(77 days)
The AuDX Pro Otoacoustic Emissions Measurement System delivers controlled acoustic signals in the ear canal and measures the resulting evoked otoacoustic emissions (OAEs) that are generated by the outer hair cells of the inner ear. The AuDX Pro device performs transient evoked otoacoustic emissions (TEOAE) and distortion product otoacoustic emissions (DPOAE) tests.
AuDX Pro is indicated for use by trained health care professionals (audiologists, physicians) and personnel (nurses, technicians) who are trained to operate the device under their supervision to perform otoacoustic emissions testing to assess cochlear function.
The device can be used for patients of all ages, from newborn infants through adults, to include geriatric patients. The otoacoustic emissions test is especially indicated for use in testing individuals for whom behavioral results are deemed unreliable, such as infants, young children, and cognitively impaired adults.
The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resulting evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved. The AuDX Pro system includes optional software selections distinguished by the AuDX Pro, AuDX Pro II, and AuDX Pro Plus naming designations.
The test consists of measuring and recording transient (clickevoked) otoacoustic emissions (TEOAE) or distortion product otoacoustic emissions (DPOAE) utilizing pure tones. The same ear probe is used for both types of tests. For transient otoacoustic emissions (TEOAEs), the reproducibility and the difference value between the TEOAE and the noise floor amplitudes appear on the LCD display on the front of the AuDX Pro unit. For distortion product otoacoustic emissions (DPOAEs), the DPOAE and noise floor amplitudes appear on the LCD. A pass or refer result is assigned at the end of the test based on a comparison of the patient's OAE response to normalized data. Additionally, a graphic display of the data is presented on the LCD allowing users to view and/or analyze the results.
The data collected by the AuDX system can be sent to a host computer where it can be saved or placed in a database. Optional Natus software programs are available for that function. Natus software programs provide a mechanism for users to define their own specific test protocols and download them to the AuDX Pro device.
The AuDX Pro Otoacoustic Emissions Measurement System expands upon the capabilities of the AuDX Otoacoustic Emissions Measurement System with AuDX I/O Function [K111618]. The AuDX Pro System provides the following enhancements over the AuDX System:
- Protocol Setup utilities to load expanded frequency protocols to the AuDX Pro:
- Options to upload data to a PC based Patient and Test Information Database (P&TI);
- Options to graphically review data from a PC based Hearing Assessment & Tracking System (HATS) software utility linked with the P&TI Database; and.
- A Graphical User Interface (GUI) on an enhanced LCD screen for testing, patient information, and data review.
The provided 510(k) summary for the AuDX Pro Otoacoustic Emissions Measurement System describes its technical characteristics and intended use, and compares it to predicate devices. However, it does not contain information about specific acceptance criteria, a dedicated study proving performance against acceptance criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in such studies for the AuDX Pro.
The document states: "Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications and demonstrates equivalence to the specified predicate devices." This is a general statement and does not provide the granular information requested by the prompt.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a breakdown of what can be inferred or directly stated from the document, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be fully provided as specific numeric acceptance criteria and resulting performance values are not detailed in the document. The comparison table primarily focuses on technical features, intended use, and safety characteristics in relation to predicate devices, rather than explicit performance metrics against predefined acceptance criteria.
The document implicitly suggests that the device meets performance specifications by stating "Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications and demonstrates equivalence to the specified predicate devices." However, these "performance specifications" are not listed with quantifiable acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not provided in the document. The 510(k) summary does not mention any specific test set, its size, or the provenance of any data used for performance validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not provided in the document. There is no mention of experts, ground truth establishment, or their qualifications in the context of a performance study for the AuDX Pro.
4. Adjudication Method for the Test Set
Not provided in the document. As there is no described test set or ground truth establishment process, an adjudication method is also not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable/Not performed according to the document. The AuDX Pro is an automated otoacoustic emissions measurement system. It performs the test and assigns a "pass or refer" result automatically based on a comparison to normalized data. The document does not describe any human reader involvement that an MRMC study would assess.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Implied, but details are not provided. The device is described as "automated" and assigns "pass or refer" results, suggesting standalone performance. However, the document does not describe a specific standalone performance study with detailed methodology, metrics, or results. It only states that "Design verification and validation were performed to assure that the AuDX Pro meets its performance specifications."
7. Type of Ground Truth Used
Cannot be explicitly determined from the document for performance validation of the "pass/refer" outcome. The device compares OAE responses to "normalized data" to assign pass/refer. The nature of this "normalized data" (e.g., whether it's derived from expert consensus, pathology, or outcomes data) is not specified for the purpose of validating the device's accuracy in assigning these outcomes.
8. Sample Size for the Training Set
Not applicable/Not provided. The AuDX Pro is a measurement device that calculates biophysical parameters (reproducibility, difference value between TEOAE and noise floor, DPOAE and noise floor amplitudes). While it uses "normalized data" for its "pass or refer" algorithm, the document does not suggest the use of a machine learning model that would require a distinct "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As there is no mention of a traditional training set for a machine learning algorithm, the establishment of ground truth for such a set is not discussed.
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.