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510(k) Data Aggregation
(191 days)
The Disposable 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 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 proposed device(s) are Blue color, and Flat Pleated type mask, utilizing Tie-On or Ear Loops way for wearing, and they all has Nose Piece design for fitting the facemask around the nose. The blue colorant is polypropylene (PP) master batch.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's 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 contained in the proposed device(s) is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
This document describes the premarket notification (510(k)) for a Disposable Surgical Face Mask, and as such, it does not detail a study involving AI or human reader performance for diagnostic purposes. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing.
Therefore, many of the requested criteria related to AI/human reader studies, expert ground truth, adjudication, and large-scale data sets for training/testing are not applicable to this type of device and submission.
However, I can provide the information that is available in the document regarding the acceptance criteria and the study that proves the device meets them, primarily focusing on its physical and biological performance characteristics.
Acceptance Criteria and Device Performance (for a Disposable Surgical Face Mask)
The acceptance criteria for this medical device are based on demonstrating that the proposed Disposable Surgical Face Mask is substantially equivalent to a legally marketed predicate device (K133070 Surgical Face Mask). This is primarily achieved through non-clinical testing against established industry standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from ASTM F2100-11 for Level 2 classification, MIL-M-36945C, 16 CFR 1610, and ISO 10993 standards for biocompatibility. The reported device performance is the result of the non-clinical tests conducted on the proposed device.
| ITEM | Acceptance Criteria (ASTM F2100 Level 2 / Other Standard) | Reported Device Performance (Proposed Device) | Remark (vs. Predicate) |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862-13) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg | SE (Substantially Equivalent) |
| Particulate Filtration Efficiency (ASTM F2299) | $\ge$ 98% | 98.46% | SE |
| Bacterial Filtration Efficiency (ASTM F2101) | $\ge$ 98% | 98.7% | SE |
| Differential Pressure (Delta P) (MIL-M-36954C) | < 5.0 mmH2O/cm² | 4.2 mmH2O/cm² | SE |
| Flammability (16 CFR 1610) | Class 1 | Class 1 (Non Flammable) | SE |
| Cytotoxicity (ISO 10993-5) | Not cytotoxic | Under the conditions of the study, not cytotoxicity effect | SE |
| Irritation (ISO 10993-10) | Not an irritant | Under the conditions of the study, not an irritant | SE |
| Sensitization (ISO 10993-10) | Not a sensitizer | Under conditions of the study, not a sensitizer. | SE |
Note: "SE" in the remark column indicates that the proposed device performed as well as, or better than, the predicate device and met the established performance requirements, thus demonstrating substantial equivalence.
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the material performance tests (e.g., how many masks were tested for BFE or PFE). However, for Fluid Resistance, the sample size is explicitly stated as 32, with the acceptance criterion being 29 out of 32 passes.
The data provenance is from non-clinical tests conducted on the proposed device. The country of origin for the manufacturing and potentially the testing facility is China (Xiantao Rayxin Medical Products Co., Ltd. is located in Hubei, China). The studies are inherently prospective in nature, as they involve conducting new tests on specific samples of the manufactured device to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of submission. The "ground truth" for material performance and biocompatibility is established by the standardized test methods themselves (e.g., ASTM, ISO standards). These standards outline the methodology and criteria for determining performance characteristics like filtration efficiency or biocompatibility, which are measured objectively. There are no human "experts" establishing unique ground truth interpretations for each test sample as in a diagnostic image analysis study. The tests are lab-based, quantitative measurements.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data (e.g., medical images) and their interpretations need to be reconciled to establish a consensus ground truth. In the case of material performance testing, the results are quantitative and objective, directly measured by laboratory instruments and procedures outlined in the test standards.
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 information is not applicable. This submission is for a physical medical device (surgical face mask), not an AI-powered diagnostic tool. Therefore, no MRMC study, human reader assistance, or AI component is involved.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This submission is for a physical medical device (surgical face mask), not an algorithm or software as a medical device (SaMD).
7. The Type of Ground Truth Used
The "ground truth" for this device is based on established industry standards and objective measurements of the device's physical and biological performance characteristics. These include:
- Standard Specifications: ASTM F2100-11 for performance of materials in medical face masks.
- Standard Test Methods: e.g., ASTM F1862-13 (Fluid Resistance), ASTM F2101-14 (BFE), ASTM F2299-03 (PFE), MIL-M-36945C (Differential Pressure), 16 CFR 1610 (Flammability).
- Biocompatibility Standards: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation and Skin Sensitization).
The ground truth is inherent in the pass/fail criteria or quantitative thresholds defined by these widely accepted standards.
8. The Sample Size for the Training Set
This information is not applicable. This submission is for a physical device, and does not involve AI or machine learning models that require training sets of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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