(106 days)
REVE134 is a sound generating software used in a Tinnitus Management Program designed to provide temporary relief for people experiencing tinnitus symptoms. It is intended primarily for adults over 18 years of age, but may also be used for children 5 years of age or older. REVE134 is for use by hearing healthcare professionals who are familiar with the evaluation and treatment of tinnitus and hearing losses. A hearing healthcare professional should recommend that a patient listen to the REVE134 signal for 30 minutes twice a day at the barely audible level (minimally detectable level).
KW EAR LAB'S REVE134 consists of software installed in PC (desktop or laptop computer). REVE134 is fitted to the patient by the hearing healthcare professional. The software enables qualified professional to create customized sounds with specific frequency range for sound therapy/masking. REVE134 software can generate either modulated white noise (233~12912 Hz) or modulated narrow band noises or tones with specific frequency range. One narrow band noise has a frequency range of approximately 1/3 octave.
The provided document is a 510(k) premarket notification from the FDA for a device called REVE134, a Tinnitus Masker. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies or statistical acceptance criteria for the device itself.
Based on the provided text, here's an analysis regarding acceptance criteria and performance studies:
Key Takeaway: The submission relies on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than providing comparative effectiveness studies or detailed quantitative performance metrics of REVE134 itself. The "Performance Data" section states that the software "functioned properly as intended and the performance observed was as expected" based on verification and validation against software and risk management standards, but no specific performance metrics or acceptance criteria are detailed.
Therefore, many of the requested details about acceptance criteria, sample sizes, ground truth establishment, and expert involvement are not explicitly provided or are not applicable in the context of this 510(k) submission, which focuses on substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, explicit numerical acceptance criteria and a table of reported device performance metrics are NOT presented. The submission states: "KW EAR LAB's REVE134 software installed and embedded in PC has been verified and validated according to relevant standards for medical device software and risk management procedure (Fig. 1). In all verification and validation process, KW Ear lab's REVE134 functioned properly as intended and the performance observed was as expected."
This indicates that while internal verification and validation were performed against standards, the specific quantitative "acceptance criteria" for clinical performance (e.g., reduction in tinnitus perception, user satisfaction scores) and the measured performance against those criteria are not detailed in this regulatory filing.
| Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Not Explicitly Stated in Document) |
|---|---|
| The document does not specify quantitative clinical performance acceptance criteria (e.g., specific thresholds for tinnitus reduction, sound generation accuracy beyond "proper functioning"). | The document states the device "functioned properly as intended and the performance observed was as expected" based on internal verification and validation against IEC 62304 and ISO 14971:2007. No specific quantitative performance data (e.g., sound output precision, masking effectiveness scores) is provided. |
2. Sample Sizes Used for the Test Set and Data Provenance
Not applicable for a clinical performance test set, as no such clinical test set is described. The "Performance Data" section refers to software verification and validation against standards, which typically involves testing and debugging, but not a "test set" in the sense of patient data for clinical performance evaluation. The data provenance is also not relevant here as clinical data is not presented.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Since no clinical performance test set with a ground truth is described, there's no mention of experts establishing ground truth. The submission focuses on software engineering and risk management standards.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No. This device is a Tinnitus Masker, a sound-generating software, not an AI-powered diagnostic or assistive tool for human readers (like in medical imaging). Therefore, an MRMC study or AI-assistance evaluation is not relevant to this device's function or the information provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Partially relevant, but not in the context of clinical "performance." The device is essentially "algorithm only" in generating sounds. However, the evaluation described is one of functional verification and validation against software standards (IEC 62304) and risk management (ISO 14971), not a "standalone performance" study measuring efficacy of tinnitus relief in patients or comparing it to a control. The document states: "KW EAR LAB's REVE134 software installed and embedded in PC has been verified and validated according to relevant standards for medical device software and risk management procedure (Fig. 1). In all verification and validation process, KW Ear lab's REVE134 functioned properly as intended and the performance observed was as expected."
7. The Type of Ground Truth Used
Not applicable in a clinical sense. For a device like a Tinnitus Masker, clinical ground truth would typically refer to objective measures of tinnitus (if available) or patient-reported outcomes. However, the performance data provided in the document focuses on internal software verification and validation, where "ground truth" relates to the software meeting its functional specifications and risk management requirements. No clinical ground truth on patient outcomes is presented.
8. The Sample Size for the Training Set
Not applicable. This device is not described as using machine learning or needing a "training set" in the context of AI model development. It's software that generates sounds based on pre-programmed parameters.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no training set for a machine learning model is mentioned, there's no ground truth established for it.
§ 874.3400 Tinnitus masker.
(a)
Identification. A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask ringing in the ears or internal head noises. Because the device is able to mask internal noises, it is also used as an aid in hearing external noises and speech.(b)
Classification. Class II. The special control for this device is patient labeling regarding:(1) Hearing health care professional diagnosis, fitting of the device, and followup care,
(2) Risks,
(3) Benefits,
(4) Warnings for safe use, and
(5) Specifications.