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The Osia System is intended for the following patients and indications:

· Patients 5 years of age or older.

• Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL.

· Bilateral fitting of the Osia System is intents having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies.

· Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided deafness or "SSD"). The pure tone average air conduction hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).

• The Osia System 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.

· Prior to receiving the device, it is recommended that an individual have experience with appropriately fitted air conduction or bone conduction hearing aids.

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 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.

Here's a breakdown of the acceptance criteria and the study details for the Cochlear Osia System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail format for this specific submission, as this submission is for an expanded pediatric indication, not a new device. However, the study aims to demonstrate safety and effectiveness in the expanded population in comparison to the existing predicate. The "acceptance criteria" can be inferred from the study's objectives and the conclusion of substantial equivalence.

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

• Sample Size: Not explicitly stated for the "test set" in a traditional sense. The document refers to a "pivotal, prospective, multi-center study... to determine the safety and effectiveness of the Osia system in children ages 5-11." The number of participants in this study is not numericaly provided.
• Data Provenance: The study was a "pivotal, prospective, multi-center study." The country of origin of the data is not specified.

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

This submission is for a medical device (hearing system), not an AI/software device requiring "ground truth" derived from expert consensus on images or similar data. The "ground truth" is based on clinical outcomes relevant to hearing devices:

• Adverse Events: Clinical reporting by medical professionals during the study.
• Quality of Life: Patient-reported outcomes via parental questionnaires.
• Speech Perception: Objective audiological testing (unaided vs. aided performance).
• Bone Conduction Thresholds: Audiological measurements by qualified audiologists.

The document does not mention a specific number of experts or their qualifications in terms of establishing a "ground truth" for the test set in the same way an imaging AI algorithm might. The clinical data itself serves as the evidence.

4. Adjudication Method for the Test Set

Not applicable in the context of this device and study. The data collected (adverse events, questionnaire results, audiological test results) are direct clinical observations and measurements, not subjective evaluations requiring adjudication by multiple experts.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the clinical performance of the device itself in a specific patient population, not on human readers' interpretation of data with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a way. The device itself (Cochlear Osia System) is the "algorithm only" in the context of its function as an active implantable bone conduction hearing system. Its performance (improvements in hearing, quality of life, speech perception) is measured as a standalone effect of the device on the patient, without human intervention during the hearing process. The human element comes in during the fitting and programming of the device by audiologists. The study's effectiveness measures (parental questionnaires, speech perception tests) evaluate the device's functional outcome.

7. The Type of Ground Truth Used

The "ground truth" for this study is derived from various clinical measures and outcomes:

• Safety: Reports of adverse events during the prospective study.
• Effectiveness (Quality of Life): Patient-reported outcomes from parental questionnaires (SSQ - Speech, Spatial and Qualities of Hearing).
• Effectiveness (Hearing Thresholds): Audiological measurements of bone conduction thresholds.
• Effectiveness (Speech Perception): Audiological tests measuring speech perception in quiet and in adaptive noise.

8. The Sample Size for the Training Set

The document does not mention a "training set." This study is a clinical trial evaluating a medical device, not an AI algorithm that requires training data in the computational sense. The device itself (the Osia System) has undergone prior development and testing, but that is distinct from a "training set" for a machine learning model.

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

Not applicable, as there is no "training set" in the context of this device and the provided document.

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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 Osia System is intended for the following patients and indications:
· Patients 12 years of age or older.
· Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2, and 3 kHz) should be better than or equal to 55 dB HL.
· Bilateral fitting of the Osia System is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies.
· Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
· The Osia System for SSD is also indicated for any patient who is indicated for an airconduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.
· Prior to receiving the device, it is recommended that an individual have experience with appropriately fitted air conduction or bone conduction hearing aids.

