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510(k) Data Aggregation
(124 days)
The AOK 95A Medical Mask (20200049) is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The AOK 95A Medical Mask (20200049) is single use, four-layer folded masks with ear loops, or straps to tie behind the user's head, and a nose piece. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The AOK 95A Medical Mask will be provided in white and blue. The AOK 95A Medical Mask is sold non-sterile and are intended to be single use, disposable devices.
This document describes the safety and effectiveness of the AOK 95A Medical Mask (K220876) by comparing it to a legally marketed predicate device (AOK Tooling Limited - K211956). The evaluation relies on non-clinical performance testing.
1. Acceptance Criteria and Reported Device Performance
The table below summarizes the acceptance criteria and the reported performance of the AOK 95A Medical Mask. These criteria are based on ASTM 2100 Level 2 standards.
| Acceptance Criteria (ASTM 2100 Level 2) | Reported Device Performance (AOK 95A Medical Mask) |
|---|---|
| Fluid resistance: Pass at 120mmHg | Pass at 120mmHg |
| Particulate efficiency level: ≥98% | ≥98% |
| Bacterial filtration level: ≥98% | ≥98% |
| Differential pressure: <6.0 mm H2O/cm² | <6.0 mm H2O/cm² |
| Flammability: Class I | Class I |
| Biocompatibility: Cytotoxicity, Sensitization, Irritation (Pass) | Cytotoxicity, Sensitization, Irritation (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for each individual test (Fluid Resistance, Flammability, PFE, BFE, Differential Pressure, Biocompatibility). However, the tests are stated as "Bench testing" and "Biocompatibility," implying laboratory-based testing on device samples. The data provenance is implied to be from AOK Tooling Limited, the manufacturer, through their conducted tests. The tests are considered prospective as they are conducted specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of medical device (surgical/medical mask) does not typically involve human expert interpretation for establishing ground truth in performance testing. The ground truth for the performance criteria (e.g., filtration efficiency, fluid resistance) is objectively measured through established ASTM testing standards and equipment. Therefore, no human experts were used to establish ground truth for the test set in the traditional sense of clinical image interpretation or diagnosis.
4. Adjudication Method for the Test Set
As mentioned above, the performance tests involve objective, standardized measurements rather than subjective human interpretation. Therefore, no adjudication method (like 2+1, 3+1) was applicable or used for the test results.
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 device is a medical mask and does not involve AI or human reader interpretation. Therefore, no MRMC comparative effectiveness study was conducted or is applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical mask, not an algorithm or AI-powered system. Therefore, no standalone algorithm performance study was conducted or is applicable.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance of the AOK 95A Medical Mask is established through objective measurements against recognized industry standards (ASTM 2100 Level 2). These standards define quantifiable thresholds for parameters like filtration efficiency, fluid resistance, and breathability. Biocompatibility is assessed against established biological safety guidelines for medical devices.
8. The Sample Size for the Training Set
This device is a physical product and does not involve machine learning algorithms that require a "training set." Therefore, no training set sample size is applicable or provided.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for this type of device, this question is not applicable.
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