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The QSCREEN device is a hand-held, portable hearing screener intended for recording and automated evaluation of Otoacoustic Emissions (OAE) and Auditory Brainstem Responses (ABR). Distortion Product Otoacoustic Emission (DPOAE) and Transient Evoked Otoacoustic Emission (TEOAE) tests are applicable to obtain objective evidence of peripheral auditory function. ABR tests are applicable to obtain objective evidence of peripheral and retro-cochlear auditory function including the auditory nerve and the brainstem. QSCREEN is intended to be used in subjects of all ages. It is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable.

The QScreen is a hand-held and portable audiometric examination device offering test methods for the measurement of Otoacoustic Emissions (OAE) including transitory evoked otoacoustic emissions (TEOAE), distortion product otoacoustic emissions (DPOAE) and Auditory Evoked Responses like Auditory Brainstem Responses (ABR) in patients of all ages. It has a touch screen display and can be used with different accessories, such as its Docking Station, Ear Coupler Cable, Ear probe, Insert earphone, and Electrode cable.

QScreen is a battery powered device which is charged by the Docking Station wirelessly and communicates with the Docking Station via Bluetooth. The Docking Station can be connected to a personal computer (PC) via USB cable on which patient and test data can be reviewed and managed with the optional software. Additionally, device and user profile configurations can be conducted with the software. Printing the data is also possible and carried out by a label printer that can be connected to the Docking Station. The QScreen device also contains a camera on the back side to read linear bar codes and QR codes. All materials that come into contact with human skin are selected to be biocompatible.

The operating system on the QScreen is a self-contained firmware. The user is guided by the menu on the touch screen through the measurement. The results are evaluated on the base of signal statistics. The device offers an automatically created result, which can have the values "PASS" (Clear Response), "REFER" (No Clear Response) or "INCOMPLETE" (Test aborted).

The provided text is a 510(k) summary for the PATH MEDICAL GmbH's QScreen device. It states that "No clinical performance data was collected for the subject device QScreen. Substantial equivalence was shown through bench testing and compliance to international standards..." As such, the document does not contain the information required to answer the prompt regarding acceptance criteria and the study that proves the device meets the acceptance criteria (specifically clinical performance data).

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document explicitly states that no clinical performance data was collected to demonstrate the device meets acceptance criteria via a clinical study. Instead, substantial equivalence to a predicate device (Sentiero) was shown through:

• Bench testing: This included tests for "frequency, timing and sound level of the stimulus as well as noise resistance and the lowest response signal detectable by the device."
• Compliance to international standards: IEC 60645-6:2009 (OAE) and IEC 60645-7:2009 (ABR).
• Biocompatibility testing: According to ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation).
• Electrical safety and electromagnetic compatibility (EMC) testing: According to IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2:2014, IEC 60601-2-40: 2016.
• Software Verification and Validation Testing: According to FDA's guidance and IEC 62304:2015.
• Usability Testing: According to EN 62366:2015.
• Mechanical and Acoustic Testing: Including maximum sound level, push, drop, and mould stress relief tests, and frequency content, timing, sound level, and repetition rate of stimuli.
• Literature Review: Citing publications on ABR algorithm and automated infant screening.

The comparison to the predicate device focuses on technical characteristics, intended use (where QScreen is a subset of Sentiero's functionality), and accessories, stating that these differences "do not raise different question of safety or effectiveness."

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Devices of the Sentiero device families offer different test methods which can be configured to fit the professional's needs for hearing screening or diagnostics and vestibular diagnostics (Sentiero Advanced only),

Available psycho-acoustical methods on Sentiero devices are especially indicated for use with cooperative patients starting at the age of two years or adequate development age, which enables them to do play/interactive audiometry. Physiological modules which require active paticipation (e.g. VEMP) are indicated for use with cooperative patients who are mentally and physically able to perform the required task. All other physiological modules are suitable to be used for all ages elder than infants from 34 weeks (gestational age) that are ready for discharge from the hospital.

