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The Cochlear Baha 7 Sound Processor is intended for the following patients and indications for use:

• Patient of any age for use with the Baha SoundBand, Baha Softband (or headband) or Baha SoundArc. 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 3kHz) should be better than or equal to 55 dB HL.
• 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-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 deadness: 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 Cochlear Baha bone conduction hearing system provides an alternate solution for patients who may not benefit from air-conduction hearing aids. Unlike air-conduction hearing aids, the Baha implant system utilizes a natural bone conduction pathway to send sound directly to the inner ear (cochlea), bypassing a damaged outer or middle ear. The Baha bone conduction hearing system has non-surgical and surgical options. For the non-surgical option, the external sound processor, which converts acoustic sound into mechanical vibrations, is securely placed behind the ear with a Baha SoundBand, Baha Softband, or Baha SoundArc. For the surgical option, the external sound processor is coupled with an abutment (Baha Connect) or magnet (Baha Attract). The mechanical vibrations travel through the abutment or magnet to a small, titanium implant, which is surgically placed into the bone. The titanium implant has an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear.

The Baha 7 Sound Processor is a firmware variant of the previously cleared Baha 6 Max Sound Processor (K202048). The changes introduced in this 510(k) are specific to the sound processor and accessories, and do not affect the cleared Baha Connect abutments, Baha Attract magnet, the BI300 titanium implant, Baha Softband, or Baha SoundArc. The Baha 7 Sound Processor does not modify the intended functionality or fundamental operating principles of the bone conduction hearing system. The changes within culminate as the next generation Baha sound processor that supports Bluetooth LE Audio streaming, which enables compatibility with the new generation wireless accessories from GN Hearing.

The Baha 7 Sound Processor will be supported by a new fitting software (Baha Fitting Software 7), an updated app (Baha Smart App), and a new non-surgical retention option (Baha SoundBand).

The provided text describes a 510(k) premarket notification for the Cochlear Baha 7 Sound Processor. It focuses on demonstrating substantial equivalence to a predicate device, the Baha 6 Max Sound Processor. While it mentions various types of testing conducted (biocompatibility, software, electromagnetic compatibility, and bench testing), it does not include specific acceptance criteria or detailed study results for device performance in the format requested.

The document primarily provides:

• A summary of the device and its components (Baha 7 Sound Processor, Baha Fitting Software 7, Baha Smart App, Baha SoundBand).
• Indications for Use.
• A comparison table (Table 1, 2, 3, 4) detailing similarities and differences between the new device and the predicate(s).
• A general statement about performance data: "The testing demonstrated that the software supported the clinician fitting and recipient control of the Baha 7 Sound Processor." and "The bench testing demonstrates that the Baha 7 SP does not result in additional safety or efficacy concerns in comparison to the predicate." and "The results demonstrated the Baha 7 Sound Processor is functionally equivalent to the Baha 6 Max Sound Processor."

Therefore, based on the provided text, it is not possible to fully answer your request regarding specific acceptance criteria, reported device performance in a table, sample sizes, ground truth establishment details, or MRMC study results because this information is not present in the excerpt. The document focuses on demonstrating substantial equivalence through feature comparison and general statements about testing, rather than presenting a performance study with quantitative acceptance criteria and results.

Here's what can be inferred or stated based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not specified. The document mentions "bench functionality and performance testing" and "software testing" but provides no details on the sample size of devices or the data used for these tests.
• Data Provenance: Not specified for any performance testing.

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

• N/A. This type of information is typically relevant for studies involving human assessment (e.g., diagnostic accuracy studies for AI in imaging). As the device is a hearing aid sound processor, and the submission focuses on functional equivalence, there is no mention of "ground truth" adjudicated by experts in this context within the provided text. The "ground truth" for the device's function would be its measured physical characteristics and software performance against specifications.

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

• N/A. Not applicable given the nature of the device and the type of information presented. Adjudication methods are typically used in clinical studies or AI performance evaluations where human interpretation or consensus is required to establish a definitive ground truth.

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, an MRMC study was not done or is not reported here. This type of study is primarily relevant for AI-powered diagnostic aids where human readers interpret medical images or data. The Baha 7 Sound Processor is a hearing aid sound processor, not an AI diagnostic tool for human interpretation.

