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

The BONEBRIDGE consists of a Bone Conduction Implant that is surgically implanted in the mastoid bone and an external Audio Processor that is held in place on the patient's scalp by magnetic attraction between the implant and the Audio Processor (Figure 1).

Here's a breakdown of the acceptance criteria and the study data provided for the BONEBRIDGE™ System:

The BONEBRIDGE™ System did not undergo a study to prove meeting "acceptance criteria" in the traditional sense of a classification algorithm with performance metrics like sensitivity, specificity, or AUC. Instead, it underwent a series of non-clinical (bench) and clinical studies to demonstrate its safety and effectiveness for its intended use as an active implantable bone conduction hearing system.

The acceptance criteria are therefore defined by the successful demonstration of:

• Biocompatibility of all components.
• Sterilization and Shelf Life validation.
• Electrical Safety and Electromagnetic Compatibility (EMC), including wireless compatibility.
• Software (SYMFIT) verification and validation at a "Minor" Level of Concern.
• Performance Testing (Bench) for the Audio Processor (SAMBA BB) and the Bone Conduction Implant (BCI 601) and surgical tools.
• Clinical Effectiveness for conductive/mixed hearing loss and single-sided deafness.
• Clinical Safety in terms of adverse events and maintenance of bone conduction thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device, the "acceptance criteria" and "reported device performance" are largely based on meeting pre-defined thresholds and "passing" various tests to demonstrate safety and functional specifications.

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The ADHEAR system is intended to treat patients of all ages with conductive hearing loss or single-sided deafness via bone conduction. The ADHEAR system is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband or an adhesive adapter that is placed behind the auricle.

Indications:

· Unilateral or bilateral conductive hearing loss, either chronic or temporary.

The pure tone average bone-conduction hearing threshold (measured at 0.5. 1. 2, and 3 kHz) should be better than or equal to 25 dB HL.

· Single-sided deafness (i.e. unilateral profound sensorineural deafness) with normal hearing on the contralateral side. 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

The ADHEAR system includes a bone conduction audio processor that can be retained on the head with an adhesive adapter or by the headband situated over the mastoid behind the auricle. The ADHEAR system is intended to be used during waking hours. While the adhesive adapter is attached to the skin for 3 to 7 days and then replaced, the audio processor is removed at night. Both the audio processor and the adhesive adapter are necessary components for the system to work. Together the components work as one system to deliver vibrations to the mastoid bone in order to conductively transmit sound to the inner ear for patients with conductive hearing loss or single sided deafness via bone conduction.

The ADHEAR system consists of an adhesive adapter sitting behind the auricle and an audio processor mounted on the attachment. The audio processor contains microphones and signal processing technology as well as a battery. It detects, processes, amplifies and finally transmits sound to the adhesive adapter which transmits vibrations to the mastoid which conducts sounds to the inner ear. The audio processor is equipped with a push button that allows the user to switch between 4 pre-defined settings. A colour sleeve is provided for pediatric use. It features a tamper-proof battery door and dampens potential drops of the processor unit.

The ADHEAR system contains the following components:

• . ADHEAR Audio Processor (model 701)
• Package of ADHEAR Adhesive Adapters
• . ADHEAR Positioning Tool
• ADHEAR Headband
• . Retention clip
• ADHEAR Sleeves

This document is a 510(k) Premarket Notification for the ADHEAR System, a bone conduction hearing device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Based on the provided text, a conventional "study" demonstrating that a device meets acceptance criteria in the context of AI/ML performance (e.g., accuracy, sensitivity, specificity) is not present. The device in question is a physical hearing aid system, not an AI/ML algorithm for image interpretation or diagnosis.

Therefore, many of the requested items related to AI/ML performance studies (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this specific submission.

The document states:
"No clinical testing was needed to support the safety, performance, and substantial equivalence of the ADHEAR System to the predicate devices. All devices are bone conduction hearing aids and all aspects to ensure consistent and safe performance can be shown through non-clinical bench testing." (Page 6)

This confirms that the acceptance criteria and proof of meeting them are based on engineering and safety standards, not clinical performance metrics typically associated with AI/ML systems.

However, I can extract information related to the types of testing and the conclusions regarding the device's performance against its design specifications and relevant standards, which serve as "acceptance criteria" for a hardware medical device.

Here's a breakdown based on the information available:

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

The document describes types of testing performed and concludes that the device complies or meets these criteria. It does not provide specific numerical targets or results in a table format for each criterion. Instead, it offers generalized statements of successful testing.

"The collective results of the non-clinical testing demonstrate that the ADHEAR System meets the established specifications to ensure consistent and safe performance for its intended use." (Page 6) |
| Software Verification and Validation | "Software verification and validation testing were conducted and documentation was provided... The software for this device was considered as a 'minor' level of concern, since failures or latent flaws in the (optional) software are unlikely to result in any harm to the patient or operator." (Page 6) |

Regarding the other requested information:

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

• Not applicable for AI/ML performance studies. The testing described is hardware and software validation/verification, and biocompatibility, which typically uses defined engineering samples or batches, not "test sets" in the AI/ML sense. No patient data or clinical trial data is mentioned.

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 in the AI/ML sense (e.g., expert annotations of medical images) is not relevant here as no such clinical image interpretation or diagnostic study was performed. The "ground truth" for the non-clinical tests would be the established engineering specifications and international standards.

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

• Not applicable. No expert adjudication of clinical data was performed.

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 a hearing aid, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or required.

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

• Not applicable. There is no standalone AI algorithm whose performance is being evaluated independently of human interaction. The device's function is to transmit sound, and its standalone performance is evaluated through the non-clinical bench tests (e.g., frequency response, gain).

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

• For the non-clinical tests, the "ground truth" implicitly are the established engineering design specifications, safety standards (e.g., IEC 60601-1), and biocompatibility standards (ISO 10993-1). Tests were conducted to verify the device performed according to these pre-defined requirements.

8. The sample size for the training set

• Not applicable. This device is hardware with embedded software, not a machine learning model trained on a dataset.

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

• Not applicable. No training set for an AI/ML model.

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