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The AuDX Pro Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The AuDX Pro device performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests.

AuDX Pro is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function.

The device can be used for patients of all ages, from newborn infants through adults, to include geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. The AuDX Pro system includes optional software selections distinguished by the AuDX Pro, AuDX Pro II, and AuDX Pro Plus naming designations.

The test consists of measuring and recording transient (clickevoked) otoacoustic emissions (TEOAE) or distortion product otoacoustic emissions (DPOAE) utilizing pure tones. The same ear probe is used for both types of tests. For transient otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes appear on the LCD display on the front of the AuDX Pro unit. For distortion product otoacoustic emissions (DPOAEs), the DPOAE and noise floor amplitudes appear on the LCD. A pass or refer result is assigned at the end of the test based on a comparison of the patient's OAE response to normalized data. Additionally, a graphic display of the data is presented on the LCD allowing users to view and/or analyze the results.

The data collected by the AuDX system can be sent to a host computer where it can be saved or placed in a database. Optional Natus software programs are available for that function. Natus software programs provide a mechanism for users to define their own specific test protocols and download them to the AuDX Pro device.

The AuDX Pro Otoacoustic Emissions Measurement System expands upon the capabilities of the AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function [K111618]. The AuDX Pro System provides the following enhancements over the AuDX System:

• Protocol Setup utilities to load expanded frequency protocols to the AuDX Pro:
• Options to upload data to a PC based Patient and Test Information Database (P&TI);
• Options to graphically review data from a PC based Hearing Assessment & Tracking System (HATS) software utility linked with the P&TI Database; and.
• A Graphical User Interface (GUI) on an enhanced LCD screen for testing, patient information, and data review.

The provided 510(k) summary for the AuDX Pro Otoacoustic Emissions Measurement System describes its technical characteristics and intended use, and compares it to predicate devices. However, it does not contain information about specific acceptance criteria, a dedicated study proving performance against acceptance criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in such studies for the AuDX Pro.

The document states: "Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications and demonstrates equivalence to the specified predicate devices." This is a general statement and does not provide the granular information requested by the prompt.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a breakdown of what can be inferred or directly stated from the document, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be fully provided as specific numeric acceptance criteria and resulting performance values are not detailed in the document. The comparison table primarily focuses on technical features, intended use, and safety characteristics in relation to predicate devices, rather than explicit performance metrics against predefined acceptance criteria.

The document implicitly suggests that the device meets performance specifications by stating "Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications and demonstrates equivalence to the specified predicate devices." However, these "performance specifications" are not listed with quantifiable acceptance criteria.

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

Not provided in the document. The 510(k) summary does not mention any specific test set, its size, or the provenance of any data used for performance validation.

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

Not provided in the document. There is no mention of experts, ground truth establishment, or their qualifications in the context of a performance study for the AuDX Pro.

4. Adjudication Method for the Test Set

Not provided in the document. As there is no described test set or ground truth establishment process, an adjudication method is also not mentioned.

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

Not applicable/Not performed according to the document. The AuDX Pro is an automated otoacoustic emissions measurement system. It performs the test and assigns a "pass or refer" result automatically based on a comparison to normalized data. The document does not describe any human reader involvement that an MRMC study would assess.

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

Implied, but details are not provided. The device is described as "automated" and assigns "pass or refer" results, suggesting standalone performance. However, the document does not describe a specific standalone performance study with detailed methodology, metrics, or results. It only states that "Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications."

7. Type of Ground Truth Used

Cannot be explicitly determined from the document for performance validation of the "pass/refer" outcome. The device compares OAE responses to "normalized data" to assign pass/refer. The nature of this "normalized data" (e.g., whether it's derived from expert consensus, pathology, or outcomes data) is not specified for the purpose of validating the device's accuracy in assigning these outcomes.

8. Sample Size for the Training Set

Not applicable/Not provided. The AuDX Pro is a measurement device that calculates biophysical parameters (reproducibility, difference value between TEOAE and noise floor, DPOAE and noise floor amplitudes). While it uses "normalized data" for its "pass or refer" algorithm, the document does not suggest the use of a machine learning model that would require a distinct "training set" in the conventional sense.

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

Not applicable/Not provided. As there is no mention of a traditional training set for a machine learning algorithm, the establishment of ground truth for such a set is not discussed.

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The Scout Sport Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE Input/Output (I/O) tests.

Scout Sport is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function.

The device can be used for patients of all ages, from infants through adults, to include geriatic patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.

The Scout Sport Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The Scout Sport device performs transient evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE), and DPOAE Input/Output (I/O) tests.

The Scout Sport Otoacoustic Emissions Measurement System performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests. Using a combination of hardware and software, the Scout Sport system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the inner ear as a result of normal hearing process. The stimuli are presented via miniature receivers and the sounds in the external ear canal are recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. For transient evoked otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes are calculated and presented to the user. For distortion product otoacoustic emissions (DPOAEs), the DP and noise floor amplitudes are calculated and presented to the user. A pass or refer recommendation is assigned at the end of the test automatically based on predefined test protocols and measured OAE test parameters.

DPOAE I/O is a software option. The standard DPOAE test measures otoacoustic response to a series of frequencypairs of tones, varying the frequency while keeping the level or intensity of the stimulus tones at a constant level. The DPOAE I/O software option enables the Scout Sport device user to perform DPOAE testing at different stimulus intensities in order to obtain the DPOAE Input / Output (I/O) function for user defined test frequencies, frequency ratios and intensity levels. The graphical representation of the test results in the form of stimulus level vs. DPOAE level provides an effective way for the user to view and evaluate stimulus level-sensitive information about DPOAE response.

