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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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The Cochlear Baha® BP110 Power 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 55 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 Baha® Intenso sound processor, which was cleared under 510(k) K081606 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 77,000 users of a Baha system globally.

Baha sound processors can be used with either the external Baha headband or Softband, 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 BP110 Power is an upgrade to the currently marketed Baha Intenso sound processor, which it will replace on the U.S. market. The BP110 Power sound processor will provide a more modern device with technological innovations compared to the predicate Intenso. As the modified device utilizes the same fundamental scientific principles, and the same intended use and indications for use as the current legally marketed device it will replace, and merely represents improvements in features and the sound processing of the amplified sound that are the same as those used in another Cochlear Baha sound processor that has already been cleared for marketing for a less hearing-impaired population (the model BP100, cleared under K090720), we believe these modifications are appropriate for the Special 510(k) process.

The primary modifications proposed are technological improvements so that the BP110 Power will be digitally programmable, allow up to three user-selectable listening programs and measurement of direct bone conduction thresholds (through the sound processor) for greater accuracy in fitting, and provide a number of sound processing improvements and features that have already been cleared for another Baha sound processor intended for a less severely impaired population (the Baha BP100. cleared under K090720). Improvements in sound processing include multichannel, non-linear programmability, advanced automatic directionality, background noise management, active feedback cancellation, and position compensation. The BP110 Power can be fit with Baha Fitting Software (also previously cleared under K090702), which has proprietary amplification strategies for direct bone conduction delivery of amplified sound. The BP110 Power also has audible and visible indicators (LEDs and beeps) for monitoring the status of the sound processor, a Europlug for compatibility with standard accessories and mainstream FM devices, and tamper proof features for the pediatric population. These modifications will result in a device that will provide more individual flexibility and accuracy in fitting and an increased number of sound processing options and features currently found in air conduction hearing aids (Class I, Exempt).

I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, sample sizes for test set or training set, data provenance, number and qualifications of experts, adjudication method, MRMC comparative effectiveness study, standalone performance, or type of ground truth.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance or describe the study that proves the device meets the acceptance criteria based on the given input.

The document is a 510(k) summary for the Cochlear Baha® BP110 Power Sound Processor, focusing on its substantial equivalence to a predicate device. It describes the device, its intended use, technological characteristics, and details the FDA's clearance. It does not provide detailed performance study results against specific acceptance criteria.

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This device is to be used by patients who have a conductive hearing loss and can still benefit from sound amplification. Also indicated are patients with mixed hearing loss with average bone conduction thresholds in the indicated ear better than 45dB HL. The nominal output from the BAHA Cordelle II is on average 13 dB stronger than the Classic 300 model (measured at 0.5,1,2,3 kHz). The Cordelle is recommended for patients having the same indications for the Classic 300 but where slightly stronger amplification is needed than what is delivered by the Classic 300 model. (Patients with bone conduction thresholds better than 45dB HL will be expected to improve, but may not activeve levels in the normal range. Patients with a bone conduction threshold where each standard measured frequency threshold is less than 25 dB HL can be expected to have restored hearing levels in the normal range.) The patients indicated for this device must also be unable to use conventional air conduction hearing aids or undergo ossicular replacement surgery because of one of the following:

1. Chronic otitis media (COM); or

2. Congenital malformation (CM) of the middle/external ear; or

3. Other acquired malfunctions of the middle or external ear canals which preclude the wearing of a conventional air conduction hearing aid.
   Additional indications to be met by perspective BAHA™Cordelle II candidates:

4. Patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful consideration must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parents or guardian.

5. For children and patients with congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation. Alternative treatment such as conventional bone conduction hearing aids, should be considered for patients having a disease state that might jeopardize osseointegration.

The Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle II System includes a titanium fixture which is placed in the temporal bone just behind the ear, an abutment, vanous accessories necessary for the placement and use of the fixture/abutment pillar, a sound processor which is attached to the abutment and a body worn unit which has two potentiometers that control threshold knee and loundness boost and a tone control switch.

The Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle IEjs a sound processor system which consists of two units; a transducer and a body worn unit. The body worn unit has two potentiometers which control threshold knee and loudness boost and a tone control switch.

Transducer: The transducer is an at-the-ear level sound processor which uses a direct connection to the skull bone without intervening skin and soft tissue. The transducer is attached to a snap coupling titanium abutment, which is fastened to a titanium flange fixture using a gold screw. The transducer is connected to a body worn unit via a cord with electrical output and input connectors.

Body Worn Unit: As noted previously the body worn unit has two potentiometers which control the threshold knee and loudness boost. The unit is also equipped with an electrical input to receive signals from a "Walkman" FM/IR system. When the electrical contact is connected it overrides the telecoil signal. The body worn unit has a tone switch which controls the frequency response. The switch can be set in three different positions. N= Normal, which gives the widest frequency response. H= High frequency emphasis (reduction of low frequency sounds). L= Low frequency emphasis (reduction of high frequency sounds). The tone switch is effective for all inputs (microphone, telecoil, electrical). The two trim controls marked LB and TK can be adjusted with a small screwdriver by the patient's audiologist. The LB adjusts the gain for loud sounds and the TK adjusts the gain for soft sounds. The body worn unit is equipped with a clip so you can attach the unit to the patient's clothing (i.e. shirt/blouse pocket ... ).

Abutment Snap: There is an abutment snap which is mounted to the transducer. It is designed to snap into the abutment and hold the transducer securely in place.

Abutment Insert: The function of the abutment insert is to act as a guide for the abutment snap. It makes it easier to connect the transducer to the abutment. It also protects the inside of the abutment from dirt.

Abutment and Abutment Screw: The abutment is a replaceable percutancous connection between the fixture and the external sound processor which is partially or totally submerged into soft tissue. The abutment is made of titanium and is fastened to the fixture via an internal an abutment screw.

Abutment Cover: When the transducer is not in place you can attach the abutment cover on the abutment to make it look more aesthetically pleasing. One can attach the cover by pressing it into place on the abutment.

Fixture: The fixture is a threaded titanium screw which is implanted into the temporal bone and intended to provide permanent bone anchorage as a means to attach the sound processor.

Cover Screw and Healing Cap: The cover screw and healing cap are temporary components utilized only during the healing periods post surgical placement of the titanium fixture. The cover screw is used during the first healing period and is arrached to the fixture and covered with the soft tissue during the healing of the bone and soft tissue. The covers the upper part of the internal threads of the fixture. Thus, the cover screw will preclude bone and soft tissue from growing into the site where the abutment will be placed. The healing cap is used during the second healing period and covers the abutment surface. These components are used only during the healing stages of the surgery and remain in place for three to four months and one to two weeks respectively.

The provided text is a pre-market notification (510(k)) for the Branemark Bone-Anchored Hearing Aid (BAHA™) Cordelle II System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study proving the device meets those criteria in the way one might expect for a novel device or a clinical trial for a new drug.

Here's an analysis based on the information provided:

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission, the "acceptance criteria" are primarily established by the performance of the predicate devices. The claim is substantial equivalence to the predicate products, not necessarily a set of quantitative performance metrics for a novel technology demonstrating clinical efficacy.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not describe a specific "test set" or a clinical study with a defined sample size to prove the device meets acceptance criteria in the traditional sense. The basis for the claims is substantial equivalence to legally marketed predicate devices. The nominal output increase of "13 dB stronger than the Classic 300" is mentioned, which implies some form of acoustic measurement or comparison, but details on the methodology, sample size for this comparison, or data provenance are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study requiring expert-established ground truth for a diagnostic outcome. The submission relies on technical comparisons and the established safety and efficacy of predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no described test set requiring adjudication is present.

