(205 days)
The Bodygard SFS Surgical Gown Level 4 is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, Bodygard SFS Surgical Gown Level 4 met the requirements for Level 4 classification.
The Bodygard SFS Surgical Gown Level 4 is a single use poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 4 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 4 is manufactured using ultrasonic bonding technique are available in the color blue and four different sizes (M, L, XL, and XXL).
Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The Bodygard SFS Surgical Gown Level 4, meets the requirements for Level 4 classification, are disposable medical devices and provided in sterile.
The provided document is a 510(k) premarket notification for a medical device, which is a Bodygard SFS Surgical Gown Level 4. This type of document focuses on demonstrating that a new device is "substantially equivalent" to predicate devices already on the market, rather than establishing a completely new safety and effectiveness profile from scratch.
Therefore, the study design elements typically associated with proving an AI/clinical diagnostic device meets acceptance criteria (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, and ground truth for training data) are not applicable to this document. This document describes the testing of a physical medical device (a surgical gown) against established performance standards for such products.
Here's a breakdown based on the information provided, focusing on what is relevant for this specific device:
1. Table of acceptance criteria and the reported device performance:
| Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| AATCC 127 (Water resistance, Hydrostatic Pressure) | >50 cm H2O (AQL 4%, RQL=20%) | All test samples were > 50 cm H2O |
| AATCC 42 (Water Resistance impact penetration) | 30 N (AQL 4%, RQL=20%) | All test samples were >30N |
| ASTM D5587-14 (Tearing Strength) | >20 N (AQL 4%, RQL=20%) | All test samples were >20 N |
| 16 CFR 1610 (Flammability testing) | Class I | Meets Class I |
| ASTM D1683-17 (Seam Strength) | >50 N (AQL 4%, RQL=20%) | All test samples were >50 N |
| D6701-16 (Water vapor transmission of Nonwoven and plastic Barriers) | >500 g/m² Day WVTR | Passed |
| ASTM D3776/D (Mass Per Area (Weight) of fabric) | Has met acceptance criteria according to ASTM F2407 | Has met acceptance criteria according to ASTM F2407 |
| ASTM F1670 (Resistance by synthetic Blood) | No Penetration at 2 psi (13.8 kPA) | Passed |
| ASTM F1671 (Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens) | No detectable transfer of the Phi-X174 Bacteriophage | Passed |
| ISO 9073-10:2003 (Lint and Other particles generation in the dry state) | Log 10 50 cm H2O") indicate that multiple samples were tested as per the respective standard's requirements, but the exact number isn't quantified. |
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the device is a physical surgical gown, not an AI/clinical diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" is determined by established physical, chemical, and biological testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable for the reasons stated in point 3.
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 as the device is a physical surgical gown. No human readers or AI assistance are involved in its performance evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical surgical gown, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this device, the "ground truth" for its performance is based on established international and national standards for physical and biological properties of protective apparel. These standards define the acceptable range or value for each characteristic (e.g., specific hydrostatic pressure, tear strength, absence of cytotoxicity).
8. The sample size for the training set:
This is not applicable as the device is a physical surgical gown and does not involve a training set as understood in machine learning/AI.
9. How the ground truth for the training set was established:
This is not applicable for the reasons stated in 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.