Sentiero is an audiometric examination platform which consists of the Sentiero device with a touch screen display together with different accessories such as mains adapter, OAE probes, headphones, bone conductor, electrode cable, ear coupler cable, patient response switch. These accessories can be connected to Sentiero based on a special plug, which holds the information about the connected transducer / cable. Therefore, the firmware can make use of this information and adapt the measurement procedures accordingly or provide information to the user via its display.

Furthermore, each model can be configured to allow different test methods and features (modules) by a license key in the device. Sentiero is based on configurable modules. Sentiero can have one single module or a combination of multiple.

The measurement application is controlled from a self-contained firmware. The measurement flow is menu guided on a touch screen. Evaluation of test results is based on signal statistics (if available for the test method). Besides that, wave forms and result information are displayed for the user's evaluation.

The patient/test data can be transferred from the device to a PC via a USB connection and the accompanied data management and archiving software MRA. Patient/test data on the PC software can be password- protected so that unauthorized access is prohibited.

Compared to the original 510(k) submission of the Sentiero in its predicate state, the Sentiero now offers a VEMP test module. Vestibular evoked myogenic potential (VEMP) is a short latency muscle reflex driven by otolithic organs that play a major role for detecting the orientation, static balance and linear acceleration of the head. Vestibular dysfunctions arise from various different regions along the vestibular pathway. Vestibular neuritis, vestibular schwannoma, multiple sclerosis or Meniere's disease will be indicated by the decrease or absence of VEMP responses.

The provided text describes a 510(k) premarket notification for a medical device called Sentiero, specifically addressing the addition of a Vestibular Evoked Myogenic Potential (VEMP) module. The document focuses on demonstrating substantial equivalence to a predicate device and a reference device, rather than presenting a performance study with detailed acceptance criteria of an AI/ML powered device.

Therefore, many of the requested criteria for acceptance and proof of performance relating to AI/ML devices (e.g., sample size for test set with provenance, number of experts for ground truth, MRMC studies, standalone AI performance, etc.) are not applicable to this submission, as the Sentiero device and its VEMP module are described as audiometric examination platforms with physiological test procedures, and do not appear to incorporate AI/ML algorithms that would require such performance evaluations.

However, I can extract information related to the device's functional performance and its verification and validation.

Here's a breakdown of the available information based on your request, highlighting what is present and what is not applicable:

1. A table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of a target metric for an AI/ML algorithm's performance (e.g., "AUC must be > 0.90"). Instead, it demonstrates the device's appropriate functionality and reliability through testing.

The primary performance data provided is related to the repeatability and reliability of the VEMP measurements.

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

• Test Set Sample Size: 16 normal hearing adults.
• Data Provenance: Not explicitly stated, but the submission is from a German company (Path Medical GmbH, Germering, Bavaria, Germany), implying that the clinical evaluation data likely originated from Europe, potentially Germany. The study is prospective as it describes "conducted tests" with "test subjects."

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

This is not applicable in the context of AI/ML algorithm evaluation for this device. The device itself is an audiometric instrument that records physiological signals (VEMPs). The "ground truth" for VEMP measurements is the actual physiological response (P1, N1 latencies, interpeak amplitude). The device's role is to accurately capture and display this response. Interpretation of these results for diagnosis is explicitly stated to be performed by an "ENT specialist."

4. Adjudication method for the test set

Not applicable. Since the device measures physiological signals, there's no diagnostic "ground truth" adjudicated by multiple experts for the device's output itself. The measurements (latencies, amplitudes) are derived from the recorded waveforms.

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 does not incorporate AI to assist human readers/clinicians in interpretation or diagnosis. It is a measurement tool.

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

Not applicable. The device is an instrument operated by a healthcare professional. There is no AI algorithm that performs a standalone diagnosis or interpretation. The performance tested is the accuracy and consistency of its measurements as a medical device.

7. The type of ground truth used

The "ground truth" is the physiological VEMP response itself, measured by the device. The study design ("Repeatability [Coefficient of variation]" and "Reliability [Coefficient of variation]") indicates that the device's ability to consistently and accurately measure these expected physiological parameters (P1 latency, N1 latency, Interpeak latency, Interpeak Amplitude) from repeated tests was evaluated. The comparison is against established academic literature for typical VEMP findings.

