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The Jabra Enhance Plus self-fitting hearing aid is intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. No pre-programming or hearing test is necessary. The device is intended for direct-to-consumer sale and use without the assistance of a hearing care professional.

The Jabra Enhance Plus is a wireless, self-fitting air-conduction hearing aid system. It incorporates microphones on the earbuds for audio input into the ear, and it can be controlled wirelessly via Bluetooth Low Energy using the mobile app, the Jabra Enhance, installed on a compatible iPhone, iOS 14 or later. Further control of the earbuds is possible via an on-device user control button on both the Left and Right earbud. In addition to hearing aid functionality for environmental listening, the Jabra Enhance Plus earbuds can be used for placing and receiving telephone calls and for streaming audio from a compatible, Bluetooth compliant mobile device that has been paired with the earbuds. The controls accessible through the Jabra Enhance mobile app and on the earbuds are used to configure parameters, settings, and listening modes of the earbuds. The earbuds integrate a rechargeable 3.7V/15mAh li-ion battery coin cell inside each earbud, and they are recharged by the on-the-go charging case that also serves as a carrying case. The mobile app is connected to the Internet Services that enable remote upgrades to the earbud firmware in support of continued enhancements.

The provided document is a 510(k) Summary for the Jabra Enhance Plus self-fitting air-conduction hearing aid. It outlines the device's characteristics, comparison to a predicate device (Bose Hearing Aid), and the studies conducted to demonstrate its safety and effectiveness for substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state acceptance criteria in numerical targets for all aspects, but rather compares the Jabra Enhance Plus (Subject Device) to a predicate device (Bose Hearing Aid) and relevant standards. The "Discussion" column often acts as a statement of meeting implied criteria (e.g., "Same as predicate," "Comparable to predicate and suitable for the intended user"). Performance is reported against technical standards and clinical equivalence.

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The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily relieve patients suffering from Tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.

The Tinnitus Sound Generator Module is targeted for healthcare professionals, which are treating patients suffering from Tinnitus, as well as conventional hearing disorders. The Tinnitus Sound Generator Module must be done during an in-office visit by a hearing professional participating in a Tinnitus Management Program. If deemed feasible by the hearing professional, subsequent fittings of the Tinnitus Sound Generator Module may be performed remotely and in real time while having live communication via live audio, video and chat on the user's dedicated app.

The Tinnitus Sound Generator (TSG) Module is software that provides a means for healthcare professionals to create a hearing instrument solution that provides temporary relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user (EU) can wear this device in all environments. The fitting of the digital device, which contains the TSG Module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient.

A mobile medical application (app) is available as an optional device to use with the TSG. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app and is part of the Smart3D app. The Smart3D app also enables a Health Care Professional (HCP) to remotely adjust the TSG settings using a Remote Fine Tuning Feature (RFT). The Support for the RFT feature for the TSG Module can be enabled by the doctor, audiologist or other hearing healthcare professional, at the time of first fitting. Afterwards, the doctor, audiologist or other hearing healthcare professional is able to remotely make adjustments to TSG Module settings. RFT is only enabled when the doctor, audiologist or other hearing healthcare professional finds it feasible, based on an initial in-office assessment of the user and communication with the user, and the parent or legal guardian in cases where the user is a minor. Subsequent to the in-office assessment, the user, or the parent or legal guardian in cases where the user is a minor, is required to accept to receive the adjustments via the TSG portion of the Smart3D app, called the Tinnitus Manager.

Compared to the Remote Fine Tuning, available in the predicate device, the subject TSG Module additionally supports Remote Fitting, being used for real time, online adjustments, with live communication with the end user. Support for Remote Fitting is a process where the end user (EU) has a scheduled appointment with the hearing Health Care Professional (HCP) while the EU is at a remote location, like at home. HCP and EU meet via an HCP initiated live audio, live video and chat on the user's Smart3D app, and adjustments can be made to the Hearing Aids per agreement and prescription of the HCP. During this process, the HCP can make multiple adjustments in real time to the Hearing Aids, including TSG, while having live communication with the EU as if they were in the same room. The session is similar to an adjustment session done at the HCP office, but with the EU at a remote location. When the final settings are decided, a fitting data package is generated by the HCP, and the Hearing Aids are updated remotely while having the live session with the EU. Subsequent to the in-office assessment, the user, or the parent or legal guardian in cases where the user is a minor, is required to accept the adjustments. The Remote Fitting is only made available and technically working for follow-up sessions when found feasible by the HCP, and not available for the initial first-time fitting of the Hearing Aids, that has to take place at the HCP office.

