Search Results

The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: x 1. Slight x 2. Mild x 3. Moderate Configuration: x 1. High Frequency -Precipitously Sloping x 2. Gradually Sloping x 3. Reverse Slope x 4. Flat Other x 1. Low tolerance To Loudness

UHS MicroNET Programmable Air Conduction Hearing Aids and Programmer Model Nos .; This hearing aid comes in your choice of models, as follows: Full Concha --P901 Demi Concha --P902 Custom Canal --P903 Mini Canal --P903m Low Profile --P906 CIC CanalMate --P909 All the above models are available in a choice of one of two circuits, the Etymotic DSD K-AMP circuit and the Gennum DSD-DynamEQ II circuit. The hearing aids are programmed using the UHS microNET Programmer, a handheld device. The aids can be fit to hearing impaired individuals with mild to moderate hearing losses. Because of the range of the programming, the aid can fit most all audiogram configurations and has provisions for patients with low tolerance to loud sounds.

The provided document is a 510(k) premarket notification for a medical device, specifically hearing aids, and as such, it does not contain the detailed study information typically found in a clinical trial report or a scientific publication that would include acceptance criteria and specific performance studies.

However, based on the information provided in the document, here's what can be extracted and inferred regarding the "acceptance criteria" for the device to be cleared by the FDA as "substantially equivalent" to a predicate device:

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

The document states:

• "Performance characteristics are Included with each aid. The performance characteristics were obtained using the test procedures outlined in ANSI S.22 (1987)."
• The FDA's letter states: "We have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...".

Therefore, the acceptance criteria by the FDA for this 510(k) submission was achieving substantial equivalence to a predicate device, demonstrated through the device meeting the ANSI S.22 (1987) standard for performance characteristics and aligning with the stated indications for use.

Since the document is a summary and an FDA clearance letter, it does not provide a table with specific numerical acceptance criteria (e.g., SNR, frequency response ranges) that would be detailed in a full testing report. Instead, it broadly states that the device adheres to recognized industry standards.

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 "test set" in terms of subject sample size for a clinical study. The performance characteristics were "obtained using the test procedures outlined in ANSI S.22 (1987)." This standard typically involves objective electroacoustic measurements of the device itself rather than clinical trials with human subjects for 510(k) submissions of this nature, especially for devices similar to those already on the market.

Therefore, there is no stated sample size for a human test set, nor is there information on data provenance (country of origin, retrospective/prospective). The "test set" in this context refers to the physical devices undergoing testing.

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 information is not provided in the document. As this concerns performance testing against an ANSI standard, rather than diagnostic interpretation or complex clinical outcomes, the ground truth would typically be established by calibrated measurement equipment and engineers/technicians following the standard's protocol.

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

This information is not provided in the document, as it likely refers to objective measurements against an ANSI standard rather than expert adjudication of clinical outcomes.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or reported in this document. This type of study is typically associated with AI/CAD systems that assist human operators in interpreting medical images or data, which is not the nature of this hearing aid device.

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

This concept is not applicable to this device. Hearing aids are inherently "human-in-the-loop" devices designed to be worn and used by individuals. The performance reported (compliance with ANSI S.22) is for the device's electroacoustic properties, which is a standalone assessment of the device's functional characteristics.

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

The "ground truth" for the device's performance, as per the submission, is compliance with the ANSI S.22 (1987) standard. This standard dictates the objective electroacoustic performance characteristics (e.g., gain, frequency response, output, distortion) that a hearing aid should meet. The ground truth is therefore based on standardized, objective physical measurements of the device's output and characteristics.

8. The sample size for the training set

No training set is referenced or applicable in this document. This device is a traditional hearing aid, not an AI or machine learning algorithm that requires a training set. The "programming" mentioned refers to adjusting acoustic parameters by a professional, not machine learning model training.

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

As there is no training set for this device, this question is not applicable.

Ask a specific question about this device