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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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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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The Cochlear Baha® 4 sound processor has the following indications for use:

• Patients of any age for use with the Baha Softband or headband. 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 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 Special 510(k): Device Modification is a modification to the Cochlear BP100 sound processor, which was cleared under 510(k) K090720 for unilateral 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 the skull bone 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 4 is an upgrade to the currently marketed Baha BP100 sound processor, which it will replace on the U.S. market. The Baha 4 sound processor is mechanically identical to the BP100, but replaces the ASIC inside the processor with an off-theshelf electronic assembly used in currently marketed air conduction devices. 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 4 is compatible with certain 2.4GHz devices currently marketed for use with air conduction hearing aids.

The provided 510(k) summary for the Cochlear Baha 4 Sound Processor does not contain acceptance criteria or a study proving that the device meets specific performance criteria.

This document is a Special 510(k), indicating that the device is a modification of a previously cleared device (Cochlear BP100 sound processor, K090720). Special 510(k)s often focus on demonstrating that the modified device is substantially equivalent to the predicate device despite technological improvements, rather than presenting new clinical performance studies against specific acceptance criteria.

The summary states that the Baha 4 sound processor is "mechanically identical to the BP100, but replaces the ASIC inside the processor with an off-the-shelf electronic assembly used in currently marketed air conduction devices." It also claims that 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."

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance studies because the information is not present in the provided text.

Here's what the document does provide and why it doesn't fit the requested format:

• Device Description and Technological Characteristics: It details the modifications made to the Baha BP100, primarily replacing the internal ASIC with a new electronic assembly from air conduction devices. These modifications allow for new features like 2.4GHz wireless connectivity, additional program slots, wind noise detection/reduction, 17-channel sound analysis, and automatic scene analysis.
• Intended Use and Indications for Use: These remain the same as the predicate device.
• Substantial Equivalence Claim: The crux of this 510(k) is the assertion that, despite the technological improvements, the Baha 4 sound processor "still has substantially equivalent function and technology, and the same intended use as the predicate Baha BP100 sound processor." This means the manufacturer is arguing that the new features do not raise new questions of safety or effectiveness and that existing performance data for the predicate device, or general understanding of the technology, applies.

In summary, the provided text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, or adjudication methods for a test set.
3. Details of a multi-reader multi-case (MRMC) comparative effectiveness study.
4. Details of a standalone algorithm performance study.
5. Information on the type of ground truth used for a performance study.
6. Sample size for a training set or how its ground truth was established.

This is typical for a Special 510(k) where the focus is on demonstrating substantial equivalence to a predicate device rather than conducting new efficacy or performance trials against novel acceptance criteria.

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