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The Cochlear Baha BP100 sound processor is intended for use with the Baha auditory osseointegrated implant (for children aged 5 and older, or adults), or with the Baha Headband or Baha Softband (no age limitations), for the following patients and indications:

• Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 45 dB HL.
• Bilateral fitting of the BP100 is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.
• Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. single-sided deafness or "SSD"). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
• Baha for SSD is also indicated for any patient who is indicated for an airconduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The Baha implant system works by combining a sound processor with an abutment and a small titanium implant placed in the skull behind the ear. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the bone, allowing high-quality amplified and processed sound to be conducted via the skull bone directly to a cochlea with residual functionality. Baha sound processors can also be fitted as external (non-implanted) bone-conduction vibrators with either the Baha Headband or Baha Softband as an alternative to a conventional bone-conduction hearing aid.

The Baha BP100 will be the newest addition to a current family of three marketed sound processors for use with the Baha auditory osseointegrated implant, or with the Baha Headband/Softband setup. In its initial release, it will provide a moderate gain ear-level sound processor that will serve as a premium-feature option to the currently marketed Baha Divino. At a later date, the BP100 platform may be used to provide a range of programmable products to meet end-user needs.

The provided text describes a 510(k) premarket notification for the Cochlear Baha BP100, a bone conduction hearing aid. The submission focuses on demonstrating substantial equivalence to predicate devices rather than a de novo clinical study with specific acceptance criteria and performance metrics.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a new clinical study. Instead, the primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to existing, legally marketed predicate devices.

The reported device performance is framed in terms of comparability to the predicate Baha Divino.

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

• Sample Size: No specific sample size for a "test set" or a new clinical study involving human subjects for the Baha BP100 is reported. The primary evidence presented is bench testing comparing the BP100 to predicate devices.
• Data Provenance: The document refers to "Published data in the literature" (Kompis et al., 2007) to support the safety and efficacy of the Baha Divino (a predicate device). This suggests the provenance is retrospective clinical literature on a different device, not new data generated specifically for the BP100. Bench testing data would be generated from the device itself.

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

This information is not applicable as no new clinical study with a "test set" requiring expert-established ground truth was conducted for the Baha BP100 for this submission. The submission relies on bench testing and previously published clinical data on predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as above. No new clinical test set requiring adjudication was performed.

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 reported. The submission explicitly states that "further clinical performance data are unnecessary" given the bench testing equivalence to the Baha Divino and its existing clinical literature.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device is a hearing aid, which requires a human user (patient). The "algorithm" here refers to the digital signal processing within the hearing aid. The document implicitly refers to standalone device performance in terms of its gain/output characteristics as measured by bench testing, independently of human interaction beyond fitting. However, this is not an "algorithm-only" study in the typical sense of AI diagnostics, but rather engineering performance of the device's internal processing.

7. The Type of Ground Truth Used:

For the demonstration of substantial equivalence, the "ground truth" implicitly relies on:

• Bench Testing Data: Direct measurements of the BP100's gain/output characteristics, compared to similar measurements for the Baha Divino.
• Predicate Device Clinical Performance: The established safety and efficacy of the Baha Divino (supported by published literature like Kompis et al., 2007) served as the "ground truth" for clinical performance for the patient population, which the BP100 is then argued to serve equally well due to its comparable technical performance.

8. The Sample Size for the Training Set:

This information is not applicable. The Baha BP100 is a medical device, not an AI/ML algorithm that is "trained" in the typical sense. Its digital signal processing algorithms are designed and programmed, not learned from a dataset.

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

This information is not applicable as there is no "training set" for the device's inherent functionality described in the conventional AI/ML context. The device's design and programming are based on established audiological principles and engineering practices for hearing aids.

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