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The Bio-logic Ear Muffins® is a disposable earphone device intended to be used as an accessory to the Bio-logic ABaer / Navigator Pro auditory evoked response screening and diagnostic systems, and the Natus Medical Inc. ALGO series auditory evoked response screening systems. The Ear Muffins® device performs as the means for delivering the auditory stimulus from the auditory stimulator to the ear of the patient under test.

The Bio-logic Ear Muffins® device is especially indicated for use in the auditory evoked response screening of newborn infants, because the Ear Muffins® can be placed to cover the entire ear of the infant, so nothing has to be placed into the ear canal.

The Bio-logic Ear Muffins consist of a pair of single-use, disposable foam & plastic donutshaped devices for delivering sound to the human ear. The Ear Muffin is specifically designed in size and shape to be used with infants. The Ear Muffin is one of the alternative sound delivery devices offered as accessory options to the ABaer and Navigator Pro product lines. The ABaer/Navigator Pro has received FDA Marketing Clearance via 510(k) #K994149. The Ear Muffins can also be used as a stand-alone device with the Natus Medical ALGO series of Newborn Hearing Screening systems, as demonstrated in the test results within this 510(k) notification.

Electrical safety is not an issue with the Ear Muffins, because the Ear Muffin is not electrical in nature, it is simply a different tubing system for sound delivery to the ear. The Ear Muffins connect to the output of Auditory Stimulator device (e.g., Natus ALGO), and provide an acoustic pathway to direct the auditory stimulus to the ear of the infant. The Muffins are applied to the baby's head to cover the ears, similar to the way a large set of headphones might cover the ears of an adult.

The Ear Muffin only makes very brief contact with the skin, and does not contact in vivo body tissues or fluids. The material used for the Ear Muffins has been found to be safe for this use by its manufacturer through appropriate biocompatibility testing.

The provided document is a 510(k) premarket notification for the Bio-logic Ear Muffins, which are disposable earphones for auditory stimulus delivery, primarily for newborn hearing screening. The study described focuses on demonstrating substantial equivalence to a predicate device, rather than establishing new performance criteria for a novel device.

Here's an analysis of the "acceptance criteria" and "study" based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are derived from the performance of the legally marketed predicate device (Natus Medical Inc. Ear Coupler) as the goal of the study was to demonstrate substantial equivalence, not to set new independent performance benchmarks.

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

• Sample Size: The document mentions "a large number of test subjects"
• Data Provenance: Not explicitly stated, but clinical studies for 510(k) submissions in the US are typically prospective or retrospective studies conducted in the US. No specific country of origin is mentioned, and it is not explicitly stated whether the data was retrospective or prospective. However, given it's a 510(k) submission, the data would generally be expected to be collected recently to support the claim.

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

This information is not applicable to this study. The study focuses on objective, physical sound level measurements (dB SPL) within the ear canal, not on diagnostic interpretations or judgments that would require expert consensus for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable to this study, as the ground truth is based on objective physical measurements rather than expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This was not an MRMC comparative effectiveness study. The device is a passive accessory (ear muff) for delivering auditory stimuli, not a diagnostic algorithm that would be used by human readers for interpretation. Therefore, there's no "human readers improve with AI vs without AI assistance" effect size to report.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable in the conventional sense of an "algorithm only" study. The device itself is a passive, non-electrical component. Its performance was measured in conjunction with an auditory stimulator device (Natus ALGO-2), but the "performance" here refers to the physical sound energy it delivers, not an algorithm's output. The measurement of sound levels is a direct physical test, not an algorithm's output.

7. Type of Ground Truth Used

The "ground truth" (or reference standard) used was objective physical sound level measurements (dB SPL) obtained directly within the ear canal of test subjects. The performance of the Bio-logic Ear Muffins was then compared against the same type of measurements obtained with the predicate device.

8. Sample Size for the Training Set

This information is not applicable. This study does not involve an AI algorithm that requires a "training set." It is a physical performance comparison study.

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

This information is not applicable, as there is no training set for an AI algorithm in this study.

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