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510(k) Data Aggregation
(412 days)
INTAI Surgical Mask is intended to be worn by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials. This is a single use, disposable device and provided non-sterile.
The INTAI Surgical Mask is single use, three-layers, flat-pleated masks with ear loops, and nose clip. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The ear loops welded are used to keep the mask close to the mouth and the nose. The ear loops are made of Nylon. The nose clip, which is made by plasticity material (HDPE), contained in masks is in the layers of the surgical mask to allow the users to fit the facemask around their nose. The surgical mask are provided in one color (blue), non-sterile and intended to be single use, disposable device.
This document is a 510(k) premarket notification for a medical device, specifically the INTAI Surgical Mask. It details the device's characteristics and its comparison to a legally marketed predicate device to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document presents the acceptance criteria and performance results directly in Table 2: Comparison of Performance testing on page 5 and the subsequent Summary of Non-Clinical Test table on page 6.
| Item | Reported Device Performance (K210422) | Acceptance Criteria (Level 3) | Result |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood | Achieve a 4% AQL at 160mmHg | Achieve a 4% AQL (29 out of 32 pass at 160mmHg) | Pass |
| Sub-Micron Particle Filtration Efficiency (PFE) | ≥98% | ≥98% | Pass |
| Differential Pressure | <6.0 mm H2O/cm$^2$ | <6.0 mm H2O/cm$^2$ | Pass |
| Bacterial Filtration Efficiency (BFE) | ≥98% | ≥98% | Pass |
| Flammability | Class 1 (Did Not Ignite (DNI)) | Class 1 (Did Not Ignite (DNI)) | Pass |
| In Vitro Cytotoxicity Test | No cell lysis, no reduction of cell growth | No cell lysis, no reduction of cell growth | Pass |
| Skin Irritation Test | Non-irritant | Non-irritant | Pass |
| Skin Sensitization Test | No visible change | No visible change | Pass |
2. Sample size used for the test set and the data provenance
- Sample Size for Resistance to Penetration by Synthetic Blood: "29 out of 32 pass at 160mmHg" indicates a sample size of 32 units for this specific test.
- Sample Size for other tests: The document generally states "Non-Clinical tests were conducted to verify that the proposed device met all design specifications" and lists the relevant ASTM/ISO standards. However, the exact sample sizes for each of the other performance tests (BFE, PFE, Differential Pressure, Flammability, Cytotoxicity, Irritation, Sensitization) are not explicitly provided in this summary document.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only states that "Non-Clinical tests were conducted."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable to this document. The device is a surgical mask, and its acceptance criteria are based on standardized performance tests (e.g., filtration efficiency, fluid resistance, flammability, biocompatibility), not on expert subjective assessment of medical images or clinical outcomes. The "ground truth" is established by the test methods themselves and their specified thresholds.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation where multiple human readers assess cases and a consensus or tie-breaking mechanism is needed to establish ground truth or evaluate reader performance. For the physical and biological performance tests described for a surgical mask, the results are quantitative measurements or direct observations (e.g., "Pass/Fail," "Class 1," "≥98%"), not subjective interpretations requiring adjudication.
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 section is not applicable. This document is for a physical medical device (surgical mask), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a surgical mask, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The 'ground truth' for this device is based on standardized laboratory test results against established performance criteria, as defined by various national and international standards (e.g., ASTM F2100, ASTM F1862, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993-5, ISO 10993-10). These standards define the methodologies and acceptance thresholds for properties like bacterial filtration efficiency, particulate filtration efficiency, fluid resistance, differential pressure, flammability, cytotoxicity, and irritation.
8. The sample size for the training set
This section is not applicable. The device is a physical product (surgical mask) that undergoes performance testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable, as there is no training set for a physical device.
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