(86 days)
The ANM T30 CR® Tinnitus Therapy System is intended to provide relief from the disturbance of tinnitus while using the system, and with regular use (over several months) may provide relief to the patient when not using the system.
The ANM T30 CR® Stimulator is a patient device for home use.
The ANM T30 CR® Stimulator is fitted and programmed by a qualified healthcare professional familiar with tinnitus treatment.
Stimulation needs to be applied for several hours a day over a period of weeks or months. The target population is adults over 18 years of age.
The ANM T30 CR® is a computer-controlled system for tinnitus therapy is provided to the patient by individualized, ambient acoustic tones. The system consists of four components:
ANM T30 CR® Programmer (computer) including the tinnitus analysis software ANM T30 CR® SW: The ANM T30 CR® Software is used to measure the tinnitus, adjust the individual therapeutic stimulation signals and program the patient device (ANM T30 CR® Stimulator).
ANM T30 CR® Patient Console: The ANM T30 CR® Patient Console is connected to the ANM T30 CR® Programmer and is used by the patient to adjust the parameters specific to his/her tinnitus (frequency and loudness) during tinnitus measurement and stimulation signal adjustment.
ANM T30 CR® Stimulator (patient device): The stimulator is used by the patient for the application of the therapeutic stimulation signal. It has a rechargeable battery for the energy supply and electronic components to generate the stimulation signal.
ANM T30 CR® Earphones: The ANM T30 CR® Earphones are to be connected either to the ANMT30 CR® Patient Console to measure the tinnitus and adjust the stimulation signal or to the ANM T30 CR® Stimulator to apply the stimulation signal.
The provided 510(k) summary for the ANM T30 CR® Tinnitus Therapy System does not contain acceptance criteria or a study that proves the device meets specific performance criteria through clinical data.
Instead, it relies on nonclinical verification and validation testing to establish substantial equivalence to predicate devices. This type of submission generally aims to demonstrate that a new device is "as safe, as effective, and performs as well as or better than" devices already on the market, rather than proving a specific clinical efficacy threshold.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, there are no explicit quantitative acceptance criteria or detailed reported device performance in terms of clinical outcomes. The submission focuses on demonstrating equivalence to predicate devices through technical specifications and intended use.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Explicitly Stated in Document) |
|---|---|
| Not explicitly stated in terms of measurable clinical outcomes or performance thresholds. | "The testing shows that the ANM T30 CR® System is as safe, as effective and performs as well as or better than the predicate devices identified in the above Comparison Table." |
| Compliance with ISO-10993 biocompatibility requirements for patient contact parts | Patient contact parts are manufactured from materials that meet ISO-10993 requirements (tested by suppliers). |
| Compliance with general electrical safety requirements | Meets applicable general electrical safety requirements of IEC 60601-1 and IEC 60601-1-2. |
| Maximum output within safety limits (with professional oversight) | Maximum output is 80 dB(A) (software-controlled), can be exceeded to 115 dB(A) with consent of a qualified healthcare professional. Warnings for OSHA 1910.95 given. |
| Frequency Range | 90 Hz - 13 kHz |
| Audio Signal Technology | Digital |
| Medium | Flash Memory |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable / Not provided. The submission focuses on nonclinical testing and comparison to predicate devices, not on a clinical test set with human subjects.
- Data Provenance: Not applicable / Not provided. The "testing" mentioned is described as "nonclinical verification and validation testing activities," implying laboratory or engineering tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable / Not provided. Since there's no clinical test set with human subjects requiring ground truth establishment, this information is not relevant to the presented data.
- Qualifications of Experts: Not applicable / Not provided.
4. Adjudication method for the test set
- Adjudication Method: Not applicable / Not provided. No clinical test set requiring adjudication 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
- MRMC Study: No. This device is a tinnitus therapy system that delivers acoustic tones, not an AI-powered diagnostic device requiring human reader interpretation or assistance.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not explicitly described in terms of clinical outcomes. The device itself is designed for "standalone" operation by the patient after programming by a healthcare professional, but there's no clinical study described that evaluates the device's performance in isolation without human interaction in a research context. The "Summary of performance data" refers to nonclinical verification and validation testing.
7. The type of ground truth used
- Type of Ground Truth: Not applicable / Not provided for clinical performance. For the nonclinical verification, the "ground truth" would likely be engineering specifications, compliance standards (e.g., ISO, IEC), and functional requirements for hardware and software.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable / Not provided. This device is not described as involving machine learning or AI that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable / Not provided. As noted above, the device does not appear to utilize machine learning or AI requiring a training set.
§ 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.