Search Results
Found 1 results
510(k) Data Aggregation
(434 days)
Surgical gowns are intended to be worn by operating room personnel procedure to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material. This device is provided sterile.
Per ASNI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.
Surgical gowns are intended to be worn by healthcare professionals to protect both the patient and the healthcare professional from the transfer or microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and ethylene oxide (EO) sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL.
The proposed surgical gowns are constructed of a Spunbond (SMS) nonwoven material, with cuffs made of polyester and elastic, offered in standard (non-reinforced) and reinforced surgical gowns, in blue color.
This is a 510(k) summary for a surgical gown, which is a low-risk medical device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI algorithm performance. Therefore, many of the requested criteria, which are typically relevant for AI/ML device evaluations, are not applicable here.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document provides a summary of performance testing in Table 2, outlining the test method, purpose, acceptance criteria, and result (Pass/Fail or specific finding).
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| AATCC 127 | Hydrostatic pressure | Level 2 > 20 cm, Level 3 > 50 cm | Pass |
| AATCC 42 | Impact penetration | ≤1g | Pass |
| ASTM F 2407 (ASTM D 5034) | Tensile Strength | Length Direction ≥ 115N, Width Direction ≥ 115N | Pass |
| ASTM D 5587 | Tearing strength by Trapezoid | Length Direction > 20 N, Width Direction > 20 N | Pass |
| ASTM D 1683 | Seam strength | ≥ 20 N | Pass |
| 16 CFR Part 1610 | Flammability of Textiles | Class 1 | Class 1 |
| ISO 10993-7 | Ethylene oxide residues | EO residual ≤ 4 mg/device, ECH residual ≤ 9 mg/device | Pass |
| ISO 9073-10 | Linting | Log10 <4 | Pass |
| Biocompatibility (ISO 10993-5) | Cytotoxicity | ISO 10993-5:2009 | Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic |
| Biocompatibility (ISO 10993-10) | Irritation | ISO 10993-10:2010 | Under the conditions of the study, the proposed device extract was determined to be non-irritating |
| Biocompatibility (ISO 10993-10) | Sensitization | ISO 10993-10:2010 | Under the conditions of the study, the proposed device extract was determined to be non-sensitizing |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document relates to non-clinical performance testing of a physical medical device (surgical gown) against established standards. It does not involve a "test set" in the context of data for an AI/ML algorithm. Therefore, information about data provenance, retrospective/prospective studies, and sample sizes for data are not applicable. The tests were likely conducted on a sample of the manufactured gowns.
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 section is not applicable. The testing involves standardized laboratory methods (e.g., AATCC, ASTM, ISO standards) to measure physical and chemical properties of the surgical gown, not expert review or interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. There is no "test set" of data requiring expert adjudication, as the conformity is based on objective laboratory measurements against defined standards.
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 is not applicable. The device is a surgical gown, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a surgical gown, not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is defined by the acceptance criteria within the international and national consensus standards listed (e.g., AATCC 127, ASTM F 2407, ISO 10993-5). The device's physical and biological properties were measured and compared directly to these established benchmarks.
8. The sample size for the training set
This is not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for an AI/ML algorithm.
Ask a specific question about this device
Page 1 of 1