(86 days)
The Sera™ with DPOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Distortion Product Otoacoustic Emissions. The target population for Sera with DPOAE includes all ages.
The Sera™ with TEOAE is intended for use in the audiologic evaluation and documentation of ear disorders using Transient Evoked Otoacoustic Emissions. The target population for Sera with TEOAE includes all ages.
The Sera™ with ABRIS is intended for use in the audiologic evaluation and documentation of ear and nerve disorders using auditory evoked potentials from the inner ear, the auditory nerve and the brainstem. The target population for Sera with ABRIS is newborns.
The Sera™ 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 and auditory brainstem abnormalities.
Sera™ features a touch-screen display and user-friendly software in a compact hardware design. Sera™ can be purchased with various licenses allowing you to perform different hearing screening tests.
Sera™ uses auditory brainstem response (ABRIS) technology to screen patients for hearing loss. A modified click stimulus, the CE-Chirp", of 35 dB nHL is delivered into the patient's ear while electrodes placed on the patient's head measure EEG activity.
Auditory brainstem response (ABRIS) test produces a short acoustic stimulus and measures via transcutaneous electrodes the auditory evoked potentials from the inner ear, the auditory nerve and the brainstem.
The provided document is a 510(k) summary for the Sera™ audiometric equipment. It indicates that no clinical tests were performed to establish acceptance criteria or demonstrate device performance. The device's safety and effectiveness were affirmed based on its fulfillment of international standards for Otoacoustic Emissions (OAE) and Auditory Brainstem Response (ABR) measurements.
Therefore, the following information cannot be extracted from the document:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Effect size of human readers improvement with AI vs without AI (Multi-reader multi-case comparative effectiveness study was not performed as no clinical testing was done).
- Standalone performance (algorithm only without human-in-the-loop) was not explicitly detailed via clinical study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Summary of Non-Clinical Testing and Device Performance (as described in the document):
The document states:
"Design verification and validation were performed according to current standards for OAE and ABR to assure the device meets its performance specifications. EMC and Safety was performed in compliance with recognized standards IEC 60601-1 series, Medical Equipment – General requirements for basic safety and essential performance. The product meets the requirements from the international standard for OAE measurements IEC 60645 series. Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in medical Devices." The software for this device was considered as a 'moderate' level of concern since a malfunction of, or a latent design flaw in, the Software Device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. The OAE and ABRIS measurements were divided into 3 phases. Phase 1 included when optimization occurred and involved feedback to the operator so that they could adjust such as probe fit, electrode impedance, ambient electrical and acoustic noise etc. Once the pre-test conditions were optimized, phase 2 of data collection proceeded as rapid as possible to allow the maximum quantity of good quality data to be collected in the shortest possible time. Phase 3 proceeded into the data assessment and decision stage and this ran concurrently with Phase 2 once the predetermined minimum amount of data had been collected. Phase 3 then went into the algorithm descriptions for each TEOAE, DPOAE and ABRIS measurements modes and is provided in detail in Annex 16D of this submission. No clinical tests were performed, but based on the fulfillment of the international standards for OAE and ABR we believe the device is safe and effective. The auditory impedance testing characteristics and safety systems were compared and found to be comparable."
Conclusion regarding acceptance criteria and study in the absence of clinical data:
The acceptance criteria for the Sera™ device and its performance are not directly demonstrated through clinical studies with a defined test set, ground truth established by experts, or statistical performance metrics. Instead, the device's acceptability is based on:
- Compliance with recognized international standards:
- IEC 60601-1 series (Medical Equipment – General requirements for basic safety and essential performance) for EMC and Safety.
- IEC 60645 series (international standard for OAE measurements).
- Software verification and validation: Per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in medical Devices." The software was deemed "moderate" level of concern.
- Bench testing and design verification/validation: To ensure the device meets its performance specifications according to current standards for OAE and ABR.
- Comparison to a predicate device (easyScreen, K171506): The document asserts substantial equivalence in technological characteristics and indications for use.
The document implies that by meeting these standards and demonstrating comparability to the predicate device through non-clinical means (bench testing, software validation), the device is considered safe and effective, and thus acceptable. The specific 'acceptance criteria' in terms of clinical performance (e.g., sensitivity, specificity for detecting hearing loss) and a study proving it meets these are not presented because clinical testing was not performed.
§ 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.