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The Otodynamics Otoport/Otocheck OAE+ABR device is indicated for use when there is a requirement to screen for hearing disorders by objective and non-invasive means. ABR, TEOAE and DPOAE screening test results are automatically interpreted and a clear 'Pass' or 'Refer' result is presented to the user who will be a trained screener, audiologist or medical professional. Use of the device is indicated when the patient is unable to give reliable voluntary responses to sound, especially with infants. Use of the device facilitates the early detection of hearing loss and its characterization.

The TEOAE and DPOAE analytical functions of the device are indicated when objective non-invasive clinical investigations require the characterization and monitoring of the functional status of the peripheral auditory function. For this purpose the device is intended to be used by audiologically skilled professionals. These TEOAE and DPOAE tests are applicable to populations of any age to obtain objective evidence of peripheral auditory function.

The Otodynamics Otoport/Otocheck OAE+ABR device is a compact, handheld, batterypowered electronic device which records physiological responses to sound for the purpose of hearing testing. The device records two responses of the auditory system to sound, namely the otoacoustic emission (OAE) response from the inner ear and the auditory brainstem response (ABR) from the brain. The OAE response is acoustically stimulated and recorded via an insert earphone device called a 'probe'. The ABR response is also acoustically stimulated via the OAE probe but is recorded electrically via self-adhesive conducting pads called 'electrodes', which are placed on the scalp.

The device provides-

• A hearing screening function based on the detection of either OAE or ABR responses
• An analysis of OAE responses for use in the clinical investigation of hearing disorders.

For hearing screening purposes the responses are automatically analyzed and interpreted to give an unambiguous Pass / Refer result. A 'Pass' result means that normally expected responses to the primary speech frequency sounds have been positively identified and no further audiological investigation is indicated. A 'Refer' result means that normally expected responses have not been identified indicating further audiological investigation unless a poor test environment is indicated in which case a retest under better conditions is recommended.

The Otoport/Otocheck OAE+ABR provides identical OAE analyses to the predicate Otoport OAE device, which is incorporated in the new device. The ABR screening function of the new device uses the same conventional ABR technologies used by the predicate devices. Tests have demonstrated the device to perform well in the clinical environment and to deliver high sensitivity and specificity as a screener.

The provided text is a 510(k) summary for the Otodynamics Otoport/Otocheck OAE+ABR device family. It discusses the device's indications for use, its similarity to predicate devices, and a general statement about performance. However, it does not provide specific acceptance criteria or detailed study results, sample sizes, or ground truth information in the format requested.

The document states:

• "Tests have demonstrated the device to perform well in the clinical environment and to deliver high sensitivity and specificity as a screener."
• "The Otoport/Otocheck OAE+ABR meets the requirements of a hearing screener met by the predicate devices viz. in that it is efficient in the detection of normal healthy ABR and OAE responses (i.e., high specificity), and reliable in its ability to detect the absence of ABR and OAE (i.e., high sensitivity)."
• "Based on the results of the bench testing validated by clinical evaluations, the Otoport/Otocheck OAE+ABR is adequately designed for its intended use and this supports a determination of substantial equivalence."

These are general statements about performance and clinical evaluation, but they lack the specific quantitative data needed to complete the requested table and answer the detailed questions about the study. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study for the device itself.

Therefore, most of the requested information cannot be extracted from this document.

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The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.

The Otoport is a compact, sclf-contained, handheld Otoacoustic emission analyzer which has integral. rechargeable batteries for use. The Otoport can screen for cochlear function using either Transicnt Evoked or Distortion Product Otacoustic Emissions (TE or DPOAEs). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneous noise. The Otoport has a high degree of connectivity, being capable of immediate connection to any IBM compatible PC via either USB port or Bluctooth wireless technology. The instrument will acccpt probes that are already in use with other products in the Otodynamics range of otoacoustic emission analyzer instruments. There is 100% compatibility between data recorded on the Otoport and data recorded on other Otodynamics OAE products.

The provided text is a 510(k) summary for the Otodynamics Otoport, an Otoacoustic emission analyzer. This document focuses on demonstrating substantial equivalence to a predicate device and lacks specific information regarding acceptance criteria and the detailed study results that would typically be presented in a clinical trial report.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and study methodologies are not available in the provided document.

