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The Cochlear Baha 7 Sound Processor is intended for the following patients and indications for use:

• Patient of any age for use with the Baha SoundBand, Baha Softband (or headband) or Baha SoundArc. Patients aged 5 and older for use with the Baha auditory osseointegrated implant system.
• Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 55 dB HL.
• Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as 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 deadness: SSD). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.
• Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The Cochlear Baha bone conduction hearing system provides an alternate solution for patients who may not benefit from air-conduction hearing aids. Unlike air-conduction hearing aids, the Baha implant system utilizes a natural bone conduction pathway to send sound directly to the inner ear (cochlea), bypassing a damaged outer or middle ear. The Baha bone conduction hearing system has non-surgical and surgical options. For the non-surgical option, the external sound processor, which converts acoustic sound into mechanical vibrations, is securely placed behind the ear with a Baha SoundBand, Baha Softband, or Baha SoundArc. For the surgical option, the external sound processor is coupled with an abutment (Baha Connect) or magnet (Baha Attract). The mechanical vibrations travel through the abutment or magnet to a small, titanium implant, which is surgically placed into the bone. The titanium implant has an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear.

The Baha 7 Sound Processor is a firmware variant of the previously cleared Baha 6 Max Sound Processor (K202048). The changes introduced in this 510(k) are specific to the sound processor and accessories, and do not affect the cleared Baha Connect abutments, Baha Attract magnet, the BI300 titanium implant, Baha Softband, or Baha SoundArc. The Baha 7 Sound Processor does not modify the intended functionality or fundamental operating principles of the bone conduction hearing system. The changes within culminate as the next generation Baha sound processor that supports Bluetooth LE Audio streaming, which enables compatibility with the new generation wireless accessories from GN Hearing.

The Baha 7 Sound Processor will be supported by a new fitting software (Baha Fitting Software 7), an updated app (Baha Smart App), and a new non-surgical retention option (Baha SoundBand).

The provided text describes a 510(k) premarket notification for the Cochlear Baha 7 Sound Processor. It focuses on demonstrating substantial equivalence to a predicate device, the Baha 6 Max Sound Processor. While it mentions various types of testing conducted (biocompatibility, software, electromagnetic compatibility, and bench testing), it does not include specific acceptance criteria or detailed study results for device performance in the format requested.

The document primarily provides:

• A summary of the device and its components (Baha 7 Sound Processor, Baha Fitting Software 7, Baha Smart App, Baha SoundBand).
• Indications for Use.
• A comparison table (Table 1, 2, 3, 4) detailing similarities and differences between the new device and the predicate(s).
• A general statement about performance data: "The testing demonstrated that the software supported the clinician fitting and recipient control of the Baha 7 Sound Processor." and "The bench testing demonstrates that the Baha 7 SP does not result in additional safety or efficacy concerns in comparison to the predicate." and "The results demonstrated the Baha 7 Sound Processor is functionally equivalent to the Baha 6 Max Sound Processor."

Therefore, based on the provided text, it is not possible to fully answer your request regarding specific acceptance criteria, reported device performance in a table, sample sizes, ground truth establishment details, or MRMC study results because this information is not present in the excerpt. The document focuses on demonstrating substantial equivalence through feature comparison and general statements about testing, rather than presenting a performance study with quantitative acceptance criteria and results.

Here's what can be inferred or stated based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not specified. The document mentions "bench functionality and performance testing" and "software testing" but provides no details on the sample size of devices or the data used for these tests.
• Data Provenance: Not specified for any performance testing.

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

• N/A. This type of information is typically relevant for studies involving human assessment (e.g., diagnostic accuracy studies for AI in imaging). As the device is a hearing aid sound processor, and the submission focuses on functional equivalence, there is no mention of "ground truth" adjudicated by experts in this context within the provided text. The "ground truth" for the device's function would be its measured physical characteristics and software performance against specifications.

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

• N/A. Not applicable given the nature of the device and the type of information presented. Adjudication methods are typically used in clinical studies or AI performance evaluations where human interpretation or consensus is required to establish a definitive 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:

• No, an MRMC study was not done or is not reported here. This type of study is primarily relevant for AI-powered diagnostic aids where human readers interpret medical images or data. The Baha 7 Sound Processor is a hearing aid sound processor, not an AI diagnostic tool for human interpretation.

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

• Yes, implied. The "functional and performance testing, hardware and interface testing, reliability and environmental testing" would be considered standalone testing of the device and its software. The document states, "The results demonstrated the Baha 7 Sound Processor is functionally equivalent to the Baha 6 Max Sound Processor," which is a statement about its standalone performance. However, no specific metrics or detailed results of this standalone testing are provided beyond this general statement.

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

• Instrumental measurements and compliance with specifications. For a device like a sound processor, the "ground truth" for performance would be established through calibrated laboratory instruments measuring audio output, frequency response, power consumption, signal processing accuracy, and electromagnetic emissions, compared against engineering specifications and regulatory standards. Biocompatibility is assessed against ISO 10993. Software functionality is tested against design requirements. The text confirms
  • "Biocompatibility evaluation and testing demonstrated that the materials... are biocompatible." (Ground truth: ISO 10993 standards and lab tests).
  • "Software testing was performed... demonstrated that the software supported the clinician fitting and recipient control of the Baha 7 Sound Processor." (Ground truth: Software specifications and functional requirements).
  • "Electromagnetic compatibility testing established that the sound processor did not emit excessive amounts of electromagnetic energy, and that it operated as intended in the presence of interference sources." (Ground truth: EMC standards).
  • "Bench functionality and performance testing... demonstrates that the Baha 7 SP does not result in additional safety or efficacy concerns in comparison to the predicate." (Ground truth: Engineering specifications and direct comparison to predicate device performance).

