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510(k) Data Aggregation
(242 days)
The Aurelia Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. The Aurelia Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, provided nonsterile.
The proposed device, Aurelia Surgical Masks are three-layer masks constructed of nonwoven polypropylene. The inner and outer layers are made of spun-bonded polypropylene. The middle layer consists of 25gsm melt-blown polypyrene. The mask contains an ear loop to secure the mask over the users' mouth and face and includes a nosepiece to provide a firm fit over the nose. Ear loops are made of polyurethane and nylon. The nose clip which is made of 3mm aluminum flat wire. The disposable surgical face mask is available in two different specifications: ASTM Level 1 and ASTM Level 2. The masks meet the following ASTM 1 and ASTM 2 Technical standards.
The provided document is an FDA 510(k) premarket notification for surgical masks (Aurelia Surgical Mask ASTM Level 1 and Level 2). It focuses on demonstrating substantial equivalence to predicate devices based on performance testing against established ASTM standards for surgical masks.
Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD) is not directly applicable to this document. The document describes a physical medical device (surgical masks) and its performance validation, not an AI or software product.
However, I can extract and present the performance criteria and the reported performance for the surgical masks as per the ASTM standards mentioned, which function as acceptance criteria for these physical devices.
1. A table of acceptance criteria and the reported device performance
The document provides the following "Acceptance Criteria per ASTM F2100-19" and "Results" for the Aurelia Surgical Masks:
Table: Acceptance Criteria and Reported Device Performance
| Test | Purpose | Acceptance Criteria per ASTM F2100-19 | Reported Device Performance (Results) |
|---|---|---|---|
| For Level 1 Mask | |||
| Fluid Resistance (ASTM F1862) | This test is performed to evaluate Personal Protective Equipment against fluid penetration. An arterial spray is simulated to test the PPE. | Level 1: 80mmHg | Aurelia Mask Level 1: 80mmHg |
| Differential Pressure (Delta-P) (ASTM F2100-19 EN 14683:2019) | The purpose of this test is to ensure the drop in pressure is not too great so the user may breathe through the subject device. | Level 1: < 5.0 mm H2O/cm² | Aurelia Mask Level 1: < 4.5 mm H2O/cm² |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | The BFE test is performed to determine the bacterial filtration efficiency of test articles. | Level 1: ≥ 95% | Aurelia Mask Level 1: ≥ 99.7% |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | The PFE test is performed to evaluate the non-viable particle filtration efficiency of the test article. | Level 1: ≥ 95% | Aurelia Mask Level 1: ≥ 99.5% |
| Flammability (16 CFR 1610) | The purpose of this test is to ensure the subject device does not ignite when exposed to flame. | Level 1: Class 1 | Aurelia Mask Level 1: Class 1 |
| For Level 2 Mask | |||
| Fluid Resistance (ASTM F1862) | This test is performed to evaluate Personal Protective Equipment against fluid penetration. An arterial spray is simulated to test the PPE. | Level 2: 120mmHg | Aurelia Mask Level 2: 120 mmHg |
| Differential Pressure (Delta-P) (ASTM F2100-19 EN 14683:2019) | The purpose of this test is to ensure the drop in pressure is not too great so the user may breathe through the subject device. | Level 2: < 6.0 mm H2O/cm² | Aurelia Mask Level 2: < 4.1 mm H2O/cm² |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | The BFE test is performed to determine the bacterial filtration efficiency of test articles. | Level 2: ≥ 98% | Aurelia Mask Level 2: ≥ 99.7% |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | The PFE test is performed to evaluate the non-viable particle filtration efficiency of the test article. | Level 2: ≥ 98% | Aurelia Mask Level 2: ≥ 99.6% |
| Flammability (16 CFR 1610) | The purpose of this test is to ensure the subject device does not ignite when exposed to flame. | Level 2: Class 1 | Aurelia Mask Level 2: Class 1 |
| Biocompatibility | |||
| Cytotoxicity (ISO 10993-5) | Not explicitly stated but implied: To evaluate potential cell toxicity. | Non-Cytotoxicity | Pass |
| Sensitization (ISO 10993-10) | Not explicitly stated but implied: To evaluate potential for allergic reaction. | Non-Sensitization | Pass |
| Irritation (ISO 10993-10) | Not explicitly stated but implied: To evaluate potential for skin irritation. | Non-Irritating | Pass |
Note: The document states that "Non-clinical performance tests and Biocompatibility were conducted to verify that the Aurelia Surgical Masks met or exceeded all the design specifications as the predicate device K082258. The results were indicated in the Predicate Comparison Section above and restated below." This acts as the "study" proving the device meets the acceptance criteria for these types of physical medical devices.
The remaining points (2-9) are typical requirements for AI/SaMD studies and are not applicable to this document, which concerns a physical surgical mask.
Therefore, for the remaining points:
- Sample size used for the test set and the data provenance: Not applicable. Performance tests (e.g., BFE, PFE, Fluid Resistance) involve standardized laboratory testing on material samples, not a "test set" of patient data as for AI.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical mask performance is established by the test methods themselves, not expert consensus on patient data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is for AI-assisted image interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth is determined by standardized physical and biological test methods.
- The sample size for the training set: Not applicable. There is no "training set" for a physical surgical mask.
- How the ground truth for the training set was established: Not applicable.
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