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510(k) Data Aggregation
(236 days)
The Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are not intended for use in the operating room.
The Dukal AAMI Level 4 Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective.
These gowns are single use, disposable medical devices provided non-sterile.
Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material These gowns are not intended - for use in the operating room. The gowns are available on Regular and X-Large sizes.
Dukal AAMI Level 4 Open-Back Protective Gowns are made with laminate material (SMS nonwoven material with polyethylene film).
All gowns are blue, with neck removal feature, belt ties, and thumb hook cuff sleeves.
These gowns are single use, disposable devices, that are provided non-sterile.
The provided document is a 510(k) premarket notification for a medical device: Dukal AAMI Level 4 Open-Back Protective Gown. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested categories related to clinical trials, multi-reader multi-case studies, and AI-specific ground truth are not applicable.
Here's the breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Test Requirements) | Reported Device Performance (Dukal AAMI Level 4 Open-Back Protective Gown) |
|---|---|---|
| Blood-Borne Pathogens penetration | Pass (For AAMI Level 4 Requirements): None Seen for Penetration of Phi-X174 Bacteriophage (ASTM F1671) | Pass |
| Hydrostatic pressure | ≥100 cm H2O (Individual) | |
| ≥140 cm H2O (Average) (AATCC 127) | >130 cm H2O | |
| Basis weight | 50±6 gsm (ASTM D3776) | 50±6 gsm |
| Tensile strength | Machine Direction (MD) ≥ 30 N | |
| Cross Direction (CD) ≥ 30 N (ASTM D5034) | Machine Direction (MD) ≥ 30 N | |
| Cross Direction (CD) ≥ 30 N | ||
| Tear strength | Machine Direction (MD) ≥ 10 N | |
| Cross Direction (CD) ≥ 10 N (ASTM D5587) | Machine Direction (MD) ≥ 10 N | |
| Cross Direction (CD) ≥ 10 N | ||
| Seam Strength | ≥30 N (ASTM D 1683) | ≥30 N |
| Lint generation | Size of particles counted: 3mcg-25mcg (ISO 9073-10) | Size of particles counted: 3mcg-25mcg |
| Flammability | Class I (16 CFR Part 1610) | Class I |
| Biocompatibility (Cytotoxicity) | Under the conditions of the study, the device does not show cytotoxicity potential. (ISO 10993-5) | Under the conditions of the study, the device did not show cytotoxicity potential. |
| Biocompatibility (Irritation) | Under the conditions of the study, the irritation response category of the device is classified as Negligible. (ISO 10993-10) | Under the conditions of the study, the irritation response category of the device was classified as Negligible. |
| Biocompatibility (Sensitization) | Under the conditions of the study, the device shows no significant evidence of causing skin sensitization. (ISO 10993-10) | Under the conditions of the study, the device showed no significant evidence of causing skin sensitization. |
| Liquid Barrier Performance Classification | All areas tested meet Level 4 performance requirements (ASTM F1671), which is the highest standardized level of barrier performance. Meets barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. (For critical zone areas: body or sleeve (same material) and heat sealed seam(s)). | All areas tested meet Level 4 performance requirements (ASTM F1671), which is the highest standardized level of barrier performance. Meets barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Testing was performed in accordance with ASTM F1671 using 3 lots and 32 samples per lot in each critical zone area. The critical zone areas tested were the body or sleeve (same material) and the heat sealed seam(s). |
2. Sample size used for the test set and the data provenance
- Sample Size: For the Liquid Barrier Performance Classification test (ASTM F1671), the testing was performed using 3 lots and 32 samples per lot in each critical zone area (body/sleeve and heat-sealed seams). For other tests, specific sample sizes are not explicitly stated within the provided text, but the results are reported as meeting the requirements.
- Data Provenance: The nature of these tests (material properties) suggests they were conducted in a laboratory setting. There is no information provided regarding the country of origin of the data or whether it was retrospective or prospective, as these terms are not typically applicable to physical product testing of this kind.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are non-clinical, objective material property tests and do not involve expert interpretation or ground truth establishment by medical professionals. The "ground truth" is determined by the standardized test methods and their defined pass/fail criteria.
4. Adjudication method for the test set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for dispute resolution or consensus building among human readers, typically in image interpretation or clinical diagnosis. These tests involve objective physical measurements against established standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI-assisted diagnostic tools with human readers. The device in question is a protective gown, which is not an AI-powered diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is not an algorithm or AI model.
7. The type of ground truth used
For this device, the "ground truth" is the objective, measurable performance against established industry standards (e.g., AAMI Level 4 requirements, ASTM, ISO, AATCC standards). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for a protective gown's material performance. The ground truth is embedded in the standardized test methods and their pass/fail criteria.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it is not an AI/machine learning model.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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