8. The sample size for the training set

Not applicable. This is a medical device that measures physiological signals, not an AI/ML model that requires a "training set" in the computational sense. The core technology is signal acquisition and processing based on established audiometry principles.

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

Not applicable. (See point 8).

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The ALGO® 71 Newborn Hearing Screener is a hand-held, portable hearing screener intended to objectively determine the hearing status of a newborn/infant from 34 weeks gestational age to 6 months old. Babies should be well enough for hospital discharge and should be asleep or in a quiet state at the time of screening.

ALGO 7i is an audiometric examination platform which consists of the ALGO 7i device with a touch screen display together with different accessories such as Multidata Cable, Docking Station, Patient Cable, ATA Cable. All connectors and transducers have a special mechanically coded plug-in order to ensure the correct connection to the device. All plugs of the transducers have a memory chip inside which stores the information about the respective transducer (including type of connector, calibration table). As a result, the ALGO 7i instrument can be connected flexibly to different ATA Cables while enabling the instrument to 'know' the calibration values and status of the connected Cable. This information is to guide the user (feedback via display) and help to ensure correct performance of the device. The ALGO 7i is designed as standalone examination platform and can be connected to a personal computer (PC) via USB using the Multidata Cable or the Docking Station for data review and management. The Device is portable and is meant to be mainly used as mobile device. Materials in contact with humans are selected to be biocompatible.

Additional features are direct printing of patient and measurement data on a label using label printer that can be connected via Multidata Cable or Docking Station.

The ALGO 7i offers hearing screening using AABR technology.

The measurement application is controlled from a self-contained firmware. The measurement flow is menu guided on a touch screen. Evaluation of test results is based on signal statistics. Besides that, result information is displayed as PASS/REFER/INCOMPLETE.

The ALGO 7i is designed to be used by trained personnel in a medical or home environment to examine hearing in infants from 34 weeks (gestational age) that are ready for discharge from the hospital up to 6 months old.

Here's a breakdown of the acceptance criteria and the study proving the ALGO 7i device meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ALGO 7i are primarily established through its substantial equivalence to the predicate device, ALGO 3i, especially regarding its ABR (Auditory Brainstem Response) technology and performance metrics. The text describes the algorithmic sensitivity and typical specificity observed in studies of the predicate device, which is foundational to the ALGO 7i's acceptance.

Details of the Study Proving Device Meets Acceptance Criteria:

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

   • Test Set Sample Size: No new clinical performance data was collected for the ALGO 7i. The performance evaluation relies entirely on the established performance of its predicate device, ALGO 3i, and non-clinical bench testing.
   • Data Provenance (Predicate Device): The original ABR template was derived from the responses of 35 neonates to 35 dBnHL click stimuli. This data was collected at Massachusetts Eye and Ear Infirmary during the design and development of the original automated infant hearing screener (ALGO I device). Clinical studies supporting the predicate ALGO devices (e.g., ALGO 3i) are referenced in the literature review. The studies mentioned are:
     • Peters, J. G. "An automated infant screener using advanced evoked response technology." The Hearing Journal 39 (1986): 25-30.
     • Herrmann, Barbara S., Aaron R. Thornton, and Janet M. Joseph. "Automated infant hearing screening using the ABR: development and validation." American Journal of Audiology 4.2 (1995): 6-14.
   • Nature of Data: Retrospective (referencing historical clinical studies and data from predicate devices) and prospective (new non-clinical bench testing for ALGO 7i).

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

   • For the original ABR template creation (for the predicate ALGO I using 35 neonates), the text does not specify the number of experts. However, it implicitly relies on the clinical expertise and methodologies employed at Massachusetts Eye and Ear Infirmary during the initial development of the ABR technology. No specific number or qualifications of experts are given for establishing the ground truth for the test set of the ALGO 7i, as its "test set" for clinical performance is essentially the historical performance data of the ALGO 3i.

