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The Integrity with VEMP provides testing that is intended to assist in the assessment of vestibular function. The target patient population ranges from school age children to geriatric adults who can complete the testing tasks. The Integrity with VEMP is intended to be used by a variety of professionals, such as clinical practitioners specialized in balance disorders, Audiologists, and Otolaryngologists (ENT doctors) with prior knowledge of the medical and scientific knowledge about the VEMP procedure.

VEMP (Vestibular Evoked Myogenic Potential) is a short latency response generated either from sternocleidomastoid muscle (cVEMP) or oblique muscle (oVEMP) which is typically evoked by high level acoustic or vibratory stimulation. VEMP is a non-invasive test that is used for diagnosis of vestibular disorders such as superior canal dehiscence, Menier's disease, vestibular neuritis, and, among others. VEMP test can be done in clinics (ENT/audiology) and hospitals provided that the users have adequate knowledge and background about underlying process of VEMP and recording auditory evoked responses.

The Integrity V500 is indicated for auditory evoked potential testing. "Integrity with VEMP" (this submission) is the addition of the VEMP test modality to the Integrity V500. The Integrity V500 is an auditory evoked auditory system response and Integrity with VEMP is an auditory evoked vestibular system response. Since the vestibular system is connected to the auditory system, a loud stimulus to the auditory system also simultaneously stimulates the vestibular system. However, the evoked signals are measured at different electrode sites. It is important to note that the methods of stimulation and data acquisition are the same for the VEMP modality as for the ABR modality (one of the Integrity V500's auditory evoked testing modalities), with differences being in electrode montage and patient's physical state. As such, it is possible to also get a VEMP response while testing in the Integrity V500's ABR modality.

Integrity with VEMP is a PC based device which uses the same hardware and similar software for evoking the stimulus, collecting the response, processing the data, and displaying the outcome on the screen as does the Integrity V500. The hardware used are: a VivoLink (patient interface device), air and bone conduction transducers (to stimulate the vestibular system), CV-Amp (bio-amplifier), and a computer. The response from the muscle is picked up by a bio-amplifier attached to the neck (for cVEMP) or under eyes (for oVEMP) and forehead with electrodes. The data is the VivoLink for pre-processing and then transferred to the PC via Bluetooth connection for full processing using the algorithm designed for VEMP processing. Through the test, the processed sweeps are filtered using the filter setting defined by the user and the averaged response is shown on the screen.

The primary diagnostic component of a VEMP measurement is the comparison of the amplitude of the primary peak of the VEMP response between right and left sides, defined as an asymmetry ratio, where a significant amount of asymmetry is indicative of a vestibular disorder. The amplitude of the vestibular response peaks is also dependent on the contraction level of the muscles involved in the recording. To minimize the muscular response biasing the result, it is important to have equal contraction levels for both sides; this is especially physically challenging to generate equivalent neck contractions needed for cVEMP. To overcome this issue, two key features were added to the Integrity with VEMP compared to Integrity V500: a biofeedback EMG monitor (which displays real-time muscular activity) and VEMP response normalization (scaling based on muscular contraction levels). The EMG monitors can be used as a guidance to the clinicians and patients for the level of muscle contraction. Normalization automatically scales the recorded sweeps based on the energy of the corresponding EMG which helps to compensate for imbalance contraction from the two sides.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed as a table of thresholds to be met, but rather are inferred from the clinical studies' conclusions regarding substantial equivalence and test reliability. The reported device performance is presented in tables comparing the device's measurements to a predicate device and to literature norms, as well as its reliability metrics against industry standards.

