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This Otonova 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 user. 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. 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.

OtoNova is a compact, portable battery-powered electronic device which records physiological responses to sound for the purpose of hearing testing. It Is controlled wirelessly from a local controlling device.

OtoNova has two hardware variants: OtoNova and OtoNova Pro.

Both the OtoNova and OtoNova Pro devices have been directly engineered from Otodynamics' currently marketed Otoport OAE+ABR device, retaining all the testing algorithms of the Otoport OAE+ABR device. The primary aim of the development was to physically separate the control console from the testing device while maintaining the same performance and effectiveness.

Like the predicate Otoport OAE+ABR device, both OtoNova devices can record two different physiological indicators of a functioning auditory system's peripheral response to sound namely a) Otoacoustic emission (OAEs), which are small sounds made by the inner ear in response to acoustic stimulation, and b) Auditory brainstem responses (ABRs) are tiny electrical signals emanating from the auditory brainstem in response to sound. Automatic recognition of an ABR response is referred to as AABR.

During ABR or OAE testing, low-level sounds are delivered to the ear. The responses to multiple presentations of these sounds (either acoustic or electrical responses) are recorded digitally and added together to enhance repeated responses with respect to the random/ noise signals that are always present. The averaged signal is automatically analysed by the device to identify and quantify true physiological response component and to assess the degree of noise contamination. This allows the quality/ accuracy of the recording to be determined for evidence of response validity. The processed data is reported to and displayed on the controlling device.

The provided text describes the regulatory clearance (K234095) for the Otodynamics OtoNova/OtoNova Pro device, comparing it to its predicate device, the Otoport/Otocheck OAE+ABR (K143395). The document focuses on demonstrating substantial equivalence, rather than detailing a specific clinical study with predefined acceptance criteria for AI model performance.

However, based on the information provided, we can infer the acceptance criteria and the study that "proves" the device meets them, primarily through the lens of functional equivalence and clinical agreement with a well-established predicate device. The core argument is that the OtoNova/OtoNova Pro performs audiological tests substantially the same as the predicate device, despite changes in physical design and user interface.

Here's an analysis based on the provided text, structured to answer your questions:

Inferred Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with quantitative metrics for the new device. Instead, the performance is deemed acceptable if it is "substantially the same" or "similar" to the predicate device, which is already legally marketed and presumed efficacious. The "study" is a combination of bench testing and a small clinical validation aimed at demonstrating this equivalence.

Here's a table based on the comparisons made in the document:

Study Details:

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

2. Sample sized used for the test set and the data provenance:

   • Clinical Testing: "data collected from 20 volunteer adult subjects" for functional equivalence comparison between OtoNova Pro and the predicate Otoport. The text does not specify the country of origin, but the company is based in the UK and the prior validation of the predicate included trials in "USA, Brazil, Israel and UK," implying international data.
   • Clinical Testing (Predicate Validation): The predicate's ABR infant screening algorithm was validated on "70 infants performed at Otodynamics Ltd" and independently trialed in "collaborating hospitals in USA, Brazil, Israel and UK." The algorithm was validated from "1078 tests files." This data is retrospective for the predicate's prior clearance, but serves as the basis for asserting current device's equivalence.
   • Human Factors/Usability Testing: "16 participants external to Otodynamics." Provenance not specified but likely conducted in the UK given the company's location.

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

   • For the current device's clinical testing, the "ground truth" is highly comparative to the predicate device's output. The subjective assessment of "similar," "no wider than," and "within expected tolerance" implies expert judgment, but the number and qualifications of experts involved in data interpretation for this specific equivalence trial are not provided.
   • For the predicate's ABR template, it was derived from a database of "1000 infant's ABR screening response waveforms independently collected using the Otodynamics ILO88 instrument... as part of a multicenter investigation into the Identification of Neonatal Hearing Impairment." This suggests a consensus-based ground truth from a large research study, likely involving multiple clinical experts (audiologists, researchers specialized in neonatal hearing). Their specific qualifications aren't listed, but the citation to a scientific publication (Norton et al., 2000) implies peer-reviewed clinical expertise.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated. Given the nature of objective audiometric measurements (Pass/Refer based on algorithms comparing to criteria, and quantitative signal levels), adjudication in the typical sense of human reader consensus for subjective interpretations (like radiology reads) is less applicable. The "ground truth" is intrinsically linked to the device algorithms and their comparison to the predicate's algorithms, which are well-established.

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 not an AI interpretation model for human readers. It's a diagnostic/screening device that produces objective measurements and automatically interpreted Pass/Refer results. The "AI" (automated interpretation) is core to the device's function, not an assistance tool for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, in essence, the "bench tests" and the comparison of the algorithms' outputs (Pass/Refer, quantitative levels) can be considered a standalone assessment of the device's core functionality as an automated system. The device automatically analyzes the recorded physiological responses and presents a clear "Pass" or "Refer" result, which is the algorithm's standalone output.

