(87 days)
Type 1053 FreeFit is intended for audiologists, hearing instrument dispensers, ENTs, speech therapists and other health care professionals. The intended use is that the user is able to visualize the amplified signal recorded in the ear(s) of persons with a hearing loss together with reference information such as target curves in order for the user to have an objective basis for adjusting the Hearing Instrument settings.
The GN Otometrics Type 1053 FreeFit is a PC-based system that contains hardware and software for one or more applications. The applications are controlled from selfcontained software modules installed on a common software platform. The following applications are available: Real ear measurement system (i.e., audio fitting system) and Simulator system.
As a real ear measurement system, the Type 1053 FreeFit plays calibrated sound files and measures the sound pressure level in the ear canal. The difference between the measured sound level outside the ear and in the ear canal gives the gain from the hearing aid. This allows for adjusting hearing aids and demonstrating hearing aid features like noise suppression. The Type 1053 FreeFit system also shows target curves that the hearing aid dispenser can use as guidelines for adjusting the hearing aid.
The real ear measurement system consists of a neckset, a charger unit with mains adapter, two probes connected to the neckset, software for installation on a PC (i.e., OTOsuite Probe Microphone Measurements (PMM)) and hardware for connection to a PC. The neckset is connected to the PC via a Bluetooth radio link (i.e. no physical connection to the PC).
The FreeFit Neckset is the actual measuring device. It contains 2 probes (one for each ear) each with 2 microphones used for measuring the sound level outside and inside the ear. Digital signal processing in form of Fast Fourier Transformations takes place inside the device and the obtained frequency spectra are transmitted to the OTOsuite via Bluetooth. The microphones measuring outside the ear are used for calibrating the sound level. Measurements inside the ear canal (near the eardrum) are conducted with a biocompatible silicone tube guiding the sound waves to the microphone. And the probes contain an o-ring also in biocompatible material for fastening at the ear (pinna).
The FreeFit Charger is used to charge the FreeFit neckset via an inductive coil system. The charger includes a power adaptor connected to mains and providing DC input to the charger stand.
OTOsuite PMM is a software platform required for measuring with the Type 1053 FreeFit, displaying the results and controlling the played sound files and levels. OTOsuite runs on most windows based PCs.
The Type 1053 FreeFit also has the capability to act as a hearing loss simulator and a hearing instrument simulator. These applications are commonly used to demonstrate the level of hearing loss suffered by a patient and the degree to which that loss can be overcome by use of a hearing instrument.
The simulator consists of software for installation on a PC (i.e., OTOsuite Counseling and Simulation (C&S)) and hardware for connection to a PC (i.e., headphones).
OTOsuite C&S is a software application that is required for simulating hearing loss and hearing instruments as part of the counseling process.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly define specific numerical acceptance criteria for the Type 1053 FreeFit device in terms of performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to a predicate device (SpeechLink 100 Type 1053) and compliance with various established international and national standards.
