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When properly worn, the surgical face mask is intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.

Ideal Med Pro 3-Ply Disposable Face Mask is a 3-ply, flat-pleated style surgical mask. The device is manufactured with three layers. The inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. Each mask contains elastic ear loops to secure the mask over the user's face and mouth with nose piece to fit firmly over the nose. This device is not made from any natural rubber latex. The product is sold non-sterile and intended to be disposable for single-use.

The provided text is for a 510(k) summary for a "Ideal Med Pro 3-Ply Disposable Face Mask." This document focuses on demonstrating substantial equivalence to a predicate device through performance testing against established standards, rather than a clinical study involving human readers or a standalone AI algorithm. Therefore, many of the requested criteria regarding MRMC studies, expert adjudications, and AI performance are not applicable.

Here's the information extracted from the document:

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

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

• Bacterial Filtration Efficiency (BFE): Not explicitly stated, but typically involves a batch of test articles.
• Particulate Filtration Efficiency (PFE): Not explicitly stated.
• Synthetic Blood Fluid Resistance: 96 total test articles (32 test articles in each of three lots).
• Differential Pressure (Delta P): 24 total test articles (8 test articles in each of three lots).
• Flammability: 24 total test articles (8 test articles in each of 3 lots).

The origin of the test articles (e.g., country of origin, retrospective or prospective) is not specified in the provided document. These are product performance tests on manufactured devices, not clinical data.

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

This is not applicable. The "ground truth" for these tests is dictated by the standardized testing protocols themselves, not by expert consensus or clinical interpretation.

4. Adjudication method for the test set

This is not applicable. The tests are objective measurements against defined 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

This is not applicable. This document describes the performance of a disposable face mask, not an AI-assisted diagnostic device.

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

This is not applicable. This document describes the performance of a physical device (face mask), not an algorithm.

7. The type of ground truth used

The ground truth is established by the specified test standards (ASTM F2101, ASTM F2299, ASTM F1862, MIL-M-36954C, 16 CFR 1610) and their defined procedures and criteria.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of physical product performance testing for a face mask.

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

This is not applicable.

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The following Prestige Ameritech Surgical Masks are single use disposable devices intended to be worn in the operating room as well as dental, isolation and other medical procedures to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.

Prestige Ameritech Earloop Surgical Mask-Blue, Pink, Green, White, Yellow, Peach Prestige Ameritech Earloop Surgical Mask with splash shield-Blue Green, White, Peach Prestige Ameritech Earloop Surgical Mask Tissue-Blue, Pink, White, Yellow Prestige Ameritech Tie on Surgical Mask-Blue, Pink, Green, White, Peach Prestige Ameritech Tie on Surgical Mask with splash shield-Blue, Green, White, Peach

The Prestige Ameritech Surgical Mask device is composed of three layers of material flat folded and pleated to form the Mask. The inner layer is composed of cellulose or spunbonded polypropylene, the middle layer is a meltblown polypropylene filter material and the outer layer is a medical grade tissue or spunbonded polypropylene. Masks with splash shields have anti-fog plastic shields attached to masks. Masks are held in place on wearer with tie strips or latex free elastic loops and contain a malleable aluminum nosepiece strip. All of the materials used in this device are typical materials commonly used in the construction of Surgical Face Masks and are being used in current legally marketed devices.

The provided 510(k) summary describes the Prestige Ameritech Face Mask, a surgical face mask. The acceptance criteria and device performance are based on bench testing of physical properties rather than clinical studies with human participants. Therefore, several of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information) are not applicable or cannot be extracted from this document.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the results of the predicate devices, as the Prestige Ameritech device aims to demonstrate substantial equivalence by performing similarly or better.

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

• Sample Size: Not specified in the document. These are bench tests, so sample sizes would refer to the number of mask samples tested for each characteristic.
• Data Provenance: The data is generated from laboratory bench testing (non-clinical tests) of the device and predicate devices. No information about the country of origin or whether it's retrospective or prospective is provided, but it's understood to be prospective testing for the submission.

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

Not applicable. The ground truth for these performance characteristics is established through standardized laboratory test methods (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL M36954C, 16CFR 1610). Experts are involved in designing and executing these tests, but "ground truth" isn't established through expert consensus in the typical sense for medical imaging or diagnostic devices.

4. Adjudication method for the test set

Not applicable. This is not a study involving human interpretation or subjective assessments 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

Not applicable. This is a surgical mask, not an AI-powered diagnostic device, so MRMC studies and AI assistance are not relevant.

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

Not applicable. This is a surgical mask, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is objective measurement against established industry standards and test methodologies. For example:

• Fluid Resistance: Visual observation of penetration after exposure to synthetic blood.
• Particulate Filtration Efficiency: Quantitative measurement of particle removal at a specific micron size.
• Bacterial Filtration Efficiency: Quantitative measurement of bacterial removal.
• Differential Pressure: Measurement of airflow resistance.
• Flammability: Classification based on burn rate.

8. The sample size for the training set

Not applicable. This is a physical device, and the submission does not describe a training set in the context of machine learning or AI.

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

Not applicable. No training set is described.

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