Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device