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The SoundBite prosthetic device is intended for the following patients and indications:

• Patients who are 18 years or older and have moderately severe, or profound . sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deathess or "SSD"). Normal hearing is defined as a pure tone average (PTA) airconduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL.
  Additionally, use of SoundBite is intended for patients with:

• At least two contiguous molar or premolar teeth with no untreated tooth . decav. Patients with tooth decay present are to first have restorations before being fitted for SoundBite:

• Healthy attachment to those teeth with tooth pockets limited to no more than 5mm; .

• No mobile teeth: .

• . Bone loss no greater than a 34% average on the mesial and distal sides of the tooth as measured on X-ray on the teeth on which the device will be worn.

The SoundBite Hearing System by Sonitus Medical consists of two main components; a behind the ear (BTE) microphone unit and an in the mouth (ITM) hearing device. Accessories include a system charger and programming software.

The BTE uses a digital signal processor to process the sound and a wireless chip to transmit the signals to the hearing device worn in the mouth. The ITM hearing device in turn creates imperceptible vibrations using a piezoelectric actuator that are sent via the teeth, through the skull bones, and ultimately to the cochleae.

Here's a breakdown of the acceptance criteria and study information for the SoundBite™ Hearing System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Sizes:
  • First Study (1-month safety and efficacy): 28 subjects
  • Second Study (6-month long-term safety): 22 subjects
• Data Provenance: The document does not explicitly state the country of origin. Both studies were prospective.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. However, the evaluation includes "comprehensive medical, audiological, and dental evaluations," implying assessment by relevant specialists (e.g., audiologists, dentists, otolaryngologists).

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The "comprehensive medical, audiological, and dental evaluations" suggest a clinical assessment process, but details on how conflicting results (if any) were resolved are not provided.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned. The study focuses on the device's efficacy and safety in improving hearing, not on diagnostic interpretation or human reader performance with AI.

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

Yes, the studies described are essentially standalone performance studies of the device itself. The "SoundBite prosthetic device" is a hearing system, and its performance (efficacy in improving HINT scores, safety regarding adverse events and physiological changes) is measured directly, not as an aid to a human interpreter. There isn't an "algorithm" in the typical AI sense that performs a diagnostic task that a human would also perform; rather, it's a device that mechanically delivers sound.

7. Type of Ground Truth Used

The ground truth for evaluating the device appears to be based on:

• Audiological Measurements: HINT scores (objective measure of speech in noise comprehension), aided hearing thresholds (objective audiological data).
• Clinical Assessments: Comprehensive otological examination results, dental outcome measures (calculus, periodontal probing, plaque index, bleeding index, gingival recession, structural changes, bone support changes, root resorption).
• Adverse Event Monitoring: Direct observation and reporting of product/procedure-related adverse events.

This constitutes a combination of objective physiological measurements and expert clinical assessments.

8. Sample Size for the Training Set

The document does not mention a training set sample size or any machine learning training process. The SoundBite system is described as having a "digital signal processor" and a "wireless chip," which indicates digital processing, but the studies described are clinical trials evaluating the device itself, not a machine learning algorithm that required a distinct training phase.

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

As no training set or machine learning algorithm is discussed, this information is not applicable.

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