• P1 [ms]: Integrity VEMP (15.6 ± 1.3, 15.8 ± 1.4) vs. Eclipse (14.7 ± 1.2, 15.1 ± 1.5). Both within literature norms (11-17 ms). ICC: 0.72 (Right), 0.91 (Left).
• N1 [ms]: Integrity VEMP (23.5 ± 1.6, 23.9 ± 1.5) vs. Eclipse (23.6 ± 1.4, 23.7 ± 1.8). Both within literature norms (18-27 ms). ICC: 0.95 (Right), 0.80 (Left).
• P1-N1 [µV]: Integrity VEMP (209.6 ± 105.3, 198.7 ± 106) vs. Eclipse (195.5 ± 54.4, 168.8 ± 48.8). Both within literature norms (28-300 µV). ICC: 0.67 (Right), 0.71 (Left).

oVEMP vs. Eclipse (K162037):

• N1 [ms]: Integrity VEMP (11.2 ± 0.8, 11.4 ± 0.9) vs. Eclipse (10.2 ± 1.1, 10.4 ± 1.1). Both within literature norms (9-19 ms). ICC: 0.63 (Right), 0.78 (Left).
• P1 [ms]: Integrity VEMP (15.9 ± 1.7, 16.3 ± 1.6) vs. Eclipse (15.2 ± 1.7, 15.2 ± 1.6). Both within literature norms (12-22 ms). ICC: 0.89 (Right), 0.76 (Left).
• N1-P1 [µV]: Integrity VEMP (17.4 ± 8.5, 17.3 ± 8.3) vs. Eclipse (16.7 ± 10.6, 14.1 ± 6.6). Both within literature norms (2-45 µV). ICC: 0.90 (Right), 0.91 (Left).

Conclusion: Both systems' results consistent with literature; statistical analysis shows good to excellent reliability. Substantial equivalency criteria met. | Test-Retest Reliability (One Session):

• cVEMP (Air Conduction): Mean (μ) = 0.92, Median = 0.94, Std Dev = 0.05, IQR = 0.07. (Meets industry std: Mean ≥ 0.879, IQR ≤ 0.111)
• oVEMP (Air Conduction): Mean (μ) = 0.89, Median = 0.89, Std Dev = 0.05, IQR = 0.08. (Meets industry std)
• cVEMP (Bone Conduction): Mean (μ) = 0.92, Median = 0.92, Std Dev = 0.05, IQR = 0.12. (Mean meets, IQR slightly high but deemed acceptable due to bone conduction variability)

Test-Retest Reproducibility (Two Sessions 24-72 hrs apart):

• cVEMP (Air Conduction): Mean (μ) = 0.92, Median = 0.93, Std Dev = 0.05, IQR = 0.08. (Meets industry std: Mean ≥ 0.879, IQR ≤ 0.111)
• oVEMP (Air Conduction): Mean (μ) = 0.89, Median = 0.87, Std Dev = 0.06, IQR = 0.11. (Meets industry std)

Conclusion: Reliability and reproducibility values are similar to those from other industry products (Eclipse K162037 document). Good test-retest reliability and reproducibility are concluded. |
| 2. Test-Reliability and Reproducibility comparable to industry standards | (See above) | (See above) |

1. Sample sizes used for the test set and the data provenance:

• Study 1 (Substantial Equivalence):
  • cVEMP: 13 normal adult participants.
  • oVEMP: 9 adult participants.
  • Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). Implied to be prospective for the purpose of this comparative study.
• Study 2 (Reliability & Reproducibility):
  • US site: 33 normal hearing adults for cVEMP (AC); 17 normal hearing adults for oVEMP (AC).
  • Canada Site: 9 school-age normal hearing children for cVEMP (BC); 8 pre-school age normal hearing children for cVEMP (AC).
  • Data Provenance: Prospective, collected from two sites (US and Canada).

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

• The ground truth in this context is established by the physiological measurements themselves, not by expert interpretation of images or other subjective data. The "normal adult/hearing" participant selection implies a pre-qualification based on typical physiological parameters, but no specific "expert" panel is described as establishing or adjudicating individual VEMP responses for ground truth. The comparison is against established literature norms and a predicate device's measured performance.

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

• Not applicable as this is a device performance study based on objective physiological measurements (latencies, amplitudes) rather than subjective assessments requiring expert consensus or adjudication. The data analysis involved statistical comparisons (mean, standard deviation, ICC, IQR).

4. 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:

• No, this type of study was not performed. The device is not an AI-powered diagnostic tool that assists human readers in interpreting complex data like medical images. It's a medical device that measures physiological responses (VEMP). The study focuses on the device's ability to accurately capture and report these responses, which are then interpreted by clinicians.

