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510(k) Data Aggregation
(60 days)
The Audioscan® Verifit™ is a hearing aid analysis system that is an electronic reference device used by manufacturers and dispensers of hearing aids intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid coupled to an ear simulator in a test chamber or a hearing aid when worn by a patient.
The Audioscan® Verifit™ is a hearing aid analysis system. The system is integrated with a hearing test chamber physically separated from the display/control unit. Signal processing and analysis is carried out digitally, with the exception of the microphone preamplifiers and output amplifiers. It includes a fluorescent backlit active color display, thermal line printer, and various connectors for peripherals and microphones. It has two stimulus channels and two measurement channels. The hearing aid test chamber has a working space of 8" x 5" x 1.5" (approx.), two 2" x 3" Independent speakers, and induction coils for Telephone Magnetic Field Simulator and a 20 cm diameter test loop. It also includes a battery simulator. The real-ear measurement component has two 2" x 3" ducted ports speakers and a Silicone 1.0mm diameter x 75mm probe microphone tube.
Acceptance Criteria and Device Performance for Audioscan® Verifit™ Model VF-1
This document outlines the acceptance criteria and the reported performance of the Audioscan® Verifit™ Model VF-1, a hearing aid analysis system. The information is derived from the provided 510(k) summary (K012306).
1. Table of Acceptance Criteria and Reported Device Performance
The Audioscan® Verifit™ Model VF-1 demonstrates compliance with established industry standards and its predicate device (Audioscan® Real Ear Measurement System RMS00, K884046/A) across various performance characteristics. The acceptance criteria for this device are implicitly derived from these standards and the performance of the predicate device.
Key Performance Standards Conformance:
- ANSI S3.46-1997, Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
- ANSI S3.22-1996, Specification of Hearing Aid Characteristics
- IEC 60601-1, EN60601-1, UL-2601, UL 544 (Safety Standards)
- Food and Drug Administration radiation safety performance standards
The following table compares key characteristics between the Audioscan® Verifit™ Model VF-1 and its predicate device, Audioscan® Real Ear Measurement System RMS00. The "Acceptance Criteria" are understood to be meeting or exceeding the predicate device's performance, as well as conforming to the cited ANSI, IEC, and UL standards.
| Characteristic | Predicate Device (MODEL RMS00) | Audioscan® Verifit™ Model VF-1 Performance (Reported) | Acceptance Criteria (Implicit) |
|---|---|---|---|
| GENERAL | |||
| Overall dimensions | 15.5" x 13.2" x 6.2" | Rear main unit 14.5" x 16" x 6.5"; Test chamber 14" x 14.4" x 4" | Device must meet or demonstrate equivalent/improved functionality within reasonable physical configuration changes. |
| Weight | 15 lbs | 16 lbs | Minimal increase in weight is acceptable if functionality is improved. |
| Display type | fluorescent backlit blue on white | fluorescent backlit active color | Improved display technology is an enhancement, meeting or exceeding predicate. |
| Display size | 6.4" diagonal | 12.1" diagonal | Larger display is an enhancement, meeting or exceeding predicate. |
| Display pixels (resolution) | 320 x 200 (VGA) | 800 x 600 (SVGA) | Higher resolution is an enhancement, meeting or exceeding predicate. |
| Printer type | thermal line printer | SAME (thermal line printer) | Equivalent performance to predicate. |
| Printer resolution | 200 dots per inch | SAME (200 dots per inch) | Equivalent performance to predicate. |
| Paper width | 3" (80 mm) | SAME (3" (80 mm)) | Equivalent performance to predicate. |
| Connectors | Fewer (e.g., 1 external monitor, 1 RS232) | More (e.g., mouse, QWERTY keyboard, ethernet, 2 USB, multiple audio) | Improved connectivity is an enhancement. |
| Headphone monitor amplifier | 1 watt into 16 ohms | SAME (1 watt into 16 ohms) | Equivalent performance to predicate. |
| Power amplifiers | 1 - 1.7 watts | 2 - 5 watts each | Increased power amplifiers are an enhancement. |
| Stimulus channels | 1 | 2 | Increased stimulus channels are an enhancement. |
| Measurement channels | 2 | SAME (2) | Equivalent performance to predicate. |
| HEARING AID TEST CHAMBER | |||
| Working space | 5.5" x 3.5" x 2" | 8" x 5" x 1.5" (approx.) | Increased working space is an enhancement. |
| Speakers | 1 - 3.5" diameter | 2 - 2" x 3" Independent | Increased speakers are an enhancement. |
| Induction coils | 1 (TMFS ANSI S3.22-1996, 1 - 20 cm diameter test loop) | SAME | Equivalent performance to predicate, conforming to ANSI S3.22-1996. |
| Battery simulator | per ANSI S3.22 - 1996 | SAME | Conformance to ANSI S3.22-1996. |
| Frequency range | 200 to 8000 Hz | SAME | Conformance to established range. |
