(155 days)
The Aero Chrome* 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* Breathable Performance Surgical Gowns meet the Level 4 requirements of the AAMI PB70:2012 Liquid Barrier classifications.
The Aero Chrome* Breathable Performance Surgical Gowns are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and Ethylene Oxide (EtO) sterilization
The Aero Chrome* Breathable Performance Surgical Gowns have 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* Breathable Performance Surgical Gown in the non-critical zone has a SMS Spunbond/meltblown/spunbond) fabric that is air-breathable and provides AAMI Level 1 liquid barrier protection. The Aero Chrome* Breathable Performance Surgical Gowns are single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations described below.
The provided document is a 510(k) premarket notification for a medical device: the Aero Chrome Breathable Performance Surgical Gown*. This type of submission focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving novel efficacy or safety through primary clinical trials for the device itself. Therefore, the "study" proving the device meets acceptance criteria primarily consists of non-clinical performance testing to show that the new device performs at least as well as, or equivalently to, the predicate device in relevant aspects.
Here's an analysis of the acceptance criteria and the provided information:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a single consolidated "acceptance criteria" table as one might find for a diagnostic AI device with precision/recall metrics. Instead, it details various performance tests demonstrating compliance with recognized standards for surgical gowns. The acceptance criteria for each test are implicitly (or explicitly, as "Pass") stated as meeting the requirements of the specified standard.
| Acceptance Criteria (Standard & Level) | Test Method | Reported Device Performance (Aero Chrome*) |
|---|---|---|
| AAMI PB70:2012 Liquid Barrier Classifications | Resistance to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage (Level 4) | Pass |
| Water resistance (Level 1 in non-critical zones) | Pass | |
| 16 CFR 1610 (Flammability) | Flammability | Pass (Class I) |
| ISO 10993-5:2009 (Biological Evaluation) | Cytotoxicity | Pass (non-cytotoxic) |
| ISO 10993-10:2010 (Biological Evaluation) | Skin Irritation Study | Pass (negligible irritant) |
| Sensitization Test | Pass (non-sensitizing) | |
| ISO 10993-7:2008 (EO Sterilization) | EO residuals | Pass |
| ISO 11810-1 (2005) (Laser Ignition Resistance) | Laser resistance | Pass |
| AATCC 42:2013 (Spray Impact) | Water resistance | Pass |
| ASTM D5034 (2009) (Grab Tensile) | Tensile Strength | Pass |
| WSP 20.5 (2008) (Abrasion Resistance) | Abrasion resistance | Pass |
| ASTM-1670-08 (2008) (Synthetic Blood Penetration) | Resistance to penetration | Pass |
| D3776 (2009) (Mass Per Area) | Fabric basis weight | Pass |
| WSP 70.4 (2008) (Water Vapor Transmission Rate) | Water Vapor Transmission | Pass |
| STM-00197 (2010) (Peel Strength) | Peel Strength | Pass |
| INDA WSP 160.1 (2009) (Linting) | Particulate | Pass |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical performance test. Standard test methods (e.g., ASTM, ISO, AAMI) typically define the minimum sample sizes required for statistically valid testing. For example, for textile testing (tensile strength, abrasion), there would be a specified number of specimens. For biocompatibility (cytotoxicity, irritation, sensitization), there would be a defined number of replicates and control groups.
- Data Provenance: The data comes from the manufacturer's (Halyard Health, Inc.) own non-clinical performance testing. It is not explicitly stated if these were internal labs or third-party labs, but generally, such tests are conducted in controlled lab environments. The document does not specify a country of origin for the data; it's implicit to be associated with Halyard Health's operations for regulatory submission in the US.
- Retrospective or Prospective: These are prospective tests performed specifically to demonstrate that the newly designed Aero Chrome* gown meets the required performance standards for its intended use and for comparison with the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and submission. This is a surgical gown, not an AI/diagnostic device that relies on expert interpretation of images or patient data to establish ground truth. The "ground truth" for a surgical gown's performance is established by objective, measurable physical, chemical, and biological properties, as defined by recognized consensus standards (e.g., AAMI, ISO, ASTM). The expertise lies in conducting the tests according to the standard protocols and interpreting the quantitative results against the specified pass/fail criteria.
4. Adjudication method for the test set:
- This question is not applicable. Since the "ground truth" is established through objective laboratory testing against predefined standards (e.g., a specific resistance value, a pass/fail for bacterial penetration), there is no human "adjudication" in the sense of multiple readers or experts reviewing subjective data. The test results are quantitative/qualitative outcomes of physical/chemical processes.
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 question is not applicable. This is a physical medical device (surgical gown), not an AI diagnostic algorithm. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- The ground truth for this device's performance is established by objective, quantitative measurements and qualitative assessments derived from standardized laboratory test methods (e.g., AAMI PB70:2012, ASTM D5034, ISO 10993 series). These standards define specific criteria (e.g., pressure resistance, microbial penetration, tensile strength limits, cytotoxicity levels) that the device must meet. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic tool would be.
8. The sample size for the training set:
- This question is not applicable. This is a physical device, and there is no "training set" in the context of machine learning. The manufacturing process of surgical gowns involves material selection, design, and fabrication, which are validated through process controls and quality assurance, not through a "training set" of data.
9. How the ground truth for the training set was established:
- This question is not applicable for the reasons stated above.
In summary: The submission for the Aero Chrome* Breathable Performance Surgical Gown focuses on demonstrating substantial equivalence to a predicate device (Aero Blue* Performance Surgical Gown) by providing comprehensive non-clinical performance test results against established industry standards. The "acceptance criteria" are the "Pass" outcomes for each of these standardized tests, indicating that the gown meets the specified physical, chemical, and biological performance requirements relevant to its intended use as protective apparel. The evaluation does not involve clinical studies with human "readers" or AI algorithms.
§ 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.