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

Not applicable. This device is a hearing aid, not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm. Performance is assessed through its function as a hearing aid in conjunction with a human user.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the safety and effectiveness of the predicate devices (Branemark BAHA, K955713 and K984162, and the Craniofacial Prosthetic Attachment System, K945154), which have already been deemed safe and effective for their indicated uses. The Cordelle II system demonstrates substantial equivalence by showing it shares the same intended use, technological characteristics, surgical technique, and similar manufacturing processes, with an improvement in output (stronger amplification) for patients where existing predicate devices might be "too weak."

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would have a "training set."

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

Not applicable.

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This device is to be used by patients who have a conductive hearing loss and can still benefit from sound amplification. Also indicated are patients with mixed hearing loss with average bone conduction thresholds in the indicated ear better than 45 dB HL. (Patients with bone conduction thresholds between 25 and 45 dB HL will be expected to improve, but may not achieve levels in the normal range. Patients with a bone conduction threshold where each standard measured frequency threshold is less than 25 dB HL can be expected to have restored hearing levels in the normal range.) The patients indicated for this device must also be unable to use conventional air conduction hearing aids or undergo ossicular replacement surgery because of one of the following:

1. Chronic otitis media (COM), or
2. Congenital malformation (CM) of the middle/external ear; or
3. Other acquired malfunctions of the middle or external ear canals which preclude the wearing of a conventional air conduction hearing aid.
   Additional indications to be met by perspective BAHA candidates:
4. Patients (either by themselves or with the aid of others) must be able to maintain the abutment/skin interface of the BAHA. Therefore, careful consideration must be given as to the patient's psychological, physical, emotional and developmental capabilities to maintain hygiene. In the case of children part, but not all, of that responsibility falls on the parents or guardian.
5. For children and patients with congenital malformations, sufficient bone volume and bone quality must be present for a successful fixture implantation. Alternative treatment such as conventional bone conduction hearing aids, should be considered for patients having a disease state that might jeopardize osseointegration.

The Branemark Bone-Anchored Hearing Aid (BAHA) System includes a titanium fixture which is placed in the temporal bone just behind the ear, an abutment, various accessories necessary for the placement and use of the fixture/abutment pillar, and a sound processor which is attached to the abutment. The fixture/abutment pillar is used as an anchor for the sound processor.

The provided text is related to a 510(k) submission for the Branemark Bone-Anchored Hearing Aid (BAHA™) System. This document focuses on regulatory approval and indications for use, rather than a clinical study evaluating specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance statistics is not present in the given text.

Based on the provided information, I can offer the following:

1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in a way that would fit into such a table. It describes the intended use and expected outcomes (e.g., "expected to improve," "restored hearing levels in the normal range") rather than quantifiable performance thresholds.

2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical study with a specified sample size or data provenance. The information provided is for a 510(k) submission seeking clearance based on substantial equivalence to predicate devices, not a new clinical trial reporting performance data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The document does not describe a clinical study involving experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set
Not applicable. The document does not describe a clinical study with an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
Not applicable. The document does not describe an MRMC study.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable. The device described is a medical implant and sound processor, not an artificial intelligence algorithm.

7. The Type of Ground Truth Used
Not applicable in the context of an AI/algorithm performance study. The "ground truth" for the device's efficacy is implied by its ability to amplify sound and improve hearing based on its mechanism of action and prior clinical experience with similar devices, as described in the predicate products.

8. The Sample Size for the Training Set
Not applicable. The document does not describe a training set for an algorithm.

9. How the Ground Truth for the Training Set was Established
Not applicable.

In summary, the provided 510(k) document is a regulatory submission focused on the safety and effectiveness of a medical device (a bone-anchored hearing aid) and its indications for use, including an expansion to pediatric patients. It establishes substantial equivalence to previously cleared predicate devices but does not detail a new clinical study with specific performance acceptance criteria or detailed study methodologies as would be expected for demonstrating algorithm performance.

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