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The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These 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, provided non-sterile.

The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Disposable Medical Face 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 proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene with steel wire. The proposed devices are sold non-sterile and are intended to be single use. disposable devices.

The provided document is a 510(k) Premarket Notification for a Disposable Medical Face Mask (Model FM-04). This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a full study proving a device meets strict acceptance criteria in a clinical setting in the way an AI/Software as a Medical Device (SaMD) study would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, training set sample size, how ground truth for training set was established) are not applicable to this type of medical device submission.

The "acceptance criteria" and "reported device performance" here refer to non-clinical performance and safety testing against established standards for medical face masks.

Here's the information extracted from the document relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:
The device meets the acceptance criteria based on non-clinical performance and biocompatibility testing conducted in accordance with relevant ASTM, EN, CFR, and ISO standards. These tests demonstrate that the Disposable Medical Face Mask (Model FM-04) performs as intended and is as safe and effective as its legally marketed predicate device (K153496).

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set:
  • For Fluid Resistance (ASTM F1862): 32 units were tested (32 out of 32 passed).
  • For other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, Biocompatibility), the specific sample size per test is not explicitly stated but implied to be sufficient for standard compliance.
• Data Provenance: The data is from non-clinical laboratory testing performed to evaluate the physical and biological characteristics of the device against international and national standards. The country of origin of the data is not specified beyond being generated for a Chinese manufacturer (Shenzhen Jinko Industrial Co., Ltd.). This is retrospective as the testing was completed prior to submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable (N/A). This is a non-clinical testing report for a physical medical device. "Ground truth" in the context of expert consensus is not relevant here. The "ground truth" is defined by the objective measurement results from standardized laboratory tests.

4. Adjudication method for the test set

Not Applicable (N/A). Adjudication methods are typically for subjective assessments, particularly in clinical or diagnostic studies involving human readers or expert consensus. This involves objective laboratory measurements.

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 (N/A). This device is a disposable medical face mask, not an AI or SaMD product.

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

Not Applicable (N/A). This device is a disposable medical face mask, not an AI or SaMD product.

7. The type of ground truth used

The "ground truth" for this device is based on objective measurements from standard laboratory tests as defined by the referenced ASTM, EN, CFR, and ISO standards. For example, a passing result in the fluid resistance test (32 out of 32 passing at 120 mmHg) is the ground truth for that performance metric.

8. The sample size for the training set

Not Applicable (N/A). This device is a physical product and does not involve AI/machine learning, therefore there is no "training set."

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

Not Applicable (N/A). As there is no training set for this physical device.

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