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510(k) Data Aggregation
(204 days)
The DISPOSABLE SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single- use and provided non-sterile.
The "DISPOSABLE SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "DISPOSABLE SURGICAL MASK" is manufactured with three layers. 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 subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of iron strip and polypropylene. The"DISPOSABLE SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
The provided text describes the performance data and acceptance criteria for a Disposable Surgical Mask (Model: YYKZ-01) in a 510(k) summary. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (ASTM F2100-19 Level 1) | Reported Device Performance |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥95% | Accepted (Average 99.9%) |
| Particulate Filtration Efficiency (PFE) | ≥95% | Accepted (Average 99.8%) |
| Differential Pressure | <5.0 mm H2O/cm² | Accepted (Average 2.7) |
| Synthetic Blood Penetration Resistance | 80 mmHg | Accepted (80) |
| Flammability | Class 1 | Class 1 |
| In Vitro Cytotoxicity | Viability ≥70% of blank | Non-cytotoxic |
| Skin Sensitization | No sensitization (Magnusson and Kligman grades <1 for test group if control <1) | Non-sensitizing |
| Skin Irritation | Low primary irritation score | Non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test within the performance and biocompatibility sections. However, it indicates standard test methods were used (e.g., ASTM F2101-19 for BFE, ASTM F2299-03(2017) for PFE, ISO 10993-5:2009 for Cytotoxicity, ISO 10993-10:2010 for Sensitization and Irritation). These methods typically specify minimum sample sizes for reliable results.
The data provenance is retrospective, as the tests were conducted on the device to demonstrate equivalence to a predicate device for marketing approval. The source of the data is implied to be from testing facilities in China, as the submitter, Jiaxing Amazing Travel-Ware CO., LTD, is located in Jiaxing, Zhejiang, China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for these tests comes directly from the established technical standards and the objective measurements performed in a laboratory setting, rather than expert interpretation of medical images or diagnoses.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation involves objective laboratory testing against defined criteria, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. The device is a physical product (Disposable Surgical Mask), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance tests (BFE, PFE, Differential Pressure, Synthetic Blood Penetration, Flammability) is based on objective measurements against established industry standards and specifications (ASTM F2100-19 Level 1 criteria).
For biocompatibility tests (Cytotoxicity, Skin Sensitization, Skin Irritation), the ground truth is established through biological assays using established protocols (ISO 10993-5 and ISO 10993-10) with clearly defined pass/fail criteria based on observed biological responses (e.g., cell viability, skin reactions).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as above.
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