(43 days)
ComPel 1-Ply Surgical gowns are medical devices that are intended to be worn by operating room personnel during surgical procedures to protect them by inhibiting the migration of liquids through the surface of the critical areas of the gown.
When processed according to instructions, ComPel 1-Ply Surgical gowns will function and perform as protective apparel. The gowns are reusable through 125 wash, dry, and sterilization cycles. They are manufactured and distributed as non-sterile products that are intended to be processed by health care facilities and/or contract laundry companies.
All the components used in these ComPel® Gowns are made from 100% Dacron polyester filaments. ComPel fabrics are dyed and treated with a fluorocarbon finish.
ComPel® Gowns will function as surgical attire when processed according to instructions through 125 complete cycles - wash, dry and sterilization. These products will be manufactured and distributed as non-sterile gowns that are intended to be processed by health care facilities and/or contract sterilization/laundry companies.
Here's an analysis of the provided information regarding the ComPel® 1-Ply Surgical Gowns, formatted to address your request:
Acceptance Criteria and Device Performance Study
The provided document describes the safety and effectiveness summary for ComPel® 1-Ply Surgical Gowns. This submission is for a medical device (surgical gowns) and the "device performance" refers to the gowns' physical properties and durability, rather than a diagnostic algorithm or AI. Therefore, concepts like "test set," "training set," "experts," and "ground truth" as they apply to AI/algorithm performance are not directly relevant in the context of this document. However, I can extract the acceptance criteria (standards/tests performed) and the reported device performance (successful completion of these tests).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test/Standard) | Reported Device Performance |
|---|---|
| Suter Hydrostatic Testing (AATCC #127-1980) | Successfully completed |
| Impact Penetration Testing (AATCC 42-2000) | Successfully completed |
| Flammability (CFR 1610 (CS-191-53)) | Successfully completed |
| Durability (through 125 processings) | Successfully completed (wash, dry, and sterilization cycles) |
| Strength (ASTM D-1682-75) | Successfully completed |
| Lint (IST 160.0-83) | Successfully completed |
| Toxicity: Cytotoxicity (MEM Elution (MG023)) | Successfully completed |
| Toxicity: Primary Skin Irritation (FHSA) | Successfully completed |
| Compatibility with Steam Sterilization | Successfully completed |
| ANSI/AAMI PB70:2003 Standard | Classified as a Level 2 Barrier (for 1-ply gowns with flat felled seam design) |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided document for each specific test. However, the tests are applied to the "ComPel® 1-Ply Surgical Gowns" product. For durability, the claim is "through 125 complete cycles – wash, dry and sterilization," implying a sample of gowns was subjected to this number of cycles.
- Data Provenance: The document does not specify the country of origin where the tests were conducted. It is a submission by an American company (Standard Textile Company, Cincinnati, Ohio) to the U.S. FDA. The data is retrospective in the sense that the tests were completed prior to the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This is not applicable for this type of medical device submission. The "ground truth" is defined by the established standards and test methodologies (e.g., AATCC #127-1980, ASTM D-1682-75). The "experts" would be the accredited laboratories and technicians performing these standardized tests, who follow the documented procedures to determine if the product meets the specified criteria. Their qualifications are in conducting these specific material science and safety tests accurately.
4. Adjudication Method for the Test Set
- Not applicable in the context of product testing against material standards. The tests have defined pass/fail criteria, and results are typically determined by measurements and observations against those criteria, not by expert adjudication of subjective interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is relevant for diagnostic devices or AI algorithms where human readers' performance is compared with and without AI assistance. This document describes physical product performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This concept is not applicable. The device is a surgical gown, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is objectively defined by established engineering and material science standards and test methods. For example, a Suter Hydrostatic Test has a quantifiable pressure reading that determines barrier performance. Toxicity tests have specific indicators for cytotoxicity or irritation.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/algorithm. There is no concept of a "training set" for a physical product like a surgical gown.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for a physical product, the method for establishing its "ground truth" is irrelevant in this context.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.