(91 days)
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.
| Acceptance Criteria (related to labelling update) | Reported Device Performance (related to labelling update) |
|---|---|
| Electromagnetic Compatibility (EMC): Device meets established specifications for EMC. | "Electromagnetic compatibility testing" was conducted. "The collective results of the non-clinical testing demonstrate that BONEBRIDGE meets the established specifications to ensure consistent and safe performance for its intended use." (Specific numerical criteria or detailed results are not provided). |
| Magnetic Resonance Imaging (MRI) Compatibility: BCI 601 implant is MR conditional at 1.5T. | "MRI compatibility testing" was conducted. The labelling update is "to label the BCI 601 implant as MR conditional at 1.5T." (Specific numerical criteria or detailed results are not provided). |
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.
§ 874.3340 Active implantable bone conduction hearing system.
(a)
Identification. An active implantable bone conduction hearing 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.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must characterize any adverse events observed during implantation and clinical use, and must also demonstrate that the device performs as intended under anticipated conditions of use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Performance data must validate force output in a clinically relevant model.
(ii) Impact testing in a clinically relevant anatomic model must be performed.
(iii) Mechanical integrity testing must be performed.
(iv) Reliability testing consistent with expected device life must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(6) Performance data must demonstrate the wireless compatibility, electromagnetic compatibility, and electrical safety of the device.
(7) Software verification, validation, and hazard analysis must be performed.
(8) Labeling must include:
(i) A summary of clinical testing conducted with the device that includes a summary of device-related complications and adverse events;
(ii) Instructions for use;
(iii) A surgical guide for implantation, which includes instructions for imaging to assess bone dimensions;
(iv) A shelf life, for device components provided sterile;
(v) A patient identification card; and
(vi) A patient user manual.