(54 days)
The Lyra with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Lyra with DPOAE includes all ages.
The Lyra with TEOAE is intended for use in the audiologic evaluation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Lyra with TEOAE includes all ages.
The Lyra System is to be used by trained personnel only, such as audiologists, ENT surgeons, doctors, hearing healthcare professionals or personnel with a similar level of education. The device should not be used without the necessary knowledge and training to understand its use and how results should be interpreted.
The device is audiometric equipment used for assisting of inner ear abnormalities. Lyra features a hardware unit connecting to a PC installed with IA OAE suite software designated for use with Lyra. The PC software provides a user interface designed to integrate in the standard Microsoft Windows environment. Lyra can be purchased with various licenses allowing you to perform different hearing screening tests.
Distortion product otoacoustic emissions (DPOAE) technology uses pairs of pure tones presented in sequence to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal.
Transient otoacoustic emissions (TEOAE) technology uses a short duration stimulus to screen patients for cochlear hearing loss. Responses to the stimulus are predictable and therefore can be measured via a sensitive microphone placed in the patient's ear canal. The response can be divided into frequency bands for assessment.
The provided text describes a 510(k) premarket notification for an audiometric device named Lyra. The submission asserts the substantial equivalence of the Lyra device to legally marketed predicate devices (Titan™ TEOAE and Titan™ DPOAE).
However, the documentation does not contain information related to acceptance criteria, a specific study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, the number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established beyond general statements about design verification and validation against standards.
The document primarily focuses on establishing substantial equivalence based on:
- Identical Indications for Use: Both Lyra and the predicate devices are intended for audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions (DPOAE) and Transient Evoked Otoacoustic Emissions (TEOAE) for all ages, to be used by trained personnel.
- Similar Technological Characteristics: The document provides detailed comparison tables highlighting that Lyra shares virtually all key technological characteristics (e.g., type, regulation number, product code, target population, intended user, anatomical sites, safety and performance standards, device type, system configuration, stimulus types, frequency ranges, levels, level steps, transducer, probe detection, recording, A/D resolution, artifact reject system, automatic test with display of PASS-REFER) with the predicate devices.
- Non-Clinical Testing Summary: It states that design verification and validation were performed according to current standards (IEC 60601-1 series, IEC 60645 series) to assure the device meets performance specifications, and software verification and validation were conducted.
- Clinical Testing Summary: Crucially, it states "Not applicable. Not required to establish substantial equivalence."
Therefore, based on the provided text, I cannot complete the requested tables and information. The submission for the Lyra device explicitly states that clinical testing was "Not applicable" and "Not required to establish substantial equivalence," meaning the detailed study design elements you requested (like acceptance criteria for performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies) were not part of this 510(k) submission.
The acceptance criteria for this submission appear to be demonstrating equivalence to established predicate devices through non-clinical performance and technological characteristics, rather than demonstrating a specific level of clinical performance against a clinical ground truth.
In summary, the provided document does not support the specific type of performance study you are asking about, as it relies on substantial equivalence to predicates rather than novel clinical performance demonstration.
§ 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.