3. Adjudication Method for the Test Set:

   • Not applicable as this was not a comparative clinical study with human readers adjudicating results for the ALGO 7i. The ALGO device itself provides a PASS/REFER/INCOMPLETE result based on its internal algorithm without human adjudication within the device's operation. The source ground truth (the ABR waveforms from the 35 neonates) would have involved clinical expertise, but the specific adjudication method (e.g., 2+1) is not described.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was done for the ALGO 7i. The device is a standalone automated screener; it is not designed to assist human readers in interpreting results. Its output is a direct PASS/REFER/INCOMPLETE.
   • Therefore, there is no effect size reported for human readers improving with AI vs. without AI assistance.

5. Standalone Performance:

   • Yes, a standalone (algorithm only) performance was done. The ALGO 7i is entirely an algorithm-driven device that provides a direct PASS/REFER/INCOMPLETE result based on its patented signal processing technology and template matching. Its performance is evaluated based on its ability to accurately classify hearing status. The "standalone" performance metrics (sensitivity, specificity, sweeps to result) are those derived from the predicate ALGO 3i, as the ALGO 7i uses the exact same fundamental algorithm.

6. Type of Ground Truth Used:

   • Expert Consensus / Physiological Data: The core ground truth for the ABR template is derived from the "morphology of normal hearing, near-threshold, infant ABR waveforms" determined by superimposing responses from 35 neonates. This implies a physiological ground truth established through clinical observation and interpretation, consistent with expert understanding of normal infant hearing.
   • Outcomes Data: While the original studies for the predicate device would implicitly rely on long-term outcomes to validate the clinical utility of the screening, the immediate ground truth for template development is physiological (ABR waveforms).

7. Sample Size for the Training Set:

   • The "training set" for the algorithm's template was generated from the ABR waveforms of 35 neonates. This serves as the basis for the fixed "template" which the algorithm matches against.

8. How the Ground Truth for the Training Set Was Established:

   • The ground truth for the training set (the ABR template) was established by superimposing the responses of 35 neonates to 35 dBnHL click stimuli. These neonates were presumed to have normal hearing, and their physiological responses (ABR waveforms) formed the "template" against which subsequent readings are compared. This data collection occurred at the Massachusetts Eye and Ear Infirmary during the design and development of the original ALGO device. The process involved collecting actual ABR waveforms from a cohort of what medical experts considered "normal-hearing" infants.

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Sentiero is a portable instrument to diagnose all ages or hearing loss. The instrument offers different test methods which can be configured to fit the professional's needs for screening or diagnostic purposes. It offers physiological test methods such as:

· Distortion Product Otoacoustic Emissions (DPOAE)

· Transient Evoked Otoacoustic Emissions (TEOAE)

· Auditory Brainstem Response (ABR)

· Auditory Steady State Response (ASSR)

· Auditory Impedance and acoustic reflex (TYMP)
Additionally if offers standard audiometry (psycho-acoustical). All physiological test methods are especially indicated for use in defining the type and configuration of hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable or to assist in the diagnosis of otologic disorders. Estimation of cochlear hearing thresholds (DPTHRESH) is possible at various frequencies without the need of cooperative interaction with the patient. Acoustic reflex and tympanometry (TYMP) are featured to evaluate the function of the middle and outer ear. For each method, several protocols can be configured. The results are to be used to make further recommendations regarding appropriate intervention strategies. Therefore, Sentiero is intended for use by trained personnel such as audiologists. pediatricians. ENT doctors and other health care professionals in a medical or home environment. In the United States of America. Federal law restricts this device to sale by or on the order of a licensed physician.

Available psycho-acoustical methods on Sentiero are especially indicated for use with cooperative patients starting at the age of 2 years or adequate development age, which enables them to do play/interactive audiometry. All other modules are suitable to be used for all ages elder than.infants from 34 weeks (gestational age) that are ready for discharge from the hospital.

Sentiero is designed for:

1. Diagnostics, monitoring and follow-up after newborn hearing screening
2. Pre-school, school, and adult hearing screening
3. ENT diagnostics based on measurement of
   a) Otoacoustic emissions
   b) Tympanometry and acoustic reflex
   c) Auditory Brainstem Responses
   d) Auditory Steady State Responses

Sentiero must not be used in cases of external otitis (outer ear canal infection) or in any case which yields to pain when inserting the ear probe or applying any other transducer.

