.
4. 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 is not applicable. This device is a surgical glove, not an AI-powered diagnostic or decision-support system. Therefore, no MRMC comparative effectiveness study was performed or is relevant.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This device is a physical product (surgical glove), not a software algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" used for this device's acceptance is adherence to established industry standards and regulatory requirements for surgical gloves (ASTM D3577, ISO 10993-1, ASTM D7102) via objective physical and chemical testing. These standards define the acceptable performance characteristics for devices of this type.
7. The sample size for the training set:
This is not applicable. This is a physical medical device, not a machine learning model that requires a training set.
8. How the ground truth for the training set was established:
This is not applicable for the same reason as above.
§ 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).