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510(k) Data Aggregation
(184 days)
Aero Chrome* Select Breathable Performance Surgical Gowns
The Aero Chrome* Select Breathable 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 Chrome* Select Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.
The Aero Chrome* Select Breathable Performance Surgical Gown has a Spunbond/Film/Spunbond/Meltblown/Spunbond design (SFSMS) that provides AAMI Level 4 liquid barrier protection in the critical zones of the gown. The back of the Aero Chrome* Select Breathable Performance Surgical Gown in the non-critical zone also has the same Spunbond/Film/Spunbond/Meltblown/Spunbond fabric (SFSMS) that provides ASTM 1671 liquid barrier protection. The Aero Chrome* Select Breathable Performance Surgical Gown is single use, disposable medical device that will be provided in a variety of sizes and sterile and non-sterile packaging configurations.
The provided text describes a medical device, the Aero Chrome* Select Breathable Performance Surgical Gown, and its equivalence to a predicate device. The information details various performance tests and their results, which serve as criteria for establishing substantial equivalence.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard/Reference & Test Method) | Reported Device Performance | Meets Requirement |
|---|---|---|
| 16 CFR 1610 (Flammability for Clothing Textiles) | Flammability | Pass |
| ISO 10993-5:2009 (Biological Evaluation of Medical Devices - Part 5: Cytotoxicity) | Cytotoxicity | Pass (non-cytotoxic) |
| ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Skin Irritation Study) | Irritation | Pass (negligible irritant) |
| ISO 10993-10:2010 (Biological Evaluation of Medical Devices - Part 10: Sensitization Test) | Sensitization | Pass (non-sensitizing) |
| ISO 10993-7:2008 (Ethylene Oxide sterilization residuals) | EO residuals | Pass |
| ISO 11810-1 (2005) (Laser Ignition Resistance) | Laser resistance | Pass |
| AAMI PB70:2012 Level 4 (Liquid Barrier Performance in Critical Zone) | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage | Pass |
| AAMI PB70:2012 Level 1 (Liquid Barrier Performance in non-critical raglan sleeve to shoulder seams) | Water resistance | Pass |
| ASTM F1671 (Liquid Barrier Performance in Non-Critical Zone fabric on the back of gown) | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage | Pass |
| ASTM D5034 (2009) (Grab Tensile, Peak Stretch, and Peak Energy - Nonwovens) | Tensile Strength | Pass |
| WSP 20.5 (2008) (Abrasion Resistance and Surface Bonding of SMS Laminates) | Abrasion resistance | Pass |
| ASTM-1670-08 (2008) (Synthetic Blood Penetration - fabric only in critical and non-critical zone) | Resistance to penetration | Pass |
| D3776 (2009) (Mass Per Area (Basis Weight) of Materials) | Fabric basis weight | Pass |
| WSP 70.4 (2008) (Water Vapor Transmission Rate Through Nonwovens and Plastic Films) | Water Vapor Transmission | Pass |
| STM-00197 (2010) (Degree Peel Strength of Laminated Nonwovens - Raw Materials) | Peel Strength | Pass |
| INDA WSP 160.1 (2009) (Resistance to Linting Dry Particle Generation) | Particulate | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gowns, or material samples tested per batch). It only lists the tests performed and that the product "met the predetermined specifications."
The data provenance is industrial testing data, generated by Halyard Health, Inc. or its designated testing facilities, to demonstrate compliance with relevant industrial standards and regulations (e.g., AAMI, ISO, ASTM, CFR). The testing appears to be prospective in nature as it is being conducted to demonstrate the performance of a new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable. The device is a surgical gown, and its performance is evaluated against objective, standardized physical and biological parameters, not subjective expert assessment as would be the case for an AI diagnostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for this type of device and testing. The tests involve quantifiable measurements according to established methods, not subjective interpretations requiring adjudication.
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. MRMC studies are typically for diagnostic imaging devices where human interpretation is involved. This device is a surgical gown.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable, as this is a physical medical device (surgical gown), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is defined by the established industry standards and regulatory requirements for surgical apparel. These standards specify objective, measurable performance criteria (e.g., liquid barrier effectiveness, flammability, biocompatibility).
8. The sample size for the training set:
This is not applicable. This is not a machine learning or AI device that requires a training set. The device's performance is tested against predetermined physical and biological standards.
9. How the ground truth for the training set was established:
This is not applicable, as there is no training set for this type of device. The ground truth for evaluating the device is based on established scientific and regulatory standards.
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