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510(k) Data Aggregation
(42 days)
The TAIJI Professional Series Level 3 Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.
The TAIJI Professional Series Level 3 Surgical Face Mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The mask is a single use, disposable device, provided nonsterile.
This document pertains to the 510(k) premarket notification for a medical device: TAIJI Professional Series Level 3 Surgical Face Mask (K211861).
The acceptance criteria and study proving the device meets these criteria are outlined in the "Summary of Non-Clinical Testing" section.
Here's the breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Standard/Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM F1862: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood | Barrier Testing | At least 29 out of 32 specimens show passing results at 160 mmHg | Samples met the predetermined acceptance criteria. |
| ASTM F2101-19: Standard Specification for Performance of Materials Used in Medical Face Masks | Barrier Testing | ≥98% | Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each). |
| EN 14683:2019 Annex C and ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks | Physical Testing | <6.0 mm H2O/cm² | Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each). |
| ASTM F2100-19: Standard Specification for Performance of Materials Used in Medical Face Masks | Barrier Testing | ≥98% | Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each). |
| 21 CFR 1610 | Safety Testing | Class 1, Does not ignite | Samples met the predetermined acceptance criteria (96 Samples, 3 non-consecutive lots of 32 each). |
| ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Safety Testing | Non-cytotoxic | Fail (The document states "Fail" for this specific test. However, the comparative table on page 4 notes "Fail - Acute Systemic Study was recommended by 3PR and agreed upon by FDA" for the subject device's cytotoxicity, while the predicate was Non-cytotoxic. The "Summary of Non-Clinical Testing" then states "Pass No systemic toxicity: device is not toxic" for ISO 10993-11 for the subject device. This implies that while the initial cytotoxicity test might have failed, a systemic toxicity test (ISO 10993-11) was subsequently conducted successfully as an alternative or follow-up to address the concern.) |
| ISO 10993-11: Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Safety Testing | Under conditions of the study, the device is non-cytotoxic | Pass (No systemic toxicity: device is not toxic). This likely addresses the initial "Fail" from ISO 10993-5. |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Safety Testing | Non-irritating | Pass |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Safety Testing | Non-sensitizing | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates the following sample sizes for the test set (non-clinical testing):
- For barrier and physical testing (ASTM F1862, ASTM F2101-19, EN 14683:2019, ASTM F2100-19, 21 CFR 1610 Flammability): "96 Samples, 3 non-consecutive lots of 32 each" are consistently reported as meeting acceptance criteria.
- For biocompatibility testing (ISO 10993-5, ISO 10993-11, ISO 10993-10): The specific sample sizes are not explicitly stated in the provided text, but testing was performed according to the ISO standards.
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond stating that they are non-clinical tests typically performed in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document is for a medical device (surgical face mask) and the testing described is non-clinical performance and safety testing (e.g., fluid resistance, particulate filtration, flammability, biocompatibility).
Therefore, the concept of "experts used to establish the ground truth" in the context of clinical decision-making (like radiologists for image interpretation) is not applicable here. The ground truth is established through standardized laboratory test methods and their defined acceptance criteria.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (e.g., medical image reading) where there might be inter-reader variability.
Since this document describes non-clinical, quantitative laboratory testing of a physical device, an adjudication method is not applicable. The results are based on objective measurements against pre-defined ASTM/ISO standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. These types of studies are relevant for AI/CADe systems that assist human readers in interpreting medical images or data. The device here is a surgical face mask, and the studies are non-clinical performance and safety tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not Applicable. This is a physical medical device (a surgical face mask), not a software algorithm. Therefore, the concept of "standalone performance" without human-in-the-loop does not apply in the context of an algorithm. The device's performance is measured directly through laboratory testing.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective measurements under standardized test methods (ASTM, EN, ISO, CFR standards). These standards define the parameters and acceptance criteria for surgical masks (e.g., fluid resistance, bacterial filtration efficiency, differential pressure, flammability, biocompatibility).
8. The Sample Size for the Training Set
Not Applicable. This is a physical medical device. The concepts of "training set" and "validation set" are used in machine learning and artificial intelligence model development. This document describes the testing of the manufactured face mask according to established regulatory standards, not the training of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As explained above, this concerns a physical device, not an AI or machine learning model.
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