The functionality of the Scout Sport system has been enhanced by addition of the following Scout software program modules: the Patient and Test Information database (P&TI), the BLReports application, and additional peripheral software utilities.

The Patient and Test Information database (P&TI) is used to store, display, and manage patient and test information records. The database stores the following:

• Patient demographic information such as Patient Name, . Patient ID, Doctor Information, and comments; and,
• Test demographic information such as ID. Test Dates. . and Test Results

The standalone BLReports application provides customizable reporting for Scout. The Scout application must invoke BLReports directly, passing the data necessary to create and use report templates. The report templates are made up of template components that can be added, modified or removed by the user.

The additional peripheral software utilities consist of the Feedback utility and the database Repair utility. The Feedback utility enables users to create an archive containing recent logs, databases, registry data and system information to be copied on a CD and provide to Natus Technical Support to assist in troubleshooting. The database Repair utility enables the repair and compaction of databases.

The provided text describes the "Scout Sport Otoacoustic Emissions Measurement System" but does not contain a specific section detailing acceptance criteria or a dedicated study explicitly proving the device meets said criteria with quantitative performance metrics. The document focuses on demonstrating substantial equivalence to predicate devices.

However, based on the information provided, we can infer some aspects related to validation and performance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative format (e.g., minimum sensitivity, specificity). Instead, it relies on demonstrating that the device "meets its performance specifications and demonstrates equivalence to the functionalities present in the respective predicate devices."

Therefore, a table of explicit acceptance criteria with reported numerical performance values cannot be constructed from the provided text. The performance is broadly described as the device accurately performing TEOAE, DPOAE, and DPOAE I/O tests to assess cochlear function, similar to its predicates.

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

The document states: "Design verification and validation were performed to assure that the Scout Sport Otoacoustic Emissions Measurement System meets its performance specifications and demonstrates equivalence to the functionalities present in the respective predicate devices."

It does not provide specific details on the sample size used for validation testing, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). This information is not typically included in a 510(k) summary for devices demonstrating substantial equivalence through functional and performance similarities to predicates rather than novel clinical performance claims.

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

The document does not mention the use of experts to establish a "ground truth" for a specific test set. The validation appears to be focused on meeting technical specifications and functional equivalence to predicate devices, rather than a clinical study requiring expert-derived ground truth.

4. Adjudication Method for the Test Set:

Not applicable, as there is no mention of a clinical test set requiring expert adjudication to establish ground truth.

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. The device is an Otoacoustic Emissions Measurement System, which assesses cochlear function directly. It's not an AI-powered diagnostic tool requiring human reader interpretation or offering "AI assistance" in the typical sense. Therefore, an MRMC study and effect size in human reader improvement are not relevant to this device.

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

The device inherently operates in a "standalone" manner in terms of its core measurement function. It delivers acoustic signals and measures emissions independently. The "pass or refer recommendation is assigned at the end of the test automatically based on predefined test protocols and measured OAE test parameters." This implies an algorithm-only decision for the "pass/refer" outcome. However, it's not described as a "standalone algorithm performance study" in the context of an AI-based diagnostic tool. The device assesses cochlear function and then provides a recommendation based on its measurements.

7. The Type of Ground Truth Used:

The ground truth used for validation is implicitly based on the established performance and expected physiological responses of similar predicate devices, and the device's ability to accurately measure and report these responses according to its specifications. There is no mention of external "ground truth" such as pathology, clinical outcomes, or expert consensus in the traditional sense of a diagnostic imaging study. The "ground truth" is the accurate capture of otoacoustic emissions and appropriate application of pre-defined protocols for pass/refer recommendations.

8. The Sample Size for the Training Set:

Not applicable. This device is not described as utilizing a machine learning or AI model that requires a "training set" in the context of deep learning or statistical pattern recognition. Its operation is based on established audiology principles and signal processing.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for a machine learning model.

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The Master II Evoked Response System is intended for the recording and analysis of human physiological data necessary for the diagnosis of audiovestibular and hearing-related disorders.

Master II Evoked Response System is a Windows® based software application for use with the Navigator Pro hardware platform using Auditory Steady State Response Modality for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of audiovestibular and hearing related disorders.

This document is a 510(k) premarket notification for the Bio-logic Systems Master II Evoked Response System, not a study report. Therefore, it does not contain the detailed information needed to fully answer all aspects of your request regarding acceptance criteria and a study proving device performance.

However, based on the provided text, I can extract what is available and identify what is missing:

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

The provided text does not contain a table of acceptance criteria or specific reported device performance metrics. The document focuses on establishing substantial equivalence to a predicate device rather than presenting quantitative performance data from a specific study.

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

This information is not available in the provided 510(k) summary. A 510(k) summary primarily addresses the device's technical characteristics and intended use in comparison to a predicate device, rather than providing details of a clinical study's test set.

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)

This information is not available in the provided 510(k) summary.

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

This information is not available in the provided 510(k) summary.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. The device described is an "Evoked Response System" which records and analyzes physiological data, implying an objective measurement system rather than an AI-assisted diagnostic aid for human readers.

