Search Results

The Entomed SA 201/202/203/204 series of audiometers are screening and diagnostic audiometers used to determine hearing thresholds and assist to diagnose hearing loss. The audiometer can be used on the majority of adults and children (from 4 years of age and upwards). The test person has to be able to understand the basic principles of the test method when explained by the operator.

The SA 201/202/203/204 audiometers are electroacoustic devices that produces controlled levels of test tones and signals. The SA201/202 are IEC 60645 Type 4 Pure Tone Audiometers and the SA203/204 Diagnostic Audiometers are IEC 60645 Type 3 Audiometers. The SA201/202 are manual pure tone air conduction, screening audiometers. SA202 has the additional capability to perform automatic pure tone audiometry. The SA203/204 are both automatic air and bone conduction audiometers with synchronized masking possibility in order to avoid overhearing to the not tested ear. The SA 204 has the additional capability of using speech-testing. Both can be operated manually if required. All models can be used for determination of hearing thresholds and assist to diagnose hearing loss. All models, 201/202/203/204 have a built-in microphone for easier communication with the test person. Furthermore they all have outputs for TDH39, Sennheiser HDA200 and EARtone 5A insert ear phones. SA203/204 have outputs for B71 Bone Conductor and Free-field system (optional).

The provided text describes the Entomed SA201/202 Screening Audiometer and SA203/204 Diagnostic Audiometer. It focuses on comparing these new devices to predicate devices (Interacoustic AD229b and GSI 61 Clinical Audiometer) to establish substantial equivalence, rather than detailing a specific study to prove the device meets acceptance criteria through performance metrics like sensitivity or specificity.

The acceptance criteria here are implicitly meeting or exceeding the performance characteristics outlined in various international standards for audiometers, as well as demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by adherence to international standards for audiometers and comparability to predicate devices. The "reported device performance" is essentially a statement of conformity to these standards and the detailed comparison to the predicates.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical "test set" in the traditional sense of patient data for evaluating performance metrics like sensitivity or specificity. Instead, the "study" demonstrating performance is a technical comparison to legally marketed predicate devices and a declaration of conformity to established audiometry standards. There is no mention of patient data, sample sizes, or data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided. The "ground truth" for this submission is adherence to established technical standards and the characteristics of existing predicate devices. No expert review of a clinical test set is described.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to international standards, not on statistical improvements in human reader performance with or without AI assistance. The device in question is an audiometer, a diagnostic instrument, not an AI-powered image analysis tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Not applicable. The device is a physical audiometer, not an algorithm. Its performance is inherent in its electroacoustic output and functionality as per the relevant standards.

7. The Type of Ground Truth Used

The "ground truth" for this submission is multi-faceted:

• International Technical Standards: The IEC and ISO standards listed (e.g., IEC 60645-1, ISO 389) define accepted performance parameters for audiometers.
• Predicate Device Specifications: The technical specifications and intended uses of the Interacoustic AD229b and GSI 61 Clinical Audiometer serve as a benchmark for comparison. The conclusion of "substantial equivalence" relies on the new device performing similarly without raising new questions of safety or effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is relevant to this device submission.

Ask a specific question about this device