(118 days)
The Hearing Healthcare Pro software will capture audiometry test results, and will allow user input of tympanometry results, physical examination results, and patient history. The software will summarize the inputted data and provide a "normal" or "abnormal" determination. If the decision is "abnormal", the software will make a recommendation for clinical follow-up. The dB Diagnostic Systems, Inc. software is for adult use only and is intended to be used by healthcare providers not normally trained or experienced in hearing, audiology, or otology, such as primary care providers.
The Hearing Healthcare Pro software is not intended to make a clinical diagnosis.
The Hearing Healthcare (HHC) Pro is software designed to be used by healthcare providers (HCP) not normally trained or experienced in hearing, audiology, or otology, such as primary care providers. The HHC Pro software is not intended to make a clinical diagnosis. The HHC Pro software is a screening product. The software aggregates the inputted data and determines whether the person's hearing is considered normal or abnormal. If the results are abnormal, the software provides a recommendation for further clinical consultation with a licensed physician with expertise in Ear, Nose and Throat (ENT).
The HHC Pro software compiles the hearing information previously available to physicians, classifies the data as normal or abnormal with respect to any measureable hearing loss, and identifies the presence of asymmetric hearing results. The health care provider uses the HHC Pro to enter hand-held tympanometry results, limited clinical history, and limited physical examination findings, including a Rinne tuning fork test at 512Hz, to further identify patients who would benefit from an ENT evaluation.
The HHC Pro device comprises the HHC Pro Software. With the HHC Pro Software. dB Diagnostic Systems distributes the Auditdata/Otovation Amplitude T4 audiometer manufactured by Auditdata A/S, a 512Hz Rinne tuning fork, and the Microsoft Surface Pro 4 tablet preloaded with the Microsoft Windows 10 operating system and the HHC Pro Software. An Amplivox Otowave 102 Tympanometer may also be distributed with the HHC Pro software.
The provided text describes the regulatory filing for the Hearing Healthcare Pro device (K171038). While it mentions performance testing and compliance with standards, it does not provide explicit acceptance criteria or a detailed study report with quantitative performance metrics for the device's determination of "normal" or "abnormal" hearing.
Here's an breakdown based on the information provided, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
Missing. The document states that the device "has been tested and is in compliance with internal software validation bench testing to compare the HHC Pro input test results to the gold standard, Board-Certified Otolaryngologist reviewers for equivalence in the output responses." However, it does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or the reported numerical performance values.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The document refers to "internal software validation bench testing" and comparing "input test results to the gold standard," but does not specify the sample size of these test cases or the provenance of the data used (e.g., number of patient records, country, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
The ground truth was established by "Board-Certified Otolaryngologist reviewers." The number of these experts and their specific qualifications (e.g., years of experience) are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. The document mentions "Board-Certified Otolaryngologist reviewers" establishing the gold standard, but does not describe the adjudication method used if multiple experts were involved (e.g., consensus, majority vote, independent review).
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
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The device is intended to assist primary care providers who are not normally trained in audiology, but the document does not detail a study comparing their performance with and without the device. The study described is a comparison of the device's output to expert interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes. The described "internal software validation bench testing" where the "HHC Pro input test results" were compared "to the gold standard, Board-Certified Otolaryngologist reviewers for equivalence in the output responses" suggests a standalone evaluation of the algorithm's performance in making "normal" or "abnormal" determinations.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was expert consensus/interpretation by "Board-Certified Otolaryngologist reviewers."
8. The sample size for the training set
Missing. The document discusses software validation for the "HHC Pro" but does not provide information on a training set or its sample size. The description points to a validation of the software's logic against expert opinion rather than a machine learning model that would require a distinct training set.
9. How the ground truth for the training set was established
Missing. As no training set is described for a machine learning model, the method for establishing its ground truth is also not provided. The document focuses on the validation of the device's output against established expert standards.
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.