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510(k) Data Aggregation
(89 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.
The surgical face mask is a non-sterile, single use, three-layer, flat, pleated style with ear loops and a nose piece. The outer and inner layers are spunbond polypropylene, and the middle layer consists of melt-blown polypropylene filter. Each mask is secured to the face with ear loops with a nosepiece to conform the mask to the shape of the nose.
This document describes the validation of a surgical face mask. As such, the concept of "AI assistance for human readers" or "ground truth established by experts with many years of experience" is not applicable in the context of device performance testing for such simple medical devices. The evaluations are based on standardized physical and biological tests against established criteria.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mm Hg | 31 out of 32 pass at 80 mm Hg30 out of 32 pass at 120 mm Hg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 98.8% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | > 99.9% |
| Differential Pressure (MIL- M-36954C) | < 5.0 mm H20/cm² | 4.4 mmH20/cm² |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
| Biocompatibility | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Non-Cytotoxic, Non-Sensitizing, Non-Irritating |
2. Sample Size Used for the Test Set and Data Provenance
- Fluid Resistance (ASTM F1862): 32 samples were tested for fluid resistance.
- Other Tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility): The document does not explicitly state the sample size for these specific tests, but performance data is provided.
- Data Provenance: The tests were conducted on the "proposed device," which implies new testing of the specific product being submitted for clearance. The document does not specify the country of origin for the testing itself, but the manufacturer is Ningbo Green Textile Co., Ltd, which is likely in China. The data would be considered prospective for the purposes of this submission as it was generated specifically for the device's clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable for this type of device and testing. The "ground truth" is established by adherence to standardized testing protocols (e.g., ASTM, MIL, ISO, CFR standards) with measurable outcomes, not by expert consensus or interpretation of medical images.
4. Adjudication Method for the Test Set
Not applicable. Testing is against objective, measurable criteria defined by international and national 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
Not applicable. This device is a surgical face mask, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a surgical face mask, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth is based on standardized physical and biological testing methods and their predefined acceptance criteria. These standards include:
- ASTM F2100: Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F1862/F1862M-17: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood
- ASTM F2299/F2299M-03: Determining the Initial Efficiency of Materials Used in Medical Face Masks to the Penetration of Particulates Using Latex Spheres
- ASTM F2101: Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials
- MIL - M-36954C: Medical face masks - Requirements and test methods, Annex C
- 16 CFR 1610: Flammability Test Method
- ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity
- ISO 10993-10: Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device (surgical face mask), not a machine learning model; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
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(209 days)
The QwikCheck™ Chemical Indicator is a chemical indicator for use in determining whether the concentration of peracetic acid, the active ingredient in CS Medical's TD-12 Solution, is above or below the manufacturer's established Minimum Recommended Concentration (MRC) of 1750 ppm.
The device is a qualitative, single use, reagent chemical indicator made up of a 0.20-inch square indicator pad that has been chemically treated to detect peracetic acid above or below the Minimum Recommended Concentration. The indicator pad is affixed to one end of a 3.25 inch by 0.20-inch white opaque plastic handle.
The QwikCheck™ Chemical Indicator is a qualitative chemical indicator designed to determine if the concentration of peracetic acid (PAA) in CS Medical's TD-12 Solution is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Study | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dynamic Range | Negative response at concentrations at or below MRC, positive responses at higher concentrations. | 100% FAIL results at and below the MRC and PASS results above the MRC. |
| Instructions for Use Validation | Negative response at concentrations at or below MRC, positive responses at higher concentrations. | Acceptable performance with an immediate dip/removal from solution time, a 5 ± 1 second side blot time, a time to blot of ≤ 1 second, and a 30 ± 5 second read time. 100% FAIL results at and below the MRC and PASS results above the MRC. |
| Closed Bottle Shelf-Life Stability | Met specifications after storage of labeled shelf life of 12 months (unopened). | Acceptable performance out to a minimum 15 months shelf-life from ambient room temperature up to 32°C, with data collection ongoing. 100% FAIL results at and below the MRC and PASS results above the MRC. A conservative 12-month shelf-life is claimed. |
| Open Bottle Use-Life Stability | Met specification for 3 months (opened). | Acceptable performance out to a minimum 5 months open bottle use-life, with data collection ongoing. 100% FAIL results at and below the MRC and PASS results above the MRC. A conservative 3-month open bottle use-life is claimed. |
| Comparative Sensitivity and Specificity | Comparative sensitivity and specificity of 1 (implicitly 100% agreement with predicate). | Comparative sensitivity of 100% and comparative specificity of 100% was found for both devices (QwikCheck and predicate). There was 100% overall agreement with values for prepared samples in both cases. |
| Analytic Specificity - Bioburden | Negative response at concentrations at or below MRC, positive responses at higher concentrations (when challenged with bioburden). | 100% FAIL results at and below the MRC and PASS results above the MRC even with the presence of fetal bovine serum (bioburden). |
| Analytic Specificity – Other Disinfectants | 100% FAIL results for all conditions tested when exposed to other disinfectants (i.e., not reacting to other disinfectants). | 100% FAIL results for all conditions tested when exposed to hydrogen peroxide and sodium hypochlorite, indicating no false positives due to other disinfectants. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test set within the "Summary of Non-Clinical Performance Data." It indicates that the performance was evaluated "in a range of concentrations below, at, and above the MRC" and that "data collection [is] ongoing" for stability studies. The provenance of the data is not specified (e.g., country of origin). The studies are non-clinical, meaning they were conducted in a laboratory setting. The data appears to be prospective in nature, as tests were performed to evaluate the device's performance under various conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of human experts to establish ground truth for the test set. Given that this is a chemical indicator designed for objective colorimetric assessment of peracetic acid concentration, the ground truth would likely be established through precise chemical analytical methods (e.g., spectrophotometry, titration) to determine the exact PAA concentration in the prepared solutions.
4. Adjudication Method for the Test Set
No adjudication method for the test set is mentioned, as human interpretation and multi-reader review are not applicable to the evaluation of a chemical indicator. The device's output (color change indicating PASS/FAIL) is compared directly against the known chemical concentration.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging or other human-interpreted medical devices where the variability of human perception is a factor. The QwikCheck Chemical Indicator is a passive device with a direct chemical reaction indicating a result.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies conducted are standalone evaluations of the chemical indicator's performance. The "device performance" refers to the indicator's ability to accurately change color (PASS/FAIL) in response to specific PAA concentrations, without human intervention in determining the PAA concentration itself (which is the ground truth from chemical analysis). The "read time" and "blot time" mentioned in the Instructions for Use Validation refer to user interaction, but the core performance being validated is the chemical reaction of the indicator.
7. The Type of Ground Truth Used
The ground truth used for performance evaluation is based on known chemical concentrations of peracetic acid in TD-12 Solution. These concentrations are precisely prepared "below, at, and above the MRC" (1750 ppm). For example, a solution known to be below 1750 ppm should result in a "FAIL" indication, and a solution known to be above 1750 ppm should result in a "PASS" indication.
8. The Sample Size for the Training Set
The document does not specify a "training set" or "sample size for the training set." Chemical indicators are typically developed through chemical formulation and optimization, rather than machine learning algorithms that require distinct training sets. The studies described are performance validation studies, not training exercises.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an algorithm, the concept of establishing ground truth for a training set is not applicable here. The ground truth for validating the device's accuracy would have been established through analytical chemistry methods to create solutions with verified concentrations of peracetic acid.
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