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

• Yes, implied. The "functional and performance testing, hardware and interface testing, reliability and environmental testing" would be considered standalone testing of the device and its software. The document states, "The results demonstrated the Baha 7 Sound Processor is functionally equivalent to the Baha 6 Max Sound Processor," which is a statement about its standalone performance. However, no specific metrics or detailed results of this standalone testing are provided beyond this general statement.

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

• Instrumental measurements and compliance with specifications. For a device like a sound processor, the "ground truth" for performance would be established through calibrated laboratory instruments measuring audio output, frequency response, power consumption, signal processing accuracy, and electromagnetic emissions, compared against engineering specifications and regulatory standards. Biocompatibility is assessed against ISO 10993. Software functionality is tested against design requirements. The text confirms
  • "Biocompatibility evaluation and testing demonstrated that the materials... are biocompatible." (Ground truth: ISO 10993 standards and lab tests).
  • "Software testing was performed... demonstrated that the software supported the clinician fitting and recipient control of the Baha 7 Sound Processor." (Ground truth: Software specifications and functional requirements).
  • "Electromagnetic compatibility testing established that the sound processor did not emit excessive amounts of electromagnetic energy, and that it operated as intended in the presence of interference sources." (Ground truth: EMC standards).
  • "Bench functionality and performance testing... demonstrates that the Baha 7 SP does not result in additional safety or efficacy concerns in comparison to the predicate." (Ground truth: Engineering specifications and direct comparison to predicate device performance).

8. The sample size for the training set:

• N/A. This device does not appear to involve machine learning models that require a "training set" in the context of typical AI device submissions for diagnostic or predictive purposes. The software mentioned (Baha Fitting Software 7, Baha Smart App) are control and interface applications, not described as adaptive or learning algorithms that require large training datasets.

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

• N/A. As no training set for an AI model is indicated, this question is not applicable.

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The contact forte Alpha is a Processor and is intended for use with the Sophono Headband or Softband (no age limitations), or with the Sophono Magnetic Implant (patients 5 years of age and up) for the following patients and indications:

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1.2, and 3 kHz).

• Bilateral fitting is applicable for most 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 4 kHz, or less than 15 dB at individual frequencies.

• Patients who have a profound sensorineural hearing loss in one ear and normal hearing in the opposite ear, who for some reason will not or cannot use an Air Conduction Contralateral Routing of Signal (AC CROS). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

The contact forte Alpha Processor is a sound processor that converts sound into mechanical vibrations. The sound processor is magnetically connected to a Sophono Headband, Sophono Softband or Sophono Attract Magnetic Spacer by the integrated metal disk. Sound enters the audio processor through the microphones, which then goes through a DSP chip for signal processing. The output of the DSP chip drives an electromechanical transducer, which converts the signal into mechanical vibrations. These vibrations are transferred to the patient's skin through the Sophono Headband, Sophono Softband or the Sophono Attract magnetic spacer. The vibrations are carried through the patient's skin and skull to the cochlea where they are perceived as sound. The device is designed for use on either the right or left side application. The device has a "oval" housing with a symmetrical design ( for right or left side application). The material used: Plastic contact with intact skin;

The FDA 510(k) Clearance Letter for the "contact forte Alpha" bone-conduction hearing aid (K243041) outlines performance data demonstrating the device's substantial equivalence to its predicate, the Sophono Alpha 2.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal table of quantitative acceptance criteria with corresponding performance numbers for the contact forte Alpha versus the Sophono Alpha 2. Instead, it relies on qualitative statements of equivalence and "good concordance" for certain measurements. The core acceptance criterion seems to be demonstrating comparable performance and no significant difference in key audiometric and output parameters compared to the predicate.

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

• Sample Size for Field Tests: 5 patients.
• Data Provenance: The document states "Field testing was conducted with five patients". Given the applicant, BHM-Tech Produktionsgesellschaft mbH, is located in Austria, and the device is manufactured there, it is highly probable the field tests were conducted in Austria or a similar European setting. The trials are implicitly prospective in nature, as they involve testing the contact forte Alpha in real-world conditions on human subjects.

