(194 days)
The TinniLogic Mobile Tinnitus Management Device is indicated for use in the temporary relief of tinnitus symptoms. The device is a player to play customized sounds and display professional counseling or education to relieve patients suffering from tinnitus and can be used in a tinnitus management program. The target population is adults (18 years or older). This is a medical device and should only be used with the advice of a physician, audiologist or other hearing healthcare professional.
The TinniLogic Mobile Tinnitus Management Device is a sound player which is designed to assist the qualified healthcare professional in delivering customized sound therapies and professional counseling or education to the patient for treatment. The TinniLogic Mobile Tinnitus Management Device provides idiopathic tinnitus sound treatment based upon sound stimulation during sleeping or waking hours. The TinniLogic Mobile Tinnitus Management Device uses amplitude modulated (SAM) tinnitus pitch matched sounds, narrow-band noise centered at the tinnitus frequency. broad-band noise, pure tone, white noise, natural sounds, and combination of these sounds. The subject device consists of a tablet, a specialized headset, a charger and a charger cable.
The provided text is a 510(k) Summary for the "TinniLogic Mobile Tinnitus Management Device." This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria based on a clinical study for a novel device.
The document explicitly states: "No clinical study is included in this submission."
Therefore, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria from the provided text in the way you've requested. The "device performance" reported here is strictly in the context of non-clinical safety/electrical tests and comparison of technical specifications to predicate devices.
However, I can extract information related to the device's technical specifications and how its performance was assessed in a non-clinical context, which serves a similar purpose in a 510(k) submission (demonstrating equivalence rather than novel efficacy).
Here's the information that can be extracted, framed within the limitations of the provided document:
Acceptance Criteria and Device Performance (Based on 510(k) Equivalence)
The TinniLogic Mobile Tinnitus Management Device (K163094) did not undergo a clinical study to establish novel acceptance criteria. Instead, its acceptance for market clearance is based on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical testing and comparison of technical characteristics. The "performance" in this context refers to its technical specifications matching or being similar to those of the predicate devices, and its compliance with relevant electrical safety and electromagnetic compatibility (EMC) standards.
1. Table of Acceptance Criteria (from predicate comparison) and Reported Device Performance
| Parameter | Acceptance Criteria (based on predicate device range/standards) | Reported Device Performance (TinniLogic) |
|---|---|---|
| Regulatory Information | ||
| Product Code | KLW (matching predicates) | KLW |
| Regulation Number | 21 CFR 874.3400 (matching predicates) | 21 CFR 874.3400 |
| Technical Characteristics | ||
| Maximum Sound Loudness Output | 85 dB SPL - 92 dB SPL (range of predicates) | 90 dB SPL |
| Sound Output Frequency | 100Hz-16KHz (Predicate 1) to 1KHz-14KHz (Predicate 2) | 50Hz~15KHz |
| Electrical Safety Standard | IEC 60601-1 (matching predicates) | IEC 60601-1 |
| EMC Standard | IEC 60601-1-2 (matching predicates) | IEC 60601-1-2 |
| Other Output Performance | Device calibration and maximum output remain valid in various settings of three possible volume controls (demonstrated by testing) | Confirmed through output performance testing |
Note: The "acceptance criteria" in this table are inferred from the demonstrated substantial equivalence to the predicate devices. The device's technical specifications fall within the range or align with the standards met by the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set: Not applicable. No clinical test set or patient data was used for evaluating performance as no clinical study was conducted.
- Data Provenance: Not applicable for clinical data. Non-clinical test data would be from laboratory testing conducted presumably at the manufacturer's facilities in China (Jiangsu BetterLife Medical Co., Ltd.).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No clinical ground truth was established, as no clinical study was conducted.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical study is included in this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a sound player for tinnitus management; it does not involve an algorithm requiring standalone performance evaluation in the context of diagnostic AI. Its performance is related to its sound output characteristics and electrical safety.
7. The Type of Ground Truth Used
Not applicable for clinical ground truth. For non-clinical testing (electrical safety, EMC, output performance), the "ground truth" would be the applicable international standards (IEC 60601-1, IEC 60601-1-2) and the technical specifications of the predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is a sound player and does not use machine learning in a way that would require a "training set" in the context of AI/algorithms generating medical insights.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As no training set was used.
§ 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.