8. The sample size for the training set:

• N/A. This device does not appear to involve machine learning models that require a "training set" in the context of typical AI device submissions for diagnostic or predictive purposes. The software mentioned (Baha Fitting Software 7, Baha Smart App) are control and interface applications, not described as adaptive or learning algorithms that require large training datasets.

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

• N/A. As no training set for an AI model is indicated, this question is not applicable.

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The Hearing Aid Feature is a software-only mobile medical application that is intended to be used with compatible wearable electronic products. The feature is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The Hearing Aid Feature utilizes a self-fitting strategy and is adjusted by the user to meet their hearing needs without the assistance of a hearing healthcare professional. The device is intended for Over-the-Counter use.

The Hearing Aid Feature (HAF) is a software-only device that is comprised of a pair of software modules which operate on two separate required products: (1) HAF iOS Application on a compatible iOS product, and (2) HAF software (i.e., firmware) on the Apple AirPods Pro 2. Refer to Figure I, middle and right, respectively, The AirPods Pro 2, formerly named AirPods Pro (2nd generation), supported this granting and are hereafter simply referred to as "AirPods Pro" in this document.

The HAF iOS Application guides users through the onboarding and setup process for the HAF. The process is self-guided by the user and includes step-by-step instructions and informational content (e.g. warnings, instructions for use). To initiate HAF setup, the user must select a saved audiogram from the iOS HealthKit.

Once the audiogram has been imported by the HAF, the feature will configure the amplification for the user's audiogram based upon Apple's proprietary fitting formula. Once the initial set-up is complete, users can listen with the HAF using the AirPods Pro and refine their settings. Fine tuning is facilitated by user controls on the iOS device that can adjust amplification, tone, and balance. A user can access the fine tuning settings at any time after setting up the HAF.

The HAF settings are transferred to the HAF Firmware Module on the AirPods Pro. The HAF Firmware Module utilizes the general purpose computing platform features of the AirPods Pro, including the microphone, speakers, amplifiers, and audio processing software, to process incoming sound and provide amplification at a specific frequency and gain based on the user's custom settings. The user's custom settings are stored on the HAF Firmware Module and will be available even when the AirPods Pro are not connected to the iOS device.

Acceptance Criteria and Device Performance for Apple's Hearing Aid Feature (HAF)

1. Table of Acceptance Criteria and Reported Device Performance

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

Bench/Non-Clinical Tests:

• Performance Testing (21 CFR 800.30(d) & (e)): No specific sample size (n) is provided, but the tests refer to "all test frequencies" and compliance with ANSI/ASA S3.22 or ANSI/CTA 2051:2017 clauses. This implies comprehensive testing across the specified parameters, rather than a limited sample.
• Human Factors Formative Testing: 39 subjects.
• Audiogram Input Risk and Mitigation Study: No specific sample size (n) for the study itself, but refers to the Hearing Test Feature (HTF) validation study dataset.

Clinical Study:

• Overall Clinical Study (HAF Self-Fit vs. Professionally-Fit): 118 total participants (59 in Self-Fit group, 59 in Professionally-Fit group for FAS/CCAS; 59 in Self-Fit, 58 in Professionally-Fit for PP analysis).
• Data Provenance: Prospective, non-significant risk study from three sites across the United States.

Supplemental Clinical Data (Apple Hearing Test Feature Validation):

• Comparison of HTF outputs to professionally derived audiograms: n = 202.
• Gain analysis for HAF with HTF vs. professionally-derived audiograms: n = 173 (subset with mild to moderate hearing loss from the n=202 dataset).

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

Bench/Non-Clinical Tests:

• Performance Testing: Ground truth is established by well-defined regulatory standards (21 CFR 800.30) and industry standards (ANSI/ASA S3.22, ANSI/CTA 2051:2017). Expertise is inherent in the test methodologies themselves.
• Human Factors Formative Testing: No explicitly stated "experts" establishing ground truth in the context of diagnostic accuracy. The testing assessed use-related risks, and findings led to software design modifications.
• Audiogram Input Risk and Mitigation Study: No explicitly stated "experts" for ground truth on this specific study, but the study for the Hearing Test Feature Validation (see below) involved professional audiograms which would have been established by qualified audiologists.

Clinical Study (HAF Self-Fit vs. Professionally-Fit):

• Ground Truth for Professional-Fit (PF) Group: The "Professionally-Fit" group had their hearing aids fitted by an audiologist and underwent an optional audiologist fine-tuning session. This implies a number of audiologists (not specified but plural) provided this professional fit, thus establishing a "ground truth" reference for professional care. The study design intrinsically compares the self-fit approach to professional audiologist care, using the latter as the benchmark for a successful fit in terms of patient-perceived benefit.

Supplemental Clinical Data (Apple Hearing Test Feature Validation):

• Comparison to Professionally Derived Audiograms: These would have been established by qualified hearing healthcare professionals, such as audiologists. The exact number of such professionals establishing these audiograms for the 202 subjects is not specified but the term "professionally derived" implies expertise.

4. Adjudication Method for the Test Set

Bench/Non-Clinical Tests:

• Performance Testing: Not applicable; compliance is determined by direct measurement against pre-defined numerical thresholds in regulatory and industry standards.
• Human Factors Formative Testing: Not applicable; the output is identification of use-related risks and subsequent design modifications.
• Audiogram Input Risk and Mitigation Study: Not applicable.