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

The "Master II Evoked Response System" is described as a "Windows® based software application for use with the Navigator Pro hardware platform using Auditory Steady State Response Modality for the recording and analysis of human physiological data." This description suggests that the system operates in a standalone capacity for data recording and analysis. However, specific standalone performance metrics or a detailed standalone study report are not provided in this 510(k) summary.

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

This information is not available in the provided 510(k) summary. For an auditory evoked response system, ground truth would typically relate to actual hearing thresholds/auditory system function, often established through behavioral pure-tone audiometry or other objective audiological assessments.

8. The sample size for the training set

This information is not available in the provided 510(k) summary. While the system uses "Auditory Steady State Response (ASSR) modality" which involves algorithms for analysis, details on a training set (which would be relevant for machine learning-based algorithms) are not provided.

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

This information is not available in the provided 510(k) summary.

Summary of available information from the 510(k) document:

• Device Name: Bio-logic Systems Master II Evoked Response System
• Intended Use: Recording and analysis of human physiological data necessary for the diagnosis of audiovestibular and hearing-related disorders.
• Technological Characteristics: Windows® based application using Auditory Steady State Response (ASSR) modality. ASSR is used to predict frequency-specific behavioral hearing thresholds, particularly for patients who cannot provide a reliable behavioral response.
• Predicate Device: K021895 Master, a Modification to Bio-logic Evoked Potential.
• Regulatory Status: Cleared as substantially equivalent to the predicate device.

The provided document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed technical or clinical study report. Therefore, it lacks the specific performance data and study design details you've requested. Such information would typically be found in dedicated validation reports or scientific publications, which are not part of this 510(k) summary.

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1. The Cochlea Scan is intended for use in automated objective hearing assessment using distortion product OAEs.
   2 The Cochlea Scan is intended for use in diagnostic hearing evaluations and assistance in the diagnosis of possible hearing disorders by means of OAEs and/or pure tone audiometry. Hearing disorders include middle ear and cochlear hearing losses.
2. The results of the Cochlea Scan can be used to assist in the selection and/or (first-) fit of conventional hearing aids. It does not provide data for prescribing or fitting cochlear implants or middle ear implants.
3. The Cochlea Scan is intended for use in hearing screening using OAEs (with optional TEOAE module).

Cochlea-Scan is a hand-held examination system based on Otoacoustic Emissions (OAE) technology. Identical techniques are used - among others - on Fischer-Zoth model Echo-Screen. The Cochlea-Scan product family is designed easy to use and employs automated OAE. The measurement flow is menu quided and the evaluation is based upon signal statistics. The Cochlea-Scan devices are designed for trained personnel in a medical or school environment to examine hearing in newborns through adults, including geriatric patients. With its built-in automated hearing threshold estimation algorithm the device does not measure hearing per se, but helps to determine whether or not a hearing loss may be present and in case of hearing loss proposes an estimation of the hearing threshold in a given frequency range. Additionally Cochlea-Scan is equipped with a standard pure tone audiometer.

The provided text is a 510(k) summary for the Bio-logic Systems Corp.'s Cochlea-Scan/Cochlea-Scan Plus, an audiometer based on Otoacoustic Emissions (OAE) technology. However, it does not contain any information about acceptance criteria or specific study results demonstrating the device meets such criteria.

The document outlines:

• Submitting company and contact information.
• Device name, classification, and predicate device (Fischer-Zoth, model Echo-Screen: 510(k) K013977).
• A general description of the device and its intended use.
• Technological characteristics, noting similarities to the predicate device.
• Regulatory information from the FDA, including the 510(k) number (K061744) and substantial equivalence determination.
• Specific indications for use.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details based on the provided text, as this information is not present. The document focuses on regulatory approval and device description rather than performance study specifics.

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The Bio-logic Ceegraph/Sleepscan Netlink Traveler is indicated for use in the recording and analysis of EEG tests. Typical routine EEG tests are 20-30 minutes in duration, but the Ceegraph/Sleepscan Netlink Traveler can also be used for longer tests, including continuous long-term EEG monitoring with patient video. Similarly, the Bio-logic Ceegraph/SleepScan Netlink Traveler is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of Sleep-related disorders. It is intended to record and present this data in a form that can improve the speed of diagnosis and assist in potential treatment decisions. In general, EEG and Sleep testing is indicated for use whenever it is necessary to measure and record a patient's electrophysiological data relating the electrical activity of the brain, by attaching multiple electrodes at various locations on the body.

The Netlink Traveler can be used for patients of all ages, from children to adults, including geriatric patients.

The use of the Ceegraph/Sleepscan Netlink Traveler is to be performed under the prescription and supervision of a physician or other trained health care professional.

The Netlink Traveler patient connection module (headbox) consists of a molded plastic enclosure approximately 5.75 x 3.9 x 1.75 in size and weighing approximately 1 lb. The Netlink Traveler can be configured to perform up to 40 channel data recordings, having 32 AC channels, and an external 8 DC channels (oximetry, body position, etc.), and additional special channels. Power to the box is supplied by an internal battery, and an external medical-grade power supply/charger may also be connected. There are two primary modes of operation: "Ambulatory Mode" (no power or Ethernet) where data is stored to internal flash memory and "Headbox Mode" (data communicated to host computer via Ethernet). External power is not required in Ambulatory Mode because the Netlink Traveler always derives its power from the battery. However, connecting the Netlink Traveler to external power supply/charger is recommended when longer tests are required in order to extend battery capacity. The AC channel electrodes are connected to safety touch-proof jacks on either of the 2 optional electrode connection accessories, the quick-disconnect box and the Netlink Traveler Electrode Block. These are connected to the Netlink Traveler box via a 68-pin cable and connector. The DC channels connect on a separate 8-pin connector. Other connectors (Ethernet, photic strobe out, Netlink) are located on the side of the Netlink Traveler box.

