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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 contact forte Alpha is a Processor and is intended for use with the Sophono Headband or Softband (no age limitations), or with the Sophono Magnetic Implant (patients 5 years of age and up) for the following patients and indications:

• Patients with conductive or mixed hearing losses, who can still benefit from amplification of sound. The pure tone average (PTA) bone conduction (BC) threshold for the indicated ear should be better than 45 dB HL (measured at 0.5, 1.2, and 3 kHz).

• 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, who for some reason will not or cannot use an Air Conduction Contralateral Routing of Signal (AC CROS). The pure tone average (PTA) air conduction (AC) threshold of the hearing ear should be better than 20 dB HL (measured at 0.5, 1, 2 and 3 kHz).

The contact forte Alpha Processor is a sound processor that converts sound into mechanical vibrations. The sound processor is magnetically connected to a Sophono Headband, Sophono Softband or Sophono Attract Magnetic Spacer by the integrated metal disk. Sound enters the audio processor through the microphones, which then goes through a DSP chip for signal processing. The output of the DSP chip drives an electromechanical transducer, which converts the signal into mechanical vibrations. These vibrations are transferred to the patient's skin through the Sophono Headband, Sophono Softband or the Sophono Attract magnetic spacer. The vibrations are carried through the patient's skin and skull to the cochlea where they are perceived as sound. The device is designed for use on either the right or left side application. The device has a "oval" housing with a symmetrical design ( for right or left side application). The material used: Plastic contact with intact skin;

The FDA 510(k) Clearance Letter for the "contact forte Alpha" bone-conduction hearing aid (K243041) outlines performance data demonstrating the device's substantial equivalence to its predicate, the Sophono Alpha 2.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly present a formal table of quantitative acceptance criteria with corresponding performance numbers for the contact forte Alpha versus the Sophono Alpha 2. Instead, it relies on qualitative statements of equivalence and "good concordance" for certain measurements. The core acceptance criterion seems to be demonstrating comparable performance and no significant difference in key audiometric and output parameters compared to the predicate.

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

• Sample Size for Field Tests: 5 patients.
• Data Provenance: The document states "Field testing was conducted with five patients". Given the applicant, BHM-Tech Produktionsgesellschaft mbH, is located in Austria, and the device is manufactured there, it is highly probable the field tests were conducted in Austria or a similar European setting. The trials are implicitly prospective in nature, as they involve testing the contact forte Alpha in real-world conditions on human subjects.

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

The document does not explicitly state the number or qualifications of experts used to establish the "ground truth" for the field test data beyond the general statement that "audiometric thresholds and speech perception thresholds" were assessed. For a hearing device, establishing ground truth would typically involve audiologists performing standardized audiological assessments. The document implies a direct comparison of the subject device and predicate on the same individuals, where the individuals' own established hearing thresholds serve as a baseline, and the objective measurements (audiometric thresholds, speech perception thresholds) and subjective reports are the core data points.

4. Adjudication Method for the Test Set:

The document does not describe any formal adjudication method beyond comparing the subject and predicate devices on the same patients and collecting objective measurements and subjective feedback. There is no mention of "2+1" or "3+1" methods typically used for image-based diagnostics. The comparison is direct and within-subject for the field test.

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 to this device. The contact forte Alpha is a bone-conduction hearing aid, not an AI-assisted diagnostic tool where human readers/interpreters would "improve" with AI assistance. The performance evaluation focuses on the device's ability to amplify and transmit sound comparably to a predicate device, as perceived by patients and measured by audiometric tests.

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

This is not applicable in the traditional sense for this device. The "performance" of a hearing aid is inherently human-in-the-loop, as its function is to assist human hearing. However, the document does describe non-clinical tests such as "Magnetic Retention forces" and "Output Level Measurements" which are standalone assessments of the device's physical and acoustic properties without a human user. These non-clinical tests were performed independently of human perception.

7. The type of ground truth used:

The ground truth for the performance evaluation in the clinical field tests consisted of:

• Objective Audiometric Measurements: "Audiometric thresholds and speech perception thresholds" measured with both the predicate and subject devices. This is a form of objective functional assessment.
• Subjective User Reports: "The patients reported that they did not notice any subjective difference in hearing between the two devices." This is outcomes data based on patient perception.
• Technical Specifications/Measurements: For non-clinical tests, the "ground truth" is adherence to predefined engineering specifications and comparison against the predicate's known performance for parameters like "Magnetic Retention forces" and "Output Level Measurements."