Clinical Study (HAF Self-Fit vs. Professionally-Fit):

• Primary Endpoint (IOI-HA score): Not applicable in the sense of expert adjudication of a diagnostic finding. The primary outcome was a patient-reported outcome measure (IOI-HA score), a subjective assessment collected directly from participants. The comparison was statistical (non-inferiority margin) between the two groups.
• Objective Measures (QuickSIN, REM): These are objective measurements and do not require adjudication.

Supplemental Clinical Data (Apple Hearing Test Feature Validation):

• Audiogram Comparison & Gain Analysis: Not applicable. The comparison was quantitative (pure-tone average, gain differences) between HTF-derived and professionally-derived audiograms.

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

• No, a traditional MRMC comparative effectiveness study, as typically seen in diagnostic imaging where multiple readers interpret cases with and without AI assistance, was not performed for the core Hearing Aid Feature.
• Instead, a clinical study compared two groups:
  • Self-Fit (SF): Users applying the HAF's self-fitting algorithm.
  • Professionally-Fit (PF): Users whose devices were fitted by an audiologist using the NAL-NL2 formula.
• This study evaluated the effectiveness of the HAF's self-fitting approach directly against professional care by assessing patient-reported outcomes (IOI-HA) and objective measures (QuickSIN, REM).
• Effect Size of Human Readers Improve with AI vs without AI assistance: This metric is not applicable as the study design was a comparison of a self-fitting AI system against professional human fitting, not a study of human readers improving with AI assistance. The study concluded that the HAF Self-Fit group achieved non-inferior perceived benefit (IOI-HA scores) compared to the Professionally-Fit group, indicating equivalent patient outcomes without the direct involvement of a hearing healthcare professional in the fitting process.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone study was inherently performed to assess the performance of the HAF's self-fitting algorithm.
• The "Self-Fit (SF)" group in the clinical study directly represents the standalone performance of the algorithm. These users utilized the HAF's automatic fitting algorithm and then could adjust amplification, tone, and balance themselves. The device's performance, as measured by IOI-HA scores, QuickSIN, and REM, was attributed to this self-fitting strategy.
• The comparison to the "Professionally-Fit (PF)" group served as a benchmark for what a human expert (audiologist) would achieve.
• Therefore, the clinical study's SF arm is a direct measure of the algorithm's standalone performance in a real-world setting.

7. Type of Ground Truth Used

Bench/Non-Clinical Tests:

• Regulatory and Industry Standards: Ground truth is defined by explicit numerical thresholds and methodologies prescribed by 21 CFR 800.30 and ANSI/ASA/CTA standards.
• Human Factors: "Ground truth" is the identification of potential use errors and associated risks, which is derived from observing user interactions and conducting risk analysis.

Clinical Study (HAF Self-Fit vs. Professionally-Fit):

• Expert Consensus / Professional Practice: The "Professionally-Fit" group, whose devices were fitted by audiologists using a standard clinical fitting formula (NAL-NL2), served as the gold standard or ground truth for best clinical practice in hearing aid fitting. The HAF's performance was evaluated against this professional benchmark.
• Patient-Reported Outcomes (IOI-HA): The primary ground truth for effectiveness was the subjective perception of benefit, satisfaction, and quality of life as reported by the patients themselves via the IOI-HA questionnaire.
• Objective Outcomes Data (QuickSIN, REM): These objective functional measures also served as ground truth regarding speech intelligibility and actual gain.

Supplemental Clinical Data (Apple Hearing Test Feature Validation):

• Expert Consensus / Professional Practice: The comparison was made against "professionally derived audiograms," implying that these audiograms, established by trained hearing healthcare professionals, served as the ground truth.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for the training set used to develop Apple's proprietary fitting formula within the HAF. The description only refers to the clinical study as establishing safety and effectiveness, and the HAF's fitting formula is described as "Apple's proprietary fitting formula." This formula would have been developed using a separate dataset prior to the validation study.

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

Since the training set size and characteristics are not provided, the method for establishing its ground truth is also not explicitly stated in this document.

However, based on the nature of hearing aid fitting algorithms and the validation study design, it is highly probable that the proprietary fitting formula was developed and refined using:

• Large datasets of audiogram data: Likely anonymized audiograms from various sources, potentially including those collected by Apple's own Hearing Test Feature over time or from research collaborations.
• Patient-reported outcomes data: To correlate objective audiometric data with subjective patient benefit and preference.
• Expert knowledge/models: Incorporating established audiological principles, validated fitting targets (e.g., NAL-NL2, DSL v5), and clinical experience synthesized into an algorithmic form.
• Iterative development and testing: The "proprietary fitting formula" would have undergone extensive internal testing, likely including simulations and pilot studies with real users, where the "ground truth" would be established by comparing algorithm outputs to professional recommendations or patient preferences.

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The hearing aid is intended to be used to amplify and transmit sound to the ear and thereby compensate for impaired hearing.

The hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is initially placed in the ear canal by an appropriately trained ENT physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. It is then replaced by a new device by the previously mentioned parties, or by an adult patient 22 years and older who have been wearing Lyric for a minimum period of 3 months under the direction and training of the ENT physician, Audiologist or Hearing Aid Dispenser. Upon device removal the hearing aid is discarded.

Lyric4 is a non-sterile, extended wear hearing aid that is worn 24 hours a day, 7 days a week for months-at-a-time. Due to the deep placement inside the ear canal, it is 100% invisible. For patients, Lyric4 is very easy to operate with no batteries to change, no ongoing maintenance required and no daily insertion or removal. Lyric4 takes advantage of the deep placement in the ear canal for natural sound quality and the natural directivity of the pinna. Lyric4 is designed for single insertion and is not reused once removed from the ear (single-use only).

