(56 days)
The Cochlear Baha® SoundArc is intended for test situations and for patients who cannot or choose not to have an implant for the following indications for use:
· Patients of any age who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing thressured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the BP100, Baha 4 and Baha 5 sound processors, 55 dB HL for use with the BP110 Power and Baha 5 Power sound processors, and better than or equal to 65 dB HL for use with the Cordelle II and Baha 5 SuperPower Sound Processors.
· 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 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. Singlesided deafness: SSDTM). 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.
· 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.
Baha SoundArc is an encapsulated spring wire that wraps around the back of the head and sits behind and above the ears. SoundArc is designed with a symmetrical disc holder that holds the Baha sound processor in place, and is compatible with existing Baha sound processors. The design of SoundArc enables the Baha device to be placed against the skull for operation without the need for a Baha implant to be placed.
The provided text describes the Cochlear™ Baha® SoundArc, a headband for bone conduction hearing aids. However, it does not contain specific acceptance criteria, detailed study results, or the methodological details typically found in a comprehensive study report. The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. As such, it focuses on asserting equivalence rather than presenting an in-depth performance study with quantitative acceptance criteria and detailed results.
Therefore, I cannot fulfill all parts of your request with the provided information. I will, however, extract all available relevant details regarding "performance data" and "study" aspects.
1. Table of acceptance criteria and the reported device performance
No explicit quantitative acceptance criteria or detailed device performance metrics (e.g., specific dB improvements, failure rates with thresholds) are provided in the document. The document states that "Substantial equivalence to the predicate system was accomplished through functional and performance tests, design and specification analysis, and biocompatibility evaluation." The conclusion is that "the Baha SoundArc is functionally equivalent to the predicate system."
| Acceptance Criteria (Not Explicitly Stated as Quantitative Criteria) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate System | Demonstrated functional equivalence to the predicate system through functional and performance tests. |
| Biocompatibility and Safety for Human Use | New materials in direct and prolonged contact evaluated per 10993-1 and shown to be biocompatible and safe for human use. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "functional and performance tests" without providing these details.
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. Ground truth establishment and expert involvement are not detailed.
4. Adjudication method for the test set
This information is not provided in the document.
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
No MRMC comparative effectiveness study is mentioned, nor is there any mention of "human readers" or "AI assistance." The device is a bone conduction hearing aid attachment, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a physical medical device like a bone conduction hearing aid attachment. The performance would be related to mechanical, acoustical, and biocompatibility aspects, not software algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify the type of "ground truth" as typically defined for diagnostic AI/imaging devices. For this type of device, performance is likely assessed against established engineering standards for hearing aids and biocompatibility standards. The basis for evaluating "functional equivalence" would be direct measurement of sound transfer, comfort, durability, and biocompatibility, not a "ground truth" derived from expert consensus or pathology in a diagnostic sense.
8. The sample size for the training set
This information is not applicable or provided. The device described is a physical product, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable or provided, as there is no mention of a training set for an algorithm.
Summary of the Study Mentioned (from the provided text):
The document describes a "performance testing" activity.
- Objective: To demonstrate "substantial equivalence" of the Cochlear™ Baha® SoundArc to the predicate Baha Softband and existing Baha sound processors.
- Methodology: Performance testing was conducted based on a comparison between the proposed SoundArc and the legally marketed Softband and current Baha sound processors. This involved:
- Functional tests
- Performance tests
- Design and specification analysis
- Biocompatibility evaluation
- Results/Conclusion: "The results demonstrated the Baha SoundArc is functionally equivalent to the predicate system." New materials were also found to be "biocompatible and safe for human use" when evaluated per ISO 10993-1.
Missing Information:
The provided text, being a 510(k) summary, is intentionally brief and does not include the detailed scientific or engineering studies that would contain the specific quantitative acceptance criteria, exact methodologies, raw data, sample sizes, and expert qualifications for ground truth that your request asks for. These details would typically be found in the full technical documentation submitted to the FDA, but not in the public 510(k) summary.
§ 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.