The provided text describes a 510(k) premarket notification for a Tinnitus Sound Generator Module. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML medical device submissions.

The document states that the Tinnitus Sound Generator Module is software embedded into a digital hearing instrument. The 510(k) is specifically for a Special 510(k), indicating a modification to an already cleared device (the predicate device K180495).

The primary focus of this 510(k) is the addition of "Support for Remote Fitting" to the existing TSG Module. The document explicitly states:

• "The TSG software is unchanged, but now claims support for the added Remote Fitting feature." (Page 6)
• "The acceptance criteria were not altered, and no additional types of evaluation was needed." (Page 6)

Therefore, the study design elements you've requested (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) are typically associated with performance studies for novel devices or significant algorithmic changes in AI/ML products. This submission is for a feature addition to existing software that, according to the manufacturer, uses "already implemented services" and does not change the "basic operating principle of the TSG module" or raise "new or different questions of safety or effectiveness."

Instead of a clinical performance study with acceptance criteria around diagnostic accuracy or efficacy, the document describes verification and validation activities focused on the software and system functionality related to the new remote fitting feature.

Here's a breakdown of what is reported, in the context of your questions, and what is not:

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

• Acceptance Criteria: The document states: "The acceptance criteria were not altered, and no additional types of evaluation was needed." This implies that the original acceptance criteria for the TSG Module itself still apply, but these are not detailed in the document. For the new remote fitting feature, the acceptance criteria appear to be an implicit set of functional and usability requirements focused on the safe and effective operation of the remote fitting process.
• Reported Device Performance:
  • "The result of the system verification show that tests has passed with no defects critical for function, form, intended use, or pose any user risks." (Page 7)
  • "The successful validation activities related to the Support for Remote Fitting feature were conducted to show that human factors and usability are safe and effective as the predicate device." (Page 7)

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

• Test Set Sample Size: Does not apply in the context of a typical clinical performance study for an AI/ML diagnostic. The "testing" described is system verification and validation. There's no mention of a "test set" of patient data in the sense of clinical images or physiological signals.
• Data Provenance: Not applicable. The "software design model" and "verification and validation method" used are "well-established" and the "same as used in the previously cleared 510(k)." (Page 6)

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

• Not applicable. There is no "ground truth" establishment described in the sense of expert annotation of patient data, as this is a software update for a sound generator, not a diagnostic AI.

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

• Not applicable. No expert adjudication process is described.

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. The device is a "Tinnitus Sound Generator Module" creating sounds for temporary relief, not a diagnostic aid that would assist human readers in interpreting medical images or data. The human interaction described is with healthcare professionals for fitting adjustments, not "readers" of medical cases.

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

• No. This is software within a hearing aid system, designed to be used by healthcare professionals and patients. Standalone performance as an algorithm without human interaction or device integration is not relevant for this type of device.

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

• Not applicable. The ground truth for a Tinnitus Sound Generator is its ability to generate specific sounds and for the new feature, to allow remote fitting of those sounds safely and effectively. This is assessed through system functional tests, rather than clinical ground truth from patient data.

8. The sample size for the training set

• Not applicable. This is not a machine learning device that requires a "training set" of data in the typical sense. It is software that generates sounds and facilitates remote adjustments.

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

• Not applicable.

Summary of Device Performance and Evidence Provided:

The evidence provided for this 510(k) consists primarily of engineering verification and validation efforts designed to demonstrate that the new remote fitting feature works as intended and does not negatively impact the safety and effectiveness of the existing Tinnitus Sound Generator Module.

