(105 days)
The Aero Blue Performance Surgical gowns are sterile, single use surgical apparel intended to be worn by healthcare professionals to help protect both the patient and the healthcare worker from the transfer of microorganisms, body fluids, and particulate matter. The Aero Blue Performance Surgical Gowns meet the Level 3 AAMI PB70:2012 Liquid Barrier classifications.
The Aero Blue Performance Surgical Gowns have a SMS/F/SMS design (Spunbond-Meltblown-Spunbond/Film/Spunbond-Meltblown-Spunbond) that provides a PB70:2012 Level 3 Liquid Barrier Performance Barrier in the critical zone. The back of the gown has a Spundbond-Meltblown-Spunbond (SMS) fabric which allows for air-breathability with an AAMI Level 1 Liquid Barrier Performance Barrier.
The Aero Blue Performance Surgical Gown is a single use gown, supplied sterile (via Ethylene Oxide) or as bulk non-sterile product. The gowns come in the following various sizes: Small, Large, X-Large, XX-Large, XXX-Large, X-Long XL, X-Long XXL.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Aero Blue Performance Surgical Gowns:
The provided documentation describes the acceptance criteria and performance of a medical device (Aero Blue Performance Surgical Gowns) for a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring a full de novo study proving efficacy and safety from scratch. Therefore, the "study" referred to is primarily a series of performance tests against established standards and a comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Aero Blue Performance Surgical Gowns (K192362)
| Test Method/Reference | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device - K192362) | Result |
|---|---|---|---|
| Spray Impact (Critical Zones) - AATCC 42 | Water Resistance - Pass | Water Resistance | Pass |
| Hydrostatic Pressure (Critical Zones) - AATCC 127 | Water Resistance - Pass | Water Resistance | Pass |
| Liquid Barrier Performance (Critical Zones) | ANSI/AAMI PB70:2012 Level 3 | ANSI/AAMI PB70:2012 Level 3 | Pass |
| Spray Impact (Non-Critical Zones) - AATCC 42 | Water Resistance - Pass | Water Resistance | Pass |
| Liquid Barrier Performance (Non-Critical Zones) | ANSI/AAMI PB70:2012 Level 1 | ANSI/AAMI PB70:2012 Level 1 | Pass |
| Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens ASTM D5034 - 9 2017 | Tensile Strength - Pass | Tensile Strength | Pass |
| Abrasion Resistance of Nonwoven Fabrics NWSP 020.5.RO (15) 2015 | Abrasion Resistance - Pass | Abrasion Resistance | Pass |
| Synthetic Blood Penetration ASTM F1670 (2017) | Resistance to Penetration - Pass | Resistance to Penetration | Pass |
| Water Vapor Transmission Rate NWSP 070.4.RO (15) 2015 | Water Vapor Transmission - Pass | Water Vapor Transmission | Pass |
| 180 Degree Peel Strength of Non-Elastic Laminated Nonwovens STM-00197 Rev 1 | Peel Strength - Pass | Peel Strength | Pass |
| Linting ISO 9073-10 2003 | Particulate - Pass | Particulate | Pass |
| Flammability for Clothing Textiles 16 CFR 1610 | Flammability - Class 1 - Pass | Flammability | Pass |
| ISO L929 MEM Elution Cytotoxicity ISO 10993-5:2009 | Cytotoxicity - Pass (non-cytotoxic) | Cytotoxicity | Pass |
| ISO Indirect Primary Skin Irritation Test ISO 10993-10:2010 | Irritation - Pass (non-irritant) | Irritation | Pass |
| ISO Kligman Maximization Test ISO 10993-10:2010 | Sensitization - Pass (non-sensitizing) | Sensitization | Pass |
| EO Sterilization Residuals ISO 10993-7:2008 (R) 2012 | EO Residuals (EO=0.5mg/dev)(ECH =0.3mg/dev) - Pass | EO Residuals (EO=0.5mg/dev)(ECH =0.3mg/dev) | Pass |
| Laser Ignition Resistance ISO 11810-1:2015 | Laser Resistance - Pass | Laser Resistance | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test within the performance testing. However, given that these are performance tests for surgical gowns demonstrating compliance with industry standards (like AAMI PB70:2012 and various ISO/ASTM standards), the sample sizes would typically be determined by the requirements of those specific standards for each test (e.g., number of specimens for tensile strength, number of samples for barrier testing).
The data provenance is retrospective, as the tests were conducted on existing product designs to demonstrate substantial equivalence to a predicate device. The country of origin of the data is not specified, but the tests are based on internationally recognized standards (ISO, AAMI, ASTM, AATCC, CFR).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of submission (510(k) for surgical apparel) does not typically involve human expert adjudication of a test set in the way an AI diagnostic device would. The "ground truth" for these tests is established by:
- Industry standards and specifications: AAMI PB70:2012, ISO 9073-10, ASTM D5034, etc., define the criteria for what constitutes a "Pass" for each physical and material characteristic.
- Laboratory testing methodologies: Standardized laboratory procedures are followed to objectively measure the performance metrics (e.g., water resistance, tensile strength, biocompatibility).
Therefore, there isn't a stated number of experts or their qualifications for establishing a "ground truth" in the diagnostic sense, but rather adherence to established scientific and engineering principles and standards.
4. Adjudication Method for the Test Set
Not applicable. As explained above, this is about adherence to objective performance standards, not expert adjudication of diagnostic outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. A MRMC comparative effectiveness study is designed to evaluate the impact of an AI system on human reader performance, typically in diagnostic imaging. This submission is for surgical gowns, which are physical barriers and do not involve diagnostic interpretation by human readers or AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This concept is not applicable to a physical medical device like a surgical gown. The "standalone performance" is essentially the physical performance of the gown itself against the specified criteria, which is what the non-clinical tests assess.
7. The Type of Ground Truth Used
The ground truth used for the assessment of the surgical gowns' performance is based on established industry standards and regulatory requirements. This includes:
- Performance Standards: Specific liquid barrier classifications (AAMI PB70:2012 Level 3 and Level 1), tensile strength, abrasion resistance, synthetic blood penetration, water vapor transmission, peel strength, linting, flammability, laser resistance.
- Biocompatibility Standards: ISO 10993 series for cytotoxicity, irritation, and sensitization.
- Sterilization Standards: ISO 10993-7 for Ethylene Oxide residuals.
These standards define the objective criteria that the device must meet to be considered safe and effective for its intended use.
8. The Sample Size for the Training Set
Not applicable. Surgical gowns are physical products, not AI algorithms that require training data. The "training set" concept is irrelevant here.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical device like a surgical gown.
§ 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.