The Netlink Traveler consists of a digital board, an analog board and an LCD display board. The analog board is very similar in function to the analog board marketed in the Netlink Predicate Device. This board provides signal amplification and conversion of the data from the 32 channel electrodes to digital. The 68-pin electrode array connector allows the use of existing patient connection hardware, such as the 32-channel electrode connection panel called the "quick disconnect box", and the new Netlink Traveler Electrode Block. The connection panel called the "quick disconnect box", and the new Netlink Traveler Electrode Block. The Electrode Block may be configured for several arrays and is especially designed to be worn comfortably by the patient. The digital board contains a microprocessor along with program and data memory, and provides control functions for reading and processing of the analog data, converting it to digital, and communicating it to the host computer and/or to the compact flash memory card. Additional features of the Netlink Traveler include the color LCD display to facilitate functions such as electrode impedance collection, setup and impedance features.

The Bio-logic Ceegraph/Sleepscan Netlink Traveler is an EEG/Sleep recording device. The provided text is a 510(k) summary for this medical device, which addresses its safety and effectiveness.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format as per your request. Instead, it demonstrates substantial equivalence to predicate devices by comparing various parameters and highlighting similarities or differences. The underlying "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate devices, with no adverse effects on product safety and effectiveness.

The table below summarizes the comparison points provided in the document between the Netlink Traveler and its predicate devices:

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

The document does not provide details on a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The safety and effectiveness analysis primarily relies on design control processes, hazard/risk analysis (FMECA), and comparison to predicate devices, rather than a separate clinical or performance test set with a defined sample size.

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

This information is not provided in the document. As there is no explicitly defined "test set" with ground truth establishment described, this detail is absent.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

The document does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance. The device is a digital EEG/Sleep recorder, not an AI-assisted diagnostic tool that would typically undergo such a study for improved human reader performance. The software "does not make any final decisions that result in any automatic forms of diagnosis or treatment."

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

The document does not report a standalone performance study. The device is a data acquisition system. While it contains an embedded microprocessor that performs control functions for reading and processing analog data, it does not function as a standalone diagnostic algorithm. Its output, specifically from the software, "does not make any final decisions that result in any automatic forms of diagnosis or treatment."

7. Type of Ground Truth Used

The document does not describe the use of a "ground truth" in the context of a performance study. The safety and effectiveness are established through design controls, risk analysis, and substantial equivalence to legally marketed predicate devices. For a device like an EEG/Sleep recorder, the "ground truth" would implicitly be the accurate physical recording of electrophysiological signals, which is assessed through hardware design, signal processing specifications (e.g., 18-bit resolution), and adherence to relevant standards.

8. Sample Size for the Training Set

The document does not describe a training set. This device is developed based on engineering principles and comparison to predicate devices, not through machine learning models requiring training data.

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

This information is not applicable as no training set or machine learning model is described in the provided document.

In summary:

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and adherence to design and risk management standards (ISO-13483, FDA QSR Design Control, EN-14971). It does not contain details about specific clinical performance studies, test sets, ground truth establishment, or AI-related metrics (like MRMC studies) that are common for devices involving diagnostic algorithms or AI. The Netlink Traveler is primarily a data acquisition device, and its safety and effectiveness are supported by its design, risk analysis, and comparison to existing, cleared devices.

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The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.

The Bio-logic Insert Earphones are transducers that convert electrical stimulus, provided by the Bio-logic ABaer / Navigator Pro Auditory Evoked Response Stimulators, into acoustic stimulus, which is then coupled to the patient's ears. They are comprised of five sections: 1.) Electrical Transmission Path, 2.) Electrical Filter, 3.) Speaker, 4.) Acoustic Transmission Path, and 5.) Transducer Case.

The provided text describes the Bio-logic Insert Earphones and compares them to a predicate device, the Etymotic Research ER-3 Insert Earphones. The study presented is a non-clinical performance test to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested elements are not applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For non-clinical performance, the acceptance criterion implicitly is "substantial equivalence" to the predicate device in key output parameters, particularly sound level and frequency bandwidth.

Note regarding "Met Criteria?": For the standard Bio-logic Insert Earphone, the differences in sensitivity were calibrated to achieve similar frequency response. For the Broadband Insert Earphone, the differences were by design to achieve a wider bandwidth. Both outcomes were deemed substantially equivalent based on the provided discussion.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This was a non-clinical laboratory test, not a study involving human subjects or collected data from a "test set" in the typical sense of a clinical trial. The "test set" comprised the Bio-logic Insert Earphone, the Bio-logic Broadband Insert Earphone, and the predicate Etymotic Research ER-3 Insert Earphones.
• Data Provenance: Not applicable. The data was generated in a controlled laboratory setting (described as measuring sound level within a Bruel & Kjaer Type 711 Occluded Ear simulator). It is not retrospective or prospective clinical data from a specific country.

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

Not applicable. Ground truth, in the sense of expert consensus on clinical findings, is not relevant for this non-clinical engineering performance study. The "ground truth" here is the physical acoustic output measurements, which are objectively measurable by standard laboratory equipment.

4. Adjudication method for the test set

Not applicable. There was no need for human adjudication of test results, as the measurements were objective physical quantities.

