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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:

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The touchTymp tympanometer is an electroacoustic test instrument that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders. It features tympanometry and acoustic reflex audiometry.

The touchTymp is an auditory impedance analyser. The device is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of middle ear pathologies. The device is also used to measure the acoustic reflex threshold which occurs due to contractions of the stapedial muscle following exposure to a strong stimulus. This test allow to assess between central and peripheral pathologies and to identify where the patients uncomfortable loudness level may reside. The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator. The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers.

The provided text details a 510(k) premarket notification for the "touchTymp" device, an auditory impedance tester. The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria or a detailed "reported device performance" table in the way one might expect for a study comparing a new algorithm's performance against a gold standard. Instead, it relies on demonstrating compliance with existing standards and substantial equivalence to a predicate device.

The closest we can get to implied "acceptance criteria" and "performance" from this document are:

Safety and EMC Compliance: The device must comply with current standards for medical device safety and electromagnetic compatibility (EMC).

Performance Equivalence: The device must perform as safely and effectively as the predicate device for its claimed purposes (conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders, featuring tympanometry and acoustic reflex audiometry).

Software Control and Interpretation: The software must effectively control probe stimuli, measure results, and present them on a display, with all functions interpretable by the operator. | Technological Characteristics Equivalence: The document explicitly states: "The technological characteristics are substantially equivalent with predicate device. All technological characteristics are in compliance with the consensus standard ANSI S3.39 for auditory impedance testers."

Safety and EMC Compliance: "The device was found in compliance with current standards [for medical device safety and EMC]."

Performance Equivalence: "The verification and validation activities show substantial equivalence with the predicate device and that the modified touchTymp is as safe and effective as the predicate device for its claimed purpose."

Software Control and Interpretation: "The instrument is software controlled. The software controls the probe (tone and pressure) stimuli, measures the result and presents the result on a built in display. All functions are set and interpreted by the operator." |

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

The document states "Clinical tests None applicable" (page 5), indicating that no clinical test set was used for this 510(k) submission. The determination of substantial equivalence was based on nonclinical tests verifying compliance with standards and technological similarity to the predicate device.

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

Not applicable, as no clinical test set was used to establish a ground truth.

4. Adjudication Method 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

No. The document explicitly states "Clinical tests None applicable." This type of study would fall under clinical testing.

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

Yes, in a way. The "Nonclinical tests summary" discusses "design verification and validation" performed "according to current standards for medical device safety and EMC and performance of impedance tester." This implies standalone testing of the device's functional performance against engineering specifications and industry standards, without human interpretation as part of a clinical study. However, this is not performance in the sense of an AI algorithm's diagnostic accuracy.

7. The Type of Ground Truth Used

For the nonclinical tests mentioned:

• Compliance with standards: The "ground truth" was the specifications and requirements outlined in standards like ANSI S3.39 for auditory impedance testers, and general medical device safety and EMC standards.
• Equivalence to predicate device: The "ground truth" was the established performance and characteristics of the predicate device (MI 24, K905704).

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that undergoes a "training set." Its functionality is based on established electroacoustic principles.

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

Not applicable, as there is no training set for this type of device.

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