Sentiero is an audiometric examination platform which consists of the Sentiero device with a touch screen display together with different accessories such as mains adapter, OAE probes, headphones, bone conductor, electrode cable, ear coupler cable, patient response switch. All connectors and transducers have a special plug in order to ensure the correct connection to the device. All plugs of the transducers have a memory chip inside which stores the information about the respective transducer (including type of connector, calibration table). As a result, the Sentiero instrument can be connected flexibly to different kind of transducers while enabling the instrument to 'know' the features of the connected transducer. This information is used within the different modules (test methods which are configured) to guide the user (feedback via display) and help to ensure correct performance of the test methods.

Sentiero is available in two different models: handheld or desktop version. The desktop version is labeled Sentiero (Type Desktop). Both versions are standalone examination platforms and can be connected to a personal computer (PC) via USB for data review and management. The handheld version is portable and is meant to be mainly used as mobile device. The desktop version is portable as well but is meant to be mainly used as stationary device. Both models base on a common hardware platform (printed circuit board, PCB) but with different configurations. Materials in contact with humans are selected to be biocompatible.

Furthermore, each model can be configured to allow different test methods and features (modules) by a license key in the device. Sentiero is based on configurable modules. Sentiero can have one single module or a combination of multiple of modules described in the following intended use.

The measurement application is controlled from a self-contained firmware (software installed on the instrument). The measurement flow is menu guided on a touch screen. Evaluation of test results is based on signal statistics (if available for the test method). Besides that wave forms and result information is displayed for the user's evaluation.

Here's a breakdown of the acceptance criteria and the study information for the Sentiero device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance for Sentiero

The provided document describes the Sentiero device and its comparison to predicate devices, primarily focusing on its substantial equivalence through adherence to standards and qualitative clinical evaluations. There are no explicit, quantifiable acceptance criteria tables with specific thresholds and reported performance metrics as one might typically find for an AI/ML device.

Instead, the acceptance criteria are implicitly defined by compliance with a comprehensive set of national and international standards related to audiological devices, electrical safety, EMC, software lifecycle, and biocompatibility, as well as qualitative clinical equivalence to predicate devices demonstrated through user feedback and expert evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of explicit performance metrics for comparison against acceptance criteria in the provided text for the Sentiero device itself, the table below will summarize the types of criteria and the manner in which performance was assessed and deemed acceptable, primarily through equivalence to predicate devices and compliance with standards.

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

• Test Set Sample Size: For the clinical evaluations, a "minimum number of participants per evaluation was 20." This applies to the external user validation studies for various modules (PTA, MAGIC, MATCH, DPTHRES, ABR, TEOAE, DPQUICK, ASSR).
  • For the ABR clinical evaluation comparing Sentiero and Chartr EP 200, the sample size is not explicitly stated but implies "the same test persons."
  • For the in-house validation using a simulator device, the "test protocol is attached in the Appendix" but not provided.
• Data Provenance: The external clinical evaluations involved various institutions, predominantly in Europe (Germany, Italy, Switzerland).
  • Center of Communication Disorders, ENT Clinic, University Medical Center of the Johannes-Guttenberg-University Mainz, Mainz, Germany
  • Department of Audiology and Speech Therapy, University of Ferrara, Ferrara, Italy
  • ENT Clinic, Klinikum rechts der Isar, Technische Universität München, Munich, Germany
  • ENT Clinic, Kantonsspital Liestal, Liestal, Switzerland
  • Department of Phoniatry and Pedaudiology, ENT Clinic, St. Elisabeth-Hospital, Bochum, Germany
• Retrospective or Prospective: The text implies prospective clinical evaluations where external users "were asked to evaluate the performance" and "Comparison measurements had to be done." The "first clinical evaluation in 2011" for ABR also suggests a prospective study explicitly comparing the two devices.

