(183 days)
The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room.
The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown gown meets the barrier protection requirements of AAMI Level 3 per ANSI/AAMI PB70:2012 – Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities.
The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is a single use, disposable medical device and is provided non-sterile.
The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is used in moderate risk situations such as venous blood draws, inserting IVs, and emergency room use. The gown is not sterile; is not an isolation gown and is not indicated for use in the Operating Room. The AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown is made of one-piece chlorinated polyethylene elastomer non-woven tri-laminate. The Level 3 gown meets the ANSI/ AAMI PB70 Level 3 standards. The gown is a single use, disposable device.
The provided document is a 510(k) premarket notification for a medical device: an AZAC Protect X Level 3, Single Use, Non-Sterile, Protective Gown. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through new clinical trials as would be required for a premarket approval (PMA) application for a novel, high-risk device.
Therefore, the information typically requested about AI/algorithm performance studies (e.g., sample sizes for test and training sets, expert ground truth establishment, MRMC studies, effect sizes of AI assistance, standalone performance) is not applicable to this document. This document describes the testing of a physical medical device (a protective gown), not an AI/algorithm-based diagnostic or assistive system.
The acceptance criteria and performance data provided relate to the physical properties and barrier performance of the gown, not to an algorithm's accuracy or clinical utility.
Here's the information extracted from the document that is relevant to the acceptance criteria and the non-clinical study proving the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Test Method (Acceptance Criteria) | Purpose | Criteria (Acceptance Criteria) | Result (Reported Device Performance) |
|---|---|---|---|
| AAMI PB70:2012 | Overall barrier performance | Meet requirements for classification as AAMI PB70 Level 3 gown | Pass |
| Hydrostatic Pressure Test (AATCC 127:2018) | Resistance to static liquid | NLT 50.0 cm H2O | Pass |
| Impact Penetration (AATCC 42-2017) | Resistance to liquid stream | No penetration | Pass |
| ASTM D 3776 - Mass/unit area | Basis weight of material | 26 g/m² | Pass |
| ASTM D5034 Breaking Strength - Grab Test | Durability: Grab test | Length – 27 N, Width – 31.5 N | Pass |
| ASTM D5587 Tear Strength - Trapezoid Test | Durability: Trapezoid | Length – 10.5 N, Width 14.0 N | Pass |
| 16 CFR 1610 - Flammability | Flammability | Class 1 | Pass |
| ISO 10993-5 Cytotoxicity | Biocompatibility: Cytotoxicity potential | Under the conditions of the study, non-cytotoxic | Pass |
| 10993-10 Sensitization/Irritation | Biocompatibility: Sensitization and irritation | Under the conditions of the study, not a sensitizer; Under the conditions of the study, non-irritating | Pass |
2. Sample sized used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of gowns or material samples) used for each non-clinical test. It states that "Results confirm that the design inputs and performance specifications are met."
- Data Provenance: The tests were conducted internally by AZAC Group or by labs on their behalf, based on "internal requirements and applicable standards." The country of origin and whether the data is retrospective or prospective are not detailed. These are standard laboratory tests for physical properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For physical and material property testing, "ground truth" is established by adhering to published ASTM, AATCC, AAMI, and ISO standard test methods and their specified procedures, rather than by human expert consensus or interpretation of complex data. The results are objective measurements or categorical determinations (e.g., pass/fail).
4. Adjudication method for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert review of medical images or clinical cases to establish ground truth in diagnostic studies. For these non-clinical material tests, the results are determined by the specified test protocols and criteria.
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:
- Not applicable. This document is for a physical protective gown, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for a physical protective gown, not an algorithm.
7. The type of ground truth used:
- For the non-clinical performance data, the "ground truth" is defined by the objective pass/fail criteria established by recognized industry standards (e.g., AAMI PB70:2012, AATCC 127:2018, ASTM D 3776, ISO 10993-5). These standards specify the test methodology and the performance thresholds required for a "Pass" result.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There is no "training set."
§ 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.