(327 days)
A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.
The subject device is a powder-free variation of the class I latex surgical gloves made by on-line polymercoating process. This process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.
The provided document is a 510(k) summary for a medical device: "Sterile Latex Surgical Gloves, Powder Free." It details the device's characteristics, comparison to a predicate device, and the results of non-clinical testing. It explicitly states that clinical testing was "Not applicable." Therefore, the document does not contain information about a study proving the device meets acceptance criteria related to a diagnostic or AI-based medical device performance study.
The questions in the prompt relate to the evaluation of an AI or diagnostic device, asking about sample sizes, expert ground truth, MRMC studies, and training sets. This information is not relevant to a 510(k) submission for surgical gloves, which are assessed based on physical properties, sterility, and biocompatibility.
However, I can extract the acceptance criteria and reported device performance for the surgical gloves based on the provided tables.
Here's the information derived from the document, tailored to the context of surgical gloves:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting the specifications of ASTM D3577-15 and other relevant standards (ISO 11737-2, ISO 10993-10, ISO 10993-5, ISO 10993-11, USP General Chapter 40). The reported device performance indicates whether the subject device "Meets" or "Passes" these specifications.
| Characteristic | Standard | Specification | Reported Device Performance (Subject Device K190241) |
|---|---|---|---|
| Dimension (Length) | ASTM D3577-15 | ||
| Length (size: 5.5), mm | 245 min | Meet 245mm min | |
| Length (size: 6.0), mm | 265 min | Meet 265mm min | |
| Length (size: 6.5), mm | 265 min | Meet 265mm min | |
| Length (size: 7.0), mm | 265 min | Meet 265mm min | |
| Length (size: 7.5), mm | 265 min | Meet 265mm min | |
| Length (size: 8.0), mm | 265 min | Meet 265mm min | |
| Length (size: 8.5), mm | 265 min | Meet 265mm min | |
| Length (size: 9.0), mm | 265 min | Meet 265mm min | |
| Dimension (Thickness) | ASTM D3577-15 | ||
| Thickness (cuff), mm | 0.10 min | Meet 0.10mm min | |
| Thickness (palm), mm | 0.10 min | Meet 0.10mm min | |
| Thickness (finger), mm | 0.10 min | Meet 0.10mm min | |
| Dimension (Width) | ASTM D3577-15 | ||
| Width (size: 5.5), mm | 70 ± 6 | Meet 70 ± 6 mm | |
| Width (size: 6.0), mm | 76 ± 6 | Meet 76 ± 6 mm | |
| Width (size: 6.5), mm | 83 ± 6 | Meet 83 ± 6 mm | |
| Width (size: 7.0), mm | 89 ± 6 | Meet 89 ± 6 mm | |
| Width (size: 7.5), mm | 95 ± 6 | Meet 95 ± 6 mm | |
| Width (size: 8.0), mm | 102 ± 6 | Meet 102 ± 6 mm | |
| Width (size: 8.5), mm | 108 ± 6 | Meet 108 ± 6 mm | |
| Width (size: 9.0), mm | 114 ± 6 | Meet 114 ± 6 mm | |
| Water Leak Test | ASTM D3577-15, ASTM D5151-06 | ||
| Before Aging, AQL | G-I, AQL 1.5 (FDA GII, AQL 1.5) | Meet AQL 1.5 | |
| After Aging, AQL | Meet AQL 1.5 | ||
| Physical Properties (Before Aging) | ASTM D3577-15 | ||
| Tensile Strength (MPa) | Min. 24 | Meet 24MPa min. | |
| Ultimate Elongation (%) | Min. 750 | Meet 750% min | |
| Stress at 500% Elongation (MPa) | Max. 5.5 | Meet 5.5 MPa max | |
| Physical Properties (After Aging) | ASTM D3577-15 | ||
| Tensile Strength (MPa) | Min. 18 | Meets 18MPa min | |
| Ultimate Elongation (%) | Min. 560 | Meet 560% min. | |
| Residual Powder Content | ASTM D3577-15, ASTM D6124-06 | Max. 2mg/glove | Meet 2mg/glove max. |
| Extractable Protein Content | ASTM D5712-10 | 50 µg/dm² and below | Meet Specification |
| Biocompatibility Tests | |||
| Primary Skin Irritation Test | ISO 10993-10 | No Animal Irritation | Passes (did not cause an irritant response) |
| Skin Sensitization Test | ISO 10993-10 | No Animal Sensitization | Passes (did not produce a skin sensitization effect) |
| Cytotoxicity Test | ISO 10995-5 | Non-cytotoxicity | moderate-cytotoxicity at 6 cm²/mL extraction |
| Acute Toxicity Oral | ISO 10993-11 | No toxic | No adverse biological reaction |
| Pyrogenic Test | USP General Chapter 40 | Non pyrogenic | Non pyrogenic |
Regarding the specific questions about an AI/diagnostic device evaluation:
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable. The device is a surgical glove, not a diagnostic or AI device. The testing involved physical and chemical properties and biocompatibility, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable. Ground truth as understood in AI/diagnostic studies (e.g., disease presence) is not relevant for surgical gloves. The "ground truth" for the gloves are the established international standards for their physical, chemical, and biological properties.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are used in interpreting ambiguous diagnostic findings, which is not relevant for surgical gloves.
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:
This information is not applicable. MRMC studies are used to evaluate human reader performance with and without AI assistance in diagnostic tasks. This device is a surgical glove.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. Standalone algorithm performance is relevant for AI devices. This device is a physical product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For surgical gloves, the "ground truth" is defined by adherence to recognized international standards (e.g., ASTM, ISO, USP) for physical properties, sterility, and biocompatibility. This involves laboratory testing using defined methodologies, not clinical outcomes data or expert diagnostic consensus.
8. The sample size for the training set:
This information is not applicable. Training sets are used for machine learning. This document describes testing of manufactured physical products, not an AI model.
9. How the ground truth for the training set was established:
This information is not applicable. There is no training set for a surgical glove.
§ 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).