Therefore, the table will reflect the general nature of the "acceptance" as described in the document, which primarily focuses on demonstrating equivalence and compliance rather than specific performance thresholds.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (SpeechLink 100 Type 1053) | Demonstrated through a side-by-side design comparison. The Type 1053 FreeFit shares the same materials, hardware, and electronics (with only cosmetic differences) as the predicate. Uses very similar signal processing and sends resulting spectra values via Bluetooth, just like the predicate. The only primary difference is improved software in the Type 1053 FreeFit. The equivalent test results to various standards for both devices support substantial equivalence. |
| Compliance with ANSI S3.46-1997 (Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids) | Non-clinical performance testing of the device against the applicable parameters of this standard was conducted. The improved calibration scheme in the Type 1053 FreeFit led to "significantly greater measurement accuracy," allowing for accurate gain curve calculations and effective comparison with target curves, which are likely key aspects of this standard. Results supported the conclusion of safety and effectiveness. |
| Compliance with EN/IEC 61669 (Electroacoustics - Equipment for the measurement of real-ear acoustical characteristics of hearing aids) | Positive results of testing to this standard were achieved. Results supported the conclusion of safety and effectiveness. |
| Compliance with IEC 60601-1 (Medical Electrical Equipment. Part 1: General requirements for safety) | The device shares the same materials, hardware, and electronics as the predicate, which had already demonstrated compliance. This implies the same results are obtained for the FreeFit. |
| Compliance with EN/IEC 60601-1-2 (Medical Electrical Equipment. Part 1: Collateral standard: Electromagnetic compatibility - Requirements and tests) | The device shares the same materials, hardware, and electronics as the predicate, which had already demonstrated compliance. This implies the same results are obtained for the FreeFit. The EN version is based directly on the IEC version. |
| Compliance with IEC 60601-1-4 (Medical Electrical Equipment. Part 1: General requirements for safety. 4. Collateral standard: Programmable electrical medical systems (Design process)) | Developed using the same design and development process as the predicate, implying the same evaluation results. |
| Compliance with ISO 10993-5 (Biological Evaluation of Medical Devices: Tests for Cytotoxicity) | The device shares the same materials, hardware, and electronics as the predicate, which had already demonstrated compliance. This implies the same results are obtained for the FreeFit. |
| Compliance with ISO 10993-10 (Biological Evaluation of Medical Devices: Tests for irritation and delayed-type hypersensitivity) | The device shares the same materials, hardware, and electronics as the predicate, which had already demonstrated compliance. This implies the same results are obtained for the FreeFit. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a sample size for any "test set" in the context of patient data or clinical trials. The testing described is primarily non-clinical, involving comparisons against a predicate device and compliance with technical standards.
- Sample Size for Test Set: Not applicable / Not specified for patient or clinical data. The "test set" here refers to the device itself being tested in a laboratory setting for compliance with standards.
- Data Provenance: Not applicable for patient or clinical data. The data provenance relates to engineering and testing against technical standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the document describes non-clinical performance data and compliance with technical standards for a sound measurement system, not a diagnostic or AI-driven system that would require expert-established ground truth from patient data.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable for the reasons stated above. There's no mention of human adjudication in the context of device performance testing against technical standards.
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 done, and therefore, there is no information on the effect size of human readers improving with or without AI assistance. The device described is a Real Ear Measurement System, which is a tool for audiologists to measure sound pressure levels, not an AI diagnostic or interpretive tool for "readers" to analyze cases.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
The document describes the device as a "PC-based system that contains hardware and software." The "FreeFit Neckset is the actual measuring device," and "Digital signal processing... takes place inside the device." The "OTOsuite PMM is a software platform required for measuring... displaying the results and controlling the played sound files and levels."
This strongly suggests a standalone performance assessment was indeed central to verifying compliance with standards. The device's ability to accurately measure sound pressure levels and perform signal processing (Fast Fourier Transformations) and calculate gain curves without human intervention in the measurement process itself is the core of its function. The "improved calibration scheme" leading to "significantly greater measurement accuracy" is a direct measure of its standalone performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance testing is defined by established technical standards and methods for acoustical measurement. Specifically:
- ANSI S3.46-1997: "Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids." This standard dictates how real-ear measurements should be performed and what constitutes accurate measurement.
- EN/IEC 61669: "Electroacoustics - Equipment for the measurement of real-ear acoustical characteristics of hearing aids." Similar to ANSI S3.46, this standard provides a framework for accurate acoustical measurements.
The device's performance is gauged against the requirements and specifications outlined in these standards, which serve as the "ground truth" for its functional accuracy.
8. The Sample Size for the Training Set
Not Applicable. The Type 1053 FreeFit is a measurement device that performs digital signal processing based on established acoustical principles. It is not an AI/ML device that requires a "training set" in the conventional sense to learn patterns or make predictions. Its "learning" is based on its engineering design and adherence to scientific principles.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As established in point 8, there is no training set in the context of AI/ML. The "ground truth" for the device's design and operation is rooted in the principles of electroacoustics and signal processing, validated by compliance with relevant international and national standards.
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.