Search Results

Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

The Medical surgical mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue K6911D /CAS number: 12239-87-1), and the middle layer is made of melt blown polypropylene. Ear loops, which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the Medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Medical surgical mask is in the middle layer of Medical surgical mask to allow the user to fit the Medical surgical mask around their noses, which is made of metallic iron wire coated with polypropylene resin. The dimensions of each Medical surgical mask are length 175±5 mm and width 95±2 mm, and the inner and outer layers' density are 25 gsm, the middle layer is 35 gsm. The dimensions of nosepiece is length 100±5 mm and width 3±0.5 mm, and the ear loop is length 175±10 mm and width 3.5±0.5 mm. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device.

The document provided describes the acceptance criteria and performance of a Medical Surgical Mask (Model: KF-B P05) by Guangdong KINGFA Sci.&Tech.Co.,Ltd. Rather than an AI device being proven to meet acceptance criteria, this is a 510(k) summary for a medical device (a mask) demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against ASTM F2100:2019 Level 1 performance requirements.

Biocompatibility Tests: The device also underwent biocompatibility testing according to ISO 10993-1:2009 for skin contact, with the following results:

• Cytotoxicity: Non-cytotoxic
• Irritation: Non-irritating
• Sensitization: Non-sensitizing

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each non-clinical performance test (e.g., number of masks tested for BFE, PFE, etc.). It only provides the test methods and results.

The testing was performed according to international standards (ASTM and EN for performance, ISO for biocompatibility). The manufacturer is Guangdong KINGFA SCI.&TECH.Co.,Ltd. from China, so it is assumed the tests were conducted in facilities that are likely in China or by labs accredited to these standards. The nature of these tests is prospective as they are conducted specifically for the purpose of demonstrating device safety and effectiveness for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of device. The "ground truth" for a medical surgical mask is established by validated scientific test methods (e.g., ASTM F2101 for BFE, ASTM F2299 for PFE) and regulatory standards (e.g., ASTM F2100 for medical face mask performance, ISO 10993 for biocompatibility). These methods have predefined criteria for success or failure, not expert consensus as would be used for image interpretation in AI.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with human readers. For this device, objective laboratory tests with defined protocols and metrics determine the performance.

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 submission is for a physical medical device (a surgical mask), not an AI algorithm. Therefore, no MRMC study or assessment of AI assistance was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable. This is not an AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance is established by the standardized test methods and their defined pass/fail criteria. For example:

• Bacterial Filtration Efficiency: Measured quantitatively as a percentage (≥95% is the pass criterion).
• Differential Pressure: Measured quantitatively in mm H2O/cm² (<5.0 mm H2O/cm² is the pass criterion).
• Biocompatibility: Determined by laboratory assessments (e.g., in vitro cell cultures for cytotoxicity, animal models or human patch tests for irritation/sensitization) against predefined biological response levels.

8. The sample size for the training set

This question is not applicable. This is not an AI device, so there is no "training set."

9. How the ground truth for the training set was established

This question is not applicable. No training set exists for this type of device.

Ask a specific question about this device