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510(k) Data Aggregation
(444 days)
EndoArmor™+ Surgical Gowns are single-use personal protective equipment intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker of microorganisms, body fluids, and particulate matter.
EndoArmor™+ Surgical Gowns meet the respective Level 3 requirements of ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
EndoArmor™+ Surgical Gowns are intended to be worn by health care professionals as personal protective equipment to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter.
The EndoArmor™+ Surgical Gown is constructed from a polyethylene film laminated with nonwoven spunbond polypropylene that provides AAMI Level 3 liquid barrier performance in the critical zones. The EndoArmor™+ Surgical Gown back was designed to allow for airflow and breathability to support user comfort. The back of the gown is constructed from spunbond polypropylene and is non-protective.
The EndoArmor™+ Surgical Gown is single-use, one-size fits most personal protective equipment supplied non-sterile with sterilization instructions and validated sterilization parameters to enable the end-user to sterilize the gown prior to being used in sterile surgical procedures.
The provided text describes the acceptance criteria and performance data for the EndoArmor™+ Surgical Gown, which is a medical device. However, it does not describe an AI/ML device or a study involving human readers and AI assistance for medical imaging. Therefore, many of the requested points related to AI/ML devices, ground truth establishment for training sets, multi-reader multi-case studies, and expert qualifications are not applicable based on the provided document.
The document primarily focuses on the physical and biological performance characteristics of the surgical gown as a personal protective equipment.
Here's the information extracted from the provided text, addressing the applicable points:
Acceptance Criteria and Device Performance for EndoArmor™+ Surgical Gown
The device in question, the EndoArmor™+ Surgical Gown, is a surgical apparel, not an AI/ML diagnostic tool. Therefore, the acceptance criteria and performance data are entirely based on physical, mechanical, and biological safety standards for such garments.
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Evaluate the cytotoxicity endpoint. | Under the test conditions, the subject device must be non-cytotoxic per ISO 10993-5. | Pass. |
| ISO 10993-7, Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals | Evaluate the EO/ECH residuals. | Under the test conditions, the EO/ECH residual levels of the subject device must be below the maximum allowable limits for adult patient populations based on body mass per ISO 10993-7. | Pass. |
| ISO 10993-10, Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization | Evaluate the irritation and skin sensitization endpoint. | Under the test conditions, the subject device must be non-irritating and non-sensitizing per ISO 10993-10. | Pass. |
| ASTM F2407-20, Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities | Evaluate the standard specification for surgical gown. | Under the test conditions, the subject device must meet the required tensile strength, tear resistance, and seam strength per ASTM F2407-20. | Pass. |
| AATCC TM42, Test Method for Water Resistance: Impact Penetration | Evaluate the impact penetration endpoint. | Under the test conditions, the subject device must meet the required resistance to the penetration of water per ANSI/AAMI PB70. | Pass. |
| AATCC TM127, Test Method for Water Resistance: Hydrostatic Pressure Test | Evaluate the Hydrostatic Pressure Test endpoint. | Under the test conditions, the subject device must meet the required resistance to the penetration of water under hydrostatic pressure per ANSI/AAMI PB70. | Pass. |
| ASTM D5034-09, Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) | Evaluate the Grab Test endpoint. | Under the test conditions, the subject device must meet the required tensile strength per ASTM F2407-20. | Pass. |
| ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure | Evaluate the Tearing Strength of Fabrics by Trapezoid Procedure. | Under the test conditions, the subject device must meet the required tear resistance per ASTM F2407-20. | Pass. |
| ASTM D1683 / D1683M-17, Standard Test Method for Failure in Sewn Seams of Woven Fabrics | Evaluate the Standard Test Method for Failure in Sewn Seams of Woven Fabrics | Under the test conditions, the subject device must meet the required seam strength per ASTM F2407-20. | Pass. |
| 16 CFR Part 1610, Standard for the Flammability of Clothing Textiles | Evaluate the Flammability of Clothing Textiles. | Under the test conditions, the subject device must meet the Class I flammability standard per 16 CFR Part 1610. | Pass. |
2. Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes (e.g., number of gowns tested for each criterion) for the performance tests. It states that "The final proposed finished device was tested..." which implies a sufficient sample size was used to meet the standard requirements, but the specific numbers are not provided. Data provenance is not described in terms of country of origin or retrospective/prospective since it involves laboratory testing of physical samples, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/ML device or a diagnostic device relying on expert interpretation of medical images. The "ground truth" is established by adherence to physical, chemical, and biological testing standards (e.g., ISO, ASTM, AATCC, CFR standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human reader interpretations.
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 device is a surgical gown, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is defined by internationally recognized and FDA-referenced standards for medical garments and biocompatibility (e.g., ISO 10993 series, ASTM F2407-20, AATCC TM42/TM127, 16 CFR Part 1610, and ANSI/AAMI PB70:2012). The determination of "Pass" or "Fail" is based on whether the device meets the quantitative and qualitative requirements set forth in these standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
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