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The Echo-Screen III hearing screener models are based upon otoacoustic emission (OAE) and auditory brainstem response (ABR) technology.

The device is intended to screen hearing for newborns through adults, including geriatric patients. The device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present.

The Echo-Screen III product family consists of handheld, automated OAE and ABR based hearing systems which are easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics. The Echo-Screen III devices are intended to be used by trained personnel in a medical or school environment. The Echo-Screen III models are not intended for fitting assistive listening devices such as hearing aids or cochlear implants.

The Echo-Screen III hearing screener is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission or Auditory Brainstem Response screening technologies. The Echo-Screen III may be configured to support one or any combination of TEOAE, DPOAE, and AABR technologies.

The device represents the next generation of the Echo-Screen product line with key enhancements over the previously cleared predicate Echo- Screen T, TA, TD, TDA, TC [K013977], hereinafter referred to as the Echo-Screen T series; specifically, use of the Android operating system, programming upgrade to C and Java languages, addition of a color screen and built-in full hardware keyboard plus icons and on-screen touch keyboard, optional barcode scanner, Li-ion rechargeable battery, and inclusion of a docking station for battery charging and data transfer.

The provided document K141446 for the Echo-Screen III does not contain a study that establishes acceptance criteria and then proves the device meets those criteria through clinical or non-clinical testing. Instead, the document states that the device's TEOAE, DPOAE, and ABR screening test performance is equivalent to the performance of the predicate Echo-Screen T series (K013977).

Therefore, the specific information requested in the prompt (acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not explicitly provided within this 510(k) summary for the Echo-Screen III as it relies on substantial equivalence to a predicate device.

The document states:

• "Clinical Tests: N/A" – indicating no new clinical studies were conducted for this submission.
• "Nonclinical Tests: Design verification and validation were performed to assure that the Echo-Screen III meets its performance specifications and demonstrates equivalence to the specified predicate device."

This means the acceptance criteria and performance are implicitly tied to the predicate device's established performance. To fully answer your question, one would need to refer to the 510(k) submission for the predicate device, K013977 (Echo-Screen T, TA, TD, TDA, TC), which would likely contain the underlying performance data and acceptance criteria based on which the substantial equivalence claim for the Echo-Screen III is made.

Without that predicate device's submission, I cannot create the table or provide the detailed study information you requested for the Echo-Screen III. The provided document focuses on describing the technological characteristics and enhancements of the Echo-Screen III compared to its predicate, and concludes that it is substantially equivalent.

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The Fischer-Zoth Audiologic Systems model family "Echo-Screen T" consisting of Echo-screen T, Echo-Screen TA, Echo-Screen TD, Echo-Screen TDA and Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) technology. The device is intended to screen hearing for newborns through adults, including geriatric patients. The device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present. The "Echo-Screen T" product family consists of handheld, automated OAE and ABR based hearing screening systems which are easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics. The "Echo-Screen T" devices are intended to be used by trained personnel in a medical or school environment. The "Echo-Screen T" models are not intended for fitting assistive listening devices such as hearing aids or cochlear implants.

The Fischer-Zoth Audiologic Systems model family 'Echo-Screen T' consisting of Echoscreen T. Echo-Screen TA. Echo-Screen TD. Echo-Screen TDA. Echo-Screen TC are based upon Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) technology. The 'Echo-Screen T' product family are handheld, automated OAE- and ABR based hearing screening systems which are easy to be used. The measurement flow is menu guided and the evaluation is based upon signal statistics.

This appears to be a 510(k) summary for the Fischer-Zoth Echo-Screen T family of devices, seeking substantial equivalence to predicate devices. It describes the device's intended use and technological characteristics, but it does not contain specific acceptance criteria or study data demonstrating performance against such criteria.

The document states:

• "The measurement flow is menu guided and the evaluation is based upon signal statistics." (Section 0)
• "Signal statistical criterion for 'PASS' condition" (Section 1)

However, it does not provide details on:

• What these "signal statistical criteria" are numerically (e.g., specific sensitivity, specificity, accuracy thresholds).
• Any studies conducted to demonstrate the device's performance against these or any other clinical acceptance criteria.

Without this information, I cannot complete the requested tables and details about the study. The provided text focuses on the device's safety, electrical standards, and substantial equivalence to predicate devices, rather than a direct performance study to meet specific acceptance criteria.

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The Echo-Screen Otoacoustic Emissions Test Instrument is a hand-held instrument with an attached probe (that is placed in the outer ear canal) which emits sound that evokes otoacoustic emissions. A microphone in the probe picks up the emissions if any are present, and the device then analyzes the emissions and mathematically separates noise from cochlear emissions. The presence of these emissions indicates cochlear function in adults, infants and children. The instrument requires no active participation from the patient.

Otoacoustic emissions (OAEs) are low-level audio-frequency sounds that are generated by the outer hair cells of the cochlea in response to sound input. The presence of OAEs is an indication of cochlear function. If the Echo-Screen signals a "pass" reading as it analyzes the presence of OAEs, the clinician can determine that the cochlea is operating normally.

The Fischer-Zoth Audiologic System model 'Echo-Screen' is based upon Otoacoustic Emissions and it is similar to the Grason Stadler Inc. GSI70 AudioPath Screener and the Otodynamics OAE Analyser, model ILO88. The 'echo-screen' is a handheld, automated OAE-based screeming-system which is easy to use. The measurement flow is menu guided and the evaluation is based upon signal statistics.

The provided K982642 510(k) summary for the "Echo-Screen" device does not contain a specific study proving the device meets particular acceptance criteria through quantifiable performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards.

Here's a breakdown of the information requested, based on the provided document:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for device performance (e.g., sensitivity, specificity for detecting hearing disorders). Instead, it establishes that the device's technological characteristics and intended use are similar to predicate devices and that it meets specified safety and quality standards.

2. Sample size used for the test set and the data provenance

The document does not describe a specific test set or clinical study with a sample size for evaluating performance. The submission relies on demonstrating substantial equivalence to predicate devices and compliance with relevant standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No performance study with a test set and ground truth established by experts is described.

4. Adjudication method for the test set

Not applicable. No performance study with a test set 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

Not applicable. The "Echo-Screen" is an automated screening device, not an AI-assisted diagnostic tool that would involve "human readers" interpreting outputs in the way an MRMC study would typically evaluate.

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

The device is described as an "automated OAE-based screening system" with "Automated stimulus adjustment and online control" and "Signal statistical criterion for 'PASS' condition." This implies a standalone (algorithm only) performance in generating a "pass" or "refer" result for OAEs. However, the document does not present quantitative performance metrics (e.g., sensitivity, specificity) for this standalone performance. The "effectiveness" is primarily described in terms of its ability to detect OAEs and that their presence indicates cochlear function, similar to predicate devices.

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

The document does not explicitly state a type of ground truth used for performance validation. Given the device's nature as an OAE screener, the implied 'ground truth' for "effectiveness" would be the presence or absence of true OAEs, and indirectly, the presence or absence of cochlear function. However, no study measuring this against a gold standard (e.g., comprehensive audiological assessment) is presented.

8. The sample size for the training set

Not applicable. The document describes the device's design and technological characteristics, and its equivalence to predicate devices. It does not refer to an AI model that underwent a "training set." The "evaluation SW" is based on "signal statistics" rather than machine learning from a large training dataset.

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

Not applicable. As there is no mention of a training set for an AI model, there is no description of how ground truth would have been established for it.

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