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

• Number of Experts: For the ABR clinical evaluation (Sentiero vs. Chartr EP 200), "All results have been evaluated by an expert in audiology." While only one explicit expert is mentioned for this specific evaluation, the list of external testers includes multiple individuals with titles like "Prof. Dr. med." and "Ph.D.", suggesting multiple expert evaluators across the various module assessments.
• Qualifications of Experts:
  • "expert in audiology" (for ABR evaluation)
  • Prof. Dr. med. Annerose Keilmann
  • Ph.D. Stavrous Hatzopoulos (Department of Audiology and Speech Therapy)
  • Prof. Dr. med. Hans Peter Niedermeyer (ENT Clinic)
  • Dr. Thomas Rosner (ENT Clinic)
  • PD Dr. med. Nicolas Schmuziger (ENT Clinic)
  • Prof. Dr. Katrin Neumann (Department of Phoniatry and Pedaudiology. ENT Clinic)
  • These qualifications (Prof. Dr. med., Ph.D., associated with university medical centers and ENT clinics) indicate highly qualified professionals in audiology, ENT, and related fields.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method like 2+1 or 3+1 for resolving discrepancies among multiple readers or interpretations of results. The clinical evaluations suggest expert review and comparison to predicate devices, where the "results have been evaluated by an expert" or "out of these studies reports were generated or published, which indicated that Sentiero is an equivalence to the given predicate devices." This implies a form of expert consensus or direct comparison, rather than a formal adjudication process for disagreements.

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

No formal MRMC comparative effectiveness study, as typically understood in the context of AI performance improvement, is described. The clinical evaluations involved "multiple users" to verify usability and comparison measurements with predicate devices. However, the goal was equivalence in clinical application and usage, not quantifying an "effect size of how much human readers improve with AI vs without AI assistance" because the Sentiero device is not an AI assistant for human readers; it's a diagnostic instrument. The "AI" (advanced algorithms/signal processing) is embedded within the device's diagnostic output, rather than providing assistance to a human making a read.

6. Standalone Performance Study (Algorithm Only)

The Sentiero device is presented as a "standalone examination platform" for measurements. The document indicates that "The measurement application is controlled from a self-contained firmware (software installed on the instrument)." The clinical evaluations and in-house validations assessed the device as a whole, including its algorithms.

• "Performance tests were also conducted on a test bench. For this reason a simulator device, which simulates TEOAE, DPOAE or ABR output was used for proof of validity of the derived signal." This simulator was used to validate the performance of the test modules, which implies assessing the algorithms' ability to correctly process simulated signals and produce valid results, thus serving as a form of standalone testing for the core algorithmic functionality.
• The "signal processing information is used in Sentiero only as an indicator (traffic light or indicator for valid response)." This suggests the internal algorithms generate definitive outputs (pass/refer type indicators, waveform analysis) that are then interpreted by the user.

7. Type of Ground Truth Used

The ground truth used for the evaluations appears to be a combination:

• Expert Consensus/Clinical Judgment: The ABR evaluation states an "expert in audiology" evaluated results. The external testers, who are medical professionals and researchers, made judgments on equivalence based on clinical application/usage.
• Comparison to Predicate Devices: Clinical evaluations explicitly involved comparison measurements with "predicate devices" on "normal hearing patients with hearing loss." The predicate devices represent the established standard of care and thus serve as a form of ground truth or reference for demonstrating equivalence.
• Simulator Data: For in-house validation, a "simulator device" delivered "noise or dedicated normative answers derived from literature." Here, the "normative answers" serve as a controlled, known ground truth for validating the device's signal processing.
• Established Algorithms/Literature: "all implemented modules on Sentiero are derived from well-known algorithms, which are described in detail in published literature... The design process of Sentiero included in-house verification tests also with respect to the mentioned literature and and establishment of normative data." This means the foundational correctness of the algorithms is rooted in established audiology science.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of modern machine learning that would require a specific sample size. The Sentiero device's modules are described as being based on "well-known algorithms" and "normative data," rather than being "trained" on a dataset in the AI/ML sense. The development process involved "in-house verification tests" and "establishment of normative data," which implies calibration and validation against known physiological responses, but not a distinct training phase with a dedicated dataset as might be found in deep learning.

9. How Ground Truth for the Training Set Was Established

As noted above, there is no explicit "training set" described for the Sentiero device in the AI/ML sense. The algorithms are based on established audiological science. The "normative data" and "well-known algorithms" from literature effectively serve as the "ground truth" for the device's inherent design and calibration. This would have been established through years of audiology research and clinical practice, rather than a specific set of labeled data for this device.

