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The Baha Attract consists of a percutaneously placed Implant Magnet and an external Sound Processor Magnet forming a magnetic connection across healed skin. A Baha Sound Processor is then attached to the Sound Processor Magnet. The Baha Attract is indicated for 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 sound processor, and 55 dB HL for use with the BP110 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 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 Baha Attract consists of a percutaneously placed Implant Magnet and an external Sound Processor Magnet forming a magnetic connection across healed skin. A Baha Sound Processor is then attached to the Sound Processor Magnet.

The provided document is a 510(k) clearance letter for the Cochlear Baha Attract/Osseointegrated Auditory system. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Instead, it states that the device is substantially equivalent to legally marketed predicate devices, which is the basis for its clearance.

Therefore, I cannot extract the requested information from the provided text. The document does not describe the specific performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications that would be present in a study report proving the device meets acceptance criteria.

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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:

(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.

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