(128 days)
The Biogel® PI UltraTouch S Surgical Glove is a disposable device made of polyisoprene, 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 Biogel® PI UltraTouch S 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.
Subject of this submission are two surgical gloves: a single-use, sterile, straw-colored overglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene, and a single-use, sterile, blue underglove which is a disposable, powder-free surgical glove made from synthetic polyisoprene. The overglove, and underglove may be used independently or worn as a double-gloving pair if desired.
The provided text describes a 510(k) premarket notification for surgical gloves and does not involve AI or algorithms. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details (sample size, data provenance, experts, adjudication, MRMC, standalone performance), or ground truth establishment for an AI device.
The document is a regulatory submission for medical devices (surgical gloves) which are classified as Class I. The submission is focused on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving the performance of an AI model against specific acceptance criteria.
The "acceptance criteria" discussed in the document relate to the physical and biocompatibility properties of the gloves, such as:
- Physical Characteristics: Dimensions, tensile strength, elongation, freedom from holes, and powder residual. These are assessed against established ASTM (American Society for Testing and Materials) standards and FDA regulations (e.g., 21 CFR 800.20, ASTM D3577-09(2015), ASTM D5151-06(2015), ASTM D6124-06(2017)).
- Biocompatibility: Primary skin irritation, ISO closed patch sensitization, and acute systemic toxicity. These are assessed against ISO 10993 standards.
- Sterilization: Sterility Assurance Level (SAL) of 10-6.
Here's a breakdown of why your specific questions cannot be answered from the provided text, and what the text does provide regarding the device's performance:
Based on the provided text, the device is a surgical glove, not an AI or algorithm-based device. Therefore, the questions related to AI/algorithm performance, such as MRMC studies, standalone performance, training sets, and expert adjudication for ground truth of an AI model, are not applicable to this document.
The document describes the acceptance criteria and device performance for surgical gloves as part of a 510(k) submission to demonstrate substantial equivalence to predicate devices.
Here's the relevant information from the document:
1. A table of acceptance criteria and the reported device performance
The document presents a "Summary of Non-Clinical Testing" which effectively serves as the acceptance criteria and the reported performance against those criteria.
| Acceptance Criteria (Standard/Test/FDA Guidance) | Reported Device Performance (Subject Device: Biogel® PI UltraTouch S Surgical Glove / Biogel® PI UltraTouch S Indicator Underglove) |
|---|---|
| Biocompatibility: | |
| Primary Skin Irritation (ISO 10993-10:2010) | Under the conditions of the study, not an irritant. |
| ISO Closed Patch Sensitization (ISO 10993-10:2010) | Under the conditions of the study, not a sensitizer. |
| Acute Systemic Toxicity Study (ISO 10993-11:2010) | Under the conditions of the study, no mortality or evidence of systemic toxicity from the extracts. |
| Physical Characteristics: | |
| Dimensions (ASTM D3577-09(2015)) | Meets ASTM D3577-09(2015) requirements for length, width, and thickness. Identical to predicate. |
| Physical Properties (ASTM D3577-09(2015)) | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging. Identical to Predicate. |
| Freedom from holes (ASTM D5151-06(2015) & ASTM D3577-09(2015), 21 CFR 800.20) | Exceeds 21 CFR 800.20 and ASTM D3577-09(2015) requirements of AQL 1.5. Identical to predicate. |
| Powder residual (ASTM D6124-06(2017) & ASTM D3577-09(2015)) | Meets powder level requirements for "Powder-free" designation per ASTM D3577-09(2015). Identical to predicate. |
2. Sample sizes used for the test set and the data provenance
The document states "Summary of Non-Clinical Testing" but does not specify the sample sizes used for each of the tests (e.g., number of gloves tested for holes, number of animals for biocompatibility). The data provenance is implied to be from laboratory testing conducted to meet the specified ASTM and ISO standards, which are international. It's not retrospective or prospective in the clinical study sense; rather, it's laboratory testing of manufactured goods.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this is for a physical device (surgical glove) and not an AI model. "Ground truth" here refers to established physical and biocompatibility standards, not expert interpretations of medical images or data.
4. Adjudication method for the test set
Not applicable. Testing involves conforming to predefined physical and chemical specifications, not subjective interpretation requiring adjudication.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.
7. The type of ground truth used
The "ground truth" for the device's performance is established by internationally recognized standards and regulations for surgical gloves, specifically:
- ASTM International standards (e.g., D3577, D5151, D6124) for physical properties.
- ISO (International Organization for Standardization) standards (e.g., 10993 series) for biocompatibility.
- FDA regulations (e.g., 21 CFR 800.20) for acceptable quality levels (AQL) for freedom from holes.
These standards define the acceptable range or threshold for each characteristic (e.g., minimum tensile strength, maximum powder residual, AQL for holes, non-irritant response).
8. The sample size for the training set
Not applicable. This is not an AI device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device.
§ 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).