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510(k) Data Aggregation
(257 days)
Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE
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.
| Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Repeatability (oVEMP) | Low variation in P1/N1 latency and interpeak latency; Medium variation in interpeak amplitude. (Inferred from "low variation" and "medium variation" statements) | P1 latency: Day 1: 1.95%, Day 2: 1.02% |
| N1 latency: Day 1: 1.23%, Day 2: 1.69% | ||
| Interpeak latency: Day 1: 7.54%, Day 2: 6.72% | ||
| Interpeak Amplitude: Day 1: 8.02%, Day 2: 12.14% | ||
| Repeatability (cVEMP) | Low variation in P1/N1 latency and interpeak latency; Medium variation in interpeak amplitude. (Inferred) | P1 latency: Day 1: 1.25%, Day 2: 2.51% |
| N1 latency: Day 1: 1.85%, Day 2: 1.21% | ||
| Interpeak latency: Day 1: 5.40%, Day 2: 5.40% | ||
| Interpeak Amplitude: Day 1: 11.48%, Day 2: 7.08% | ||
| Reliability (oVEMP) | Low variation in P1/N1 latency and interpeak latency; Medium variation in interpeak amplitude. (Inferred) | P1 latency: 2.98% |
| N1 latency: 2.38% | ||
| Interpeak latency: 10.86% | ||
| Interpeak Amplitude: 23.64% | ||
| Reliability (cVEMP) | Low variation in P1/N1 latency and interpeak latency; Medium variation in interpeak amplitude. (Inferred) | P1 latency: 3.32% |
| N1 latency: 4.05% | ||
| Interpeak latency: 11.15% | ||
| Interpeak Amplitude: 18.80% | ||
| General Suitability | Must be suitable for recording VEMPs to assist ENT Doctors in diagnosis. | "Overall, the EP system as implemented in the subject Sentiero with VEMP can be considered suitable for the recording of VEMPs to assist ENT Doctors in a diagnosis of deficiencies in the vestibular system." |
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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