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 was not a comparative effectiveness study involving human readers or AI.

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

Not applicable. This device is an earphone, not an algorithm, and does not involve AI or human-in-the-loop performance in the sense of diagnostic interpretation.

7. The type of ground truth used

The "ground truth" relevant to this submission is the objective physical measurement of acoustic output (sound level, frequency response) as measured by a Bruel & Kjaer Type 711 Occluded Ear simulator.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

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

Not applicable. As above, this is a physical device.

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The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing-related disorders. Auditory stimuli are presented to the patient's ear through an earphone or headphones, and the corresponding Auditory Brainstem Responses (ABR) from the patient are recorded using EEG electrodes placed on the scalp. Standard ABR testing is most used clinically for 2 reasons: (1) to predict behavioral audiometric thresholds, and (2) as an audiological testing tool to assist in the assessment of possible auditory nervous system abnormalities.

The Bio-logic Evoked Potential family of products is intended to be used for the recording and display of human physiological data for auditory testing purposes and to assist in determining possible auditory and hearing-related disorders. The predicate device referenced above is the latest in a series of systems of this type marketed by Bio-logic. The Navigator Pro Evoked Potential Predicate Device performs ABR recording functions with two channels of simultaneous data recording. The software for the Navigator Pro implements the standard Auditory Brainstem Response (ABR) functions common to most similar systems on the market for many years. One of these functions is the testing for auditory nervous system abnormalities but these measures are only effective once the abnormality has sufficiently progressed so as to affect a large number of fibers in the auditory nerve. The Stacked ABR for Navigator Pro device provides software additions to the Predicate Device for the purpose of displaying ABR activity affecting a subset of the nerve. These additional features include automated masking, filtering and data manipulation functions, which allow the observation of ABR test results for frequency band subsets of the nerve fibers in addition to the fibers as a whole.

The provided document is a 510(k) summary for the "Stacked ABR for Navigator Pro," a device modification to the Bio-logic Evoked Potential product. It primarily focuses on demonstrating substantial equivalence to a predicate device (Bio-logic Navigator Pro) rather than detailing specific acceptance criteria and a dedicated study to prove device performance against those criteria.

Therefore, the requested information, specifically regarding detailed acceptance criteria with numerical performance targets, a specific study designed to show the new device meets those criteria, and information like sample sizes for test/training sets, expert qualifications, and ground truth establishment, is generally not present in this type of regulatory submission.

What is present is a comparison table that highlights similarities and differences between the new device and the predicate device to argue for substantial equivalence. The "Safety and Effectiveness Summary" section describes the processes followed during development to ensure safety and effectiveness, but it does not present a formal study to demonstrate achievement of quantified acceptance criteria for performance.

Here's an attempt to answer based on the provided text, noting where information is explicitly not available:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria or quantifiable reported device performance in the manner typically found in a clinical study report for proving performance. Instead, the submission focuses on demonstrating substantial equivalence to an existing predicate device (Bio-logic Navigator Pro) by showing that the new device (Stacked ABR for Navigator Pro) has no significant differences that would adversely affect product safety and effectiveness.

The comparison table provided in the document focuses on similarities and differences in technological characteristics, not on quantitative performance metrics or acceptance criteria.

Note: The "acceptance criteria" here are implied by the nature of a 510(k) submission, which aims to show "substantial equivalence." The "reported device performance" is essentially the assertion that the device modification successfully implements the described features without negatively impacting safety or effectiveness compared to the predicate.

2. Sample size used for the test set and the data provenance

Not available in the provided document. The submission describes the functionality of the Stacked ABR software and its relation to the predicate device. It does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This type of detail would typically be found in a separate validation study report, not in a 510(k) summary focused on substantial equivalence for a software modification.

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

Not available in the provided document. No test set or ground truth establishment process with experts is described.

4. Adjudication method for the test set

Not available in the provided document. No test set or adjudication method is described.

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 and not available in the provided document. This device is a software modification for an Evoked Potential system, primarily automating data manipulation, masking, filtering, and averaging for auditory testing (ABR). It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance in an MRMC study. The software "does not make any final decisions that result in any automatic forms of diagnosis or treatment." Its purpose is to provide "additional functionality" and present "a new overall ABR more representative of the patient's hearing across all frequency bands," which is then reviewed by a "qualified user."

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

Not applicable and not available in the provided document for performance evaluation in the typical sense. The device is a "software addition" to an existing system, and it is explicitly stated that "All program 'recommendations' are subject to review by the EP Technologist or Physician, and may be modified, overridden or deleted as determined by a qualified user." Therefore, it is designed as a human-in-the-loop system, and a standalone performance evaluation in the absence of human input would not be relevant in the context of diagnostic decision-making. The "standalone" aspect would relate to the software's ability to perform its defined data manipulation steps correctly, which is assumed to be part of the internal product development and verification processes mentioned (ISO-9001, ISO-13485, FDA QSR Design Control).

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

Not applicable and not available in the provided document. Since no explicit performance study with a test set generating a "ground truth" for diagnostic accuracy or similar metrics is described, no type of ground truth is mentioned. The device's "effectiveness" is linked to its ability to generate a "Stacked ABR" that "equally reflects the contributions of all frequency regions of the auditory nerve" and provides "a new overall ABR more representative of the patient's hearing across all frequency bands." This is based on established audiological techniques (derived band technique) and is a data processing function, not a direct diagnostic output that requires a "ground truth" in the same way an AI diagnostic algorithm might.

