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The SoundBite Hearing System is intended for patients 18 years and older with the following indications:

• Patients with moderately severe, severe, or profound sensorineural hearing loss in one ear and normal hearing in the other ear (i.e. single sided deafness or "SSD"). Normal hearing is defined as a pure tone average (PTA) air-conduction (AC) hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 25 dB HL.
• Patients with conductive hearing loss where the average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) is 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 decay. 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.

The provided text is a 510(k) summary for the SoundBite Hearing System. It discusses the device's indications for use, contraindications, and substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria, specific study designs (like sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods), or performance metrics.

The document details:

• Indications for Use:
  • Patients 18+ with moderately severe, severe, or profound sensorineural hearing loss in one ear (SSD) and normal hearing in the other ear (PTA AC threshold ≤ 25 dB HL).
  • Patients with conductive hearing loss where average bone-conduction hearing threshold (0.5, 1, 2, 3 kHz) is ≤ 25 dB HL.
  • Specific dental health requirements (contiguous molar/premolar teeth, no untreated decay, healthy attachment, no mobile teeth, bone loss ≤ 34% on X-ray).
• Contraindications: MRI environment, hypersensitivity to components, vulnerable populations unable to use hands.
• Equivalent Device: SoundBite Hearing System (K100649) and Cochlear Baha (K090720).
• Basis for Submission: Expanded Indication for Use to include conductive hearing loss.
• Substantial Equivalence Discussion: Argues safety and effectiveness based on previous FDA clearance for SSD and comparison to Baha, both of which use bone conduction.

Therefore, I cannot provide the requested table of acceptance criteria, reported device performance, or details about the studies (sample sizes, expert qualifications, ground truth, etc.) because this information is not present in the provided text. The document focuses on regulatory compliance and substantial equivalence, not detailed clinical trial results or performance metrics against specific acceptance criteria.

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