Here's what can be extracted and what is missing:

Description of the Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a new study. Instead, it presents a comparison table showing the specifications of the new device (Otodynamics Otoport) against two predicate devices (Otodynamics ILO2088 Echocheck and Otodynamics ILO292 DP EchoportPlus). The implication is that the Otodynamics Otoport is acceptable because its specifications are comparable to or exceed those of the legally marketed predicate devices.

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

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

• Not provided. The document is a 510(k) summary focused on substantial equivalence through device specifications, not a clinical study report. There is no mention of a "test set" in the context of clinical performance evaluation with a specific sample size.

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)

• Not provided. Since there's no described "test set" for performance evaluation, there's no mention of experts establishing ground truth.

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

• Not provided. Not applicable as there is no described test set or ground truth establishment process.

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. This device is an Otoacoustic emission analyzer, not an AI-assisted diagnostic tool that would involve "human readers" or AI assistance in interpretation in the typical sense for an MRMC study. It measures physiological responses.

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

• Not explicitly stated in these terms. The "study" presented here is a comparison of technical specifications to predicate devices to establish substantial equivalence. The device itself operates independently to generate OAE measurements. Its performance is demonstrated by meeting the functional specifications comparable to the predicate devices.

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

• Not provided. For this type of device (a measurement tool), "ground truth" would typically refer to the accuracy of its physical measurements against a known standard (e.g., sound pressure level, frequency response against calibrated equipment). The document implies that the device's measurement capabilities are accurate and comparable to the predicate.

8. The sample size for the training set

• Not applicable. This device is hardware-based with signal processing, not a machine learning/AI model that requires a "training set" in the conventional sense.

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

• Not applicable. As above, no training set is described.

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The Otodynamics ILO292 DP ECHOPORTplus system performs an auditory screening function by objectively testing for normal function of the cochlea. It is a new concept in OAE screening and analysis since it operates in standalone mode, without a PC. It is based on the DP ECHOPORT Instrument but with added built-in processor and graphic display.

Otodynamics ILO292 DP ECHOPORTplus system provides DPOAE facilities in addition to all the screening and TEOAE functions of the ECHOPORT plus. Both TEOAE's and DPOAE's are useful as screening tests for cochlear function in infants, children and adults. They are particularly useful when the patient is unable to respond

DPOAE's are useful with older patients, as the method can tolerate sub-clinical depression of cochlear activity. DPOAE's are also of use to test the higher frequency region of the cochlea.

The Otodynamics ILO292 DP ECHOPORTplus system performs an auditory screening function by objectively testing for normal function of the cochlea. It is a new concept in OAE screening and analysis since it operates in standalone mode, without a PC. It is based on the DP ECHOPORT Instrument but with added built-in processor and graphic display. Otodynamics ILO292 DP ECHOPORTplus system provides DPOAE facilities in addition to all the screening and TEOAE functions of the ECHOPORT plus.

I am sorry, but the provided text from the FDA 510(k) letter and the "Indications for Use" section does not contain the detailed information necessary to answer your request regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The documents provided are primarily a 510(k) clearance letter (K983351) for the Otodynamics ILO292 DP ECHOPORTplus OAE System, confirming its substantial equivalence to a predicate device. It states the indications for use of the device for auditory screening but does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Information about MRMC comparative effectiveness studies.
• Details of standalone performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of detailed study information is typically found in the 510(k) submission itself, which is a much larger document than what has been provided here. The clearance letter only summarizes the FDA's decision based on the submitted information.

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The Otodynamics ILO288 ECHOPORTplus OAE System is designed to perform an auditory screening function by objectively testing for normal function of the cochlea. The system is designed to operate standalone, or optionally interface to an IBM compatible PC, using the parallel port.

Not Found

This document is a 510(k) clearance letter from the FDA for the ILO288 ECHOPORTplus OAE System. It states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request for the specific information laid out in your numbered points, as that data is not present in the provided text.

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Ask a specific question about this device

Ask a specific question about this device