8. The sample size for the training set

Not available in the provided document. The software implements established algorithms (derived-band technique, noise estimation for averaging termination). It is not a machine learning model that requires a "training set" in the common sense for model development.

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

Not applicable and not available in the provided document. As it's not a machine learning model requiring a training set, the concept of establishing ground truth for a training set does not apply here.

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The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and display of human physiological data, for auditory screening purposes and to assist in determining possible auditory and hearing-related disorders. Auditory stimuli are presented to the patient's ear through an earphone or headphones, and the corresponding Auditory Brainstem Responses (ABR) from the patient are recorded using EEG electrodes placed on the scalp. Standard ABR testing is most used clinically for 2 reasons: (1) to predict behavioral audiometric thresholds, and (2) as an audiological testing tool to assist in the assessment of possible auditory nervous system abnormalities.

The Bio-logic Auditory Evoked Potential (AEP) family of products is used for the recording, display, computation, and manipulation of human physiological data, for auditory screening purposes and to provide assistance in the neurological assessment and treatment of auditory sensory disorders. The predicate device referenced above is the latest in a series of complete systems of this type marketed by Bio-logic.

The Navigator Pro Evoked Potential Predicate Device performs Auditory Brainstem Response (ABR) recording functions with two channels of simultaneous data recording. The software for the Navigator Pro implements the standard ABR functions common to most similar systems on the market for many years.

The standard ABR test works on the basis of repeating a stimulus-response cycle. An auditory stimulation (click, tone, etc.) is presented to the patient through the use of an earphone or headphones. The EEG response from the brain is read through the use of one or more scalp electrodes placed on the patient. The response time of interest is approximately from 1 - 20 milliseconds following the stimulus. The response voltage readings for this time period are amplified, digitized and stored in the AEP system computer's memory. The stimulation is then repeated, the EEG response is read again, and this cycle is repeated many times. Each time the response is read, it is averaged together with all previous responses. The final data record is the result of averaging several thousand (usually 2000-3000) responses. This averaging process is necessary because the ABR signal is very small, much lower in voltage than the surrounding EEG "noise" present in the recording. The noise is averaged out over the many readings, because the noise will have a very low average net value. The result from the averaging process will be the signal.

The reason for this 510(k) is that the software for the host computer (PC) in the Evoked Potential system has been modified. The host computer software for the Predicate Device is DOS-based, whereas the host software for this modified Bio-logic AEP program is WINDOWS-based. The WINDOWS program has the same features and functionality as that of the predicate device, but with improved user interfaces and overall ease-of-use. The functions of the hardware are the same as those of the Predicate Device (Navigator Pro) hardware. The host computer software for control of the hardware has the same functionality as that of the DOS-based Predicate Device software. Direct hardware control of all Navigator Pro functions is provided from the Digital Signal Processor (DSP) and its program code located inside the Navigator Pro module, instead of directly from the host computer program. (There are no changes to the DSP program code in the Navigator Pro module as a result of this host computer software modification.) By distributing the hardware-specific functions to the DSP, the Windows-based host computer program has fewer real-time demands, and performance and reliability are improved. Together, the hardware and software implement the same functionality and perform the same intended use as the Predicate Device, but with improved ease-of-use and flexibility for the user.

This document describes a 510(k) submission for a modification to the Bio-logic Evoked Potential (EP) System. The core of the submission is to demonstrate substantial equivalence to a predicate device, the Bio-logic Navigator Pro (K994149), due to a software update from DOS-based to WINDOWS-based.

1. Table of Acceptance Criteria and 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)

The document does not explicitly state a specific sample size used for a test set or the data provenance for evaluating the modified device's performance. The submission focuses on demonstrating substantial equivalence by comparing technological characteristics and functionality to the predicate device.

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)

The document does not mention a test set with independently established ground truth or the involvement of external experts for such a purpose. The safety and effectiveness summary relies on internal product development procedures, risk analysis, and direct comparison to the predicate device's established functionality.

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

Since no specific test set requiring ground truth establishment is detailed, there is no mention of an adjudication method.

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

No MRMC comparative effectiveness study was done or mentioned. The device is an Evoked Potential System software modification, not an AI-assisted diagnostic tool for "human readers" in the traditional sense of medical imaging. The software provides data recording, display, computation, and manipulation, with program "recommendations" subject to review by a qualified healthcare professional.

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

This would not apply in the typical sense for this device. The existing ABR test itself is an "algorithm" of signal averaging, which is fundamental to the evoked potential technology. The changes are to the host computer software that controls the hardware and presents the data. The document explicitly states: "As with the Predicate Device, the modified software does not make any final decisions that result in any automatic forms of diagnosis or treatment. All program "recommendations" are subject to review by a qualified health care professional, and may be modified, overridden or deleted as determined by the qualified user." Therefore, the device is not intended for standalone (algorithm-only) diagnostic performance.

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

Given that the submission is for a software modification of an existing evoked potential system, and not a new diagnostic algorithm, the concept of "ground truth" for a test set as typically used in AI/diagnostic studies is not directly applicable here. The "ground truth" for the device's functionality is implicitly derived from the long-standing clinical acceptance and performance of the predicate device and the standard physiological principles of ABR testing. The "truth" being established is that the new software performs the same core functions and produces physiologically accurate representations of ABR data as the predicate device.

