(160 days)
The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders.
Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions: The Type 1077 DPOAE module and TEOAE module can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired adults.
Auditory Brainstem Response: The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age.
When the device is used to screen infants. they should be asleep or in a quiet state at the time of screening. The device is intended for use by audiologists. ENT's and other healthcare professionals.
The device is identical to our own device described in K122067. Only the indications for use has changed. The age range has been expanded. Different models of the device are capable of the following list of tests: AccuScreen TE (TEOAE), AccuScreen DP (DPOAE), AccuScreen TE/DP (TEOAE and DPOAE), AccuScreen ABR (ABR), AccuScreen ABR/TE (ABR and TEOAE), AccuScreen ABR/DP (ABR and DPOAE), AccuScreen ABR/TE/DP (ABR, TEOAE and DPOAE). The measurement application is controlled from a self-contained firmware (software) module installed in the handheld device. The firmware module can be configured to allow different OAE measurement types (DPOAE and/or TEOAE) by a license key stored in the device. For automated OAE measurements, the handheld device uses an OAE probe, designed and manufactured by PATH Medical GmbH. The OAE probe is fitted with an ear-tip (constructed of biocompatible material) and inserted in the ear canal of the patient. The AccuScreen device plays stimulus sounds in the ear canal via small speakers in the OAE probe. The AccuScreen device measures the patient's response to the stimulus sounds via a microphone in the probe. The measured response is processed by the AccuScreen device using statistics to help deter or not a hearing loss may be present. When the OAE measurement is a DPOAE measurement, the stimulus signal is composed of two pure tone signals, each presented by a speaker in the OAE measurement is a TEOAE measurement, the stimulus signal is a series of broadband clicks presented by one speaker in the OAE probe.
Here's an analysis of the acceptance criteria and the study details for the MADSEN AccuScreen Type 1077, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The clinical study's primary objective was to demonstrate comparable performance to the predicate device (Echo-Screen T, TA, TD, TDA, TC, K013977) across an expanded age range for OAE measurements. The acceptance criteria essentially translate to reaching a high percentage agreement with the predicate device.
| Test Type | Acceptance Criteria (Implicit from comparator study design) | Reported Device Performance (Agreement with Predicate) |
|---|---|---|
| DPOAE | Assumed high agreement with predicate across age groups | Overall 93.8% agreement |
| TEOAE | Assumed high agreement with predicate across age groups | Overall 91.5% agreement |
2. Sample Size and Data Provenance for Test Set
- Sample Size for Test Set: 130 ears were tested. (This implicitly refers to 65 individuals if testing both ears.)
- Data Provenance: Not explicitly stated, but the study was conducted to compare against a predicate device, which implies a prospective data collection for the comparison. The country of origin is not mentioned.
3. Number of Experts and Qualifications for Ground Truth for Test Set
- The ground truth for the primary comparison was the predicate device's result.
- In cases of discrepancy between the device under review (Type 1077) and the predicate, a "diagnostic OAE device" was used to re-test the subjects. The summary does not specify the number or qualifications of experts involved in operating this diagnostic device or interpreting its results to resolve discrepancies.
4. Adjudication Method for the Test Set
- The primary method was a direct comparison between the Type 1077 and the predicate device.
- For discrepant results (where Type 1077 and the predicate did not agree), a "diagnostic OAE device" was used for re-testing. This acts as an adjudication method, essentially using a third, presumably more accurate or established, method to determine the "correct" result in ambiguous cases. The document does not specify if expert consensus was involved in interpreting the diagnostic OAE device results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This study focuses on device performance comparison rather than human reader improvement with or without AI assistance. The device is an automated screening tool, not an AI-assisted diagnostic aid for human readers.
6. Standalone Performance Study
- Yes, a standalone performance was done in the sense that the device's output (Pass/Refer for DPOAE and TEOAE) was directly compared to the predicate device's output. The goal was to establish that the Type 1077 provides results comparable to a legally marketed equivalent device without human intervention in the interpretation of the screening result.
7. Type of Ground Truth Used
- The primary "ground truth" for the comparison was the result from the predicate device (Echo-Screen).
- For discrepant cases, the ground truth was derived from re-testing using a "diagnostic OAE device." This implies a more definitive diagnostic result was used to resolve discrepancies between the two screening devices.
8. Sample Size for the Training Set
- The document does not provide information about a training set. This is a medical device clearance for an auditory stimulator and analysis system, not a machine learning algorithm that typically requires a distinct training set. The device likely relies on established signal processing and statistical methods for OAE analysis, which were developed and validated during its initial design (pre-K122067 and K122067).
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set is mentioned in the provided documentation.
§ 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).