(148 days)
The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.
The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite breathable film. The proposed device is available in four different sizes, include M, L, XL,TL. The proposed devices can meet the requirements for Level 3 per ANSVAAMI PB70:2012. The proposed devices are disposable medical devices and provided sterile.
The document is a 510(k) Premarket Notification from the FDA regarding a Disposable Surgical Gown. It outlines the device's technical specifications and compares it to a predicate device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance and safety testing required for regulatory clearance, not studies involving AI or human reader performance as one might expect for a diagnostic AI device.
Here's an analysis based on the provided document:
This document describes the testing for a Disposable Surgical Gown, which is a physical medical device, not a diagnostic AI/algorithm. Therefore, concepts like "MRMC comparative effectiveness study," "standalone algorithm performance," "human readers improve with AI," "number of experts for ground truth," "adjudication method," and "training set size/ground truth establishment" are not applicable to this type of medical device submission. The "acceptance criteria" relate to physical and biological performance characteristics of the gown.
Non-Clinical Performance and Safety Testing for Disposable Surgical Gown
1. A table of acceptance criteria and the reported device performance:
| Test Methodology | Test Methodology Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| AAMI/ANSI PB70:2012 (Liquid Barrier) | Determine classification of subject surgical gown product. | N/A (classification level) | PASS (Level 3) |
| ASTM D5587-15 (Tearing Strength) | Evaluate tearing strength. | >30N | PASS (72/59N average from 3 nonconsecutive batches) |
| ASTM D5034-21 (Breaking Strength) | Evaluate breaking strength. | >10N | PASS (99/81N average from 3 nonconsecutive batches) |
| ASTM D1683M-17 (Seam Strength) | Evaluate failure in sewn seams. | >30N | PASS (Sleeve: 68.3N, Side: 69.7N, Belt: 71N average from 3 nonconsecutive batches) |
| AATCC 42-2013 (Water Impact) | Evaluate water impact. | ≤1.0 g | PASS (0~0.019 g average from 3 nonconsecutive batches) |
| ASTM F1868-17 (Evaporative Resistance) | Evaluate evaporative resistance. | 50 cm | PASS (52~290 cm average from 3 nonconsecutive batches) |
| CPSC 16 CFR Part 1610-2008 (Flammability) | Evaluate flammability. | Meets Class I requirements | PASS (Class I average from 3 nonconsecutive batches) |
| ISO 9073-10:2003(E) (Linting) | Evaluate lint and other particles generation. | Log10(particle count) |
§ 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.