8. The sample size for the training set

The document does not refer to a training set in the context of machine learning. The software modification is a re-platforming of existing functionality from DOS to Windows, not the development of a new algorithm requiring a training set.

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

As there is no mention of a training set, the establishment of ground truth for such a set is not applicable or addressed in this submission.

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The Bio-logic Evoked Potential (EP) product family is indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders.

This product, MASTER, like its predicate device, the Navigator Pro, is a diagnostic device intended to be used as part of a set of audiometric test protocols. It is especially indicated for use in defining the configuration of the hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. It allows for the estimation of behavioral hearing threshold at various frequencies, through the use of ABR (Auditory Brainstem Response) or ASSR (Auditory Steady-State Response) test protocols. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

Bio-logic EP Systems can be used for patients of all ages, from children to adults, including infants and geriatric patients. The use of the Bio-logic EP family of products is to be performed under the prescription and supervision of a physician or other trained health care professional.

The Bio-logic Evoked Potential family of products is intended to be used for the recording and analysis of human physiological data for the purpose of neurological diagnosis and treatment of sensory disorders. The predicate device referenced above is the latest in a series of diagnostic systems of this type marketed by Bio-logic. Other related diagnostic devices in the Evoked Potential family include:

• 510(k) #K803226 Bio-logic Evoked Response Stimulators. 1.
• 510(k) #K842543 Bio-logic Evoked Potential System. 2.
• 510(k) #K844992 Bio-logic Portable Evoked Response System. 3.
• 510(k) #K862690 -- Bio-logic Traveler LT System. 4.
• 5. 510(k) #K930328 - Navigator and Traveler Evoked Potential Product.

The predicate device, the Bio-logic Evoked Potential system with Navigator Pro hardware, performs Evoked Potential recording and analysis functions, including up to 2 channels of data recording and numerous diagnostic protocols and modalities. This new MASTER Evoked Potential with Navigator Pro device performs many of these same functions in essentially the same ways with a one-channel version of the same hardware, but employs a new software application package with significant new capabilities over those of the predicate device. Through the use of the Auditory Steady State Response (ASSR) modality, which is a variant of the MLR / 40 Hz test modality used in the referenced systems already on the market, hearing threshold levels can quickly and reliably be determined based on physiological rather than behavioral means.

The Auditory Steady State Response test is an alternative to tone burst Auditory Brainstem Response (ABR) testing which is used to predict frequency-specific behavioral hearing thresholds particularly for patients who cannot provide a reliable behavioral response. The ASSR technique avoids one of the inherent pitfalls of the tone burst ABR technique which is the problem of "spectral splatter" (distortions in frequency-specific data due to the start/stop actions of the tone burst) of the short duration acoustic stimulus that is required for ABR measurement. The ASSR technique uses a continuous frequency and/or amplitude modulated tone as the stimulus and can combine several stimuli together simultaneously to assess responses to various frequencies all at the same time. The evoked response recorded from scalp electrodes is reflective of the frequency of the modulation envelope of the stimulus. Thus, assessment of the response spectrum can yield information about the presence of the response to stimuli of varying intensities in order to determine the response threshold. ASSR thresholds have a predictable relationship to behavioral thresholds that is dependent on stimulus frequency and the presence and degree of hearing loss.

The MASTER application software is a modification of software originally designed by and exclusively licensed from researchers at the Rotman Research Institute, Baycrest Centre for Geriatric Care, at The University of Toronto. This software was designed originally for research purposes, and Bio-logic made significant modifications to create double fault conditions for any situation that could impact patient safety (e.g. presentation of prolonged, intense acoustic stimuli), to block the user from making parameter changes that are known to result in poor quality data, and to improve overall reliability, performance and ease of use. Additionally, the user interface has been simplified in terms of operation and information display so that only the relevant operations and data are available. More complex functions that do not have clinical relevance were eliminated from the software.

This system will be used to assist in defining the configuration of the hearing loss particularly in populations that are difficult to test using traditional behavioral audiometry. It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

The provided text is a 510(k) summary for the Bio-logic MASTER Evoked Response System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria.

The document states that the modification was designed and incorporated "in accordance with the Bio-logic internal Product Development procedures which are intended to meet ISO-9001. EN-46001 and FDA QSR Design Control specifications." It also mentions a "Hazard/Risk analysis ... performed using the Fault Tree analysis (FTA) approach, and a detailed Risk Assessment was written in accordance with EN-1441." An addendum to this hazard/risk file was written for the new MASTER software.

Therefore, based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as the detailed study information requested, cannot be fully generated as such a study is not explicitly described.

However, I can extract information related to the device's design control and risk assessment, which are usually components of meeting acceptance criteria for medical devices:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table with specific, quantifiable acceptance criteria (e.g., specific accuracy metrics, threshold determination accuracy) and corresponding reported performance metrics from a clinical study. Instead, it focuses on demonstrating that the new MASTER device has "no significant differences which would adversely affect product safety and effectiveness" compared to its predicate.

The closest to "acceptance criteria" are the statements regarding safety and effectiveness, and the comparison table highlighting similarities and differences with the predicate device.

2. Sample Size for Test Set and Data Provenance:

• The document does not specify a sample size for a test set or discuss any clinical data provenance (e.g., country of origin, retrospective/prospective study). The submission is primarily focused on software modification and substantial equivalence to a predicate device, relying on design controls and risk analysis rather than a new clinical performance study.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• This information is not provided in the document as there is no mention of a clinical test set requiring expert-established ground truth.

