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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.

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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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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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