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

   • Primary Ground Truth: For the current device, the ground truth is established by functional and clinical equivalence to a legally marketed predicate device. The presumption is that the predicate's performance is already validated against a clinical ground truth.
   • Underlying Ground Truth (for predicate's algorithms):
     • OAE Screening: Based on the "Rhode Island Hearing Screening Assessment Project" and its reported algorithm, which was verified against clinical outcomes or established audiometric standards for hearing screening.
     • ABR Screening: Derived from a database of "1000 infant's ABR screening response waveforms Independently collected" as part of a "multicenter investigation into the Identification of Neonatal Hearing Impairment" (Norton et al., 2000). This implies a large-scale clinical dataset with established diagnoses/outcomes as the ultimate ground truth for the ABR algorithm's development.

8. The sample size for the training set:

   • The document explicitly states that the OtoNova/OtoNova Pro uses the "same DSP firmware algorithms" as the predicate device. Therefore, there was no new training set specifically for this device's algorithms.
   • The training data implied for the predicate's ABR algorithm development was a database of "1000 infant's ABR screening response waveforms." This served as the basis for the "newborn ABR template" used by both devices.
   • The OAE algorithm's "training" or validation was performed as part of the "Rhode Island Hearing Screening Assessment Project," though no specific sample size for a "training set" is provided for that.

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

   • For the ABR "training" (template creation): The "newborn ABR template" was derived from "1000 infant's ABR screening response waveforms independently collected." The ground truth for these 1000 waveforms would have been established through a comprehensive clinical protocol, likely involving repeated measures, follow-up diagnostics, and potentially consensus interpretation by expert audiologists from the multicenter investigation. The goal was to characterize "normal" ABR responses in neonates.
   • For the OAE algorithm: While not explicitly detailed as a "training set," the underlying principles and validation came from the "Rhode Island Hearing Screening Assessment Project," suggesting that the "Pass/Refer" criteria were correlated with actual hearing status as determined by more definitive diagnostic tests, forming the ground truth.

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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.

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

• Test Set Sample Sizes:
  • TEOAE Screening: 17 subjects
  • DPOAE Screening: 16 subjects
  • AABR Screening: 14 subjects
  • Clinical Measurement TEOAE/DPOAE: 15 subjects (implied for DPOAE, TEOAE not explicitly stated as separate for clinical but likely from the same cohort)
• Data Provenance: The study was conducted on a cohort of adult volunteers who gave informed consent. The tests were performed in a sound booth by a qualified audiologist. This indicates a prospective study design conducted under controlled conditions. The country of origin is not explicitly stated, but the manufacturer is Otodynamics Ltd, based in the United Kingdom.

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

The document states that tests were conducted "by a qualified audiologist." This suggests at least one qualified audiologist was involved in performing the tests and likely verifying the outcomes. Their specific qualifications (e.g., years of experience) are not detailed beyond "qualified audiologist." For AABR, the predicate device was audiologically calibrated on 25 healthy young adults, which speaks to a baseline calibration process rather than ground truth for the test set itself.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "ground truth" for the screening portion appears to be established by the consistent "Pass" or "Refer" results from both the predicate and subject devices, performed by a qualified audiologist. Discrepancies were not noted, suggesting high agreement between devices.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not reported. The study focused on comparing the Otoport Pro's performance directly against the predicate device, not on assessing human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the core of the clinical performance testing for screening modes (TEOAE, DPOAE, AABR) is essentially a standalone assessment of the device's automatic interpretation capabilities ("Pass" or "Refer" results are automatically interpreted and presented to the user). The audiologist's role was to perform the test, implying they observed the device's outcome, but the Pass/Refer decision was made by the device itself and then compared to the predicate's automated output.

7. Type of Ground Truth Used

The ground truth for the clinical performance testing (screening results) appears to be based on:

• Comparison to a Legally Marketed Predicate Device (Otoport OAE+ABR): The consistency of "Pass" or "Refer" results between the Otoport Pro and the predicate device, performed on the same subjects, served as the primary method to establish substantial equivalence.
• Expert Observational Consensus: The tests were conducted by a "qualified audiologist," suggesting that the audiologist's observation and the predicate device's established performance provided the reference.
• Objective Physiological Measurements: The device measures objective physiological responses (OAEs and ABRs) and provides an automated interpretation. The ground truth essentially relied on the established reliable performance of the predicate device for such measurements.

8. Sample Size for the Training Set

The document does not provide information about the sample size used for any training set. The device is presented as a hardware/software revision with the same underlying principles and response analysis techniques as the predicate. This suggests that the "training" (development and refinement of internal algorithms for interpretation) largely predates this submission and was established with the predicate device, or that the algorithm is based on well-understood physiological models rather than machine learning on a large dataset.

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

As no training set is explicitly mentioned for the Otoport Pro as a new algorithmic development, the method for establishing its ground truth for training is not provided. Given the nature of the device (audiometer with established physiological measurement techniques) and its comparison to a predicate, it's highly probable that the underlying algorithms for interpreting OAE and ABR responses were developed based on physiological and audiological research, clinical guidelines, and extensive testing over the lifespan of the predicate device and related technologies, rather than a new machine learning paradigm requiring a distinct, large, and newly defined training set with expert-labeled ground truth for this specific 510(k) submission.

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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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