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510(k) Data Aggregation
(335 days)
The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face masks are single use, disposable device, provided non-sterile.
The Unico High Performance Surgical Mask and the Unico High Performance Surgical Mask with Face Shield are composed of four layers and are flat-pleated and offers both ear loops and tie strings types. The mask materials consist of outer layer (Polypropylene Spunbond), insertion layer (Polypropylene Spunbond) and inner layer (Polypropylene Spunbond), and middle layer filter (polypropylene melt-blown). Each mask contains ear loops or tie strings to secure the mask over the user's mouth and face with nose piece to firmly fit over the nose. The mask may also contain a face shield made from a polyethylene terephthalate film, with an anti-glare strip. The face shield is adhered to the top edge of the mask to cover the upper part of the face to prevent potential exposure to blood and body fluids. The mask(s) are single use, disposable device(s), provided non-sterile.
The provided text describes a 510(k) premarket notification for a surgical mask, not an AI/ML medical device. Therefore, most of the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, data provenance, expert adjudication, MRMC studies, and standalone performance, is not applicable.
However, I can extract the acceptance criteria and reported performance for the surgical mask based on the provided tables and text.
Acceptance Criteria and Device Performance for Unico High Performance Surgical Mask
| No. | Test | Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|---|
| 1 | Particle Filtration Efficiency (PFE) | ASTM F2299 | ≥98% @ 0.1 micron (Implicit from comparison chart) | 98.3% |
| 2 | Synthetic Blood Penetration for Face Masks | ASTM F1862 and ISO 22609 | Passed at 160mmHg (Implicit from comparison chart) | Not Seen (meaning passed) |
| 3 | Differential Pressure (Delta P) | EN 14683:2019, Annex C and ASTM F2100-19 |
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(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 |
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