(42 days)
BARRIER® surgical gowns are intended for single use to be worn by the Surgical Team Members in the operating room during surgical procedures to protect both the patient and the operating room personnel from the transfer of microorganisms, body fluids and particulate material.
The BARRIER® Surgical Gowns have been designed with an assortment of fabrics and have been on the market for a number of years cleared under predicate 510(k) notifications. BARRIER surgical gowns have been developed for general surgical procedures and for procedures which represent possible exposure to bloodborne pathogens and other potentially infectious materials which require increased levels of protection.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (AAMI Level) | Reported Device Performance (AAMI Level) |
|---|---|
| BARRIER® Standard and Standard Fabric Reinforced Surgical Gowns: Level 2 | Level 2 |
| BARRIER® Extra and Ultra Protection Gowns: Level 3 | Level 3 |
| BARRIER® Extra and Ultra Protection Plus Surgical Gowns: Level 4 | Level 4 |
| BARRIER® Surgical Gown II and BARRIER® Surgical Gown II, Fabric Reinforced: Level 3 | Level 3 |
| BARRIER® Fluid Protection Plus Surgical Gowns: Level 3 | Level 3 |
| BARRIER® Urology Gown: Level 4 | Level 4 |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "BARRIER® Surgical Gowns have been evaluated using the ANSI/AAMI PB-70:2003 Standard. (Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities)."
- Sample Size for Test Set: The exact sample size for each gown type is not explicitly stated in the provided 510(k) summary. The AAMI PB-70:2003 standard likely specifies the minimum sample size required for testing.
- Data Provenance: The document does not provide details on the country of origin of the data or whether the study was retrospective or prospective. It only mentions the standard used for evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of device (surgical gowns) and the testing performed. The "ground truth" here is objective physical testing against a recognized standard (ANSI/AAMI PB-70:2003) for liquid barrier performance, not subjective human assessment.
4. Adjudication Method for the Test Set:
This information is not applicable. As stated above, the evaluation is based on objective physical testing according to a published standard, not on human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with and without AI assistance. Surgical gowns are protective apparel, and their performance is assessed through laboratory testing against industry standards.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable. There is no "algorithm" or AI component to the BARRIER® Surgical Gowns. Their performance is inherent to their material and construction, measured through physical tests.
7. The Type of Ground Truth Used:
The ground truth used is the objective measurements of liquid barrier performance as defined and specified by the ANSI/AAMI PB-70:2003 Standard. This standard outlines the specific test methods and criteria to classify protective apparel based on its barrier performance against liquids.
8. The Sample Size for the Training Set:
This question is not applicable. Since there is no AI or machine learning component, there is no "training set." The performance of the surgical gowns is determined through physical testing of manufactured samples.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reason as point 8.
§ 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.