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The Cochlear Baha® 5 Power Sound Processor is intended for the following patients and indications for use:

*Patient of any age for use with the Baha Softband. 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 intents 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. Singlesided 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 Baha 5 Power Sound Processor functions by combining the external sound processor with an abutment (the Connect system) or with a magnet (the Attract system) and small titanium implant that is placed in the skull behind the ear during a simple surgical procedure. The sound processor transmits acoustic signals into electrical signals which then causes mechanical action in the transducer to transmit sound transcranially to the functioning auditory system.

Unlike hearing aids, the Baha hearing system utilizes a natural bone conduction pathway to send sound directly to a cochlea with residual functionality. The Baha system combines an external sound processor, in this application the Baha Power Sound processor, with small titanium implant placed into the bone through a simple surgical procedure. The implant is either attached to the sound processor via an abutment or internal titanium-encased magnet paired with an external magnet. The implant subsequently forms an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear, bypassing a damaged outer or middle ear. The Baha system provides an alternate pathway for patients who may not benefit from wearing an air-conduction hearing aid.

The modified sound processor, the Baha 5 Power Sound Processor is an upgrade to the currently marketed BP110 Sound Processor (which it will replace on the US market) and the Baha 5 Sound Processor. The Baha 5 Power Sound Processor provides gain sufficient to match the Indications for Use of the currently marketed BP110 Sound Processor.

The provided text describes the Cochlear Baha 5 Power Sound Processor and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for a study or a study proving that the device meets specific acceptance criteria in the context of diagnostic performance or clinical effectiveness studies in humans.

Instead, the document details a 510(k) submission for a medical device (a hearing aid), which typically focuses on demonstrating that the new device is substantially equivalent to a legally marketed predicate device. This is primarily established through:

• Indications for Use: Ensuring the new device has the same or very similar intended use.
• Technological Characteristics: Comparing materials, fundamental operating principles, and functional characteristics.
• Performance Data (Bench Testing): Demonstrating that the device performs as expected in controlled, non-human environments.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document refers to "bench testing" to compare the device to predicates and show functional equivalence, which is a different type of evaluation than what is typically associated with acceptance criteria for a study demonstrating clinical performance or diagnostic accuracy.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance (in a human study context).
2. Sample size used for a test set and data provenance (for a human study).
3. Number of experts used to establish ground truth or their qualifications (for a human study).
4. Adjudication method (for a human study).
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone performance study (in a clinical context).
7. Type of ground truth used (pathology, outcomes data, etc.) (for a human study).
8. Sample size for a training set (as this is not an AI/algorithmic device in the typical sense of a training set).
9. How ground truth for a training set was established.

The document's "Performance Data" section states: "Bench testing was conducted to compare the Cochlear Baha® 5 Power Sound Processor with the predicate implant / abutment systems. Substantial equivalence to the predicate devices was accomplished through environmental testing, reliability testing, electrical interface testing, and functional testing. The results demonstrated the Cochlear Baha 5 Power Sound Processor is functionally equivalent to the predicate devices."

This indicates engineering and functional tests, not clinical performance acceptance criteria or a clinical study in the way implied by your request.

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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):

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.

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The Cochlear Baha 5 sound processor has the following indications for use:

• Patients of any age for use with the Baha Softband or headband. Patients aged 5 and o 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 o amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 45 dB HL.
• . Bilateral fitting is intended for patients who meet the criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction 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 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 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 subject of this 510(k) is a modification to the Cochlear Baha 4 sound processor, which was cleared under 510(k) K132278 for unilateral or bilateral use with conductive and mixed hearing losses (as a result of congenital malformations such as atresia, or certain medical conditions such as chronic suppurative otitis media), and for cases of single-sided sensorineural deafness (SSD, caused by a congenital condition, surgery, trauma or disease). The Baha system has been marketed for more than 30 years throughout the world, and there are now more than 100,000 users of a Baha system globally.

