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The Bonebridge is intended to improve hearing for patients with conductive or mixed hearing losses, bilateral fitting, and single-sided deafness.

INDICATIONS:
The Bonebridge bone conduction hearing implant system is intended for the following patients and indications:

• Patients 12 years of age or older.
• Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3kHz) should be better than or equal to 45 dB HL.
• Bilateral fitting of the Bonebridge is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2 and 3kHz, or less than 15 dB at individual frequencies.
• Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3kHz).
• The Bonebridge for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
• Prior to receiving the device, it is recommended that an individual has experience with appropriately fit air conduction or bone conduction hearing aids.

The MED-EL BONEBRIDGE System augments hearing by providing acoustic input to the inner ear via bone conduction. The MED-EL BONEBRIDGE System consists of two major components: The implant, called Bone Conduction Implant (BCI) and the external audio processor, e.g. the SAMBA 2 BB. The SYMFIT 8.0 software enables the fitting and configuration of the SAMBA 2 BB audio processor and is indicated for professional use only, i.e. used by hearing healthcare professionals during a fitting session of the external audio processor SAMBA 2 BB. Additionally, the SAMBA 2 GO and SAMBA 2 Remote are also subject to this 510(k). Both devices offer a convenient option to adjust simple, pre-defined settings of the compatible SAMBA 2 BB audio processor. Additionally, the SAMBA 2 GO can also be used as an assistive streaming device. The MED-EL BONEBRIDGE System is an active implantable bone conduction hearing system. The MED-EL BONEBRIDGE System is a prescription device consisting of an implanted transducer, implanted electronics components, and an audio processor. The active implantable bone conduction hearing system is intended to compensate for conductive or mixed hearing losses by conveying amplified acoustic signals to the cochlea via mechanical vibrations on the skull bone.

The provided text is a 510(k) summary for the MED-EL Elektromedizinische Geraete GmbH's BONEBRIDGE System components (SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving acceptance criteria for a novel device or AI.

Therefore, much of the requested information, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, is not applicable or not present in this type of regulatory submission.

The document primarily describes comparative bench testing against a predicate device.

Here's the information that can be extracted from the provided text based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or specific numerical performance metrics in the format of a table you've requested. Instead, it relies on demonstrating that the new devices perform "as intended" and are "at least as safe and effective" as the predicate devices, based on various bench tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "bench testing" and "non-clinical performance testing." This usually implies testing on physical devices or software in a laboratory setting, not patient data. Therefore, concepts like sample size of a patient test set, data provenance (country, retrospective/prospective), etc., are not explicitly provided or relevant in the context of this 510(k) summary, which focuses on device modifications and substantial equivalence via engineering and verification testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth typically refers to clinical data interpreted by experts. This document describes bench testing of hardware and software components.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are for human interpretation of clinical data sets.

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

Not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned. The device is a hearing aid system.

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

This refers to software performance, specifically for SYMFIT 8.0, SAMBA 2 GO, and SAMBA 2 Remote. The document states "Software testing according to software's defined Level of Concern" was conducted. This implies standalone testing of the software components. However, specific performance metrics for the software in a "standalone" fashion are not provided, beyond confirming it meets specifications and does not affect safety or effectiveness compared to the predicate.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the "bench testing," the "ground truth" would be established engineering specifications, industry standards, and the performance of the predicate device. This is not expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device is not an AI/Machine Learning device that requires a training set in the typical sense.

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

Not applicable.

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