8. The sample size for the training set:

The document does not specify a training set size. This device is a hearing aid, not an AI/machine learning model that typically requires a large training dataset for model development. The development and validation likely followed traditional engineering design and testing principles, not machine learning paradigms involving distinct training and test sets in the AI context.

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

As there's no mention of a training set in the context of an AI/ML model, this question is not applicable. The "ground truth" for the device's design and development would stem from established audiology principles, acoustic engineering standards, and the performance characteristics of the predicate device.

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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 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 ADHEAR system is intended to treat patients of all ages with conductive hearing loss or single-sided deafness via bone conduction. The ADHEAR system is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband or an adhesive adapter that is placed behind the auricle.

Indications:

· Unilateral or bilateral conductive hearing loss, either chronic or temporary.

The pure tone average bone-conduction hearing threshold (measured at 0.5. 1. 2, and 3 kHz) should be better than or equal to 25 dB HL.

· Single-sided deafness (i.e. unilateral profound sensorineural deafness) with normal hearing on the contralateral side. 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

The ADHEAR system includes a bone conduction audio processor that can be retained on the head with an adhesive adapter or by the headband situated over the mastoid behind the auricle. The ADHEAR system is intended to be used during waking hours. While the adhesive adapter is attached to the skin for 3 to 7 days and then replaced, the audio processor is removed at night. Both the audio processor and the adhesive adapter are necessary components for the system to work. Together the components work as one system to deliver vibrations to the mastoid bone in order to conductively transmit sound to the inner ear for patients with conductive hearing loss or single sided deafness via bone conduction.

The ADHEAR system consists of an adhesive adapter sitting behind the auricle and an audio processor mounted on the attachment. The audio processor contains microphones and signal processing technology as well as a battery. It detects, processes, amplifies and finally transmits sound to the adhesive adapter which transmits vibrations to the mastoid which conducts sounds to the inner ear. The audio processor is equipped with a push button that allows the user to switch between 4 pre-defined settings. A colour sleeve is provided for pediatric use. It features a tamper-proof battery door and dampens potential drops of the processor unit.

The ADHEAR system contains the following components:

• . ADHEAR Audio Processor (model 701)
• Package of ADHEAR Adhesive Adapters
• . ADHEAR Positioning Tool
• ADHEAR Headband
• . Retention clip
• ADHEAR Sleeves

This document is a 510(k) Premarket Notification for the ADHEAR System, a bone conduction hearing device. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Based on the provided text, a conventional "study" demonstrating that a device meets acceptance criteria in the context of AI/ML performance (e.g., accuracy, sensitivity, specificity) is not present. The device in question is a physical hearing aid system, not an AI/ML algorithm for image interpretation or diagnosis.

Therefore, many of the requested items related to AI/ML performance studies (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this specific submission.

The document states:
"No clinical testing was needed to support the safety, performance, and substantial equivalence of the ADHEAR System to the predicate devices. All devices are bone conduction hearing aids and all aspects to ensure consistent and safe performance can be shown through non-clinical bench testing." (Page 6)

This confirms that the acceptance criteria and proof of meeting them are based on engineering and safety standards, not clinical performance metrics typically associated with AI/ML systems.

However, I can extract information related to the types of testing and the conclusions regarding the device's performance against its design specifications and relevant standards, which serve as "acceptance criteria" for a hardware medical device.

Here's a breakdown based on the information available:

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

The document describes types of testing performed and concludes that the device complies or meets these criteria. It does not provide specific numerical targets or results in a table format for each criterion. Instead, it offers generalized statements of successful testing.

"The collective results of the non-clinical testing demonstrate that the ADHEAR System meets the established specifications to ensure consistent and safe performance for its intended use." (Page 6) |
| Software Verification and Validation | "Software verification and validation testing were conducted and documentation was provided... The software for this device was considered as a 'minor' level of concern, since failures or latent flaws in the (optional) software are unlikely to result in any harm to the patient or operator." (Page 6) |

Regarding the other requested information:

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

• Not applicable for AI/ML performance studies. The testing described is hardware and software validation/verification, and biocompatibility, which typically uses defined engineering samples or batches, not "test sets" in the AI/ML sense. No patient data or clinical trial data is mentioned.

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

• Not applicable. Ground truth in the AI/ML sense (e.g., expert annotations of medical images) is not relevant here as no such clinical image interpretation or diagnostic study was performed. The "ground truth" for the non-clinical tests would be the established engineering specifications and international standards.

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

• Not applicable. No expert adjudication of clinical data was performed.

