(121 days)
Conductive, mixed and single sided deafness. Patients should have sufficient bone quality and quantity to support successful implant placement.
The Cochlear Baha® Attract 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, Baha 4 and Baha 5 sound processors. 55 dB HL for use with the BP110 sound processor. and better than or equal to 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: 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.
The Cochlear Baha Attract auditory implant system consists of three parts: a titanium implant, a titanium-encased magnet pair, and an external magnet pair with a replaceable soft pad. The existing range of Baha sound processors attach to this external magnet via a snap coupling. 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 transcutaneous magnetic coupling to the titanium implant. The vibrating implant creates vibrations within the skull that stimulate the nerve fibers of the inner ear, allowing hearing.
The Baha Cordelle II Sound Processor is an external sound processor that utilizes analog signal processing with K-Amp circuitry (Killion, 1993) for use with the Baha auditory osseointegrated implant.
The provided text describes a 510(k) premarket notification for a medical device, the Cochlear™ Baha® Cordelle II Sound Processor, and its expanded indications for use with the Baha Attract System. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance metrics for a novel AI/medical device.
Therefore, the information required to fully answer the prompt is not present in the provided text. The document describes a traditional 510(k) for expanding the indications of an existing device, which relies heavily on demonstrating the device's technological characteristics and performance are "substantially equivalent" to already legally marketed devices, rather than establishing new performance criteria through a detailed clinical study with the elements requested in the prompt.
However, I can extract the information that is present and highlight what is missing based on your request.
Here's what can be inferred/extracted and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Inferred from 510(k) Process): The primary "acceptance criterion" for a 510(k) submission like this is "substantial equivalence" to a predicate device. This means the new/modified device must be as safe and effective as a legally marketed device that is not subject to premarket approval (PMA). The specific performance metrics are typically compared against those of the predicate device.
- Reported Device Performance:
- The document states: "The results of the bench testing support the conclusion that the performance of the Cordelle II Sound Processor with Baha Attract is substantially equivalent to the Cordelle II Sound Processor used with the Baha Softband."
- It mentions: "Technical feedback and force transfer measurements with the Cordelle II Sound Processor used with the Baha Attract System were completed in support of this 510k submission."
Table (Best Effort based on available info - Note: Specific quantitative criteria/results are NOT provided):
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety: | Assessed as safe based on substantial equivalence to predicate devices. |
| Effectiveness: | Assessed as effective based on substantial equivalence to predicate devices. |
| Technological Characteristics: | The fundamental operating principle (hearing rehabilitation through bone conduction) remains unchanged. Components are not new to this submission. |
| Force Transfer Measurements: | Results support substantial equivalence between Cordelle II with Baha Attract and Cordelle II with Baha Softband. |
| Patient Satisfaction/Outcomes (Not directly stated as a specific criterion, but implied by effectiveness): | Not quantifiably reported in this document. |
Missing Information for a comprehensive table:
- Specific quantitative metrics for performance (e.g., sound output levels, frequency response, bone conduction thresholds).
- Defined thresholds or ranges for these metrics to meet "acceptance."
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "bench testing" but does not give a number of devices or test conditions for this testing.
- Data Provenance: Not explicitly stated. Given it's a 510(k) for a company based in Colorado (US) and a manufacturer in Sweden, testing could have occurred in either location. It is "pre-market" data, likely from laboratory testing rather than a clinical trial.
- Retrospective/Prospective: Implied to be prospective bench testing for the submission. Not a retrospective analysis of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. This submission is for a device, not an AI algorithm that requires expert annotation for ground truth. The "ground truth" here is the physical performance measured in bench tests and comparison to established predicate device performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable/Not Provided. This is relevant for studies involving human interpretation or subjective assessments, not for bench testing of a physical device.
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. This is not an AI-assisted device. It is an auditory implant sound processor. Therefore, no MRMC study or AI-related metrics found.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device (sound processor) that interacts with a human. It's not an algorithm evaluated in isolation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Bench Testing Data / Comparison to Predicate Performance. The "ground truth" for demonstrating substantial equivalence for this type of device lies in engineering specifications, physical measurements (e.g., force transfer), and adherence to established performance metrics or standards for hearing aids/processors. The document explicitly mentions "Technical feedback and force transfer measurements."
8. The sample size for the training set:
- Not Applicable/Not Provided. This is a physical device, not a machine learning model; therefore, there is no "training set" in the AI sense.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided. See answer for point 8.
In summary, the provided document is a 510(k) premarket notification for a medical device where the primary goal is demonstrating "substantial equivalence" to a predicate device through bench testing. It does not contain the characteristics of a study for an AI/ML-based device, which typically involves detailed performance metrics against a human-adjudicated ground truth.
§ 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.