Compared to the currently marketed Lyric4, there are no modifications to the technology (hardware and software), materials, or accessories when Lyric4 is used for self-replacement. Only the indications for use statement and labeling have been modified.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Lyric4 Hearing Aid (for self-replacement)

Clinical Study Objective: To demonstrate the effectiveness and safety of the HCP-guided Lyric4 self-replacement procedure compared to the commercially available HCP-replacement procedure.

1. Table of Acceptance Criteria and Reported Device Performance

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Ponto 5 SuperPower sound processors are intended for the following patients and indications:

· Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 65 dB HL for use with the Ponto 5 SuperPower sound processor.

· Bilateral fitting is applicable for most 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 4 kHz, or less than 15 dB at individual frequencies.

Patients who have a 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· 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 placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/ abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto Bone Anchored Hearing System consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor can be connected and disconnected by the user by the snap coupling.

The sound processors are individually adjusted to the patient audiogram and needs via the Genie Medical BAHS fitting software by the Hearing Care Professional (HCP). The HCP connects the sound processors to the computer running the Genie Medical BAHS fitting software through either a wireless connection or a cable.

Ponto 5 SuperPower sound processor is a further development of and substantially equivalent to the primary predicate Ponto 3 SuperPower (K161671) and predicate Ponto 5 Mini (K211640).

As for both predicates, the Ponto 5 SuperPower sound processor is intended for improvement of hearing for patients with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single-sided deafness.

Ponto 5 SuperPower sound processor is indicated for hearing losses up to and including 65 dB HL (BC), same as the primary predicate Ponto 3 SuperPower sound processor.

Ponto 5 SuperPower sound processor includes the same sound processing platform and wireless technology as the predicate Ponto 5 Mini sound processor, enabling the same sound processing features and compatibility options as Ponto 5 Mini.

A minor updated hardware design (electronic and mechanic) is implemented in Ponto 5 SuperPower sound processor as compared to Ponto 3 SuperPower (K161671), to allow for a side neutral design that carries the same design and look as Ponto 5 Mini (K211640).

The functionality and features of the firmware in Ponto 5 SuperPower are the same as for predicate device Ponto 5 Mini, however updated in a new revision. No functionality or features of the firmware are changed, added or removed by this update.

Other than the minor updates in hardware design and the very minor change to the firmware, the technological characteristics of the Ponto 5 sound processors remain unchanged from the original design (as latest cleared in K161671 for Ponto 3 SuperPower and K211640 for Ponto 5 Mini).

Additional purposes of this 510(k) notice is to include a minor modification to the accessory Genie Medical BAHS fitting software and to include the addition of Softband 5 to the Ponto Bone Anchored Hearing System:

• The fitting software is, as part of this 510(k), updated to include compatibility with Ponto 5 SuperPower in addition to Ponto 5 Mini and Ponto 4. No feature or functionality is changed, added or deleted in Genie Medical BAHS 2022.1, when compared to the current version Genie Medical BAHS 2021.2 (cleared together with Ponto 5 Mini in K211640).
• -The Softband, previously cleared through K082108 and latest in K161671. consists of a band placed around the wearers head with a connector plate to which the sound processor is attached. The Softband can be used by patients in the pre-operative evaluation phase or as a long-term solution to benefit from the sound processor without having an implant (primarily children). The Softband can be used also bilaterally. The band and the connector plate have been modified for optimal comfort and use.

The provided text describes the regulatory clearance for the Ponto 5 SuperPower sound processor. It clarifies that this device is a modification of previously cleared sound processors, the Ponto 3 SuperPower (K161671) and Ponto 5 Mini (K211640), and asserts substantial equivalence to these predicates. The document focuses on demonstrating that the new device does not raise new safety or effectiveness concerns.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the primary "acceptance criterion" is proving substantial equivalence to predicate devices, particularly in terms of performance characteristics relevant to hearing aids. The key performance aspect explicitly mentioned and compared is "Maximum Force Output."

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

The document does not specify a "test set" in the context of human subjects or a defined dataset with a particular sample size for performance evaluation. Instead, it refers to "performance data" derived from standard engineering and regulatory tests. The provenance of this data (country of origin, retrospective/prospective) is not explicitly stated, but it is implied to be internal testing conducted by the manufacturer for regulatory compliance.

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

This information is not applicable in the context of this document. The device is a medical device (hearing aid), not an AI/ML algorithm that requires expert consensus for ground truth on a test set. The performance evaluation relies on established engineering standards and comparative analysis with predicate devices.

4. Adjudication Method for the Test Set:

This information is not applicable. See point 3.

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

This information is not applicable. The document does not describe an MRMC study comparing human readers with and without AI assistance. The device is a hearing aid, not an AI diagnostic tool that assists human readers in interpreting medical images or data.

6. Standalone (Algorithm Only) Performance:

This information is not applicable. The Ponto 5 SuperPower is a physical hearing aid device with embedded software and hardware for sound processing. Its performance is evaluated as a complete system, not as a standalone algorithm without human interaction.

7. Type of Ground Truth Used:

The "ground truth" here is based on established engineering standards and measurements for hearing aid performance (e.g., IEC 60118-9:2019 for Maximum Force Output) and the performance characteristics of the legally marketed predicate devices. The comparison relies on demonstrating that the new device meets or is comparable to these established standards and predicate performances.

8. Sample Size for the Training Set:

This information is not applicable. The Ponto 5 SuperPower is not an AI/ML device that requires a "training set" in the conventional sense for machine learning model development. Its development and verification involve engineering design, testing, and comparison to existing products and standards.

