(84 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 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.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | "The BCI Lifts made of PEEK have been evaluated and shown to be biocompatible." (Per ISO 10993-1) |
| Sterilization | "The BCI Lifts made of PEEK have been evaluated as per AAMI TIR28:2016 and it was concluded that the new Lifts can be adopted into the existing sterilization of the BCI Lifts (PEKK) without further study." |
| Mechanical Properties (Material) | "An assessment and comparison of the mechanical properties of the two materials was performed." (Implies equivalence was established, but no specifics given). |
| Performance (Device-Level) | "Performance testing was performed on BCI Lifts made of PEEK according to existing test methods." |
| Torque/Force Stability (with BCI implants) | "Testing of the new BCI Lifts with the BCI implants was performed according to existing test methods that covered: Torque/Force Stability." (Implies satisfactory performance, but no specific values). |
| Dynamic Impact at 2.5J (with BCI implants) | "Testing of the new BCI Lifts with the BCI implants was performed according to existing test methods that covered: Dynamic Impact at 2.5J." (Implies satisfactory performance, but no specific values). |
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.
§ 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.