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The Circumaural Adhesive Replacement is used to make earphones reusable for newborn hearing screening tests. It is a single use disposable to seal the earphones in place during the screening process. This skin adhesive is intended for use on the circumaural area of babies between the ages of 34 weeks (gestational age ) and 6 months. Sites appropriate for this screening test may include the well-baby nursery, NICU, mother's bedside, audiology suite, outpatient clinic, or doctor's office.

Circumaural Adhesive Replacement is acrylic hydrogel adhesive rings supplied on a release card in a packages of ten. After the original adhesive is removed from the disposable ear couplers, the top liner covers are removed to apply the adhesive rings to the earphones thereby making them reusable and reducing medical test costs. The then reusable ear couplers with the disposable adhesive rings are placed around the infant ears for the duration of the test. The Circumaural Adhesive Replacement is then removed and discarded. After an alcohol wipe of the same earphones, another Circumaural Adhesive Replacement is applied for the next patient test.

This document describes the Circumaural Adhesive Replacement, a disposable hydrogel adhesive for re-using earphones in newborn hearing screening tests.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for specific performance tests (e.g., bench testing for adhesive characteristics). However, it mentions that Biocompatibility testing was performed. For these types of tests (cytotoxicity, sensitization, primary skin irritation), standardized protocols typically involve a certain number of test subjects or samples. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. The studies described are primarily technical performance tests and biocompatibility, not studies requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided in the document. The tests performed are objective measurements (e.g., passing ISO standards, 0% residue, 100% attachment), not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an adhesive replacement, not an imaging or diagnostic AI tool that would typically involve human readers.

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

This concept is not applicable to the device described. The "device" is a physical adhesive. The performance tests are for the adhesive's physical and biological properties.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Predicate device's established performance and characteristics: The comparison is against the Natus Flexicoupler's performance, which is already an approved device.
• Objective material and performance specifications: Such as ISO 10993 standards for biocompatibility, and quantitative measures like 100% attachment, 0% residue, and "none" for pain upon removal.

8. The Sample Size for the Training Set

This concept is not applicable as the device is a physical product (adhesive) and not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a substantial equivalence evaluation compared to a legally marketed predicate device (ALGO-3 Newborn Hearing Screener and Accessories, specifically the Flexicoupler Disposable Earphone accessory, K013317).

The document states:

• Performance Testing:

  • Biocompatibility: Tests were performed, and the device "passed the required skin sensitivity testing criteria." It "met specifications as established in ISO 10993-1 for skin contact," including cytotoxicity, sensitization, and primary skin irritation tests. This directly addresses the "Biocompatibility: Passed ISO 10993" acceptance criterion. The predicate device uses the same materials and meets the same ISO 10993 specifications.
  • Bench Testing: Bench testing "demonstrated that the adhesive characteristics of the Circumaural Adhesive Replacement are substantially equivalent to those of the predicate device." This supports the acceptance criteria related to "Hydrogel Attachment to Coupler" (100%), "Acoustic Seal" (100%), "Adhesive Residue" (0%), and "Pain Upon Removal" (None).

• Technological Comparison & Materials: The device uses the same material (acrylic hydrogel) as the predicate device. The contact area, earphone component, indications for use, shelf life, and prescription status are also identical to the predicate.

The conclusion from testing is that "In all material respects, the Circumaural Adhesive Replacement on the Natus Flexicoupler is substantially equivalent to the predicate device. Both use acrylic hydrogel adhesives. Test results support the conclusion that the adhesive performance is substantially equivalent to the predicate devices, and there are no differences in construction and materials between the devices to pose new questions of safety or effectiveness."

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