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

This information is not applicable. See point 8.

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The Cochlear™ Baha System is intended for the following patients and indications for use:

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

• Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The . pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 55 dB HL.
  . Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as 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 deadness: SSD). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.

Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing . of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The Cochlear Baha bone conduction hearing system provides an alternate solution for patients who may not benefit from an air-conduction hearing aids. Unlike air-conduction hearing aids, the Baha implant system utilizes a natural bone conduction pathway to send sound directly to the inner ear (cochlea), bypassing a damaged outer or middle ear. The Baha bone conduction hearing system has non-surgical and surgical options. For the non-surgical option, the external sound processor, which converts acoustic sound into mechanical vibrations, is securely placed behind the ear with a Baha Softband or Baha SoundArc. For the surgical option, the external sound processor is coupled with an abutment (Baha Connect) or magnet (Baha Attract). The mechanical vibrations travel the abutment or magnet to a small, titanium implant, which is surgically placed into the bone. The titanium implant has an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear.

The updates made to Baha Fitting Software 6 and Baha Smart App add Remote Assist capabilities to the previously cleared Baha Fitting Software 6 and Baha Smart App (K202048). The changes introduced in this 510(k) are specific to the fitting software and smart app, and do not affect the cleared Baha 6 Max Sound Processor, Softband, SoundArc, Baha Connect abutments, Baha Attract magnet, or the BI300 titanium implant. Introduction of Remote Assist does not modify the intended functionality or fundamental operating principles of the bone conduction hearing system.

By introducing Remote Assist, the healthcare professional can:

• Communicate in real-time via video, audio, or messaging, and ●
• Connect to and remotely adjust the recipient's Baha 6 Max Sound Processor through the . Baha Fitting Software 6 and Baha Smart App interface.

The provided text describes a 510(k) premarket notification for the Cochlear Baha 6 System, specifically focusing on updates to the Baha Fitting Software 6 and Baha Smart App to introduce "Remote Assist" capabilities.

However, the document does not contain the detailed study information typically associated with acceptance criteria and proof of a device meeting those criteria in the context of advanced AI algorithms for medical image analysis or similar diagnostic tools. The device in question is a hearing aid system, and the "Remote Assist" features relate to remote programming and communication, not to complex diagnostic or predictive AI.

Therefore, many of the requested points relying on AI-specific study designs (like MRMC studies, expert consensus for ground truth on large image datasets, training set details, or standalone algorithm performance) are not applicable to this document. The provided text primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance.

Below, I will answer the applicable questions based on the provided text. For those that are not applicable, I will explicitly state so and explain why.

Device: Cochlear™ Baha® 6 System, Cochlear™ Baha® Fitting Software 6, Cochlear™ Baha® Baha Smart App
Regulatory Clearance: K212136

Acceptance Criteria and Device Performance

The document does not explicitly present a table of predetermined "acceptance criteria" in the format of specific quantifiable metrics (e.g., sensitivity, specificity, AUC values) and then report performance against them. Instead, the "performance data" section focuses on demonstrating functional equivalence and safety/effectiveness compared to a predicate device through various testing types.

The implicit acceptance criterion for this 510(k) submission is that the updated device, with its new "Remote Assist" functionalities, is as safe and as effective for its intended uses compared to the predicate Baha 6 System.

Table of Device Performance (Based on provided text's summary of testing):

• Software testing of new features.
• Regression testing of existing functionality (component and system level).
• Smoke testing.
• Functional test cases (e.g., measurements and programs).
• Non-functional test cases (e.g., cybersecurity and deployment).
• Hazard control verification.
• System-level integration, performance, and design analysis tests. |
  | User Needs & Intended Use | Design validation demonstrated compliance of the new features with user needs and intended use. |
  | Usability Verification | Summative usability testing was conducted. Participants completed a series of tasks throughout a Remote Assist session, and feedback was collected. The results of this testing supported the overall conclusion of safety and effectiveness. (Specific quantitative results or measures of usability are not provided in this summary, but the general statement implies successful completion). |
  | Safety and Effectiveness | The updates have been shown to be as safe and as effective for their intended uses compared to the predicate Baha 6 System. This is the overarching conclusion of the submission, based on all the testing and comparisons. |

Study Details (Applicable points only)

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

• Sample Size: The document does not specify a quantitative sample size for any "test set" in terms of number of patients or cases. It mentions "participants" for usability testing, but no number is given. The testing described is primarily software verification and validation, not a clinical trial with a patient-based test set as might be seen for a diagnostic AI.
• Data Provenance: Not explicitly stated in terms way data for an AI would be (e.g., country of origin). The testing seems to be internal development and verification. No mention of retrospective or prospective clinical data.

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

• Not Applicable. This device is a hearing aid system with remote programming capabilities, not a diagnostic tool requiring expert interpretation of medical images or clinical data to establish a "ground truth" for disease states. The "ground truth" for its functionality is based on its engineering specifications, user needs, and established audiological principles.

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

• Not Applicable. An adjudication method is typically used in studies involving human readers or multiple experts to resolve discrepancies in ground truth labeling or diagnostic assessments. This type of study design is not described here, as the testing focuses on software functionality, safety, and effectiveness compared to a predicate device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not Applicable. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance (e.g., radiologists reading images with and without AI assistance). This device is not an AI diagnostic tool and its purpose is to provide hearing assistance and remote fitting, not to aid human "readers" in diagnosis or interpretation.

