(83 days)
Intended Use: The Articulate Fitting System™ is used with the ProDigit 2000™ Personal Digital Audiometer to fit and program Articulate Hearing Devices. The ProDigit 2000™ Audiometer 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.
The Articulate Fitting System™ is used with the Decibel Instruments ProDigit 2000™ Personal Digital Audiometer for audiometric testing, real ear measurements, and fitting and programming the commercially available Decibel Instruments Articulate Hearing Devices. The System has four main components:
- The legally marketed Decibel Instruments ProDigit 2000™ Personal Digital Audiometer, a computer-based audiometry system;
- The Decibel Instruments IntraCanal Probe™ (ICP), a transducer placed in the ear canal for audiometric testing;
- The Decibel Instruments IntraCanal Probe™ Interface, which provides the communication link between the ICP and the ProDigit 2000™ Audiometer and allows real ear measurements; and
- The commercially available HI-PRO hearing aid programmer with the Articulate Fitting software utilizes automated fitting algorithms and visual tools to program the Articulate Hearing Devices following audiometric evaluation.
Here's a breakdown of the requested information based on the provided text, though it's important to note that this document is a 510(k) summary for an audiometer system from 1997, and details on modern AI-driven device studies are not present.
The document describes an "Articulate Fitting System™" primarily for audiometric testing and fitting/programming hearing aids. The performance data provided is for the IntraCanal Probe (ICP) component, which is a transducer.
Acceptance Criteria and Device Performance
There is no explicit table of acceptance criteria or reported device performance in the format of specific metrics (sensitivity, specificity, AUC) in this document. The performance data focuses on the electroacoustic characteristics of the IntraCanal Probe (ICP).
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electroacoustic Performance of ICP | |
| Frequency Response | "demonstrated a smooth, well-defined acoustic frequency response within specified limits" |
| Linearity | "the response was linear below the maximum undistorted acoustic output levels" |
| Maximum Undistorted Acoustic Output vs. Constant Voltage Input & Frequency | (No specific values provided, but implied to be acceptable based on conclusion) |
Study Details
Given this is a 510(k) submission from 1997 for an audiometer system, the concept of a "test set" and "training set" for AI/ML algorithms, as well as multi-reader multi-case studies, are not applicable in the modern sense. The "performance data" section focuses on hardware component validation.
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Sample size used for the test set and the data provenance: Not applicable in the context of an algorithmic test set. The testing was conducted on the physical device component (ICP). The provenance of the data refers to "Decibel Instruments. Inc." as the conductor of the tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for the ICP's electroacoustic performance would be established by engineering and audiometric standards, measured with calibrated equipment, not by expert consensus on clinical cases.
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Adjudication method for the test set: Not applicable.
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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. This device is an audiometer system, not an AI diagnostic tool that assists human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes the "Articulate Fitting System™" as having "automated fitting algorithms and visual tools" and "auto-fit calculations." However, it clarifies that this system is intended to be used with the ProDigit 2000™ Personal Digital Audiometer by "trained and qualified audiologists or other audiometric professionals." Therefore, while there are automated elements, it's explicitly designed to operate with a "human-in-the-loop," and no standalone algorithm performance study is described. The performance data section focuses on the physical transducer (ICP), not the fitting algorithms.
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The type of ground truth used: For the ICP, the ground truth was based on engineering and audiometric standards for electroacoustic performance (frequency response, linearity, maximum undistorted output) measured against specified limits.
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The sample size for the training set: Not applicable. There is no mention of a "training set" for machine learning.
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How the ground truth for the training set was established: Not applicable.
§ 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.