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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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The Osia System is intended for the following patients and indications:

· Patients 5 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 3 kHz) should be better than or equal to 55 dB HL.

· Bilateral fitting of the Osia System is intents 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 3 kHz, 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., singlesided deafness or "SSD"). The pure tone average air conduction hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).

• The Osia System 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 have experience with appropriately fitted air conduction or bone conduction hearing aids.

The Osia System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness (SSD).

The Osia System is made up of several components. The Osia Implant consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia System is a sound processor, worn off-the-ear, which picks up the sound from the environment, and sends, after processing, the information to the implant via a transcutaneous inductive link. This link is also referred to as radiofrequency (RF) link. Each Osia System is configured to meet an individual's hearing needs, using dedicated fitting software.

Here's a breakdown of the acceptance criteria and the study details for the Cochlear Osia System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail format for this specific submission, as this submission is for an expanded pediatric indication, not a new device. However, the study aims to demonstrate safety and effectiveness in the expanded population in comparison to the existing predicate. The "acceptance criteria" can be inferred from the study's objectives and the conclusion of substantial equivalence.

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

• Sample Size: Not explicitly stated for the "test set" in a traditional sense. The document refers to a "pivotal, prospective, multi-center study... to determine the safety and effectiveness of the Osia system in children ages 5-11." The number of participants in this study is not numericaly provided.
• Data Provenance: The study was a "pivotal, prospective, multi-center study." The country of origin of the data is not specified.

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

This submission is for a medical device (hearing system), not an AI/software device requiring "ground truth" derived from expert consensus on images or similar data. The "ground truth" is based on clinical outcomes relevant to hearing devices:

• Adverse Events: Clinical reporting by medical professionals during the study.
• Quality of Life: Patient-reported outcomes via parental questionnaires.
• Speech Perception: Objective audiological testing (unaided vs. aided performance).
• Bone Conduction Thresholds: Audiological measurements by qualified audiologists.

The document does not mention a specific number of experts or their qualifications in terms of establishing a "ground truth" for the test set in the same way an imaging AI algorithm might. The clinical data itself serves as the evidence.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and study. The data collected (adverse events, questionnaire results, audiological test results) are direct clinical observations and measurements, not subjective evaluations requiring adjudication by multiple experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This study focuses on the clinical performance of the device itself in a specific patient population, not on human readers' interpretation of data with and without AI assistance.

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

Yes, in a way. The device itself (Cochlear Osia System) is the "algorithm only" in the context of its function as an active implantable bone conduction hearing system. Its performance (improvements in hearing, quality of life, speech perception) is measured as a standalone effect of the device on the patient, without human intervention during the hearing process. The human element comes in during the fitting and programming of the device by audiologists. The study's effectiveness measures (parental questionnaires, speech perception tests) evaluate the device's functional outcome.

7. The Type of Ground Truth Used

The "ground truth" for this study is derived from various clinical measures and outcomes:

• Safety: Reports of adverse events during the prospective study.
• Effectiveness (Quality of Life): Patient-reported outcomes from parental questionnaires (SSQ - Speech, Spatial and Qualities of Hearing).
• Effectiveness (Hearing Thresholds): Audiological measurements of bone conduction thresholds.
• Effectiveness (Speech Perception): Audiological tests measuring speech perception in quiet and in adaptive noise.

8. The Sample Size for the Training Set

The document does not mention a "training set." This study is a clinical trial evaluating a medical device, not an AI algorithm that requires training data in the computational sense. The device itself (the Osia System) has undergone prior development and testing, but that is distinct from a "training set" for a machine learning model.

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

Not applicable, as there is no "training set" in the context of this device and the provided document.

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The Cochlear Osia System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing. Osia Implants are single use devices intended for long term implantation under the skin in the mastoid region of either side of the head. They are for professional use only.

The Osia System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness (SSD). The Osia System is made up of several components. The Osia Implant (OSI300) consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia System is a sound processor, worn off-the-ear, which picks up the sound from the environment, and sends, after processing, the information to the implant via a transcutaneous inductive link. This link is also referred to as radiofrequency (RF) link. Each Osia System is configured to meet an individual's hearing needs, using dedicated fitting software.

The provided text describes a 510(k) premarket notification for the Cochlear™ Osia® System, an active implantable bone conduction hearing system. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (Cochlear™ Osia® 2 System) for an updated version of the system.