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

• Not Applicable/Implicit. The "algorithm" here is the software that facilitates remote programming and communication for a hearing aid. The performance described (functional equivalence, cybersecurity, etc.) is inherently "standalone" in the sense that the software's core functions are tested. However, this is not an AI algorithm performing a diagnostic task without human intervention; it's a software system designed to be used by both clinicians (human-in-the-loop for programming) and patients for control. The testing confirmed the software's ability to perform its intended functions.

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

• The "ground truth" for this device's performance is its engineering specifications, functional requirements traceability to user needs, and compliance with general safety and performance principles for medical devices. For example, a "ground truth" for a functional test might be "the software successfully adjusted gain by X dB as per the input, and the sound processor responded correctly." This is based on design documents and expected behavior, not external clinical "ground truth" like pathology.

8. The sample size for the training set:

• Not Applicable. This device description does not mention the use of machine learning or deep learning algorithms that would require a distinct "training set" of data for model development. The software is programmatic, not primarily data-driven in its learning capacity at the point of clearance.

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

• Not Applicable. As there's no stated training set for AI/ML, there's no process described for establishing ground truth for such a set.

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Ponto 5 Mini sound processors are intended for the following patients and indications:

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto 5 Mini sound processor.
• Bilateral fitting is applicable for most 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 4 kHz, or less than 15 dB at individual frequencies.
• Patients who have a 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).
• 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 placement of a bone anchored implant is contraindicated for patient below the age of 5.
  The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible Baha abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

The Ponto Bone Anchored Hearing System consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor can be connected and disconnected by the snap coupling.
Ponto 5 Mini is a further development of the Ponto 4, cleared in K190540.The main difference between Ponto 5 Mini and Ponto 4 is a modification to the firmware in the Ponto 5 sound processors to additionally include the sound processing feature OpenSound™ Optimizer and an added compatibility with Oticon RemoteCare App from SBO Hearing A/S. Other than the minor changes to the firmware and compatibility, the technological characteristics of the Ponto 5 sound processors remain unchanged from the original design (most recently cleared in K190540).
Additionally, minor modifications to the accessory Genie Medical BAHS fitting software are made (e.g., added compatibility with Oticon RemoteCare App, addition of special purpose programs, and inclusion of DSL BC).

The provided text does NOT describe an AI/ML powered medical device, an acceptance criteria table, a study proving the device meets the acceptance criteria (except for performance data of an existing device), sample sizes for test/training sets, or details about establishing ground truth by experts. The document is an FDA 510(k) clearance letter for a hearing aid and focuses on substantial equivalence to a predicate device.

Therefore, I cannot answer the request with the information provided. The document outlines:

• Trade/Device Name: Ponto 5 Mini (a hearing aid)
• Predicate Device: Ponto 4
• Key Differences: Modification to firmware to include OpenSound™ Optimizer and compatibility with Oticon RemoteCare App.
• Performance Data: States "Electroacoustic verification includes Maximum output responses, Output for full-on gain at 50 dB SPL and 60 dB SPL, Equivalent input noise level, Total harmonic distortion, Frequency range, Battery voltage, Current Consumption, Battery lifetime, IRIL (input related interference level) and Processing delay. The results were according to requirements and equivalent to the performance of the predicate device, Ponto 4." It also mentions "same electrical and mechanical safety, electromagnetic compatibility (EMC), and radio properties and performance, that was established for the predicate, Ponto 4."

Since the request is about an AI/ML powered device and its validation study, this document does not contain the necessary information.

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The Ponto Bone Anchored Hearing System (Ponto sound processors and implant system) is intended for the following patients and indications:

· Patients with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto 4 sound processors, 55 dB HL for use with the Ponto 3 Power sound processors and 65 dB HL for use with the Ponto 3 SuperPower sound processor.

· Bilateral fitting is applicable for most 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 4 kHz, or less than 15 dB at individual frequencies.

· Patients who have a 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· 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 placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto sound processors are intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant/ abutment system (refer to the Ponto labeling for compatible BAHA sound processor models).

The Ponto Bone Anchored Hearing System consists of an external sound processor unit and an implant with a skin penetrating abutment. The implant with the abutment is surgically anchored in the bone behind the ear. Vibrations generated by the sound processor are transmitted directly through the skull bone to the cochlea as bone conduction sound. The sound processor can be connected and disconnected by the user by the snap coupling. The technological characteristics of the Ponto Bone Anchored Hearing System, Ponto Implant System, remain unchanged from the original design (most recently cleared in K152067).

The Ponto Bone Anchored Hearing System also include accessories and instruments for installation of the implantable components, and the Ponto Surgical Manual and Surgical Manual Addenda include step by step instructions for a number of safe alternative surgical approaches for implant installation.

The main purpose of this 510(k) notification is a modification to the drilling to prepare the osteotomy for installation of a Ponto bone anchored implant, from two-step drilling (MIPS previously cleared in K152067) to a single drill step (MONO). The MONO Surgery Kit is a further development of the MIPS Surgery Kit previously cleared in K152067.

The provided document is a 510(k) Premarket Notification from the FDA regarding the Oticon Medical AB's Ponto Bone Anchored Hearing System, specifically the MONO Surgery Kit. This document focuses on demonstrating substantial equivalence to a predicate device (K152067), rather than providing detailed acceptance criteria and the comprehensive study results typical of a novel device or a device making significant new claims.

Therefore, many of the requested details about acceptance criteria, test set sizes, expert involvement, and ground truth establishment are not explicitly stated in this type of regulatory submission, as the primary goal is to show that the modified device (MONO Surgery Kit) is as safe and effective as the previously cleared predicate. The "study" here is a set of pre-clinical bench tests demonstrating equivalence rather than a clinical trial validating performance against specific acceptance criteria for diagnostic accuracy.

