(87 days)
The ReSound® Loudness Growth in Octave Bands (LGOB) Loudness Scaling System is a new indication for use for the ReSound Digital 5000 hearing device family. The control for the system is incorporated into ReSound ReSource II fitting application software. The testing procedure is intended to be performed only by qualified hearing healthcare professionals.
ReSound's Digital 5000 series hearing devices are built using a custom software programmable digital signal processor. The DSP includes two analog to digital converters (ADC) at the input stage and one digital to analog converter (DAC) at the output stage. Using a personal computer (PC) connected to the hearing device via standard CS45 cable, numerous signal processing and amplification parameters may be adjusted to help compensate for impaired hearing. In addition, proprietary software used only by hearing health care professionals can instruct the output DAC to produce specific sounds. These sound stimuli, when delivered at different amplitudes and frequencies, can be used for loudness scaling measurements helpful in fitting the hearing device more precisely to the patient's residual hearing dynamic range.
The LGOB test equipment is comprised of proprietary PC software and a ReSound Digital 5000 series hearing device. Similar to the Loudness Growth in Octave Bands (LGOB) test provided with the original ReSound® P3 System, this new hearing device fitting method is designed to subjectively measure loudness growth in hearingimpaired subjects using the subject's own hearing aid, instead of using insert phones. The test is to be performed only by qualified hearing healthcare professionals. When the hearing aids are disconnected from the fitting computer, they function normally.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ReSound LGOB Test using Digital Hearing Devices:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document, a 510(k) Premarket Notification, focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and performance metrics for the new device. Therefore, a table in the traditional sense, with quantitative acceptance criteria and reported values, cannot be fully constructed from this document.
However, based on the principle of substantial equivalence, the implicit acceptance criteria are that the new device performs at least as well as and is as safe and effective as the predicate device for its intended use. The performance characteristics described are qualitative comparisons to the predicate.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety: Device does not introduce new safety concerns compared to predicate. | "The use of the ReSound® LGOB loudness scaling system with the Digital 5000 series hearing devices does not significantly affect the safety or effectiveness of the currently marketed ReSound Digital 5000 family of hearing devices or the currently marketed ReSound ReSource II fitting software." |
| Effectiveness: Device performs diagnostic function effectively and is at least as accurate as predicate. | - Produces sound stimuli: "This system produces speech shaped noise stimuli delivered directly to the patient's ear canal" (similar to predicate's function through insert earphones). |
| - Measures perceived intensity: "Measures the perceived intensity of the signals via a hand held 7-button Personal Selector" (identical to predicate's recording device). | |
| - Displays results: "Displays the measurement results on the PC screen." | |
| - "The intended use, method and theory of test operation, fundamental testing protocol, application and calibration of test results are equivalent to the predicate ReSound P system." | |
| Intended Use: Device serves the same intended purpose as predicate. | "The 'Loudness Growth in Octave Bands' (LGOB) loudness scaling test is intended to be used by hearing health care professionals as a supplemental audiometric measurement... substantially equivalent to the LGOB test developed by ReSound and provided with the original ReSound® P3 System." |
| Technical Characteristics: Device functions comparably to predicate. | - Produces sound stimulus directly from hearing device DAC (different from predicate's insert earphones, but described as an improvement/alternative). |
| - Uses patient's own digital hearing device or a stock "Digital Master" device (predicate used insert earphones). | |
| - Initiated and controlled by PC with proprietary software (similar to predicate). | |
| - Patient indicates perceived loudness using handheld Personal Selector (identical to predicate). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The filing is based on demonstrating substantial equivalence through comparison of design, intended use, and technical principles, rather than presenting a new clinical trial for performance validation. The comparison is conceptual, referring to the functionality and method of the predicate device (ReSound Portable Prescriptive Programming (P3) System, K912669).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
No explicit "ground truth" establishment by experts for a specific test set is described. The validity of the LGOB method itself is referenced through a published scientific paper: "J. B. Allen. J. L. Hall, and P. S. Jeng. 'Loudness growth in 1/2-octave bands (LGOB) - A procedure for the assessment of loudness', Journal of the Acoustical Society of America - 1988 (2), 1990, pp. 745-753." This publication describes the scientific basis for the LGOB procedure, which is the foundation of both the predicate and the new device.
The document states the device is intended to be used by "qualified hearing healthcare professionals," implying that the interpretation and application of the results would be done by these experts.
4. Adjudication Method for the Test Set
Not applicable, as no specific test set requiring adjudication is described in the document.
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
Not applicable. The device described is not an AI-assisted diagnostic tool in the sense of image interpretation for human readers. It's an audiometric diagnostic device where the patient provides subjective responses, and the hearing healthcare professional uses this data for fitting. No MRMC study or AI assistance is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The device is inherently not standalone in terms of interpretation or final action. While the software generates stimuli and collects data, a human hearing healthcare professional is explicitly required to perform the test, interpret the results, and adjust hearing aid settings. The patient's "human-in-the-loop" subjective response is central to the LGOB test itself.
The document states: "The software which controls the system is incorporated into ReSound® ReSource II software (K945750) that runs as a standalone application or can be integrated under the Noah operating system (K942749)." This refers to the software application running on a PC, not the diagnostic device itself performing standalone interpretation.
7. The Type of Ground Truth Used
The "ground truth" for the LGOB test is the patient's subjective perception of loudness. The test relies on the patient indicating their perceived loudness ("Too Loud, Very Loud, Loud, Comfortable, Soft, Very Soft or Inaudible") for various sound stimuli. This subjective data, combined with objective audiometric threshold data (entered separately by the professional), forms the basis for calculating fitting recommendations.
The scientific validity of the method (Loudness Growth in Octave Bands) is established by the referenced scientific literature (Allen, Hall, and Jeng, 1988/1990), which provides the theoretical and empirical underpinnings for using subjective loudness scaling.
8. The Sample Size for the Training Set
The document does not refer to a "training set" in the context of machine learning or AI models. This device is not described as utilizing a machine learning algorithm that requires a training set. The software likely implements established algorithms for calculating fitting recommendations based on the LGOB data and audiometric thresholds, rather than learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning model is mentioned. The "ground truth" for the device's function is rooted in audiology principles and the subjective responses of the patient as described in point 7.
§ 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.