The core of the submission involves bench testing to compare the updated system with the predicate. There is no evidence of a clinical study or performance study with patients designed to establish specific acceptance criteria directly tied to the device's clinical efficacy or diagnostic accuracy (e.g., sensitivity, specificity, AUC). The acceptance criteria, therefore, appear to be based on functional equivalency, safety, and performance compared to the predicate device through non-clinical means.

Here's a breakdown of the information based on your request, with an emphasis on what is not present in the provided text regarding specific performance criteria as typically understood in a clinical study for diagnostic or AI-based devices:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and the provided text focuses on demonstrating substantial equivalence through non-clinical testing (bench testing), explicit quantitative clinical acceptance criteria like sensitivity, specificity, or AUC are not stated, nor are their corresponding reported device performance values from a clinical study. Instead, the "acceptance criteria" are implied by successful completion of various verification activities ensuring the updated device functions as intended and is as safe and effective as the predicate.

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

The document explicitly states that bench testing was conducted. This implies that the "test set" consisted of physical devices, prototypes, or simulated scenarios in a lab environment. There is no mention of human subjects, patient data, or a clinical test set. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature is not applicable to the described study.

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

Since the study described is non-clinical bench testing, the concept of "ground truth established by experts" in a clinical context (e.g., radiologist opinions) is not applicable. The "ground truth" for bench testing is derived from engineering specifications, established standards (e.g., ISO, FDA guidance), and physical measurements by engineers and technicians.

4. Adjudication method for the test set

As the evaluation was non-clinical bench testing, an adjudication method like 2+1 or 3+1 for clinical interpretation is not applicable. Test results are typically evaluated against pre-defined engineering criteria and specifications.

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

There is no mention of an MRMC study or any study involving human readers with or without AI assistance. The device is a hearing system, not an AI-assisted diagnostic tool for human interpretation.

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

The device itself is a hearing system that directly assists the patient, not a diagnostic algorithm. Therefore, the concept of "standalone algorithm performance" (in the typical AI/diagnostic sense) is not applicable. The device's performance is inherently "human-in-the-loop" as it's worn by a person to enhance hearing. However, its individual components' functional performance was evaluated independently through bench testing.

7. The type of ground truth used

For the non-clinical bench testing and verification activities, the "ground truth" used was based on:

• Engineering specifications and design requirements of the device.
• Established industry standards (e.g., ISO 10993-1:2018, ISO 14708-7:2013, ISO 11135:2014, EN 45502-1, EN ISO 11607-2009 +A1:2014).
• FDA guidance documents.
• Comparative data against the performance of the predicate device (Cochlear™ Osia® 2 System).

8. The sample size for the training set

This is not applicable as the document does not describe the development of an AI algorithm or model that requires a training set. The descriptions are about hardware revisions, firmware updates, and software modifications for a medical device.

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

This is not applicable as no training set for an AI algorithm or model is described.

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The Osia 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 3 kHz) should be better than or equal to 55 dB HL.
· Bilateral fitting of the Osia System 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 3 kHz, 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 3 kHz).
· The Osia System 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.
· Prior to receiving the device, it is recommended that an individual have experience with appropriately fitted air conduction or bone conduction hearing aids.

The Osia 2 System, also known as Osia System, mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness (SSD).
The Osia 2 System is made up of several components. The Osia implant (OSI200) consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia 2 System is a sound processor, worn off-the-ear, which picks up the sound from the environment, and sends, after processing, the information to the implant via a transcutaneous inductive link. This link is also referred to as radiofrequency (RF) link. Each Osia 2 System is configured to meet an individual's hearing needs, using dedicated fitting software.
In normal operation, the Osia System functions as follows:

• 1. The external sound processor captures and digitally processes sound.
• 2. The sound processor transmits power and digital information to the implant coil/receiver.
• 3. The implant stimulator/actuator converts the digital information into an electric analogue signal that is converted to vibrations by the implant piezoelectric actuator.
• This implant is fixed to the bone by the BI300 implant (K100360). 4.
  The actuator converts the electrical signal into an amplified mechanical stimulation, bypassing the impaired middle ear (origin of the conductive part of the hearing loss) and providing some level of mechanical amplification in order to compensate for the damaged inner ear (sensorineural part of the hearing loss, in case of mixed hearing loss).
  The updated Osia 2 System consists of modifications to the cleared OSI200 Implant, Osia 2 Sound Processor and Osia Fitting Software 2. All other components of the system remain unchanged from the cleared predicate.
  The Cochlear MRI Kit is being introduced for use by Osia recipients. The MRI Kit is an accessory that enables an MR scan at 1.5T without the need to surgically remove a compatible Osia implant's magnet.