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The Ear Probe is intended to be an accessory to auditory testing equipment that use evoked responses (e.g. DPOAE, ABR) to assess hearing function.
· The Ear Probe is capable of both generating and recording sounds in the ear canal.
· The Ear Probe is intended for use in all ages.
The interface to the patient's ear is provided by means of disposable standard eartips, which are available as separate consumables.

The Earprobes EP-DP and EP-TE are passive Transducers, which are used to covert electrical stimulus into acoustical stimulus. The electrical stimuli are provided by otoacoustic emissions devices or auditory evoked responses stimulators (afterwards referred as interfacing instruments). The acoustical stimulus is then coupled into the patient's ear.
The probe comprises of four sections:
a) Electrical transmission path
b) speaker and microphone
c) acoustic transmission path
d) transducer case

Here's a breakdown of the acceptance criteria and study information for the Earprobe EP-DP and EP-TE, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not explicitly state numerical "acceptance criteria" for the Earprobe EP-DP and EP-TE that were established prior to testing. Instead, the study conducted was a performance comparison against a legally marketed predicate device (Echo-Screen TDA probe). The "reported device performance" is essentially the finding of substantial equivalence to the predicate in acoustical and electrical parameters.

• Earprobe EP connected to AccuScreen (equivalent to EchoScreen TDA) showed "proof of substantial equivalence in performance" when compared to the original AccuScreen probe connected to AccuScreen. |
  | Overall Performance/Functionality (e.g., generating/recording sounds, compatibility with auditory testing equipment) | The device was certified with a CE mark together with the Sentiero device, indicating it met required performance standards for that certification for "preschooler's hearing screening." This implies successful demonstration of generating and recording sounds as an accessory to auditory testing equipment. |

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

• Sample Size for Test Set: Not explicitly stated as a numerical value (e.g., number of patients or specific measurements). The studies mention testing in "different hospitals in Germany and Danmark" and comparisons to predicate devices.
• Data Provenance:
  • Country of Origin: Germany and Danmark.
  • Retrospective or Prospective: The description indicates that "performance studies were conducted," implying a prospective nature for these tests, where the Earprobe EP was actively tested in various configurations.

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 510(k) summary. The studies described are performance comparisons against a predicate device and certification efforts, rather than studies requiring expert adjudication of data for establishing ground truth in the traditional sense (e.g., clinical diagnosis). The "ground truth" here is the performance of the predicate device, or established engineering specifications for electrical and acoustical parameters.

4. Adjudication Method for the Test Set:

This information is not applicable/provided as the studies described are performance comparisons and certification processes, not clinical studies requiring expert adjudication of patient outcomes or interpretations.

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 described is a passive transducer (ear probe) used as an accessory for auditory testing equipment. It is not an AI-powered diagnostic or interpretive device, nor does it involve "human readers" in the context of interpretation that would necessitate an MRMC study.

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

Not applicable. The device is a physical accessory (ear probe), not an algorithm. Its performance is tested in conjunction with the interfacing instruments it connects to. However, the 510(k) application focuses on the probe itself "without instrument and without eartips" for the electrical interface comparison, which could be considered a form of "standalone" testing for its intrinsic electrical properties.

7. The Type of Ground Truth Used:

The ground truth used for evaluating the Earprobe EP-DP and EP-TE was primarily:

• Predicate Device Performance: The performance of the "original AccuScreen probe connected to AccuScreen" (which is equivalent to the EchoScreen TDA probe) served as the benchmark for demonstrating "substantial equivalence."
• Engineering Specifications/Standards: For the CE mark certification and the comparison of electrical and acoustical parameters, the device's performance was measured against established technical specifications or standards relevant to auditory transducers.

8. The Sample Size for the Training Set:

Not applicable. The Earprobe EP-DP and EP-TE is a passive transducer and does not involve machine learning algorithms that require a "training set."

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

Not applicable. As the device does not employ machine learning, there is no training set or corresponding ground truth establishment process in this context.

