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510(k) Data Aggregation
(227 days)
The Surgical Mask 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 Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. The Surgical Masks 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 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 Polyvinyl chloride coated iron wire. The surqical masks will be provided in blue. The surqical masks are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) Pre-Market Notification for a Surgical Mask (K202647). It does not include information about AI/ML device performance or clinical studies in humans.
This document describes the performance of a physical medical device (a surgical mask) against established standards. The questions you've asked are typically relevant for AI/ML-powered medical devices that analyze medical images or data.
Therefore, many of your questions, such as those related to "AI," "human readers," "effect size," "training set," and "ground truth for training set," are not applicable to the content of this document.
However, I can extract the relevant information regarding the surgical mask's acceptance criteria and the study that proves it meets those criteria.
Acceptance Criteria and Device Performance for Surgical Mask (K202647)
1. A table of acceptance criteria and the reported device performance
| Test Method (Standard) | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg (16.0 kPa) | 31 out of 32 pass at 120 mmHg (16.0 kPa) | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | Average 99.6% | Pass |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | Average 99.75% | Pass |
| Differential Pressure (Delta P) (MILM-36954C) | < 6.0 mmH2O/cm² | Average 2.2 mmH2O/cm² | Pass |
| Flammability (16 CFR 1610) | Class 1 | Class 1 | Pass |
| Cytotoxicity (ISO 10993-5) | Not cytotoxicity effect | Device is noncytotoxic | Pass |
| Irritation (ISO 10993-10) | Not an irritant | Device is nonirritating | Pass |
| Sensitization (ISO 10993-10) | Not an sensitization | Device is nonsensitizing | Pass |
2. Sample size used for the test set and the data provenance
The document mentions "31 out of 32" for the Fluid Resistance test, indicating a sample size of 32 for that specific test. Sample sizes for other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) are not explicitly stated in the summary, though "Average" values imply multiple samples were tested.
For biocompatibility tests (Cytotoxicity, Irritation, Sensitization), standard ISO methods were used, but the specific number of test items or biological replicates is not provided in this summary.
Data Provenance: The tests were conducted on the "Subject Device" (Ningbo Green Textile Co., Ltd. Surgical Mask, K202647). The location of testing is not explicitly stated, but the manufacturer is based in China. The data would be considered prospective as it was generated specifically for this submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical surgical mask, not an AI/ML system requiring expert interpretation of data. The "ground truth" for the performance tests consists of objective measurements against established engineering and biological standards.
4. Adjudication method for the test set
This question is not applicable. The performance testing involves objective measurements rather than human interpretation that would require 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 question is not applicable. This document describes a physical medical device (surgical mask), not an AI/ML algorithm intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for proving the device meets the acceptance criteria are established performance standards and laboratory test results for surgical masks, as specified by ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) guidelines, and other regulatory standards (e.g., 16 CFR 1610 for flammability, MILM-36954C for differential pressure). These are objective, measurable criteria.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This question is not applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.
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