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The Otoport Pro 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 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.

Where the individual to be screened is healthy with no medical conditions related to the ear, as in the case of well-baby hearing screening, the user can be a trained screener. In all other cases the user should be an audiologist or medical professional.

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

The Otodynamics Ltd ("Otodynamics") Otoport Pro device is a compact handheld device capable of high quality OAE measurements for clinical purposes and also automated ABR and OAE testing for fast infant screening.

Responses to sound are recorded via an applied earphone and or adhesive surface electrode pad. Specifically, the device can record Otoacoustic Emissions (type DPOAEs or TEOAEs) and auditory brainstem responses (ABRs) to sound. These responses are especially useful in the hearing of infants for deafness. The more detailed analysis of DPOAE and TEOAE responses is additionally useful as a component of the audiological diagnostic test battery.

The Otoport Pro is simple to use with customizable automation to make testing easy and the results clear. It has user access controls, graphical display panel, and extensive test database features. The Otoport Pro when configured for clinical use has advanced test features including extensive raw data capture for offline review and analysis if required.

Otoport Pro device is a hardware/ software revision of the currently marketed Otoport OAE+ABR, having the same performance and intended uses as the Otoport OAE+ABR device.

Here's a breakdown of the acceptance criteria and study information for the Otoport Pro device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance of the Otoport Pro in comparison to its predicate device (Otoport OAE+ABR, K143395) rather than setting distinct acceptance criteria with specific threshold values. The primary acceptance criterion appears to be demonstrating substantial equivalence in performance to the predicate device.

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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

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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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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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