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The Cochlear Osia System uses bone conduction to transmit sounds to the cochlea (inner ear) with the purpose of enhancing hearing. Osia Implants are single use devices intended for long term implantation under the skin in the mastoid region of either side of the head. They are for professional use only.

The Osia System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided sensorineural deafness (SSD). The Osia System is made up of several components. The Osia Implant (OSI300) consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia System is a sound processor, worn off-the-ear, which picks up the sound from the environment, and sends, after processing, the information to the implant via a transcutaneous inductive link. This link is also referred to as radiofrequency (RF) link. Each Osia System is configured to meet an individual's hearing needs, using dedicated fitting software.

The provided text describes a 510(k) premarket notification for the Cochlear™ Osia® System, an active implantable bone conduction hearing system. This submission primarily focuses on demonstrating substantial equivalence to a predicate device (Cochlear™ Osia® 2 System) for an updated version of the system.

The core of the submission involves bench testing to compare the updated system with the predicate. There is no evidence of a clinical study or performance study with patients designed to establish specific acceptance criteria directly tied to the device's clinical efficacy or diagnostic accuracy (e.g., sensitivity, specificity, AUC). The acceptance criteria, therefore, appear to be based on functional equivalency, safety, and performance compared to the predicate device through non-clinical means.

Here's a breakdown of the information based on your request, with an emphasis on what is not present in the provided text regarding specific performance criteria as typically understood in a clinical study for diagnostic or AI-based devices:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission and the provided text focuses on demonstrating substantial equivalence through non-clinical testing (bench testing), explicit quantitative clinical acceptance criteria like sensitivity, specificity, or AUC are not stated, nor are their corresponding reported device performance values from a clinical study. Instead, the "acceptance criteria" are implied by successful completion of various verification activities ensuring the updated device functions as intended and is as safe and effective as the predicate.

2. Sample size used for the test set and the data provenance

The document explicitly states that bench testing was conducted. This implies that the "test set" consisted of physical devices, prototypes, or simulated scenarios in a lab environment. There is no mention of human subjects, patient data, or a clinical test set. Therefore, information regarding human sample size, country of origin, or retrospective/prospective nature is not applicable to the described study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since the study described is non-clinical bench testing, the concept of "ground truth established by experts" in a clinical context (e.g., radiologist opinions) is not applicable. The "ground truth" for bench testing is derived from engineering specifications, established standards (e.g., ISO, FDA guidance), and physical measurements by engineers and technicians.

4. Adjudication method for the test set

As the evaluation was non-clinical bench testing, an adjudication method like 2+1 or 3+1 for clinical interpretation is not applicable. Test results are typically evaluated against pre-defined engineering criteria and specifications.

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

There is no mention of an MRMC study or any study involving human readers with or without AI assistance. The device is a hearing system, not an AI-assisted diagnostic tool for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device itself is a hearing system that directly assists the patient, not a diagnostic algorithm. Therefore, the concept of "standalone algorithm performance" (in the typical AI/diagnostic sense) is not applicable. The device's performance is inherently "human-in-the-loop" as it's worn by a person to enhance hearing. However, its individual components' functional performance was evaluated independently through bench testing.

7. The type of ground truth used

For the non-clinical bench testing and verification activities, the "ground truth" used was based on:

• Engineering specifications and design requirements of the device.
• Established industry standards (e.g., ISO 10993-1:2018, ISO 14708-7:2013, ISO 11135:2014, EN 45502-1, EN ISO 11607-2009 +A1:2014).
• FDA guidance documents.
• Comparative data against the performance of the predicate device (Cochlear™ Osia® 2 System).

8. The sample size for the training set

This is not applicable as the document does not describe the development of an AI algorithm or model that requires a training set. The descriptions are about hardware revisions, firmware updates, and software modifications for a medical device.

9. How the ground truth for the training set was established

This is not applicable as no training set for an AI algorithm or model is described.

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The Cochlear Baha 6 Max Sound Processor is intended for the following patients and indications for use:

· Patient of any age for use with the Baha Softband (or headband) or Baha SoundArc. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.

· 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 55 dB HL.

· 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-conduction thresholds are defined as 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB 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 deadness: 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 Cochlear Baha bone conduction hearing system provides an alternate solution for patients who may not benefit from an air-conduction hearing aids. Unlike air-conduction hearing aids, the Baha system utilizes a natural bone conduction pathway to send sound directly to the inner ear (cochlea), bypassing a damaged outer or midle ear. The Baha bone conduction hearing system has non-surgical and surgical options. For the non-surgical option, the external sound processor, which converts acoustic sound into mechanical vibrations, is securely placed behind the ear with a Baha Softband or Baha SoundArc. For the surgical option, the external sound processor is coupled with an abutment (Baha Connect) or magnet (Baha Attract). The mechanical vibrations travel through the abutment or magnet to a small, titanium implant, which is surgically placed into the bone. The titanium implant has an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear.

The Baha 6 Max Sound Processor is a modification of the previously cleared Baha 5 Power Sound Processor (K161123). The changes introduced in this 510(k) are specific to the sound processor and accessories, and do not affect the cleared Softband, SoundArc, Baha Connect abutments, Baha Attract magnet, or the B1300 titanium implant. The Baha 6 Max Sound Processor does not modify the intended functionality or fundamental operating principles of the bone conduction hearing system. The changes within culminate as the next generation Baha sound processor that provides recipients with moderate hearing loss, up to 55 dB, access to sound.

The Baha 6 Max Sound Processor will be supported by a new fitting software, Baha Fitting Software 6, and a new app, Baha Smart App.

The provided text describes the Cochlear Baha 6 Max Sound Processor and associated software (Cochlear Baha Fitting Software 6, Cochlear Baha Smart App) and states that they are substantially equivalent to their predicate devices. However, the document does not describe a study involving acceptance criteria and device performance as requested in the prompt.

The content focuses on a 510(k) summary, which outlines the device's indications for use, technological characteristics, and a comparison to a predicate device (Cochlear Baha 5 Power Sound Processor). It mentions "Performance Data" but only states that "Bench testing was conducted to compare the Baha 6 Max Sound Processor with the Baha 5 Power Sound Processor, including use with the predicate implant / abutment systems." It further states that "Substantial equivalence to the predicate device was accomplished through functionality and performance testing, hardware and interface testing, reliability and environmental testing, as well as system and subsystem level testing." Software verification and validation were also completed.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as these specific details are not present in the provided text.

The document concludes that based on indications for use, technological characteristics, and performance data (without detailing the data itself or the acceptance criteria), the new device is substantially equivalent to the predicate.

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