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The Cochlear Baha® SoundArc is intended for test situations and for patients who cannot or choose not to have an implant for the following indications for use:

· Patients of any age who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing thressured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the BP100, Baha 4 and Baha 5 sound processors, 55 dB HL for use with the BP110 Power and Baha 5 Power sound processors, and better than or equal to 65 dB HL for use with the Cordelle II and Baha 5 SuperPower Sound Processors.

· Bilateral fitting 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-conductive thresholds are defined as 10 dB average difference between ears (measured at 0.5, 1,2, and 3 kHz), or less than a 15dB difference at individual frequencies.

· Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Singlesided deafness: SSDTM). 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 air conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

Baha SoundArc is an encapsulated spring wire that wraps around the back of the head and sits behind and above the ears. SoundArc is designed with a symmetrical disc holder that holds the Baha sound processor in place, and is compatible with existing Baha sound processors. The design of SoundArc enables the Baha device to be placed against the skull for operation without the need for a Baha implant to be placed.

The provided text describes the Cochlear™ Baha® SoundArc, a headband for bone conduction hearing aids. However, it does not contain specific acceptance criteria, detailed study results, or the methodological details typically found in a comprehensive study report. The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. As such, it focuses on asserting equivalence rather than presenting an in-depth performance study with quantitative acceptance criteria and detailed results.

Therefore, I cannot fulfill all parts of your request with the provided information. I will, however, extract all available relevant details regarding "performance data" and "study" aspects.

1. Table of acceptance criteria and the reported device performance

No explicit quantitative acceptance criteria or detailed device performance metrics (e.g., specific dB improvements, failure rates with thresholds) are provided in the document. The document states that "Substantial equivalence to the predicate system was accomplished through functional and performance tests, design and specification analysis, and biocompatibility evaluation." The conclusion is that "the Baha SoundArc is functionally equivalent to the predicate system."

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "functional and performance tests" without providing these details.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. Ground truth establishment and expert involvement are not detailed.

4. Adjudication method for the test set

This information is not provided in the document.

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

No MRMC comparative effectiveness study is mentioned, nor is there any mention of "human readers" or "AI assistance." The device is a bone conduction hearing aid attachment, not an AI diagnostic tool.

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

This concept is not applicable to a physical medical device like a bone conduction hearing aid attachment. The performance would be related to mechanical, acoustical, and biocompatibility aspects, not software algorithms.

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

The document does not specify the type of "ground truth" as typically defined for diagnostic AI/imaging devices. For this type of device, performance is likely assessed against established engineering standards for hearing aids and biocompatibility standards. The basis for evaluating "functional equivalence" would be direct measurement of sound transfer, comfort, durability, and biocompatibility, not a "ground truth" derived from expert consensus or pathology in a diagnostic sense.

8. The sample size for the training set

This information is not applicable or provided. The device described is a physical product, not a machine learning algorithm that requires a "training set."

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

This information is not applicable or provided, as there is no mention of a training set for an algorithm.

Summary of the Study Mentioned (from the provided text):

The document describes a "performance testing" activity.

• Objective: To demonstrate "substantial equivalence" of the Cochlear™ Baha® SoundArc to the predicate Baha Softband and existing Baha sound processors.
• Methodology: Performance testing was conducted based on a comparison between the proposed SoundArc and the legally marketed Softband and current Baha sound processors. This involved:
  • Functional tests
  • Performance tests
  • Design and specification analysis
  • Biocompatibility evaluation
• Results/Conclusion: "The results demonstrated the Baha SoundArc is functionally equivalent to the predicate system." New materials were also found to be "biocompatible and safe for human use" when evaluated per ISO 10993-1.

Missing Information:

The provided text, being a 510(k) summary, is intentionally brief and does not include the detailed scientific or engineering studies that would contain the specific quantitative acceptance criteria, exact methodologies, raw data, sample sizes, and expert qualifications for ground truth that your request asks for. These details would typically be found in the full technical documentation submitted to the FDA, but not in the public 510(k) summary.

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The Cochlear Baha® BP110 Power sound processor has the following indications for use:

• Patients of any age for use with the Baha Softband or headband. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
• 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 55 dB HL.
• Bilateral fitting is intended for patients who meet the 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: 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 air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The subject of this Special 510(k): Device Modification is a modification to the Cochlear Baha® Intenso sound processor, which was cleared under 510(k) K081606 for unilateral or bilateral use with conductive and mixed hearing losses (as a result of congenital malformations such as atresia, or certain medical conditions such as chronic suppurative otitis media), and for cases of single-sided sensorineural deafness (SSD, caused by a congenital condition, surgery, trauma or disease). The Baha system has been marketed for more than 30 years throughout the world, and there are now more than 77,000 users of a Baha system globally.

Baha sound processors can be used with either the external Baha headband or Softband, or, for children aged 5 or older, with the Baha auditory osseointegrated implants. The external Baha headband or Softband system works via conventional transcutaneous bone conduction amplification. The Baha implant system works by combining the external sound processor with an abutment and a small titanium implant placed in the skull behind the ear in a simple surgical procedure. 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 surrounding bone, allowing high-quality amplified and processed sound from the Baha sound processor to be conducted via the skull bone directly to a cochlea with residual functionality. For either form of transmission, the processed sound either bypasses a conductive block in those patients with conductive or mixed hearing loss, or transfers sound through the skull to the opposite-ear normal cochlea for patients with SSD.

The modified sound processor, the Baha BP110 Power is an upgrade to the currently marketed Baha Intenso sound processor, which it will replace on the U.S. market. The BP110 Power sound processor will provide a more modern device with technological innovations compared to the predicate Intenso. As the modified device utilizes the same fundamental scientific principles, and the same intended use and indications for use as the current legally marketed device it will replace, and merely represents improvements in features and the sound processing of the amplified sound that are the same as those used in another Cochlear Baha sound processor that has already been cleared for marketing for a less hearing-impaired population (the model BP100, cleared under K090720), we believe these modifications are appropriate for the Special 510(k) process.

The primary modifications proposed are technological improvements so that the BP110 Power will be digitally programmable, allow up to three user-selectable listening programs and measurement of direct bone conduction thresholds (through the sound processor) for greater accuracy in fitting, and provide a number of sound processing improvements and features that have already been cleared for another Baha sound processor intended for a less severely impaired population (the Baha BP100. cleared under K090720). Improvements in sound processing include multichannel, non-linear programmability, advanced automatic directionality, background noise management, active feedback cancellation, and position compensation. The BP110 Power can be fit with Baha Fitting Software (also previously cleared under K090702), which has proprietary amplification strategies for direct bone conduction delivery of amplified sound. The BP110 Power also has audible and visible indicators (LEDs and beeps) for monitoring the status of the sound processor, a Europlug for compatibility with standard accessories and mainstream FM devices, and tamper proof features for the pediatric population. These modifications will result in a device that will provide more individual flexibility and accuracy in fitting and an increased number of sound processing options and features currently found in air conduction hearing aids (Class I, Exempt).

I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, sample sizes for test set or training set, data provenance, number and qualifications of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, or type of ground truth.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance or describe the study that proves the device meets the acceptance criteria based on the given input.

The document is a 510(k) summary for the Cochlear Baha® BP110 Power Sound Processor, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, technological characteristics, and details the FDA's clearance. It does not provide detailed performance study results against specific acceptance criteria.

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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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