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The device DPOAE and TEOAE modules are intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions or Transient Otoacoustic Emissions technology. The target population for the modules includes all ages.

The device ABR module is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for the ABR module is newborns and infants up to 6 months of age.

The easyScreen is intended to be used by audiologists, ENTs, hearing healthcare professionals, or other trained technicians in a hospital, clinic, healthcare facility or other suitable quiet environment as defined in standard ISO 8253-1.

The device is audiometric equipment used for testing of inner ear and auditory brainstem abnormalities.

easyScreen features a touch-screen display and user-friendly software in a compact hardware design. easyScreen can be purchased with various licenses allowing you to perform different hearing screening tests.

easyScreen uses auditory brainstem response (ABR) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp , of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity.

The EEG is processed and analyzed automatically using the easyScreen's response detection algorithm. When a response is detected, the screening is stopped automatically and a Pass result is assigned to the test ear. When no response is detected after 3 minutes of EEG activity has been processed, a Refer result is assigned.

Auditory brainstem response (ABR) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.

Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal.

Transient otoacoustic emissions (TEOAE) technology uses a click stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.

The easyScreen consists of a handheld unit that utilizes a touchscreen display and a rechargeable battery. A simple cradle is included to support charging of the device's battery. The device supports Bluetooth communication with a label printer for the purpose of printing screening results.

The provided document does not contain an acceptance criterion table or a detailed study description with specific performance metrics. It's a 510(k) clearance letter and associated summary information for the "easyScreen" audiometric device, establishing substantial equivalence to predicate devices rather than providing detailed performance study results against specific criteria.

However, based on the information provided, here's what can be extracted regarding the device and its assessment:

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

The document does not provide a specific table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) for a study. Instead, the equivalence charts compare technical specifications and features of the easyScreen to its predicate devices, implying that meeting these comparable specifications is the "performance" considered for substantial equivalence.

Implied Performance Benchmarks from Predicate Comparison:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states in Section VII, "Summary of Clinical Testing," that "Not applicable. Not required to establish substantial equivalence." This indicates that no clinical testing with a specific test set was performed for this 510(k) submission. The evaluation was based on non-clinical testing and comparison to predicates.

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)

Since no clinical testing was performed on a test set, no experts were used to establish ground truth for such a set in this submission.

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

Not applicable, as no clinical test set was used.

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

Not applicable. The easyScreen is an audiometric screening device that provides PASS/REFER results programmatically, not a device requiring human readers or AI assistance in interpretation in the context of MRMC studies. The document also states "No clinical tests were performed."

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

The device is inherently a standalone algorithm-based screening device for ABR and OAE. The "easyScreen's response detection algorithm" processes and analyzes EEG for ABR, assigning "Pass" or "Refer" results automatically. Similarly, OAE technologies measure responses and categorize them. While not formally called a "standalone study" in the context of AI regulatory submissions, the non-clinical design verification and validation tests performed to assure the device meets its performance specifications (as per Section VI) would evaluate this algorithmic performance.

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

For the non-clinical design verification and validation, the "ground truth" would be established by reference to engineering specifications, recognized international standards (IEC 60601-1 series, IEC 60645 series), and comparison to the known performance and characteristics of the predicate devices. There is no mention of clinical ground truth (e.g., confirmed hearing status by independent audiologist, pathology) because no clinical study was performed.

8. The sample size for the training set

The document does not mention a "training set" in the context of machine learning or AI development. The device's ABR response detection algorithm and OAE measurement capabilities are likely based on established physiological principles and signal processing, rather than being "trained" on a dataset in the modern AI sense. Therefore, no sample size for a training set is provided.

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

Not applicable, as there is no mention of a training set for machine learning. The algorithms are presumed to be developed based on audiological principles and validated against expected physiological responses and international standards.

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