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The Ear Probe is intended to be an accessory to auditory testing equipment that use evoked responses (e.g. DPOAE, ABR) to assess hearing function.
• The Ear Probe is capable of both generating and recording sounds in the ear canal.
· The Ear Probe is intended for use in infants from 34% week (gestational age) up to 6 months of age.
The interface to the patient's ear is provided by means of disposable standard eartips, which are available as separate consumables.

The Earprobes EP-DP and EP-TE are passive Transducers, which are used to covert electrical stimulus into acoustical stimulus. The electrical stimuli are provided by otoacoustic emissions devices or auditory evoked responses stimulators (afterwards referred as interfacing instruments). The acoustical stimulus is then coupled into the patient's ear.
The probe comprises of four sections:
a) Electrical transmission path

• b) speaker and microphone
• c) acoustic transmission path
• d) transducer case

a) The electrical transmission path is connected to the interfacing instrument by a connector, which is connected to a shielded cable. The other end of the cable is attached to the microphone and speaker svstem.
Within the connector, an EEPROM is placed to store calibration data of the probe and to enable an interfacing device to identify the attached probe.
b) Each of the two speakers (in case of EP-DP) or the only speaker (in case of EP-TE) converts the electrical stimulus into an acoustic stimulus. The acoustic stimulus is delivered to the patient's ear by means of the acoustic transmission path.
One microphone in the probe is used to pick up the acoustical stimulus (which is delivered by the acoustical transmission path) and convert it to an electrical stimulus.
c) The acoustic transmission path is separated for each speaker and microphone. It consists of a silicone sealing which contains the speaker and microphones and connects to the acoustic ducts, which are implemented within the probe tip. The ducts are separated from each other and are used to smooth the acoustic output at the probe tip. Ear tips, which is not part of the probe, are put onto the tip of the probe tip in order to interface to the patient's ear.
d) The transducer case is the housing of the speaker and microphone and acts as the bridge between electrical and acoustical transmission path. It also provides means of handling.

Acceptance Criteria and Study for Earprobe EP-DP and EP-TE

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit quantifiable acceptance criteria for novel performance. The acceptance criteria are implicitly met by demonstrating that the new device performs similarly to the predicate device in relevant non-clinical and clinical settings.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated for specific tests (e.g., number of individuals or test runs). The description mentions "different hospitals in Germany and Danmark" for performance and safety testing.
• Data Provenance: The studies were conducted in Germany and Denmark. The type of study design (e.g., randomized controlled trial) is not specified, but the comparative nature suggests an observational or comparative effectiveness design.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this device is not based on expert interpretation of medical images or other subjective assessments. Instead, it relies on objective physical measurements and comparisons to a predicate device.

4. Adjudication Method

Not applicable, as this is not an interpretive device requiring human adjudication of results.

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

No. This type of study is typically performed for interpretive medical devices (e.g., AI for radiology). This device is a passive transducer, and its performance is evaluated through acoustical and electrical measurements, not human interpretation.

6. Standalone (Algorithm Only) Performance

Yes, implicitly. The performance of the probes (Earprobe EP-DP and EP-TE) was tested in conjunction with various instruments (AccuScreen, Otobox, Sentiero). While the probe itself is passive, its acoustical and electrical characteristics are the "algorithm only" in the context of its function, and these characteristics were assessed independently of a human operator's judgment. The 510(k) application specifically compares the probe "without instrument and without eartips with respect to the electrical interface," demonstrating a standalone assessment of its core characteristics.

7. Type of Ground Truth Used

• Objective Physical Measurements: The ground truth for this device is based on objective acoustical and electrical measurements that demonstrate "substantial equivalence to the EchoScreen," the predicate device. This involves comparing parameters like frequency response, sound pressure level, electrical impedance, etc., to established performance characteristics of the predicate.
• Predicate Device Performance: The primary "ground truth" used for comparison is the established performance of the legally marketed predicate device, the probe of the Echo-Screen T series (K013977).

8. Sample Size for Training Set

Not applicable. This device is a passive transducer, not an AI/machine learning algorithm that requires a "training set."

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this device.

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