4. Adjudication Method (Test Set):

• This information is not provided as there is no mention of a clinical test set requiring adjudication.

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

• The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device's standalone capability for diagnostic testing by trained healthcare professionals.

6. Standalone Performance Study:

• No specific standalone performance study with detailed metrics is reported in this summary. The document states that the software was "originally designed for research purposes" and Bio-logic "made significant modifications... to improve overall reliability, performance and ease of use." The claim of performance is inferred from the device's design to estimate behavioral hearing thresholds reliably through ASSR, a variant of an existing modality. The safety and effectiveness are established through adherence to design control procedures, hazard/risk analysis, and comparison with the predicate device.

7. Type of Ground Truth Used (if standalone study was done):

• Since no specific standalone study is described, the type of ground truth is not explicitly stated. However, the product's function is to "estimate behavioral hearing threshold," implying that the ultimate ground truth for auditory devices would typically relate to actual behavioral hearing thresholds or objective physiological measures that correlate strongly with them.

8. Sample Size for the Training Set:

• The document does not provide information on a training set sample size. The software was "originally designed by and exclusively licensed from researchers at the Rotman Research Institute... at The University of Toronto" for "research purposes." This suggests it was developed based on existing research data, but the specific size or nature of this "training" data is not detailed as part of the submission.

9. How Ground Truth for Training Set was Established:

• This information is not provided. Given the software's origin in research for "estimating behavioral hearing threshold," the ground truth in the original research would likely have been established through a combination of psychoacoustic behavioral audiometry and physiological measurements (e.g., ABR) that the ASSR technique is designed to complement or predict. However, the document does not elaborate on this for the software's development.

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The Bio-logic Otoacoustic Emissions (OAE) and Evoked Potential (EP) product families are indicated for use in the recording and analysis of human physiological data necessary for the diagnosis of auditory and hearing-related disorders. This product, the ABaer Cub with Automated OAE and ABR, like it's predicate devices, the AuDX and the ABaer Cub, is especially indicated for use in the screening of infants to determine hearing loss. The Bio-logic QAE and EP Systems can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired or uncooperative adults. The use of the Biologic OAE and EP families of products is to be performed under the prescription and supervision of other trained health care professional.

The Bio-logic Hearing Screening products, including the OAE and ABR test instruments Scout/AuDX and ABaer Cub, are intended to be used for the purpose of testing for hearing loss in patients of all ages, but primarily in infants. This new product, ABaer Cub with OAE, is the integration of both OAE and ABR screening functions into one portable unit, the ABaer Cub, with additional OAE software functions added to the Pocket PC host computer for the ABaer Cub. The ABaer Cub predicate device performs Evoked Potential screening, recording and analysis functions, provides one channel of data recording, and includes the Point Optimized Variance Ratio (POVR) algorithm for optimizing signal quality, implementing the screening function and enhancing speed of test completion. This new ABaer Cub with OAE device performs these same functions in the same ways, but has the added capability of performing the OAE tests of the Sport/AuDX predicate device, all within the same hardware package as the ABaer Cub. The Sport/AuDX predicate device can be used in either a stand-alone (AuDX) or host-connected (Sport) mode. The same DSP software is used in both types of box. The primary difference between the two products is that the Sport requires the use of a host computer for user control information and to store and display the data returned from the Sport box. For the AuDX, all user control and display is right at the AuDX box, making this a fully portable test instrument but with limited control and display capability. However, after an AuDX test is completed, it can be connected to a host computer to download test data for display on the host computer screen if desired. This same Sport/AuDX DSP software functionality has been incorporated into the ABaer Cub box. Much of the Sport host computer display software has been incorporated into the ABaer Cub Pocket PC (host computer), resulting in a completely battery-powered, portable hand-held test instrument capable of performing both the Automated OAE and ABR tests. The Sport OAE predicate device uses a desktop or laptop computer instead of the Pocket PC. The electronic hardware is the same as the ABaer Cub hardware used in that predicate device. Because both the Pocket PC and the ABaer Cub unit are battery powered, this significantly improves the portability and usability of the device over that of the Sport OAE predicate device. The ABaer Cub software for control of this device is a combination of the Sport and ABaer Cub predicate device software, with some GUI changes necessary in the Sport OAE software to modify the graphics display for use with the smaller Pocket PC LCD screen. The host software for the Sport/AuDX OAE predicate device is written in the C++ programming language for the Windows 95/98/ME operating system, whereas the host software for the ABaer Cub is written in the C++ programming language for the Windows Pocket PC operating system. Together, these software additions implement the same functionality and perform the same intended use as both predicate devices, but with improved portability and ease-of-use.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary and FDA clearance letter for the Bio-logic ABaer Cub with OAE device. It describes the device, its intended use, and establishes substantial equivalence to predicate devices (Sport/AuDX and ABaer Cub) based on the functions and integration of existing technologies.

Specifically, the text is focused on:

• Device Description: Explaining that the new device integrates the OAE functions of the Sport/AuDX and the ABR functions of the ABaer Cub into a single portable unit.
• Predicate Devices: Identifying the legally marketed devices to which the new device is substantially equivalent.
• Intended Use: Stating the purpose of the device (screening for hearing loss, especially in infants, and recording/analysis of physiological data for auditory disorders in all ages).
• FDA Clearance: The letter from the FDA stating that the device is substantially equivalent to predicate devices and can be legally marketed.

Therefore, I cannot provide the requested information in the table or the study details because they are not present in the provided document.

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