The provided document is a 510(k) Summary for the Cochlear Osia 2 System. It describes the device, its intended use, indications for use, and a comparison to a predicate device. The primary purpose of this submission is seeking clearance for an updated Osia 2 System, which includes modifications to existing components (OSI200 Implant, Osia 2 Sound Processor, Osia Fitting Software 2) and the introduction of a new accessory, the Cochlear MRI Kit.

The core of the "acceptance criteria" and "proof" in a 510(k) submission like this is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific quantitative performance metrics against a defined standard (which would be more typical for a PMA or de novo submission). Therefore, the "acceptance criteria" here largely refers to the criteria for demonstrating substantial equivalence, and the "study" is the collection of non-clinical (bench) testing performed to support this claim.

Here's an attempt to extract and describe the information requested based on the provided text, recognizing that a 510(k) summary primarily focuses on substantial equivalence rather than explicit performance criteria against a predefined threshold:

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

Since this is a 510(k) for an updated device, the primary "acceptance criterion" is functional equivalence and maintaining safety and effectiveness compared to the predicate device. The "reported device performance" is the conclusion that this equivalence was achieved through testing.

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 primarily discusses bench testing and verification/validation activities for hardware, software, and accessories. It does not mention clinical trials with human subjects. Therefore, the concept of "sample size" in the context of a "test set" for clinical data or "data provenance" (country/retrospective/prospective) is not directly applicable here. The testing is non-clinical.

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)

This section is not applicable as the document describes non-clinical (bench) testing, software verification, and usability testing for an accessory, not a diagnostic AI system requiring expert-established ground truth on medical images or patient data. The "summative usability testing" for the MRI Kit involved "specialized healthcare professionals," but their specific number, qualifications, or their role in establishing a "ground truth" (rather than evaluating usability) are not detailed.

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

This is not applicable as the device is not software for diagnostic image interpretation or a similar application that would require expert adjudication for 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

This is not applicable. The device is an active implantable bone conduction hearing system and an associated MRI kit, not an AI-assisted diagnostic tool. No MRMC study or AI assistance to human readers is mentioned.

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

This is not applicable. The device is a physical hearing implant system and an MRI accessory, not an algorithm. The testing described is performance testing of the device components and system.

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

This is not applicable. For this type of device (hearing implant, MRI accessory), "ground truth" typically relates to engineering specifications, functional performance requirements, regulatory standards (e.g., for MRI compatibility), and safety profiles, which are assessed through bench testing and verification activities. It does not involve "ground truth" from medical images or patient outcomes in the sense of diagnostic accuracy.

8. The sample size for the training set

This is not applicable. The document describes a medical device (hardware and firmware/software) and its accessory, not a machine learning or AI model that requires a "training set."

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

This is not applicable for the same reason as point 8.

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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 3 kHz) should be better than or equal to 45 dB HL. · Bilateral fitting of the BONEBRIDGE is intents 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 3 kHz, 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., singlesided deafness or "SSD"). The pure tone average air conduction hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz). · 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 BCI Lifts are optional accessories that can be implanted together with the BONEBRIDGE Bone Conduction Implant (model BCI 601 or BCI 602). They are attached to the fixation wings of the BCI and serve as a spacer to increase the distance between the fixation wings and the skull bone. The devices can be used if the necessary drill depth for the BCI implant cannot be achieved for anatomical reasons. They are attached to the fixation wings of the BCI implant to reduce the necessary drill depth for the Bone Conduction - Floating Mass Transducer (BC-FMT) in the skull bone.

This document is a 510(k) summary for the BCI Lifts, which are accessories for the BONEBRIDGE bone conduction hearing implant system. The purpose of this submission is to request clearance to update the materials of the BCI Lifts from PEKK to PEEK.

Here's an analysis of the provided text in relation to the requested information:

1. Table of acceptance criteria and the reported device performance:

The document focuses on demonstrating bioequivalence and functional equivalence of the new material (PEEK) for the BCI Lifts compared to the existing material (PEKK). It does not present specific quantitative acceptance criteria or performance metrics in a tabular format as one might expect for an AI/ML device. Instead, it describes general categories of evaluation.

The overall conclusion is that the new material is "at least as safe and effective" as the predicate.