• Risk Analysis: Performed to demonstrate that all risks are mitigated to an acceptable level.
• Verification & Validation: "Necessary verification and validation activities" performed to show that "design outputs... meet the design input requirements" for the remote fitting feature.
• System Verification: Included "end-to-end testing and interoperability performance testing" of the integrated system (Hearing Instrument hardware, TSG Module, App, Fitting Software).
• Validation for Remote Fitting: Focused on "human factors and usability" to show they are "safe and effective as the predicate device."

In essence, for this specific 510(k) submission, the "study" proving the device met "acceptance criteria" was a comprehensive software and system verification and validation process demonstrating that the updated software behaves functionally as expected and does not introduce new safety concerns for the remote fitting functionality, relying on the already cleared predicate for the core TSG module's performance.

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The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily relieve patients suffering from Tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older. The Tinnitus Sound Generator module is targeted for healthcare professionals, which are treating patients suffering from Tinnitus, as well as conventional hearing disorders. The Tinnitus Sound Generator module must be done by a hearing professional participating in a Tinnitus Management Program.

The Tinnitus Sound Generator (TSG) Module provides a means for healthcare professionals to create a hearing instrument solution that provides temporary relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user (EU) can wear this device in all environments. The fitting of the digital device, which contains the TSG Module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient. A mobile medical application (app) is available as an optional device to use with the TSG. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app and is part of the Smart3D app. The subject TSG Module has a new feature. i.e., Remote Fine-tuning (RFT) communication software (PC Interface software) that communicates with a healthcare professional's Fitting Software (FSW) via the user's Smart3D app and is part of the general software on the digital signal processor in GN's legally marketed, class II, 510(k) exempt Hearing Aids (Reference Device). The RFT communication software in the Reference device enables the healthcare professional to remotely adjust the Hearing Aid settings for these legally marketed, class II, 510(k) exempt Hearing Aids, including Hearing Aids that are compatible with the predicate TSG Module and the new TSG Module. Similarly, the new TSG Module has a PC Interface Software modification that supports fine tuning of TSG Module settings from a remote location. The new TSG Module's PC Interface Software modification opens a bridge between the general RFT function on the Hearing Aid's digital signal processor and the TSG feature settings, that are also available for adjustments via the user's Smart3D app. Therefore, the RFT communication software part of the general software on the Hearing Aids containing the new TSG Module is also part of new TSG Module device. The Health Care Professional (HCP) can make all of the same changes (Volume/loudness, Pitch/frequency. Nature sounds, and Amplitude modulation) that the user can make. Additionally, the HCP can turn the TSG/tinnitus masker on or off and can set and adjust the Volume Control range and environmental steering sounds. The TSG Volume Control range feature is available only to the HCP. This feature allows the HCP to set a limit on the TSG volume range an EU can adjust. This feature is specifically designed for the safety of the EU, ensuring that an EU cannot increase the TSG volume above a level determined appropriate by the HCP. The system can in no case exceed 100dB SPL for TSG. The TSG Volume Control range has a range of +12dB to -6dB from the TSG fitting by the HCP and can be found in the FSW under the Fitting / Manual Controls / Volume Control Range. For example, if the HCP sets the TSG Volume Control range to +6dB to -6dB, this means an EU cannot set the TSG volume more than 6dB above or below the initial fitting.

The provided text is a 510(k) summary for the Tinnitus Sound Generator Module (K180495). It details the device, its intended use, comparison with a predicate device, and performance data. However, it does not include specific quantitative acceptance criteria or a detailed study proving the device directly meets those criteria with statistical data.

Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device (Tinnitus Sound Generator Module, K181586) and a reference device (LiNX3D hearing aid) by showing that the minor modifications do not raise new questions of safety or effectiveness.

Therefore, the following information is extracted and where specific details are not present, it is noted.

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

The document does not explicitly present quantitative acceptance criteria or performance metrics for the Tinnitus Sound Generator Module itself (e.g., how effectively it reduces tinnitus symptoms in a specific percentage of patients). Instead, it relies on demonstrating that its design, performance, and technological characteristics are safe and effective, and do not differ significantly from a legally marketed predicate device.

