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The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6%) that inactivate influenza viruses.

The Innonix Anti-Influenza Child's Face Masks, (both Model BF-200-3015A and BF-200-2005A) comprise four layers of material: an outer layer of spun bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bond polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and being used in current legally marketed devices, and are not made with natural rubber latex. The outer active layer of the face mask is coated with a hydrophilic plastic containing citric acid. The second inner layer is treated with copper and zinc ions. Both of these layers inactivate influenza viruses using different mechanisms of action (pH lowering and ionic disruption).

Model: BF-200-3015A is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.

Model: BF-200-2005A is a flat pleated mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.

This document is a 510(k) premarket notification for the Innonix Anti-Influenza Child's Face Mask, detailing its acceptance criteria and non-clinical studies.

1. Table of Acceptance Criteria and Reported Device Performance

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Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Mask, Medicom SafeMask Premier Procedure Earloop Face Mask (ASTM Level 1) and Medicom SafeMask Premier Pediatic Procedure Earloop Face Mask are intended to be worn by the patient/ child (recommended 4-12 years of age). The face mask is to be placed on nose and mouth as a protective barrier to provide respiratory protection in procedures or situations where there is a risk of microorganism, body fluid and particulate aerosol transfer. It is a single use, non-sterile disposable device that is recommended for use in healthcare settings with appropriate adult supervision.

Medicom Pediatric/Child's Face Mask is a manufactured pleated three-layer mask construction utilizing ultrasonic bonding. The patterned (ink printed) outer layer is composed of spunbound polypropylene (SBPP) material. The filter media is composed of meltblown polypropylene (MBPP). The inner is either tissue/ cellulose or a spunbound polypropylene (SBPP) layer. Bindings are composed of nonwoven polyester and earloops are made of flat elastic knitted polyester band. A malleable polypropylene nosepiece (made of plastic covered iron wire or 100% aluminum piece) is placed within the bindings for comfort and individualized fit around the wearer's nose. Medicom Pediatric/Child's Face Mask is a non-sterile single use disposable device. The device safety of effectiveness is not affected by storage conditions with no shelf life.

The provided text describes the acceptance criteria and performance data for AMD Medicom's pediatric procedure earloop face masks.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual performance test (PFE, BFE, differential pressure, blood penetration). It only provides the performance range for a "range of performance based on design variations" for the subject device.

For the anthropometry study, the subject device's evaluation involved participants aged 4-12 years old, ranging from 84.8 cm (33.4 inches) to 170.2 cm (67 inches) in height and 16.3 kg (35.94 pounds) to 76.7 kg (169.1 pounds) in weight. The sample size for this study is not explicitly stated, but it refers to a study on children based on the given age, height, and weight ranges.
The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin of the data provided. However, the manufacturer is in Canada, and the predicate device's anthropometric study refers to the "current US population."

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

This information is not provided in the document. The tests performed are laboratory-based and do not involve expert interpretation or ground truth establishment in the context of medical image analysis or similar fields.

4. Adjudication method for the test set

This information is not applicable as the tests are laboratory measurements of physical and biological properties.

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 information is not applicable. The device is a medical face mask, not an AI-powered diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant.

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

This information is not applicable as the device is a medical face mask, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests (PFE, BFE, differential pressure, etc.) is established by the specifications defined in the referenced ASTM, Mil, and EN standards. These standards dictate the methodology and expected outcomes for measuring the specific properties of the face masks. For biocompatibility and product safety tests, the "ground truth" is defined by meeting the specified criteria (e.g., "Criteria met," "≤20 ppm," "Class 1") according to the referenced ISO and CPSC standards.

8. The sample size for the training set

This information is not applicable. The device is a physical product (face mask), not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as point 8.

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