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

• Not applicable. This device is a hearing aid, not an AI-assisted diagnostic tool for human readers. No MRMC study was performed or required.

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

• Not applicable. There is no standalone AI algorithm whose performance is being evaluated independently of human interaction. The device's function is to transmit sound, and its standalone performance is evaluated through the non-clinical bench tests (e.g., frequency response, gain).

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

• For the non-clinical tests, the "ground truth" implicitly are the established engineering design specifications, safety standards (e.g., IEC 60601-1), and biocompatibility standards (ISO 10993-1). Tests were conducted to verify the device performed according to these pre-defined requirements.

8. The sample size for the training set

• Not applicable. This device is hardware with embedded software, not a machine learning model trained on a dataset.

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

• Not applicable. No training set for an AI/ML model.

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The Cochlear Baha® SoundArc is intended for test situations and for patients who cannot or choose not to have an implant for the following indications for use:

· Patients of any age who have a conductive or mixed hearing loss and can still benefit from sound amplification. The pure tone average bone-conduction hearing thressured at 0.5, 1, 2, and 3kHz) should be better than or equal to 45 dB HL for use with the BP100, Baha 4 and Baha 5 sound processors, 55 dB HL for use with the BP110 Power and Baha 5 Power sound processors, and better than or equal to 65 dB HL for use with the Cordelle II and 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 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. Singlesided deafness: SSDTM). Normal hearing is defined as a pure tone average air-conduction hearing threshold (measured at 0.5, 1, 2, and 3 kHz) of better than or equal to 20 dB HL.

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

Baha SoundArc is an encapsulated spring wire that wraps around the back of the head and sits behind and above the ears. SoundArc is designed with a symmetrical disc holder that holds the Baha sound processor in place, and is compatible with existing Baha sound processors. The design of SoundArc enables the Baha device to be placed against the skull for operation without the need for a Baha implant to be placed.

The provided text describes the Cochlear™ Baha® SoundArc, a headband for bone conduction hearing aids. However, it does not contain specific acceptance criteria, detailed study results, or the methodological details typically found in a comprehensive study report. The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device. As such, it focuses on asserting equivalence rather than presenting an in-depth performance study with quantitative acceptance criteria and detailed results.

Therefore, I cannot fulfill all parts of your request with the provided information. I will, however, extract all available relevant details regarding "performance data" and "study" aspects.

1. Table of acceptance criteria and the reported device performance

No explicit quantitative acceptance criteria or detailed device performance metrics (e.g., specific dB improvements, failure rates with thresholds) are provided in the document. The document states that "Substantial equivalence to the predicate system was accomplished through functional and performance tests, design and specification analysis, and biocompatibility evaluation." The conclusion is that "the Baha SoundArc is functionally equivalent to the predicate system."

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

The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "functional and performance tests" without providing these details.

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. Ground truth establishment and expert involvement are not detailed.

4. Adjudication method for the test set

This information is not provided in the document.

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 MRMC comparative effectiveness study is mentioned, nor is there any mention of "human readers" or "AI assistance." The device is a bone conduction hearing aid attachment, not an AI diagnostic tool.

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

This concept is not applicable to a physical medical device like a bone conduction hearing aid attachment. The performance would be related to mechanical, acoustical, and biocompatibility aspects, not software algorithms.

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

The document does not specify the type of "ground truth" as typically defined for diagnostic AI/imaging devices. For this type of device, performance is likely assessed against established engineering standards for hearing aids and biocompatibility standards. The basis for evaluating "functional equivalence" would be direct measurement of sound transfer, comfort, durability, and biocompatibility, not a "ground truth" derived from expert consensus or pathology in a diagnostic sense.

8. The sample size for the training set

This information is not applicable or provided. The device described is a physical product, not a machine learning algorithm that requires a "training set."

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

This information is not applicable or provided, as there is no mention of a training set for an algorithm.

Summary of the Study Mentioned (from the provided text):

The document describes a "performance testing" activity.

• Objective: To demonstrate "substantial equivalence" of the Cochlear™ Baha® SoundArc to the predicate Baha Softband and existing Baha sound processors.
• Methodology: Performance testing was conducted based on a comparison between the proposed SoundArc and the legally marketed Softband and current Baha sound processors. This involved:
  • Functional tests
  • Performance tests
  • Design and specification analysis
  • Biocompatibility evaluation
• Results/Conclusion: "The results demonstrated the Baha SoundArc is functionally equivalent to the predicate system." New materials were also found to be "biocompatible and safe for human use" when evaluated per ISO 10993-1.