The Osia 2 System, also known as 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 2 System is made up of several components. The Osia implant (OSI200) consists of a receiver/coil and an actuator/stimulator (vibrator) which is surgically implanted on the skull bone. The external component of the Osia 2 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 2 System is configured to meet an individual's hearing needs, using dedicated fitting software.
In normal operation, the Osia System functions as follows:

• 1. The external sound processor captures and digitally processes sound.
• 2. The sound processor transmits power and digital information to the implant coil/receiver.
• 3. The implant stimulator/actuator converts the digital information into an electric analogue signal that is converted to vibrations by the implant piezoelectric actuator.
• This implant is fixed to the bone by the BI300 implant (K100360). 4.
  The actuator converts the electrical signal into an amplified mechanical stimulation, bypassing the impaired middle ear (origin of the conductive part of the hearing loss) and providing some level of mechanical amplification in order to compensate for the damaged inner ear (sensorineural part of the hearing loss, in case of mixed hearing loss).
  The updated Osia 2 System consists of modifications to the cleared OSI200 Implant, Osia 2 Sound Processor and Osia Fitting Software 2. All other components of the system remain unchanged from the cleared predicate.
  The Cochlear MRI Kit is being introduced for use by Osia recipients. The MRI Kit is an accessory that enables an MR scan at 1.5T without the need to surgically remove a compatible Osia implant's magnet.

The provided document is a 510(k) Summary for the Cochlear Osia 2 System. It describes the device, its intended use, indications for use, and a comparison to a predicate device. The primary purpose of this submission is seeking clearance for an updated Osia 2 System, which includes modifications to existing components (OSI200 Implant, Osia 2 Sound Processor, Osia Fitting Software 2) and the introduction of a new accessory, the Cochlear MRI Kit.

The core of the "acceptance criteria" and "proof" in a 510(k) submission like this is demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific quantitative performance metrics against a defined standard (which would be more typical for a PMA or de novo submission). Therefore, the "acceptance criteria" here largely refers to the criteria for demonstrating substantial equivalence, and the "study" is the collection of non-clinical (bench) testing performed to support this claim.

Here's an attempt to extract and describe the information requested based on the provided text, recognizing that a 510(k) summary primarily focuses on substantial equivalence rather than explicit performance criteria against a predefined threshold:

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

Since this is a 510(k) for an updated device, the primary "acceptance criterion" is functional equivalence and maintaining safety and effectiveness compared to the predicate device. The "reported device performance" is the conclusion that this equivalence was achieved through testing.

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

The document primarily discusses bench testing and verification/validation activities for hardware, software, and accessories. It does not mention clinical trials with human subjects. Therefore, the concept of "sample size" in the context of a "test set" for clinical data or "data provenance" (country/retrospective/prospective) is not directly applicable here. The testing is non-clinical.

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)

This section is not applicable as the document describes non-clinical (bench) testing, software verification, and usability testing for an accessory, not a diagnostic AI system requiring expert-established ground truth on medical images or patient data. The "summative usability testing" for the MRI Kit involved "specialized healthcare professionals," but their specific number, qualifications, or their role in establishing a "ground truth" (rather than evaluating usability) are not detailed.

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

This is not applicable as the device is not software for diagnostic image interpretation or a similar application that would require expert adjudication for ground truth.

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

This is not applicable. The device is an active implantable bone conduction hearing system and an associated MRI kit, not an AI-assisted diagnostic tool. No MRMC study or AI assistance to human readers is mentioned.

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

This is not applicable. The device is a physical hearing implant system and an MRI accessory, not an algorithm. The testing described is performance testing of the device components and system.

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

This is not applicable. For this type of device (hearing implant, MRI accessory), "ground truth" typically relates to engineering specifications, functional performance requirements, regulatory standards (e.g., for MRI compatibility), and safety profiles, which are assessed through bench testing and verification activities. It does not involve "ground truth" from medical images or patient outcomes in the sense of diagnostic accuracy.

8. The sample size for the training set

This is not applicable. The document describes a medical device (hardware and firmware/software) and its accessory, not a machine learning or AI model that requires a "training set."

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

This is not applicable for the same reason as point 8.