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

The document describes "bench testing" and evaluations of materials and devices. It does not provide specific sample sizes (e.g., number of units tested) for these engineering tests. There's no indication of clinical test sets or data provenance (country of origin, retrospective/prospective) because this submission is about a material change, not a new clinical indication or AI/ML algorithm.

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

This is not applicable to this 510(k) submission. This submission does not involve an AI/ML device that requires human expert review for establishing ground truth on image data or similar diagnostic tasks. The evaluation is focused on material science and mechanical engineering properties.

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

Not applicable. As there's no expert review of data for ground truth establishment relevant to AI/ML, there's no adjudication method described.

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 510(k) is not for an AI/ML device that assists human readers. It's for a change in material for an implant accessory.

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

Not applicable. This is not an AI/ML algorithm.

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

The "ground truth" in this context is established through industry standards and established engineering test methods for biocompatibility (ISO 10993-1), sterilization (AAMI TIR28:2016), and mechanical performance (e.g., torque/force stability, dynamic impact). This is not a "ground truth" in the clinical AI sense.

8. The sample size for the training set:

Not applicable. There is no training set mentioned or implied as this is not an AI/ML device.

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

Not applicable. There is no training set or clinical ground truth in the context of an AI/ML device. The "ground truth" for the engineering tests mentioned is inherent in the established test methods and material science principles.

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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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The Osia 2 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 3 kHz) should be better than or equal to 55 dB HL.
· Bilateral fitting of the Osia 2 System 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 3 kHz, 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 3 kHz).
· The Osia 2 System 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 have experience with appropriately fitted air conduction or bone conduction hearing aids.

Cochlear™'s Osia 2 System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided deafness (SSD).
The Osia 2 System is made up of several components. The Osia Implant (OSI200) consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia System is a sound processor, worn off-the-ear, which picks up the sound from the environment, and sends, after processing, the information to the implant via a transcutaneous inductive link. This link is also referred to as radiofrequency (RF) link. Each Osia 2 System is configured to meet an individual's hearing needs, using dedicated fitting software.

Here's an analysis of the provided information regarding the acceptance criteria and the study conducted for the Cochlear™ Osia™ 2 System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and detailed device performance metrics in a table. However, it does highlight key comparisons and generally indicates that the Osia 2 System either performs "Same" as the predicate or has "improved" features. The clinical study's conclusion also states "did not reveal significant differences in hearing performance."

Below is a reconstructed table based on the information provided, inferring acceptance criteria by the demonstrated equivalence to the predicate. Specific numerical performance values beyond those for hearing loss thresholds are not provided in this summary.

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

The document states: "Clinical performance data was gathered through a simulation study that allowed audiological testing of the Osia 2 Systems and Osia Systems without having to surgically implant the OSI200 Implant and OSI100 Implant, respectively."

• Sample Size: The exact sample size for the "simulation study" is not specified in the provided text.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a prospective simulation designed to assess audiological performance without physical implantation of the investigational device.

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. The study described is a "simulation study" for audiological testing. If human subjects were involved, the "ground truth" would likely be their measured hearing thresholds and subjective speech recognition scores. There is no mention of experts establishing ground truth in the context of diagnostic performance or image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The study described is an audiological performance simulation, not a diagnostic study requiring adjudication of interpretations.

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. The device is an active implantable bone conduction hearing system, not an AI-powered diagnostic tool requiring human reader interpretation of images or other data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described.

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

This is not applicable. The device is a hearing system, not a standalone algorithm. The "clinical performance data" discussed refers to the audiological efficacy of the device (or its simulated function), not the performance of an independent algorithm.

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

For the audiological performance assessment, the "ground truth" would have been the measured audiological outcomes (e.g., adaptive speech recognition scores) of the participants in the simulation study. This is directly related to hearing function.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a physical hearing aid system, not a machine learning algorithm that requires a training set in the conventional sense. The "simulation study" would involve testing against human participants or a defined audiological standard, not training a model.

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

This information is not applicable as there is no training set for a machine learning algorithm.

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INTENDED USE:

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 3 kHz) 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 3 kHz, 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 3 kHz).

-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.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called the "BONEBRIDGE System." This document primarily focuses on the regulatory clearance process, outlining the device's intended use, indications, and contraindications. It does not contain any information about acceptance criteria, study methodologies (like sample sizes, expert qualifications, adjudication methods), or performance data that would prove the device meets specific acceptance criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to present detailed performance study results against predefined acceptance criteria in the format requested. While performance data may have been submitted as part of the 510(k) application, that information is not present in this public clearance letter.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and the study proving the device meets them based solely on the provided text. The document is a regulatory communication, not a clinical study report.

