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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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Conductive, mixed and single sided deafness. Patients should have sufficient bone quality and quantity to support successful implant placement.

The Cochlear Baha® Attract is intended for the following patients and indications for use:

• Patients aged 5 and older ●
• . 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 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 sound processor. and better than or equal to 65 dB HL for use with the Cordelle II sound processor.
• 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 less than a 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. Single-sided 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.

The Cochlear Baha Attract auditory implant system consists of three parts: a titanium implant, a titanium-encased magnet pair, and an external magnet pair with a replaceable soft pad. The existing range of Baha sound processors attach to this external magnet via a snap coupling. The system works by utilizing natural bone transmission as a pathway for sound to travel to the inner ear, bypassing the external auditory canal and middle ear. After surgical placement, the titanium implant naturally integrates with the skull bone over time through a process known as osseointegration. The external sound processor transmits sound vibrations through the transcutaneous magnetic coupling to the titanium implant. The vibrating implant creates vibrations within the skull that stimulate the nerve fibers of the inner ear, allowing hearing.

The Baha Cordelle II Sound Processor is an external sound processor that utilizes analog signal processing with K-Amp circuitry (Killion, 1993) for use with the Baha auditory osseointegrated implant.

The provided text describes a 510(k) premarket notification for a medical device, the Cochlear™ Baha® Cordelle II Sound Processor, and its expanded indications for use with the Baha Attract System. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI/medical device.

Therefore, the information required to fully answer the prompt is not present in the provided text. The document describes a traditional 510(k) for expanding the indications of an existing device, which relies heavily on demonstrating the device's technological characteristics and performance are "substantially equivalent" to already legally marketed devices, rather than establishing new performance criteria through a detailed clinical study with the elements requested in the prompt.

However, I can extract the information that is present and highlight what is missing based on your request.

Here's what can be inferred/extracted and what is explicitly missing:

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

• Acceptance Criteria (Inferred from 510(k) Process): The primary "acceptance criterion" for a 510(k) submission like this is "substantial equivalence" to a predicate device. This means the new/modified device must be as safe and effective as a legally marketed device that is not subject to premarket approval (PMA). The specific performance metrics are typically compared against those of the predicate device.
• Reported Device Performance:
  • The document states: "The results of the bench testing support the conclusion that the performance of the Cordelle II Sound Processor with Baha Attract is substantially equivalent to the Cordelle II Sound Processor used with the Baha Softband."
  • It mentions: "Technical feedback and force transfer measurements with the Cordelle II Sound Processor used with the Baha Attract System were completed in support of this 510k submission."

Table (Best Effort based on available info - Note: Specific quantitative criteria/results are NOT provided):

Missing Information for a comprehensive table:

• Specific quantitative metrics for performance (e.g., sound output levels, frequency response, bone conduction thresholds).
• Defined thresholds or ranges for these metrics to meet "acceptance."

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document mentions "bench testing" but does not give a number of devices or test conditions for this testing.
• Data Provenance: Not explicitly stated. Given it's a 510(k) for a company based in Colorado (US) and a manufacturer in Sweden, testing could have occurred in either location. It is "pre-market" data, likely from laboratory testing rather than a clinical trial.
• Retrospective/Prospective: Implied to be prospective bench testing for the submission. Not a retrospective analysis of clinical data.

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

• Not Applicable/Not Provided. This submission is for a device, not an AI algorithm that requires expert annotation for ground truth. The "ground truth" here is the physical performance measured in bench tests and comparison to established predicate device performance.

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

• Not Applicable/Not Provided. This is relevant for studies involving human interpretation or subjective assessments, not for bench testing of a physical device.

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. This is not an AI-assisted device. It is an auditory implant sound processor. Therefore, no MRMC study or AI-related metrics found.

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

• Not Applicable. This is a hardware device (sound processor) that interacts with a human. It's not an algorithm evaluated in isolation.

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

• Bench Testing Data / Comparison to Predicate Performance. The "ground truth" for demonstrating substantial equivalence for this type of device lies in engineering specifications, physical measurements (e.g., force transfer), and adherence to established performance metrics or standards for hearing aids/processors. The document explicitly mentions "Technical feedback and force transfer measurements."

8. The sample size for the training set:

• Not Applicable/Not Provided. This is a physical device, not a machine learning model; therefore, there is no "training set" in the AI sense.

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

• Not Applicable/Not Provided. See answer for point 8.

In summary, the provided document is a 510(k) premarket notification for a medical device where the primary goal is demonstrating "substantial equivalence" to a predicate device through bench testing. It does not contain the characteristics of a study for an AI/ML-based device, which typically involves detailed performance metrics against a human-adjudicated ground truth.

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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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