However, I can extract information related to the device modifications, the comparative testing performed, and the conclusions drawn for substantial equivalence.

Here's a breakdown of the available information:

Key Takeaway: This 510(k) submission is for a modification to an existing device (a new surgical drilling technique and associated kit - MONO Surgery Kit) and aims to prove substantial equivalence to a predicate device (K152067). It is not a submission for a novel device requiring extensive clinical validation against specific performance metrics for diagnostic accuracy. Therefore, information typically found in such studies (like MRMC, detailed ground truth establishment, or large-scale clinical trials) is largely absent or not relevant in this context.

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

The document does not present a formal table of "acceptance criteria" and "reported device performance" in the way one might expect for a diagnostic AI device. Instead, it describes comparative bench testing against a predicate device to demonstrate equivalence.

The implicit acceptance criteria are that the new "MONO" drill performs comparably to the "MIPS" predicate drill across key metrics, confirming "equivalence" in safety and efficiency.

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

• Sample Size: The document mentions "Comparative testing to install 4 mm Ponto implant (Ø4.5 mm) in artificial bone." It does not specify the number of tests or samples conducted.
• Data Provenance: The tests were "Pre-clinical bench tests." The location of these tests or the origin of the "artificial bone" is not specified. It is a laboratory, not a clinical, test.
• Retrospective or Prospective: Not applicable as these are bench tests, not patient studies.

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 information is not applicable and not provided in the document. The "ground truth" for these bench tests would be directly measured physical properties (heat, torque, etc.) in artificial bone, not expert consensus on medical images or clinical outcomes.

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

• This information is not applicable as the study involved bench testing of a physical device/technique, not human interpretation or adjudication of data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was NOT done. This type of study (MRMC) is typically performed for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is evaluated. The device subject to this 510(k) is a surgical kit for a hearing system, not an AI diagnostic tool.

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

• This question is not applicable to this device. The device is a surgical kit, not an algorithm. The "performance" evaluated was the physical interaction and outcomes of the drill in artificial bone.

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

• The "ground truth" for the pre-clinical bench tests was based on direct measurements of physical properties (heat generation, insertion torque, installation turns, seating, ISQ-value) in artificial bone. The performance was then compared against the established performance of the predicate device.

8. The sample size for the training set

• This document describes a 510(k) for a medical device (surgical kit), not an AI/Machine Learning algorithm. Therefore, there is no "training set" in the context of machine learning.

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

• As there is no AI/Machine Learning algorithm or training set involved, this question is not applicable.

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

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

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

· Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conduction thresholds are defined as 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15 dB difference at individual frequencies.

· Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deadness: SSD). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.

· Baha for SSD is also indicated for any patient who is indicated for an air-conduction contralateral routing of signals (AC CROS) hearing aid, but who for some reason cannot or will not use an AC CROS.

The Cochlear Baha bone conduction hearing system provides an alternate solution for patients who may not benefit from an air-conduction hearing aids. Unlike air-conduction hearing aids, the Baha system utilizes a natural bone conduction pathway to send sound directly to the inner ear (cochlea), bypassing a damaged outer or midle ear. The Baha bone conduction hearing system has non-surgical and surgical options. For the non-surgical option, the external sound processor, which converts acoustic sound into mechanical vibrations, is securely placed behind the ear with a Baha Softband or Baha SoundArc. For the surgical option, the external sound processor is coupled with an abutment (Baha Connect) or magnet (Baha Attract). The mechanical vibrations travel through the abutment or magnet to a small, titanium implant, which is surgically placed into the bone. The titanium implant has an osseointegrated bond with the surrounding bone, allowing transmission of high-quality sound directly to the inner ear.

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

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

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

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

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

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

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Ponto 4 sound processors are intended for the following patients and indications:

· Patient with conductive or mixed hearing losses, who can still benefit from amplification of the sound. The pure tone average (PTA) bone conduction (BC) threshold (measured at 0.5, 1, 2 and 3 kHz) of the indicated ear should be better than or equal to 45 dB HL for use with the Ponto 4 sound processor.

· Bilateral fitting is applicable for most 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 4 kHz, or less than 15 dB at individual frequencies.

· Patients who have a 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 (PTA) air conduction (AC) threshold of the hearing ear should then be better than or equal to 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

· 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 placement of a bone anchored implant is contraindicated for patient below the age of 5.

The Ponto 4 sound processors are intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS) (refer to the Ponto 4 labeling for specific compatible Cochlear models). In addition, selected Cochlear Baha sound processors can be used with the Ponto implant abutment system (refer to the Ponto labeling for compatible Baha sound processor models).

A bone anchored hearing system consists of a sound processor connected to an implant with a skin penetrating abutment. The implant is surgically anchored in the skull bone behind the ear. Vibrations generated by the sound processor are transmitted via the implant directly through the skull bone to the cochlea as bone conduction sound processor has a coupling so that it can be easily connected to and disconnected from the abutment by the user. Alternatively, it can be connected to head band accessories, to function as a conventional bone conductor. Using a computer based fitting system the sound processor can be adjusted to the patient's individual hearing requirements. The Ponto family is intended to be used with either the Ponto implant system or with specific compatible BAHA abutments/implants from Cochlear Bone Anchored Solutions (BAS).

Here's a breakdown of the acceptance criteria and study information for the Ponto 4 sound processor, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes the Ponto 4 as a modification of a previously cleared device (Ponto 3) and relies on demonstrating similar safety and effectiveness. Therefore, the "acceptance criteria" presented are implicitly aligned with the performance and safety characteristics of the predicate device. The Ponto 4's reported performance is stated to be "as expected" and "as safe and effective" as the Ponto 3.