Baha sound processors can be used with either the external Baha headband or Softband in persons of any age, or for children aged 5 or older with the Baha auditory osseointegrated implants. The external Baha headband or Softband system works via conventional transcutaneous bone conduction amplification. The Baha implant system works by combining the external sound processor with an abutment and a small titanium implant placed in the skull behind the ear in a simple surgical procedure. The system is based on the process of "osseointegration" through which living tissue integrates with titanium in the implant. Thus, the titanium implant becomes one with the surrounding bone, allowing high-quality amplified and processed sound from the Baha sound processor to be conducted via an abutment or a magnetic coupling to the skull bone and directly to a cochlea with residual functionality. For either form of transmission, the processed sound either bypasses a conductive block in those patients with conductive or mixed hearing loss, or transfers sound through the skull to the opposite-ear normal cochlea for patients with SSD.

The modified sound processor, the Baha 5 is an upgrade to the currently marketed Baha 4 sound processor. The Baha 5 sound processor has the same signal processing functionality as the Baha 4, but incorporates a new transducer into a smaller outer casing while providing comparable output. The modified device utilizes the same fundamental scientific principles, and has the same intended use and indications for use as the current legally marketed device it will replace. In addition, the Baha 5 is compatible with the same range of 2.4GHz devices currently marketed for use with the Baha 4, but also incorporates Bluetooth functionality directly into the device without the need for an external accessory. The Baha 5 also supports a mobile medical app, the Baha Smart App, which acts as an enhanced remote control for the device, and offers improved auditory streaming capabilities and mobile phone integration.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Cochlear™ Baha® 5 Sound Processor:

First, it's important to note that this document is a 510(k) summary for a premarket notification to the FDA. As such, it focuses on demonstrating substantial equivalence to a predicate device (the Baha 4 sound processor), rather than a comprehensive de novo clinical trial proving new acceptance criteria. Therefore, the "acceptance criteria" discussed are largely tied to demonstrating that the new device performs comparably to the predicate and meets general industry standards for medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) summary for a modified device, the "acceptance criteria" are implied to be that the Baha 5 Sound Processor performs comparably to the Baha 4 Sound Processor and meets relevant safety, performance, and functionality standards for a bone conduction hearing aid. The document doesn't present a formal table of quantitative acceptance criteria with corresponding performance metrics like a typical clinical trial report would for a novel device. Instead, it describes general categories of testing and their successful outcomes as evidence of equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any "test set" in terms of human subjects or patient data. The testing described appears to be primarily non-clinical bench testing and simulated use testing of the device itself.

• Data Provenance: Not applicable in the context of clinical patient data, as the focus is on device performance. The testing was conducted by Cochlear Americas/Cochlear Bone Anchored Solutions AB.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided as the document describes technical verification and validation testing, not a clinical study involving expert interpretation of patient data to establish ground truth. "Ground truth" in this context refers to the successful operation of the device against predefined engineering specifications and functional requirements.

4. Adjudication Method for the Test Set

This information is not provided and is generally not relevant for the type of technical verification and validation testing described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret medical images or data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. This document focuses on substantial equivalence based on technical and functional performance, not clinical effectiveness studies with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The primary "device" here is a sound processor, which inherently involves a "human-in-the-loop" (the patient wearing it). While specific functional tests of the device (e.g., sound output, wireless connectivity) can be considered "standalone" tests of its technical performance, the device's overall purpose and function (hearing improvement) is not standalone from human interaction. The document describes tests of the device's components and integrated system, which are standalone in their verification against specifications, but not a standalone AI algorithm in the typical sense.

7. The Type of Ground Truth Used

The "ground truth" for the various tests described is based on:

• Engineering specifications and design requirements: For safety, reliability, acoustic performance, firmware, Bluetooth, and wireless compatibility.
• Industry standards: For biocompatibility and electromagnetic compatibility (EMC).
• Performance of the predicate device (Baha 4): As a benchmark for "comparable output" and overall function.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The Baha 5 Sound Processor is a hardware device with embedded firmware, not an AI/machine learning algorithm that requires a "training set" of data in the conventional sense. The "training" in the context of device development would refer to engineering design, iteration, and testing phases.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reasons as point 8.

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