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

The document does not explicitly state the number or qualifications of experts used to establish the "ground truth" for the field test data beyond the general statement that "audiometric thresholds and speech perception thresholds" were assessed. For a hearing device, establishing ground truth would typically involve audiologists performing standardized audiological assessments. The document implies a direct comparison of the subject device and predicate on the same individuals, where the individuals' own established hearing thresholds serve as a baseline, and the objective measurements (audiometric thresholds, speech perception thresholds) and subjective reports are the core data points.

4. Adjudication Method for the Test Set:

The document does not describe any formal adjudication method beyond comparing the subject and predicate devices on the same patients and collecting objective measurements and subjective feedback. There is no mention of "2+1" or "3+1" methods typically used for image-based diagnostics. The comparison is direct and within-subject for the field test.

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:

This is not applicable to this device. The contact forte Alpha is a bone-conduction hearing aid, not an AI-assisted diagnostic tool where human readers/interpreters would "improve" with AI assistance. The performance evaluation focuses on the device's ability to amplify and transmit sound comparably to a predicate device, as perceived by patients and measured by audiometric tests.

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

This is not applicable in the traditional sense for this device. The "performance" of a hearing aid is inherently human-in-the-loop, as its function is to assist human hearing. However, the document does describe non-clinical tests such as "Magnetic Retention forces" and "Output Level Measurements" which are standalone assessments of the device's physical and acoustic properties without a human user. These non-clinical tests were performed independently of human perception.

7. The type of ground truth used:

The ground truth for the performance evaluation in the clinical field tests consisted of:

• Objective Audiometric Measurements: "Audiometric thresholds and speech perception thresholds" measured with both the predicate and subject devices. This is a form of objective functional assessment.
• Subjective User Reports: "The patients reported that they did not notice any subjective difference in hearing between the two devices." This is outcomes data based on patient perception.
• Technical Specifications/Measurements: For non-clinical tests, the "ground truth" is adherence to predefined engineering specifications and comparison against the predicate's known performance for parameters like "Magnetic Retention forces" and "Output Level Measurements."

8. The sample size for the training set:

The document does not specify a training set size. This device is a hearing aid, not an AI/machine learning model that typically requires a large training dataset for model development. The development and validation likely followed traditional engineering design and testing principles, not machine learning paradigms involving distinct training and test sets in the AI context.

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

As there's no mention of a training set in the context of an AI/ML model, this question is not applicable. The "ground truth" for the device's design and development would stem from established audiology principles, acoustic engineering standards, and the performance characteristics of the predicate device.

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The Sentio Ti implant, in combination with Sentio 1 Mini, is indicated for the following patients:

· Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL.

• Patients having a symmetrically conductive or mixed hearing loss are candidates for a bilateral fitting. 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 3 kHz, or less than 15 dB at individual frequencies.

· Patients who have a 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· Patients who are 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 fitted air conduction or bone conduction hearing aids.

· Patients 12 years of age or older.

The Sentio system is an osseointegrating, transcutaneous active bone conduction hearing system that uses the body's natural ability to transfer sound through bone conduction, thus offering improvement of hearing for patients with conductive or mixed hearing loss whether unilaterally or bilaterally fitted, or for those with single sided deafness. A bone conduction system transmits sound directly to the cochlea independently of the function of the ear canal and middle ear.

The Sentio system primarily consists of a sound processor (Sentio 1 Mini) and an implant (Sentio Ti Implant). The two components are kept in relation to each other by means of a magnetic retention system. The sound is picked up by the microphones in the external sound processor, processed and transmitted by a transmission coil using a radio frequency (RF) link through the intact skin to an implant placed in the temporal and mastoid bone area. The receiver coil of the implant receives the signal that is converted into mechanical energy (vibrations) by the transducer. The vibrations are conveyed from the bottom of the transducer to the skull and thereafter by means of bone conduction to the cochlea. In the cochlea the vibrations are converted to signals that are transmitted to the brain through the auditory nerve.

The Sentio system is intended for improvement of hearing for patients with conductive or mixed hearing losses up to 45 dB BC. The implant has been tested and verified to allow for larger mixed hearing losses, up to an anticipated 65 dB BC.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

The document describes the Sentio Active Implantable Bone Conduction Hearing System, including the Sentio Ti Implant Kit, Sentio 1 Mini, and Genie Medical BAHS. The primary study referenced for demonstrating safety and performance is Study BC101.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria" table with pre-defined thresholds for performance that the device must meet in a comparative format. Instead, it discusses performance results in context of showing meaningful improvement and equivalence to predicate devices. However, we can infer performance targets based on the documented results and comparisons to normal hearing/speech levels.

