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510(k) Data Aggregation
(76 days)
This surgeon's glove is a sterile and single use device intended to be worn on the hands of 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 polyisoprene.
The provided text is for a 510(k) premarket notification for Sterile Polyisoprene Powder Free Surgical Gloves and details the device's technical characteristics and substantial equivalence to a predicate device, rather than a study proving performance against acceptance criteria in the context of an AI/medical imaging device. Therefore, many of the requested categories for AI/medical imaging studies are not applicable.
However, I can extract the acceptance criteria and the device's reported performance from the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Technological Characteristics | Acceptance Criteria (Standard/Test/Guidance) | Reported Device Performance (Result Summary) |
|---|---|---|
| Dimensions | ASTM D3577-09(2015) requirements for length, width, and thickness | Meets ASTM D3577 requirements for length, width and thickness |
| - Length | Minimum 265mm | Average 305mm |
| - Palm Width (size 5½) | 70mm | 73mm |
| - Palm Width (size 6) | 76mm | 79mm |
| - Palm Width (size 6½) | 83mm | 86mm |
| - Palm Width (size 7) | 89mm | 91mm |
| - Palm Width (size 7½) | 95mm | 97mm |
| - Palm Width (size 8) | 102mm | 105mm |
| - Palm Width (size 8½) | 108mm | 111mm |
| - Palm Width (size 9) | 114mm | 117mm |
| - Thickness (Finger) | Minimum 0.10mm | 0.22mm |
| - Thickness (Palm) | Minimum 0.10mm | 0.20mm |
| - Thickness (Cuff) | Minimum 0.10mm | 0.18mm |
| Physical Properties | ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging | Meets ASTM D3577-09(2015) requirements for tensile strength and elongation at break before and after accelerated aging |
| - Tensile Strength, Before Aging | 17MPa, min | Average 19.4MPa |
| - Ultimate Elongation, Before Aging | 650%, min | Average 823% |
| - Stress at 500% Elongation | 7.0 MPa, max | Average 2.2MPa |
| - Tensile Strength, After Accelerated Aging | 12MPa, min | Average 17.1 MPa |
| - Ultimate Elongation, After Accelerated Aging | 490%, min | Average 748% |
| Freedom from holes | ASTM D3577-09(2015) and ASTM D5151-06(2015) requirements of AQL 1.5 | Meets ASTM D3577-09(2015) and ASTMD5151-06(2015) requirements of AQL 1.5 |
| Powder-Free | ASTM D3577-09(2015) and ASTM D6124-06(2011) - ≤ 2 mg per glove | Meets Applicable requirement for Powder Free; ≤ 2 mg per glove |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL | Meets ANSI/AAMI/ISO 11137-1:2006 requirement of 10-6 SAL |
| Biocompatibility (Skin Irritation) | ISO 10993-10:2010 | Under the conditions of the study, not an irritant |
| Biocompatibility (Maximization Sensitization) | ISO 10993-10:2010 | Under the conditions of the study, not a sensitizer |
Regarding the other requested information (primarily for AI/medical imaging studies):
- 2. Sample sized used for the test set and the data provenance: Not applicable. This document describes testing for physical and biological properties of surgical gloves, not an AI model. The tests refer to ASTM and ISO standards, which define the testing methodologies and sample sizes for those specific tests.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in AI/medical imaging (e.g., expert consensus on image findings) is not relevant here. The "ground truth" for the glove's performance is adherence to established engineering and biocompatibility standards.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to consensus methods for expert reviewers, which is not relevant for this type of device testing.
- 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 (expert consensus, pathology, outcomes data, etc): For this device, the "ground truth" is defined by the objective performance specified in the referenced ASTM and ISO standards (e.g., a specific tensile strength value, freedom from holes at a certain AQL).
- 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.
Key takeaway from the document: The device demonstrates compliance with recognized national and international standards (ASTM and ISO) for surgical gloves. The "study" proving the device meets the acceptance criteria consists of various material, physical, and biological tests conducted according to these standards, with the results compared directly to the specified requirements within those standards. A clinical study was explicitly stated as not conducted for either the subject or predicate devices.
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