| Test stimuli | tone | tone, broad-band noise, recorded speech | Added stimuli are an enhancement. |
| Test stimulus levels | 40 to 90 dB SPL in 5 dB steps | SAME | Conformance to established levels. |
| Test stimulus levels (inductive) | 31.6 mA/m per ANSI S3.22 -1996 | SAME | Equivalent performance to predicate, conforming to ANSI S3.22-1996. |
| Test stimulus distortion | <2% at 90 dB SPL; <0.5% at 70 dB SPL | SAME | Maintaining low distortion, equivalent to predicate. |
| Test stimulus accuracy at reference microphone (tones 200 - 2000 Hz) | ± 1.5 dB SPL | SAME | Conformance to established accuracy. |
| Test stimulus accuracy at reference microphone (tones 2000 - 8000 Hz) | ± 2.5 dB SPL | SAME | Conformance to established accuracy. |
| Equalization method | pressure method | SAME | Equivalent performance to predicate. |
| Analysis frequencies per octave | 12 | SAME | Equivalent performance to predicate. |
| Analysis filter bandwidth | 1/7 octave | 1/12 octave | Improved (finer) filter bandwidth is an enhancement. |
| Measurement accuracy at 1 kHz | ± 1 dB | SAME | Conformance to established accuracy. |
| Measurement accuracy re 1 kHz | ± 1 dB (200-5000 Hz); ± 2.5 dB (5000-8000 Hz) | SAME | Conformance to established accuracy. |
| Measurement range | 30 - 140 dB SPL | SAME | Conformance to established range. |
| Harmonic distortion measurement | 2nd plus 3rd | 2nd and 3rd or 2nd plus 3rd | More comprehensive measurement options are an enhancement. |
| Harmonic distortion range | 200 to 2670 Hz | 200 to 4000 Hz | Wider range for harmonic distortion measurement is an enhancement. |
| Harmonic distortion accuracy | ± 1% | SAME | Conformance to established accuracy. |
| Battery drain range | 0-20 mA | SAME | Conformance to established range. |
| Battery drain accuracy | ± .01 mA | SAME | Conformance to established accuracy. |
| ANSI S3.22-1996 tests available | Standard set (e.g., OSPL90, Full-on Gain) | SAME, plus "Coupler SPL - Vertical" and "Magnetic Field - Test Loop Sensitivity" | Device must perform existing tests equivalently and offer added features. |
| Other tests available | Standard set (e.g., coupler SPL vs frequency) | SAME, plus "coupler gain vs frequency" and "distortion vs frequency" | Device must perform existing tests equivalently and offer added features. |
| REAL-EAR MEASUREMENT | |||
| Speakers | 1 - 3.5" diameter | 2 - 2" x 3" ducted ports | Improved speaker configuration is an enhancement. |
| Probe microphone tube | Silicone 1.0mm diameter x 75mm | SAME | Equivalent performance to predicate. |
| Frequency range | 200 to 8000 Hz | SAME | Conformance to established range. |
| Test stimuli | frequency-modulated tone, tone burst, amplitude-modulated tone | frequency-modulated tone, tone burst, broad-band noise, recorded speech | Added stimuli are an enhancement. |
| Frequency modulation | triangular ±5% at 36 Hz | SAME | Equivalent performance to predicate. |
| Test stimulus levels at reference microphone for tones at 1m | 40 to 85 dB SPL in 5 dB steps | 40 to 90 dB SPL in 5 dB steps | Wider range for stimulus levels is an enhancement. |
| Test stimulus accuracy at reference microphone (tones 200 - 2000 Hz) | ± 1.5 dB SPL | SAME | Conformance to established accuracy. |
| Test stimulus accuracy at reference microphone (tones 2000 - 8000 Hz) | ± 2.5 dB SPL | SAME | Conformance to established accuracy. |
| Equalization method | pressure method | SAME | Equivalent performance to predicate. |
| Analysis frequencies per octave | 12 | SAME | Equivalent performance to predicate. |
| Analysis filter bandwidth | 1/7 octave | 1/12 octave | Improved (finer) filter bandwidth is an enhancement. |
| Measurement accuracy at 1 kHz | ± 1 dB | SAME | Conformance to established accuracy. |
| Measurement accuracy re 1 kHz | ± 1 dB (200-5000 Hz); ± 2.5 dB (5000-8000 Hz) | SAME | Conformance to established accuracy. |
| Measurement range | 20-135 dB SPL (200-2500 Hz); 30-140 dB SPL (2500-8000 Hz) | SAME | Conformance to established range. |
| ANSI S3.46-1997 tests available | Standard set (e.g., Real-Ear Unaided Response) | SAME | Device must perform existing ANSI S3.46-1997 tests equivalently. |
| Other tests available | Standard set (e.g., Real-ear harmonic distortion) | SAME | Device must perform existing tests equivalently. |
| Prescriptive fitting methods available | Standard set (e.g., NAL-R, Pogo II) | SAME | Device must incorporate existing fitting methods equivalently. |
2. Sample size used for the test set and the data provenance
The document provided (510(k) Summary K012306) does not explicitly detail a clinical test set with a specific sample size for human participants or a defined dataset of hearing aid measurements. Instead, the device's performance is demonstrated through:
- Conformance to internationally recognized standards: ANSI S3.46-1997, ANSI S3.22-1996, IEC 60601-1, EN60601-1, UL-2601, UL 544, and FDA radiation safety standards. This implies comprehensive testing against these standards, which themselves define test methods and parameters.
