(257 days)
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:
- Diagnostics, monitoring and follow-up after newborn hearing screening
- Pre-school, school, and adult hearing screening
- 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.
| Acceptance Criterion Type | Specific Criteria/Standard (as implied) | Reported Device Performance/Evidence |
|---|---|---|
| Safety | IEC 60601-1 (various editions: 1988, 2005) | Sentiero successfully passed tests for these standards, demonstrating safety. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2007 | Sentiero successfully passed tests for this standard, demonstrating EMC. |
| Programmable Electrical Systems (Software) | IEC 60601-1-4:1996, IEC 62304:2006 (Software lifecycle) | Sentiero successfully passed tests for these standards, confirming proper functioning of programmable systems and adherence to software lifecycle requirements. PATH medical GmbH is ISO 9001:2008 and ISO 13485:2003 certified, indicating a robust quality management system for medical devices, including software. |
| Biocompatibility | ISO 10993-1:2009 | Sentiero's materials in contact with humans are selected to be biocompatible, and the device passed tests for this standard. |
| Audiometer Standards | IEC 60645-1:2001 (Pure-tone audiometer), ISO 389 series (reference levels for various transducers) | Sentiero successfully passed tests for these standards. |
| Otoacoustic Emissions (OAE) | IEC 60645-6:2009 | Sentiero successfully passed tests for this standard. Performance for TEOAE, DPOAE, DPTHRES against predicate devices (Cochlea-Scan, AccuScreen) was validated in-house using a simulator, and in external clinical evaluations. Considered "similar safe, effective and performant." |
| Evoked Potentials (ABR, ASSR) | IEC 60601-2-40:1998 (Safety of electromyographs and devices for evoked potentials), IEC 60645-7:2009 (Acoustically evoked potentials) | Sentiero successfully passed tests for these standards. A clinical evaluation in 2011 compared Sentiero and Chartr EP 200 (predicate ABR device) on the same test persons. Morphology and latencies of wave V were analyzed. "Both systems, Sentiero and Chartr EP 200, were described as reliable clinical ABR devices, which supports the substantial equivalence between both instruments with respect to clinical performance." External tests involved comparison with Chartr EP 200 and Eclipse. |
| Impedance Audiometry (TYMP) | IEC 60645-5/ANSI S3.39, Type 1 (impedance audiometry), IEC 60645-1/ANSI S3.6, IEC 60645-3 (test signals) | Sentiero's TYMP module is conform to IEC 60645-5 / ANSI S3.39 Type 1. Probe tone frequency and level are identical to the predicate (Titan IMP440). Pressure safety limits (-700...+500 daPa) are within the required range (-800...+600 daPa), considered "Equivalent" with increased safety due to a smaller range. Transducers and reflex stimuli are "Same" or "Equivalent", complying with standards. "Overall Conclusion" explicitly states similar safety, effectiveness, and performance to predicate devices. |
| Clinical Performance/Usability | Equivalence to predicate devices (e.g., Cochlea-Scan, AccuScreen, Chartr EP 200, Titan IMP440) in clinical application/usage, usability for trained personnel. | Clinical tests "showed that Sentiero can be used by professionals as efficiently as the respective predicate devices." External users validated measurement results and device usage, comparing against predicate devices with normal hearing patients and those with hearing loss. |
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.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.