(372 days)
The Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE) are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the healthcare worker from the transfer of microorganisms, body fluids and particulate matter.
The subject device offers the two material models which are Unico Global Level 3 Surgical Gown (Film-reinforced SMS) and Unico Global Level 3 Surgical Gown (PP+PE). The two models use different base materials but use the same PE film layer in addition to the fabric. They have slightly different design elements in neck, body, and belt straps.
The Unico Global Level 3 Surgical Gowns (Film-reinforced SMS and PP+PE) have been tested according to AATCC Test Method 127:2017, ANSI/AAMI PB70:2012, and ISO 811, and meet the AAMI Level 3 barrier level protection for a surgical gown.
The Unico Global Level 3 Surgical Gowns are single use that will be provided in both sterile and non-sterile packaging configurations and offer a variety of sizes ranging from medium to XX-large.
The provided document is a 510(k) summary for a medical device: Unico Global Level 3 Surgical Gown. It is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. This document does NOT contain information about an AI/ML powered device, nor does it contain a comparative effectiveness study with human readers (MRMC study) or a standalone algorithm performance study.
Therefore, many of the requested details about acceptance criteria and study design for an AI/ML device cannot be extracted from this document. The document describes the performance testing of a physical product (surgical gowns) against established standards for physical properties and safety.
However, I can extract the acceptance criteria and performance for the surgical gown itself as presented in the document.
Detailed Breakdown based on the provided document:
The product in question is a physical medical device (surgical gown), not an AI/ML powered device. As such, the study design and acceptance criteria relate to the physical properties, safety, and performance of the gown, not to AI model performance, human reader improvement, or ground truth establishment in the context of AI/ML.
Here's an attempt to answer your questions based on the available information in the provided document, acknowledging the mismatch with a typical AI/ML device request:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Sterility Assurance Level: 10^-6 | Pass |
| Shelf-Life Validation | Bioburden test: ISO 11737-1 ('Sterilization of medical devices – Microbiological methods – Part 1: Determination of a population of microorganisms on products' Sterility test: No microbial growth Seal Strength Test (Blister): Maximum seal strength (N/15mm) ->>1.2 Dye Penetration test: No leakage | Pass |
| Acute systemic toxicity | Adverse no effects occurring at any time within 72h after single, multiple or continuous exposures of a test sample for 24h. | Pass |
| Sensitization & Irritation Tests | Sensitization test: The observations are scored between 0 (no visible change) to 3 (intense erythema and swelling). More than grade 0 indicates sensitization. Irritation tests: The test result obtained is a score between 0 and 8 calculated from the various observations, considered as negligible (0-0.4), slight (0.5-1.9), moderate (2-4.9), or severe (5-8). | Pass |
| Water Resistance: Impact Penetration | Visual Penetration: None seen Amount of Penetration (g) : ≤ 1.0 g | Pass |
| Water Resistance: Hydrostatic Pressure | Pressure: ≥ 50 cm (Specifically for Level 3 Surgical Gowns based on ANSI/AAMI PB70:2012) | Pass |
| Tear Resistance | No acceptance criteria currently exist for this test. | Pass |
| Basis Weight | Test articles should be weighed, and the basis weight should be calculated as the mass divided by the area. all should weigh the same. | Pass |
| Sterilant Gas Residue Analysis | Maximum levels of sterilant residuals: ETO |
§ 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.