(65 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 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.
| Acceptance Criteria (Implicit) | Reported Device Performance (Findings from Studies) |
|---|---|
| Electrical Interface Performance (between probe and instrument) | "In this 510 (k) application, the probe without instrument and without eartips shall be compared to the substantial equivalent probe of echo-screen with respect to the electrical interface." (Implies meeting the electrical interface performance of the predicate) |
| Acoustical Parameters (sound generation and recording) | "Substantial equivalence to the EchoScreen is based on non clinical performance testing of the acoustical and electrical parameters." |
| Specifically, for the study: |
- 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.
§ 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).