Table 1: Acceptance Criteria and Reported Device Performance

Study Information

The document describes the testing performed to demonstrate substantial equivalence, rather than a standalone clinical study to establish new performance metrics.

1. Sample size used for the test set and the data provenance:

   • The document does not specify a sample size for a "test set" in terms of patient data.
   • The testing described is primarily for device-centric performance verification (electroacoustic and EMC), not clinical data from patients.
   • Data provenance: Not applicable in the context of patient data for a test set, as the testing focuses on the device itself. The studies are described as internal verification tests by the manufacturer, Oticon Medical AB (Sweden).

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

   • Not applicable as the testing is device-centric, not based on expert-adjudicated clinical data to establish a ground truth for a diagnostic or screening algorithm. The "truth" for electroacoustic measurements comes from established physical principles and measurement standards.

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

   • Not applicable for the type of device-centric testing described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not conducted. This device is a hearing aid, not an AI-powered diagnostic or screening tool that would involve human "readers" or AI assistance in interpretation.

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

   • This is not an AI algorithm in the context of medical image analysis or diagnosis. The "standalone" performance refers to the device's inherent electroacoustic, EMC, and functional capabilities, which were indeed tested as described. The performance is assessed based on the device's output and specifications, without continuous human intervention during its operation.

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

   • For the device's performance testing (electroacoustic, EMC), the "ground truth" is based on engineering specifications, physical laws, and established measurement standards. For example, a nominal frequency response or maximum output level would be the "ground truth" against which the device's measured performance is compared.
   • For biocompatibility, the ground truth refers to established standards for medical-grade materials and their safety.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI algorithm in the sense of requiring a training set from clinical data. The "training" for such devices involves product development, engineering design, and iterative testing.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set in the context of machine learning. The design and performance targets for the device are established through engineering design principles, previous device generations (Ponto 3), and relevant industry standards for hearing aids.

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The Cochlear Baha Connect System (Baha sound processors and implant/abutment system) is intended for the following patients and indications for use:

• Patients aged 5 and older
• Patients who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing threshold (measured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the Baha 4 and Baha 5 sound processors, 55 db HL for use with the Baha 5 Power sound processors, and 65 db HL for use with the Baha 5 SuperPower Sound Processors.
• Bilateral fitting is intended for patients who meet the above criterion in both ears, with bilaterally symmetric moderate to severe conductive or mixed hearing loss. Symmetrical bone-conductive thresholds are defined as less than a 10 dB average difference between ears (measured at 0.5, 1, 2, and 3 kHz), or less than a 15dB difference at individual frequencies.
• Patients who suffer from unilateral sensorineural deafness in one ear with normal hearing in the other ear (i.e. Single-sided deafness: 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.

Specific models of the Cochlear Baha abutments can be used with either the Cochlear Baha Connect System or compatible sound processors from Oticon Medical AB. Refer to the Cochlear Baha abutment labeling for a list of compatible Oticon Medical sound processors.

A bone anchored hearing system consists of a sound processor connected to an implant with a skin penetrating abutment. The implant is surgically anchored in the skull bone behind the ear. Vibrations generated by the sound processor are transmitted via the implant directly through the skull bone to the cochlea as bone conduction sound. The BA310 abutments are modifications of the previously cleared BA300 abutments and provide additional sound processor compatibility than the previously cleared abutments. Compared to the currently cleared BA300 and BA400 Abutments, a small "flange" has been added to the upper part of the BA310 Abutment and the core diameter of the abutment has been reduced by 0.7mm. This design allows sound processors from Oticon Medical to snap on the outside of the abutment while maintaining the same snap in coupling design for connection to Baha sound processors.

This document describes the premarket notification for the Cochlear BA310 Abutment and BIA310 Implant/Abutment, a bone-conduction hearing implant system. The submission focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a design modification to the abutment.

Here's an analysis based on your request, highlighting what information is present and absent:

1. Table of Acceptance Criteria and Reported Device Performance

Gaps in information: The document states that performance data "verifies the compatibility" and that "All design requirements were met," but it does not provide specific numerical acceptance criteria (e.g., a minimum rotation torque value) or the quantitative results from the tests. It broadly indicates that the relevant parameters were "tested and verified."

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

Sample Size for the test set: Not specified. The document mentions "non-clinical testing and analysis" but does not detail the number of units or conditions tested.
Data Provenance: Not specified. Given it's a non-clinical/bench testing study for a medical device modification, the data would typically originate from a laboratory setting. It is not a clinical study involving human patients.

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

This information is not applicable and not provided. The "ground truth" concept, in this context, would typically refer to clinical diagnosis or outcome verification against which an AI algorithm's performance is measured. This document describes bench testing of a physical device modification, not an AI algorithm.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert review processes, typically for establishing ground truth for diagnostic accuracy, which is not what this submission is about.

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 information is not applicable and not provided. This submission concerns a physical medical device (a hearing implant abutment) and its bench testing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant here.

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

This information is not applicable and not provided. This document does not describe an algorithm or AI device; it describes a mechanical component of a hearing aid system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable and not explicitly defined in the context of "ground truth" as typically used for AI/diagnostic studies. For this device modification, the "ground truth" would be the engineering specifications and functional requirements for the abutment's mechanical performance and compatibility. The document states that "All design requirements were met," implying these engineering specifications served as the "ground truth" for the non-clinical tests.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This is not an AI/machine learning study, so there is no concept of a "training set."

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

This information is not applicable and not provided. As there is no training set, the establishment of its ground truth is irrelevant.

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