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The Osia 2 System is intended for the following patients and indications:
· Patients 12 years of age or older.
· Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5. 1, 2, and 3 kHz) should be better than or equal to 55 dB HL.
· Bilateral fitting of the Osia 2 System is intended for patients having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies.
· Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., single-sided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).
· The Osia 2 System 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.
· Prior to receiving the device, it is recommended that an individual have experience with appropriately fitted air conduction or bone conduction hearing aids.

Cochlear™'s Osia 2 System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided deafness (SSD).
The Osia 2 System is made up of several components. The Osia Implant (OSI200) 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 2 System is configured to meet an individual's hearing needs, using dedicated fitting software.

Here's an analysis of the provided information regarding the acceptance criteria and the study conducted for the Cochlear™ Osia™ 2 System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria and detailed device performance metrics in a table. However, it does highlight key comparisons and generally indicates that the Osia 2 System either performs "Same" as the predicate or has "improved" features. The clinical study's conclusion also states "did not reveal significant differences in hearing performance."

Below is a reconstructed table based on the information provided, inferring acceptance criteria by the demonstrated equivalence to the predicate. Specific numerical performance values beyond those for hearing loss thresholds are not provided in this summary.

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

The document states: "Clinical performance data was gathered through a simulation study that allowed audiological testing of the Osia 2 Systems and Osia Systems without having to surgically implant the OSI200 Implant and OSI100 Implant, respectively."

• Sample Size: The exact sample size for the "simulation study" is not specified in the provided text.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was a prospective simulation designed to assess audiological performance without physical implantation of the investigational device.

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

This information is not provided in the document. The study described is a "simulation study" for audiological testing. If human subjects were involved, the "ground truth" would likely be their measured hearing thresholds and subjective speech recognition scores. There is no mention of experts establishing ground truth in the context of diagnostic performance or image interpretation.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The study described is an audiological performance simulation, not a diagnostic study requiring adjudication of interpretations.

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

This is not applicable. The device is an active implantable bone conduction hearing system, not an AI-powered diagnostic tool requiring human reader interpretation of images or other data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described.

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

This is not applicable. The device is a hearing system, not a standalone algorithm. The "clinical performance data" discussed refers to the audiological efficacy of the device (or its simulated function), not the performance of an independent algorithm.

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

For the audiological performance assessment, the "ground truth" would have been the measured audiological outcomes (e.g., adaptive speech recognition scores) of the participants in the simulation study. This is directly related to hearing function.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a physical hearing aid system, not a machine learning algorithm that requires a training set in the conventional sense. The "simulation study" would involve testing against human participants or a defined audiological standard, not training a model.

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

This information is not applicable as there is no training set for a machine learning algorithm.

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The Osia System is intended for the following patients and indications:

· Patients 12 years of age or older.

· Patients who have a conductive or mixed hearing loss and still can benefit from sound amplification. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5. 1, 2, and 3 kHz) should be better than or equal to 55 dB HL.

· Bilateral fitting of the Osia System is intents having a symmetrically conductive or mixed hearing loss. The difference between the left and right sides' BC thresholds should be less than 10 dB on average measured at 0.5, 1, 2, and 3 kHz, or less than 15 dB at individual frequencies.

· Patients who have profound sensorineural hearing loss in one ear and normal hearing in the opposite ear (i.e., singlesided deafness or "SSD"). The pure tone average air conduction hearing thresholds of the hearing ear should be better than or equal to 20 dB HL (measured at 0.5, 1, 2, and 3 kHz).

• The Osia System 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.

· Prior to receiving the device, it is recommended that an individual have experience with appropriately fitted air conduction or bone conduction hearing aids.

Cochlear's Osia System mechanically vibrates the skull bone and subsequently the cochlea to compensate for conductive hearing loss, mixed hearing loss, or single-sided deafness (SSD).

The Osia System is made up of several components. The Osia Implant (OSI100) consists of a receiver/stimulator and an actuator (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.

In normal operation, the Osia System functions as follows:

• The external sound processor captures and digitally processes sound.
• The sound processor transmits power and digital information to the implant.
• The implant receiver-stimulator converts the digital information into an electric analogue signal.
• This electric signal is converted to vibrations by the implant piezoelectric actuator.