The performance data described focuses on verification and validation of the system and its RFT feature, rather than direct clinical efficacy trials with acceptance criteria.

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

The document does not specify a separate "test set" with a given sample size in the context of clinical data or patient studies. The performance data refers to verification and validation activities of the device's design and software, and electromagnetic compatibility (EMC) testing. These are primarily engineering and technical tests.

• Sample Size: Not applicable in a clinical sense. The hardware and software components of the system (Hearing Instruments, App, Fitting Software) were tested.
• Data Provenance: The EMC testing was performed by DEKRA Testing and Certification, S.A.U. in Spain. The nature of the other verification and validation activities (e.g., system end-to-end testing) suggests they were conducted internally by GN Hearing. The document does not specify if any user data was collected for these tests, nor its country of origin or whether it was retrospective or prospective.

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 is not applicable as the document describes technical verification and validation, and EMC testing, rather than a study requiring expert consensus for a ground truth derived from clinical data. The "ground truth" for these tests would be compliance with engineering standards and design requirements, as determined by qualified engineers and testers.

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

This is not applicable. The verification and validation activities described are technical and engineering-focused, not clinical studies requiring adjudication of results based on expert review.

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

This is not applicable. The Tinnitus Sound Generator Module is a therapeutic device that generates sounds for tinnitus relief, not an diagnostic AI tool for human readers. No MRMC study was mentioned.

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

The device is a "Tinnitus Sound Generator Module" embedded within a digital hearing instrument platform. It is designed to be used in conjunction with a "Tinnitus Management Program" and involves a healthcare professional for fitting and potentially remote fine-tuning.

While the module generates sounds (an algorithmic function), it is not described as a "standalone algorithm" in the typical sense of AI performing an independent diagnostic or predictive task. It functions as part of a system with human intervention (HCP fitting, patient use, remote adjustments).

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

For the technical performance data, the "ground truth" refers to compliance with established engineering and safety standards (e.g., IEC standards for EMC) and the device's design input requirements. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for a clinical study within this 510(k) summary. The summary focuses on demonstrating substantial equivalence through technical comparisons and verification activities.

8. The sample size for the training set

This is not applicable. The document describes a medical device, not a machine learning or AI model that typically requires a "training set" of data.

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

This is not applicable, as there is no mention of a training set for a machine learning or AI algorithm.

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The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from Tinnitus. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older.

The Tinnitus Sound Generator module is targeted for healthcare professionals, which are treating patients suffering from Tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound Generator module must be done by a hearing professional participating in a Tinnitus Management Program.

The Tinnitus Sound Generator provides a means for healthcare professionals to create a hearing instrument solution that provides relief for Tinnitus patients. This software solution is embedded into a digital hearing instrument platform, so that the end-user can wear this device in all environments. The fitting of the digital device, which contains the Tinnitus Sound Generator module, is performed by a healthcare professional, in order to meet the exact needs of the Tinnitus patient.

A mobile medical application (app) is available as an optional device to use with the Tinnitus Sound Generator. The mobile medical app allows the user to adjust the hearing aid within the limits set by the healthcare professional during fitting of the hearing aid. The app is known as the TSG Tinnitus Manager app.

This document describes a 510(k) premarket notification for a Tinnitus Sound Generator Module (K181586). However, the document does not describe acceptance criteria for algorithmic performance or a study proving the device meets such criteria.

Instead, it focuses on demonstrating substantial equivalence to a predicate device (K150171) based on:

1. Technological characteristics comparison: Highlighting minor software advancements that improve functionality with minimal risk.
2. Performance Data: Stating that risk analysis, verification, and validation activities were conducted to show the modified device meets design input requirements and is substantially equivalent. These activities appear to be internal and relate to the device's design and functionality rather than clinical efficacy.

Therefore, I cannot provide the requested information regarding acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The document does not contain details of such a study or information for establishing those criteria.

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