Missing Information:

The provided text, being a 510(k) summary, is intentionally brief and does not include the detailed scientific or engineering studies that would contain the specific quantitative acceptance criteria, exact methodologies, raw data, sample sizes, and expert qualifications for ground truth that your request asks for. These details would typically be found in the full technical documentation submitted to the FDA, but not in the public 510(k) summary.

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Intended use:

The Ponto 3 sound processors are intended for improvements with conductive or mixed hearing losses, whether unilaterally or bilaterally fitted, or for those with single sided deafness.

Indications for use:

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower 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 3 sound processor, 55 dB HL for use with the Ponto 3 Power sound processor 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.

· Indicated for 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 3, Ponto 3 Power and Ponto 3 SuperPower 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 3 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 3, Ponto 3 Power and Ponto 3 SuperPower are modifications of the previously cleared Ponto Plus and Ponto Plus Power (K132775) and represent three latest sound processor models in the Ponto bone anchored hearing system. (Hereinafter referred to as the Ponto 3 sound processors or as the Ponto 3 family when referring to all three models and Ponto 3, Ponto 3 Power and Ponto 3 SuperPower when referring to the 3 different 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. The 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 3 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).

The Ponto 3 family incorporates Inium Sense platform that is also used in the predicate Oticon A/S air conduction hearing aids legally marketed as class II. 510(k)-exempt devices. With the Injum Sense platform the microphone directionality system is updated. Furthermore, for Ponto 3 wireless transmission is enabled allowing for binaural signal processing.

In addition to the regular and power version sound processors, the Ponto 3 family introduces a SuperPower version with UltraDrive, consisting of a redesigned amplifier and optimized transducer. Ponto 3 SuperPower provides equivalent maximum force output (MFO) as the Baha Cordelle II, previously cleared through K080363, and thus expanded indication up to and including 65 dB HL is proposed.

This submission also includes minor modifications to the previously cleared accessories Genie Medical fitting software, Soft band and Streamer.

This document is a 510(k) premarket notification for the Ponto 3, Ponto 3 Power, and Ponto 3 SuperPower hearing aid devices. It aims to demonstrate substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here relate to demonstrating substantial equivalence with predicate devices, rather than specific performance metrics against a fixed standard. The "acceptance criteria" are implied by the comparisons made to predicate devices and the absence of new safety/efficacy concerns.

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 describes functional testing and firmware validation for the Ponto 3 sound processors.

• Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical trials. The testing seems to be primarily bench testing on the devices themselves.
• Data Provenance: Not applicable as it primarily describes bench testing, not patient data from a specific country or whether it was retrospective/prospective.

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

Not applicable. The ground truth for this submission is based on engineering specifications and performance measurements against established standards for hearing aids and comparison to predicate devices, rather than expert interpretation of a clinical dataset.

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

Not applicable. There is no mention of a human adjudication method, as the testing described is technical/bench-based.

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

Not applicable. This device is a hearing aid, not an AI-powered diagnostic tool requiring human reader studies.

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

This refers to the performance of the device itself (hearing aid) without a human "in-the-loop" as a diagnostic interpreter. The "Performance data" section (Section 5) describes standalone performance testing:

• Ponto 3 SuperPower underwent EMC emissions, immunity, and ESD tests.
• Electroacoustical verification was conducted for Ponto 3 SuperPower (battery voltage, current consumption, frequency range, Peak OFLs, THD, EIN).
• Current consumption and battery voltage were verified for Ponto 3 and Ponto 3 Power.
• Bench tests were conducted to verify binaural coordination and updated microphone directionality system.
• Maximum output force measurements were done for Ponto 3 SuperPower.

These indicate standalone testing of the device's technical specifications and performance.

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

The ground truth for demonstrating substantial equivalence is based on:

• Engineering Specifications and Performance Standards: The device's technical performance (e.g., EMC, electroacoustical output, MFO) against established industry standards for hearing aids.
• Predicate Device Performance: Comparison to the known and cleared performance characteristics of the Ponto Plus sound processors, Ponto Plus Power, Baha Cordelle II, and existing Class II 510(k)-exempt Oticon A/S air conduction hearing aids.
• Functional Equivalence: Demonstrating that new features (binaural signal processing, updated microphone directionality) are functionally equivalent to those in legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is a medical device (hearing aid), not an AI algorithm that requires a training set of data.

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

Not applicable, as no training set is used for this type of device.

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