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The Medical 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 surgical 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 Medical Surgical Mask is single use, flat-pleated masks that are provided in blue. The Medical Surgical Mask is available in two types, which are Level 3 based on ASTM F2100-19. The inner and outer layers of the mask are made of polypropylene non-woven fabric, the middle layer is made of polypropylene meltblown fabric, and the nose clip is made of polypropylene and iron wire. Users can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loops are made of spandex. The ear loops are held in place over the users' mouth and nose by two ear loops welded to the mask. This is a single use, disposable device(s), provided non-sterile.

The provided document is a 510(k) premarket notification for a Medical Surgical Mask. It details the device's characteristics, intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the request asks for information regarding an AI/Software as a Medical Device (SaMD) study, specifically about acceptance criteria, ground truth establishment, sample sizes for training and testing, expert qualifications, and potential MRMC studies.

The provided document is NOT for an AI/SaMD device. It is for a physical medical device (a surgical mask) and therefore does not contain any of the information requested about AI/SaMD acceptance criteria or study methodologies.

Therefore, I cannot fulfill the request using the provided text. The document discusses:

• Acceptance Criteria (for a physical surgical mask): These are performance standards like Bacterial Filtration Efficiency (BFE), Differential Pressure, Sub-micron Particulate Filtration Efficiency, Resistance to Penetration by Synthetic Blood, and Flame Spread, as well as Biocompatibility.
• Device Performance: The document states "Passed" for all the listed performance tests against the specified acceptance criteria for Level 2 and Level 3 masks.
• Study That Proves the Device Meets Acceptance Criteria: This is the "Non-Clinical Test Conclusion" section (pages 4-5), where various physical and biological tests were performed according to recognized standards (e.g., ASTM F2101, EN14683, ASTM F1862, 16CFR Part 1610, ISO 10993).

To explicitly address the numbered points in the prompt based on the provided document (even though it's not an AI/SaMD):

1. A table of acceptance criteria and the reported device performance:

   Performance Testing	Purpose	Acceptance Criteria for Level 2 Barrier	Acceptance Criteria for Level 3 Barrier	Result
   Bacterial Filtration Efficiency ASTM F2101	Measure bacterial filtration efficiency	≥98%	≥98%	Passed
   Differential Pressure (mm H2O/cm2)	Determine breathability of a mask	<6.0 H2O/cm²	<6.0 H2O/cm²	Passed
   Sub-micron Particulate Filtration Efficiency ASTM F2299/F2299M-03	Measure initial particle filtration efficiency	≥98%	≥98%	Passed
   Resistance to Penetration by Synthetic Blood ASTM F1862/F1862M-2017	Evaluate the resistance to penetration by impact of small volume of synthetic blood	120 mmHg	160 mmHg	Passed
   Flame spread 16CFR Part 1610-2008	Response of materials to heat and flame	Class I	Class I	Passed

   Biocompatibility Acceptance Criteria and Results:

   Biocompatibility Evaluation	Biological Effect	Standard	Results
   	Cytotoxicity	ISO 10993-5	Not cytotoxic
   	Sensitization	ISO 10993-10	Non sensitizing
   	Irritation	ISO 10993-10	Negligibly irritating

2. Sample sizes used for the test set and the data provenance: The document does not specify the sample sizes used for each of the non-clinical tests (e.g., how many masks were tested for BFE). It also does not specify the country of origin of the data or whether the testing was retrospective or prospective, though it implicitly describes a prospective testing process for compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to the type of device. The "ground truth" for a surgical mask's performance is established by standardized test methodologies and equipment, not human expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical performance testing of a physical device.

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 not an AI/SaMD, so no MRMC study or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI/SaMD.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device's performance is determined by adherence to established, quantitative non-clinical testing standards and their respective measurement methods. For biocompatibility, it's based on biological responses in standardized in-vitro and in-vivo tests according to ISO 10993.

8. The sample size for the training set: Not applicable. There is no AI/ML model for this physical device that would require a "training set."

9. How the ground truth for the training set was established: Not applicable.

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