The actuator converts the electrical signal into an amplified mechanical stimulation, bypassing the impaired middle ear (origin of the conductive part of the hearing loss) and providing some level of mechanical amplification in order to compensate for the damaged inner ear (sensorineural part of the hearing loss, in case of mixed hearing loss).

The provided document (K190589) describes the Cochlear™ Osia™ System, an active implantable bone conduction hearing system. However, it does not include specific acceptance criteria or a study designed to explicitly prove that the device meets those criteria with numerical performance targets (e.g., a specific sensitivity, specificity, or improvement in a metric).

Instead, the document details a substantial equivalence (SE) submission to the FDA. The purpose of this submission is to demonstrate that the new device (Cochlear™ Osia™ System) is as safe and effective as a legally marketed predicate device (Bonebridge™ System). The document describes the system and presents performance data in the context of supporting this claim of substantial equivalence, rather than hitting pre-defined acceptance criteria for a novel device.

The "performance data" section (Section K) broadly states that clinical performance data was gathered and showed significant improvements, similar to the predicate device. It doesn't present specific acceptance criteria in a table format with corresponding performance metrics.

Therefore, I cannot generate the table as requested because the specific acceptance criteria and their corresponding numerical outcomes are not explicitly stated in the provided text.

However, I can extract the information related to the clinical study and its findings to give you the context of the device's performance as described:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as pass/fail numeric targets in the document. The general acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device, meaning the new device is as safe and effective.
• Reported Device Performance:
  • Audiometric thresholds: Significant improvements reported when compared to the pre-implant condition.
  • Speech in noise: Significant improvements reported when compared to the pre-implant condition.
  • Speech in quiet: Significant improvements reported when compared to the pre-implant condition.
  • Patient reported outcomes: Significant benefits demonstrated.
  • Hearing Loss Accommodation: The Osia System can accommodate greater degrees of hearing loss (45 dB vs. 55 dB for the predicate, though the document states "greater degrees of hearing loss (45 versus 55 dB)" which seems to be a typo and likely means 55dB for Osia which is higher).
  • Force output measurements: Higher for the Osia System at the same frequencies compared to the predicate device, enabling an expanded fitting range.

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

• Sample Size: Not explicitly stated. The document mentions "data gathered in a multi-center trial."
• Data Provenance:
  • Country of Origin: One site was in the United States; other sites not specified.
  • Retrospective or Prospective: Prospective clinical investigation.

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

• This information is not provided in the document. The study was a clinical trial on human patients, and the "ground truth" would be the patient's actual hearing ability and perceived benefit, measured through audiometric tests and patient-reported outcomes, rather than expert interpretation of data for ground truth establishment.

4. Adjudication Method for the Test Set:

• This information is not provided in the document. The study was an "open, two-armed" clinical investigation. It was not blinded.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC study was not described. The study focused on the effectiveness of the device itself by comparing pre-implant conditions to post-implant conditions with the Osia device, and implied similar performance to a predicate device. It did not involve comparing human readers with and without AI assistance, as this is a medical device for hearing, not an AI diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance:

• Not applicable in the typical sense of AI standalone performance. The "algorithm" here is the signal processing within the sound processor. The clinical study did evaluate the performance of the device system (implant + sound processor) in a "standalone" fashion (i.e., its performance in patients), but not in the context of an AI algorithm making a diagnosis without human interaction.

7. Type of Ground Truth Used:

• Clinical Outcomes and Audiometric Data: The "ground truth" was established by objective audiometric measures (pure tone average bone conduction thresholds, air conduction hearing thresholds) and subjective patient-reported outcomes regarding hearing ability and benefit.

8. Sample Size for the Training Set:

• Not applicable. This device is a hearing aid system, not a machine learning model that requires a training set in the conventional sense. The "training" in this context would be the device development and engineering process to optimize its acoustic and mechanical properties, not a machine learning training phase on data.

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

• Not applicable. As above, there isn't a machine learning training set with established ground truth described in this submission.

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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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