(163 days)
The Cochlear Baha® auditory osseointegrated implant system using model BA400 abutment is intended for the following patients and indications for use:
- Patients aged 5 and older
- Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the BP100 sound processor, 55 dB HL for use with the Intenso sound processor, 55 db HL for use with the BP110 Power sound processor, and 65 db HL for use with the Cordelle II Sound Processor.
- Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conductive thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15dB difference at individual frequencies.
- Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deafness: SSD™). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 ав нг
- Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
The Baha implant system functions by combining 3 parts: a titanium implant, a percutaneous abutment, and a sound processor. The system works by utilizing natural bone transmission as a pathway for sound to travel to the inner ear, bypassing the external auditory canal and middle ear. After surgical placement, the titanium implant naturally integrates with the skull bone over time through a process known as osseointegration. The external sound processor transmits sound vibrations through the percutaneous abutment to the titanium implant. The vibrating implant creates vibrations within the skull that stimulate the nerve fibers of the inner ear, allowing hearing. The minor changes to this device are only to the abutment, the piece that serves as the connection between the osseointegrated implant and the external sound processor. The changes include a modified design and the addition of a hydroxyapatite coating, neither of which modify the intended functionality or fundamental operating principles of the implant/abutment system.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance Study for Cochlear™ Baha® Implant System (BA400 Abutment)
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Performance testing was conducted based on a comparison between proposed and predicate implant/abutment systems. The results were equal or better than established acceptance criteria, where predicate testing was used as a baseline."
However, the specific quantitative acceptance criteria (e.g., minimum tensile strength, corrosion resistance thresholds) and the exact reported performance values are not explicitly detailed in the provided text. The summary implies a successful comparison against the predicate device (Cochlear™ Baha® Implant System, K100360) for safety and effectiveness.
Based on the provided text, a detailed table with specific numerical acceptance criteria and reported device performance cannot be generated. The general statement is provided:
| Acceptance Criteria Category | Acceptance Criteria (from predicate) | Reported Device Performance (BA400) |
|---|---|---|
| Mechanical Design | Same as predicate | Same as predicate |
| Functional Characteristics | Same as predicate | Same as predicate |
| Fundamental Operating Principles | Same as predicate | Same as predicate |
| Material Composition | Same as predicate (Titanium) | Same as predicate (Titanium) |
| Other Performance Tests | Established acceptance criteria (based on predicate testing as baseline) | Equal or better than acceptance criteria |
(Note: The actual numerical values for "Other Performance Tests" are not present in the provided document.)
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Performance testing was conducted based on a comparison between proposed and predicate implant/abutment systems." It does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically found in detailed study reports, which are not included in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
The document does not mention the use of experts to establish ground truth for any test set or their qualifications. The testing appears to be centered on direct performance comparison of the modified device against its predicate, rather than human interpretation tasks requiring expert consensus.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method as typically used for human-reviewed test sets (e.g., 2+1, 3+1, none). This information is not relevant given the nature of the performance testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device in question is an implanted medical device (abutment for a hearing system), not a diagnostic imaging or interpretive aid that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical component of a hearing system. Therefore, the concept of "standalone algorithm only" performance does not apply in this context. The performance testing would be mechanical, material, and potentially biocompatibility-related.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing appears to be the established performance characteristics and safety profile of the predicate device. The modified device (BA400 abutment) was shown to have "equal or better" performance compared to this baseline. This isn't "expert consensus" or "pathology" in the typical sense, but rather a direct comparison to an already-cleared, safe, and effective device.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This is because the device is a hardware component; it doesn't involve machine learning or AI algorithms that would require a training set.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this device, the question of how its ground truth was established is not applicable.
§ 874.3302 Bone-conduction hearing aid.
(a)
Identification. A bone-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing and that conducts sound to the inner ear through the skull. The non-implantable components of a bone-conduction hearing aid, such as the external sound processor, are subject to the requirements in § 801.422 of this chapter.(b)
Classification. Class II.