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The Osia 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 3 kHz) should be better than or equal to 55 dB HL.

· Bilateral fitting of the Osia System is intents 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 3 kHz, 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., singlesided 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 3 kHz).

• The Osia System 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 have experience with appropriately fitted air conduction or bone conduction hearing aids.

Cochlear's Osia System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided deafness (SSD).

The Osia System is made up of several components. The Osia Implant (OSI100) consists of a receiver/stimulator and an actuator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia System is a sound processor, worn off-the-ear, which picks up the sound from the environment, and sends, after processing, the information to the implant via a transcutaneous inductive link. This link is also referred to as radiofrequency (RF) link. Each Osia System is configured to meet an individual's hearing needs, using dedicated fitting software.

In normal operation, the Osia System functions as follows:

• The external sound processor captures and digitally processes sound.
• The sound processor transmits power and digital information to the implant.
• The implant receiver-stimulator converts the digital information into an electric analogue signal.
• This electric signal is converted to vibrations by the implant piezoelectric actuator.

The actuator converts the electrical signal into an amplified mechanical stimulation, bypassing the impaired middle ear (origin of the conductive part of the hearing loss) and providing some level of mechanical amplification in order to compensate for the damaged inner ear (sensorineural part of the hearing loss, in case of mixed hearing loss).

The provided document (K190589) describes the Cochlear™ Osia™ System, an active implantable bone conduction hearing system. However, it does not include specific acceptance criteria or a study designed to explicitly prove that the device meets those criteria with numerical performance targets (e.g., a specific sensitivity, specificity, or improvement in a metric).

Instead, the document details a substantial equivalence (SE) submission to the FDA. The purpose of this submission is to demonstrate that the new device (Cochlear™ Osia™ System) is as safe and effective as a legally marketed predicate device (Bonebridge™ System). The document describes the system and presents performance data in the context of supporting this claim of substantial equivalence, rather than hitting pre-defined acceptance criteria for a novel device.

The "performance data" section (Section K) broadly states that clinical performance data was gathered and showed significant improvements, similar to the predicate device. It doesn't present specific acceptance criteria in a table format with corresponding performance metrics.

Therefore, I cannot generate the table as requested because the specific acceptance criteria and their corresponding numerical outcomes are not explicitly stated in the provided text.

However, I can extract the information related to the clinical study and its findings to give you the context of the device's performance as described:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail numeric targets in the document. The general acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device, meaning the new device is as safe and effective.
• Reported Device Performance:
  • Audiometric thresholds: Significant improvements reported when compared to the pre-implant condition.
  • Speech in noise: Significant improvements reported when compared to the pre-implant condition.
  • Speech in quiet: Significant improvements reported when compared to the pre-implant condition.
  • Patient reported outcomes: Significant benefits demonstrated.
  • Hearing Loss Accommodation: The Osia System can accommodate greater degrees of hearing loss (45 dB vs. 55 dB for the predicate, though the document states "greater degrees of hearing loss (45 versus 55 dB)" which seems to be a typo and likely means 55dB for Osia which is higher).
  • Force output measurements: Higher for the Osia System at the same frequencies compared to the predicate device, enabling an expanded fitting range.

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

• Sample Size: Not explicitly stated. The document mentions "data gathered in a multi-center trial."
• Data Provenance:
  • Country of Origin: One site was in the United States; other sites not specified.
  • Retrospective or Prospective: Prospective clinical investigation.

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

• This information is not provided in the document. The study was a clinical trial on human patients, and the "ground truth" would be the patient's actual hearing ability and perceived benefit, measured through audiometric tests and patient-reported outcomes, rather than expert interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set:

• This information is not provided in the document. The study was an "open, two-armed" clinical investigation. It was not blinded.

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

• No, an MRMC study was not described. The study focused on the effectiveness of the device itself by comparing pre-implant conditions to post-implant conditions with the Osia device, and implied similar performance to a predicate device. It did not involve comparing human readers with and without AI assistance, as this is a medical device for hearing, not an AI diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance:

• Not applicable in the typical sense of AI standalone performance. The "algorithm" here is the signal processing within the sound processor. The clinical study did evaluate the performance of the device system (implant + sound processor) in a "standalone" fashion (i.e., its performance in patients), but not in the context of an AI algorithm making a diagnosis without human interaction.