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

• The device inherently involves a human-in-the-loop for proper patient setup, transducer placement, monitoring for muscle contraction via biofeedback, and ultimately interpreting the results. The "performance" being evaluated is the system's ability to consistently provide objective VEMP measurements. There isn't an "algorithm only" mode separate from its intended use with a human operator. The software's processing of data from the hardware is integral to its function.

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

• The ground truth is based on physiological measurement consistency and comparison to established literature norms and a legally marketed predicate device.
  • For Study 1, the ground truth for "normal" VEMP responses is referenced against "Norms from Literature" for P1/N1 latencies and P1-N1 amplitudes. The predicate device's performance also serves as a comparative "ground truth" for substantial equivalence.
  • For Study 2, "industry-accepted standards" for test-retest repeatability and reproducibility (derived from the predicate device's 510(k) document) served as the benchmark for reliability.

7. The sample size for the training set:

• This information is not provided. The document describes clinical studies that served as part of the regulatory submission (verification and validation), not studies for training a machine learning model.

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

• This information is not provided, as the studies described are related to clinical validation for regulatory clearance, not the development or training of a machine learning model. If any internal models (e.g. for artifact rejection or signal processing) were trained, their training data and ground truth establishment are not detailed in this document.

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Vivosonic NeuroScreen™ is indicated for use in the recording and analysis of human auditory brainstem response data necessary for the screening for hearing loss. The Vivosonic NeuroScreen M is indicated for newborns and infants from 34 weeks gestational age to 6 months.

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I am sorry, but the provided text is a 510(k) summary from the FDA for the Vivosonic NeuroScreen™ Infant Hearing Screener. It outlines the regulatory approval process and includes the indications for use.

However, it does not contain any information about the acceptance criteria, the specific study conducted to prove device performance, sample sizes, data provenance, ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot fulfill your request for this information based on the provided text.

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The Integrity V500 with DPOAE and TEOAE test options is indicated for use when it is necessary for a trained health care professional (for example, an Audiologist) to measure or determine cochlear function by measuring, recording, and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation.

DPOAE and TEOAE tests do not measure hearing per se, but measure whether or not the cochlear hair cells are functioning. This device does not determine hearing levels, but allows the operator to establish specific pass or refer criteria.

The Integrity V500 with ABR/ASSR options is indicated for auditory evoked potential testing as an aid in detecting hearing loss and lesions in the auditory pathway.

Not Found

This is a 510(k) premarket notification for the Vivosonic Integrity Model V500, a device for measuring otoacoustic emissions (DPOAE and TEOAE Test Option) and auditory evoked potentials (ABR/ASSR Test Option). This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) process is a pre-market submission demonstrating that the device is substantially equivalent to a legally marketed predicate device. It typically focuses on comparing the new device's technological characteristics, indications for use, and performance to a predicate device already on the market, rather than presenting a novel study to establish performance against pre-defined acceptance criteria (as might be seen in a de novo classification or PMA pathway).

Therefore, I cannot extract the requested information from the provided text because it is not present. The document focuses on regulatory approval based on substantial equivalence to a predicate device.

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The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for use when it is necessary for a trained health care professional (for example an Audiologist) to measure or determine cochlear function by measuring, recording and displaying otoacoustic emissions. This device does not measure hearing, but helps to determine whether or not a hearing loss may be present, requiring further evaluation.

The Vivo 200 DPS VivoScan™ Version 2.0 does not measure hearing per se, but measures whether or not the cochlear hair cells are functioning. This device does not determine hearing levels, but allows the operator to establish specific pass or refer criteria.

The Vivo 200 DPS VivoScan™ Version 2.0 is indicated for patients of all ages from newborn through adults, to and including geriatic patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults.

The Vivo 200 DPS VivoScan™ Version 2.0 is a prescription device. The labeling instructions and user operations are designed for trained professionals.

Vivo 200 DPS™ Version 2.0 is a diagnostic system that assists clinical professionals in the assessment and screening of cochlear function. The device includes a probe with a disposable tip that fits in the patient's ear canal. The probe contains a tiny speaker for stimulating the patient's ear with sound and a microphone for receiving low-volume otoacoustic emissions (OAEs).