- Substantial Equivalence to a Predicate Device: The primary comparison is against the Audioscan® Real Ear Measurement System RMS00 (K884046/A). This involves demonstrating that the new device performs equivalently or better than the predicate device across all relevant technical specifications. The comparison table above illustrates this.
- Software Validation: "development, verification, validation, and testing procedures are in accordance with FDA guidances for devices containing software." This refers to internal software testing, not a clinical test set with patient data.
Therefore, it is not possible to specify a sample size, country of origin, or whether the "data" was retrospective or prospective in the context of a clinical test set from this document. The validation relies on engineering testing, compliance with standards, and comparative analysis with a predicate device's established performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given that the performance assessment relies on conformance to technical standards and comparison with a predicate device, as opposed to a clinical study with human interpretation, the concept of "experts establishing ground truth for a test set" with a specified number and qualifications (e.g., radiologists with 10 years of experience) is not applicable in the context of this device's submission.
The "ground truth" here is essentially the established specifications and accuracy requirements set forth by the ANSI, IEC, and UL standards, and the known performance baseline of the predicate device. The experts involved would be the engineers and quality assurance personnel who performed the testing and verified compliance with these standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there is no described clinical "test set" requiring interpretation or consensus among experts, no adjudication method (e.g., 2+1, 3+1) is mentioned or relevant in this 510(k) summary. The evaluation focuses on objective measurements against defined performance criteria.
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
This device is a "Hearing-Aid Calibrator & Analysis System" designed for the objective measurement and calibration of hearing aids, not a diagnostic AI system assisting human readers. Therefore, an MRMC comparative effectiveness study evaluating human reader improvement with AI assistance is not applicable and was not performed or mentioned in this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The Audioscan® Verifit™ Model VF-1 is inherently a standalone device in terms of its ability to perform measurements and analysis based on its internal algorithms and hardware. Its primary function is to objectively measure electroacoustic characteristics. The "software algorithms are essentially equivalent for both the Audioscan® Verifit™ and predicate devices," and the device performs signal processing and analysis digitally.
Therefore, yes, its performance is de facto standalone in its measurement capabilities. However, it's crucial to understand that this is not an "AI algorithm only" device in the modern sense of a black-box AI standalone performance study. It is a measurement instrument that uses established algorithms to perform its functions. The device's "performance" described is its ability to accurately and consistently perform these measurements against known physical standards, rather than an "algorithm-only" performance compared to human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Audioscan® Verifit™ Model VF-1 is based on:
- Established engineering and electroacoustic standards: Primarily ANSI S3.46-1997 and ANSI S3.22-1996. These standards define how hearing aid characteristics should be measured and what acceptable performance ranges are.
- Physical calibration references: The device measures physical properties (frequency, sound intensity, harmonic distortion, battery drain) against calibrated references.
- Performance of the predicate device: The Audioscan® Real Ear Measurement System RMS00 (K884046/A) serves as a benchmark for equivalence.
Therefore, the ground truth is objective measurements against recognized standards and a known predicate device's performance, not expert consensus, pathology, or outcomes data from a clinical trial.
8. The sample size for the training set
The concept of a "training set" in the context of machine learning for an AI-powered device is not applicable here. The Audioscan® Verifit™ is a measurement and calibration instrument based on established scientific principles and algorithms, not a machine learning model that requires a training set of data. Its performance is validated against physical standards and a predicate device.
9. How the ground truth for the training set was established
Since the concept of a "training set" as understood in machine learning is not applicable to this device, the question of how its ground truth was established is also not applicable. The device's foundational principles are rooted in electroacoustic engineering and adherence to international measurement standards.
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