7. Type of Ground Truth Used:

• Clinical Outcomes and Audiometric Data: The "ground truth" was established by objective audiometric measures (pure tone average bone conduction thresholds, air conduction hearing thresholds) and subjective patient-reported outcomes regarding hearing ability and benefit.

8. Sample Size for the Training Set:

• Not applicable. This device is a hearing aid system, not a machine learning model that requires a training set in the conventional sense. The "training" in this context would be the device development and engineering process to optimize its acoustic and mechanical properties, not a machine learning training phase on data.

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

• Not applicable. As above, there isn't a machine learning training set with established ground truth described in this submission.

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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 3 kHz) 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 3 kHz, or less than15 dB at individual frequencies.

· Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided 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 at0.5, 1, 2, and 3 kHz).

· 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 have experience with appropriately fit air conduction or bone conduction hearing aids.

BONEBRIDGE augments hearing by providing acoustic input to the inner ear via bone conduction. BONEBRIDGE consists of the following components: The Bone Conduction Implant (BCI) and the externally worn audio processor.

The BCI 601 implant is provided in an implant kit together with two templates to determine optimal implant placement, one drill bit, two regular cortical titanium screws (gold surface) and one emergency screw (blue surface).

All devices are shipped in one sterile tray and are for single-use only.

The Bone Conduction Implant (BCI) is the implantable part of BONEBRIDGE and can only be used together with compatible MED-EL external components. The device is an osseointegrated bone conduction implant system, intended to provide a level of useful sound perception for individuals with conductive and mixed hearing loss, as well as those suffering from single-sided deafness. The BCI is surgically implanted into the mastoid bone.

The BCI 601 has two main sections, the coil section and the transducer section.

The BCl 601 consists of a magnet surrounded by the receiver coil, the electronics (demodulator), the transition and the Bone Conduction - Floating Mass Transducer (BC-FMT). The BCI 601 is activated by placing the external audio processor over the magnet of the BCI 601. The signal and the energy to drive the BC-FMT are transferred via an inductive link to the internal coil, processed by the demodulator and then relayed to the BC-FMT. The BC-FMT transduces the signal into mechanical vibrations, which are conducted to the mastoid bone via the cortical titanium screws. These vibrations stimulate the auditory system through the bone conduction pathway to allow the patient to hear.

The provided text is a 510(k) summary for the MED-EL BONEBRIDGE device. This document primarily focuses on obtaining clearance for labeling updates regarding Electromagnetic Compatibility (EMC) and Magnetic Resonance Imaging (MRI) compatibility, rather than presenting a performance study for the device's primary function as a hearing system, or an AI-based system.

Therefore, much of the requested information about acceptance criteria, efficacy studies, sample sizes, expert ground truth, and AI specifics are not available in this document. The document states that "No changes have been made to the devices themselves. Only the product labelling is affected." and the updates "do not affect the device intended use, fundamental operating principles or functional characteristics." This implies that the performance related to hearing augmentation was presumed to be established by previous clearances (DEN170009).

Here's what can be extracted from the document:

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

The document does not provide a table of acceptance criteria for the hearing performance of the device, nor does it report the device's clinical performance in that regard. It focuses on the safety aspects related to EMC and MRI.

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

• Test Set Sample Size: Not applicable. The document describes "bench testing" for EMC and MRI compatibility, not a clinical test set of patients or data in the typical sense for evaluating clinical performance. These tests are conducted on the device itself.
• Data Provenance: Not applicable for clinical data. The tests are non-clinical bench tests. The document does not specify the location where these bench tests were conducted.

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 for EMC and MRI compatibility is established through standardized testing protocols (e.g., ISO, IEC standards) and engineering evaluations, not typically by clinical experts in the same way as, for example, image interpretation.

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

Not applicable. This concept is relevant for studies involving human interpretation or clinical endpoints, which this document does not cover for the labeling update.

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 device is not an AI-assisted diagnostic tool, and no MRMC study is mentioned or relevant to the reported labeling update.

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

Not applicable. This device is not an algorithm, but an implantable hearing system.

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

For the EMC and MRI compatibility bench tests, the "ground truth" would be objective measurements against established engineering and safety standards (e.g., electromagnetic interference limits, heating, artifact, or force limits within an MRI environment). The document does not explicitly detail these standards or the specific measurements. For the hearing performance (which is not evaluated in this document), the ground truth would typically be audiometric data and patient-reported outcomes.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable.

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