The probe is connected to a probe adaptor circuit that generates the acoustic stimuli and amplifies the OAE responses. The probe adaptor circuit initiates stimulus delivery under the control of a dedicated notebook computer. The notebook computer reads the response from the probe adaptor and processes the signal digitally to measure and detect the OAE signal level, estimate the noise and display the results.

The Vivo 200 DPS™ Version 2.0 probe adaptor is capable of producing stimuli and eliciting Transient Evoked OAEs (TEOAEs) and Distortion Product OAEs (DPOAEs). TEOAEs are produced by the cochlea in response to short duration click sounds. DPOAEs are produced in response to two continuous pure tones that are close to each other in frequency.

The Vivo 200 DPS™ Version 2.0 software contains digital signal processing algorithms for measuring and detecting responses to both types of OAEs. The DPOAE and TEOAE responses are acquired and detected using the same probe. probe adaptor circuit and computer interface. The stimuli for both types of OAEs use the same probe, amplification circuitry and computer interface but utilize different modules in the probe adaptor circuit to generate their respective waveforms.

Software running on the notebook computer under the Windows XP™ operating system incorporates a graphical user interface that allows the user to configure the OAE test protocol, initiate and stop the test, print, save and review test results, and store patient information.

The provided document, K033108, is a 510(k) Summary for the Vivo 200 DPS VivoScan™ Version 2.0 OAE Audiometer. It primarily focuses on demonstrating substantial equivalence to a previously marketed device rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics.

Based on the information provided in the document, here's a breakdown of the requested information:

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

The document does not explicitly state specific, quantifiable acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or specific response levels) for the Vivo 200 DPS VivoScan™ Version 2.0. The primary "performance" discussed is its substantial equivalence to a predicate device.

The main change in this version is the addition of Transient Evoked Otoacoustic Emissions (TEOAE) functionality. The "Software algorithm" comparison parameter notes:

This indicates the method used for TEOAE processing, but not its performance against a specific criterion. The document also states that the device "is designed to meet the EN 60601 series of standards for electromagnetic (EMI) and electrical safety," which are safety and electrical performance standards, not diagnostic performance acceptance criteria.

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

The document does not provide details about a specific test set, its sample size, data provenance, or study type (retrospective/prospective) for evaluating the diagnostic performance of the Vivo 200 DPS VivoScan™ Version 2.0. The submission is a 510(k) for substantial equivalence, which often relies on demonstrating that the new device does not raise new questions of safety and effectiveness compared to a predicate device, sometimes without new clinical studies if the changes are minor.

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)

Since no specific test set or study validating diagnostic performance is detailed, there is no information provided on the number or qualifications of experts used to establish ground truth.

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

Given the lack of a detailed performance study with a test set, no adjudication method is mentioned.

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

The document does not mention any MRMC comparative effectiveness study or any AI component that would assist human readers. The device is described as a diagnostic system that assists clinical professionals by measuring, recording, and displaying otoacoustic emissions, implying it's a measurement tool rather than an AI-assisted diagnostic aid in the modern sense.

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

While the device includes "digital signal processing algorithms" for measuring and detecting responses, the document does not describe a standalone performance study of these algorithms in isolation (i.e., algorithm only without human-in-the-loop performance as a diagnostic tool). The device is intended for use by a "trained health care professional."

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

Since no specific performance study with a test set is described, the type of ground truth used is not mentioned.

8. The sample size for the training set

The document does not describe a training set sample size. This type of information is typically related to machine learning models, which are not explicitly detailed as a primary component of this device beyond "digital signal processing algorithms."

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

As no training set is described, how ground truth for a training set was established is not provided.

Summary of what is present in the document:

The 510(k) summary primarily asserts substantial equivalence to a predicate device, noting the addition of TEOAE functionality using digital signal processing algorithms (averaging and FFT). It defines the device's intended use and patient population. It does not provide details of clinical studies, performance metrics, acceptance criteria, or ground truth establishment typically found in submissions with novel diagnostic algorithms requiring such validation. The focus is on demonstrating that the updated device is safe and effective in a manner similar to its predecessor.

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