Note: PPS = Per Protocol Set, FAS = Full Analysis Set. The document clarifies that a calibration error impacted some early subjects, leading to the use of both sets for analysis.

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

• Sample Size (Study BC101): 51 adult patients (18 years or older) were included in the Full Analysis Set (FAS).
• Data Provenance (Study BC101):
  • Country of Origin: Multi-center study, including six clinics in three countries (specific countries are not named in the provided text).
  • Retrospective or Prospective: Prospective study.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the test set. Clinical studies of this nature typically involve audiologists and ENT surgeons who administer tests and evaluate outcomes, but no explicit details are provided regarding their role in establishing a "ground truth" independent of the device's own performance measurements. The "normal hearing threshold for pure tones (20 dB HL)" and "normal speech level (65 dB SPL)" serve as general external benchmarks.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For an audiology study focused on objective measurements (e.g., dB HL, speech recognition percentages) and patient-reported outcomes, a formal adjudication process akin to image interpretation may not be necessary in the same way. The results are primarily based on quantifiable audiometric tests and standardized questionnaires.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted in the traditional sense involving multiple human readers interpreting cases with and without AI assistance. This device is a hearing aid system, not an imaging AI diagnostic tool. The "assistance" it provides is direct auditory amplification and sound processing for the patient, not a clinical interpretation aid for a human expert.

The study does compare aided performance (with the device) against unaided performance (without the device), demonstrating the effectiveness directly. For example:

• "Speech recognition in quiet is significantly improved with the Sentio system compared to unaided for patients with conductive and mixed hearing losses as well as patients with single sided deafness."
• "The study concludes that the primary end-points (improved hearing and improved speech recognition on the implanted ear) were statistically significant in favor of the Sentio when compared to reference values."

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Performance

The device's core function is as a "standalone" system in its operation for the patient. While it requires clinical fitting and programming (Genie Medical BAHS software, performed by a Hearing Care professional), the performance metrics presented (e.g., aided thresholds, speech recognition, functional gain) are reflective of the device's performance as used by the patient, meaning the algorithm's output directly impacts the patient's hearing perception. There's no separate human-in-the-loop task where the algorithm assists a human to perform a diagnostic task; rather, the device is the therapeutic intervention.

7. Type of Ground Truth Used

The ground truth for evaluating the device's performance is established through a combination of:

• Objective Audiometric Measurements: This includes bone conduction thresholds, air conduction thresholds, pure tone average (PTA), functional gain, and speech intelligibility percentages. These are standard, quantifiable audiological assessments.
• Patient-Reported Outcomes (PROs): Standardized questionnaires, specifically the Glasgow Benefit Inventory (GBI), were used to assess health-related quality of life and patient satisfaction.
• Safety Data: Adverse event reporting and MRI experience questionnaires.
• Comparison to Reference Values: Performance is compared to established "normal" hearing thresholds (20 dB HL) and speech levels (65 dB SPL), and also to unaided listening conditions.

8. Sample Size for the Training Set

The document does not explicitly describe a separate "training set" for the Sentio system in the context of an AI/machine learning model. The device is a medical device (active implantable bone conduction hearing system) with specific mechanical and electrical properties, and its "programming" or "fitting" (e.g., using Genie Medical BAHS software) is based on established audiological science and algorithms, not typically on a large-scale, iterative machine learning training process with a distinct training dataset.

The clinical studies (O1, C58, BC114, BC101) described are clinical trials to evaluate the device's safety and performance in humans, not "training sets" for an AI algorithm in the conventional sense. Previous design iterations or prototypes might have undergone internal development and testing, but the text doesn't detail this as a formal "training set."

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

As noted above, the concept of a "training set" and associated ground truth is not directly applicable in the typical AI/ML sense for this device based on the provided text. The device's design, functionality, and fitting parameters are developed and refined through engineering principles, audiological research, and validation against clinical needs and outcomes (as demonstrated in the clinical studies listed).

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