(115 days)
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
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Acoustical and Electrical Parameters | Substantial equivalence to the predicate device (Echo-Screen T series probe) | Device was certified with CE mark with the Sentiero device. Studies conducted with AccuScreen (equivalent to EchoScreen TDA), Otobox, and Sentiero demonstrated performance. |
| Safety | Demonstrated safety in various hospitals (implied by CE mark and clinical testing) | Performance and safety testing was conducted in different hospitals in Germany and Denmark. |
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.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).