(151 days)
ACAM® 5 is intended as an aid in diagnosing hearing loss and fitting of hearing aids. The device consists of an audiometer that can be used individually or with the other ACAM modules for performing Real Ear Measurements (REM), Hearing Instrument Test (HIT) and loudness scaling. ACAM 5 should be used by persons trained in audiology on patients of any age who are able to understand the basic principles of the test method when explained by the operator.
ACAM® 5 is an audiometer with optional components for performing Real Ear Measurements (REM) Hearing Instrument Testing (HIT) and loudness scaling. It is intended to aid trained audiologists and hearing aid professionals in the diagnosis of hearing loss and the fitting of hearing aids. As a part of the REM and HIT modules ACAM performs several kinds of signal analysis including root mean squared (RMS), fast Fourier transformation (FFT) and percentile analysis (PA). ACAM® 5 gives an audiologist the ability to use one or any combination of the diagnostic tools recommended by the National Acoustics Laboratory (NAL) and Dr. Richard Seewald (DSL-IO).
Available ACAM® 5 hardware consists of an audiometer with a modular control unit for peripheral components, which include a large or small hearing instrument test box and an in sity ear probe for real ear measurement. Headphones for audiometry, bone conduction and loudness scaling. loudspeakers, a microphone and an interrupter switch are available for use with the audiometer.
ACAM®'s operational software meets the international software standards established by the Hearing Instruments Software Manufacturers Association (HIMSA) and the speech recognition standards (ISTS, International Speech Test Signals) established by the-European Hearing Instrument Manufacturers Association (EHIMA).
The ACAM® 5 system meets or exceeds the following international standards: IEC 60645, ISO 8253, ISO 16832, ANSI S3.6, ANSI S3.22, EN 60118-0, EN 60118-7, DIN IEC 60118-15, ISO 12124, ANSI S3.43
ACAM® 5 should be operated by individuals with education and training in the field of audiology such as audiologists, hearing aid dispensers, health care and school nurses and ear nose and throat specialists.
Here's a summary of the acceptance criteria and the study details for the ACAM 5 Audiometer System based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the ACAM® 5 Audiometer System are primarily based on compliance with established international and national standards for audiometers and hearing instrument analyzers. The document presents a comparison to a predicate device (Siemens Unity 2 with HIA and Probe) to demonstrate substantial equivalence, rather than a direct performance study with a specific set of acceptance metrics for diagnostic accuracy.
The reported device performance, in terms of meeting these standards, is stated as "in compliance with the requirements of the international consensus standards shown below."
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|---|
| Safety | EN 60601-1 1996-03 (Medical electrical equipment: Part 1: General requirements for safety) | Complies with requirements |
| EN 60601-1-1:2001 (Medical electrical equipment; Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems) | Complies with requirements | |
| EN 60601-1-2:2001 (Medical electrical equipment; Part 1: General requirements for safety; Collateral standard: Electromagnetic compatibility - Requirements and tests) | Complies with requirements | |
| Effectiveness | ANSI S3.6-2004 (Specification for Audiometers) | Complies with requirements |
| ANSI S3.46-1997(R2007) (Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids) | Complies with requirements | |
| ANSI S3.22-2003 (Specification of Hearing Aid Characteristics) | Complies with requirements | |
| Additional Standards Met (implicitly part of acceptance of substantial equivalence) | IEC 60645, ISO 8253, ISO 16832, ANSI S3.6, ANSI S3.22, EN 60118-0, EN 60118-7, DIN IEC 60118-15, ISO 12124, ANSI S3.43 (These are listed as standards the ACAM® 5 system meets or exceeds) | Meets or exceeds these standards |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical performance study involving human subjects or a specific test set for evaluation of diagnostic accuracy. The "test set" in this context refers to the rigorous testing against engineering and clinical performance standards.
- Sample Size for Test Set: Not applicable in the context of human subject data. The testing involved physical device measurements against specified standard requirements.
- Data Provenance: Not applicable for human subject data. The "provenance" of the compliance data comes from internal testing and validation against international and national standards by the manufacturer. The location of the manufacturer (Germany) suggests the testing likely occurred in Germany or by an accredited European testing body. The document states it was subjected to electrical safety and EMC testing and performance specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the sense of expert consensus on patient diagnoses or conditions, is not described as part of this submission. The "ground truth" for the device's technical specifications and performance is the requirements set forth in the various international and national standards. These standards are established by expert bodies in the field of audiology and medical device safety/performance.
4. Adjudication Method for the Test Set
Not applicable. Since there isn't a human-read or AI-interpreted test set with subjective outcomes needing adjudication, this section is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This submission focuses on demonstrating substantial equivalence to a predicate device (Siemens Unity 2) based on technical characteristics and compliance with recognized standards. It is not an AI-assisted diagnostic device, so a study on human readers' improvement with AI assistance is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The "performance test data" discussed are essentially standalone evaluations of the device's adherence to technical standards. The system itself is an audiometer, and its performance (e.g., accuracy of frequency output, intensity output, signal distortion) is evaluated independently against engineering specifications as defined by the standards (e.g., ANSI S3.6-2004 for audiometers). This is not an "algorithm only" in the modern AI sense, but rather a standalone device performance check.
7. The Type of Ground Truth Used
The "ground truth" used is defined by the technical specifications and requirements outlined in recognized international and national standards for audiometers and hearing instrument analyzers. The device's performance parameters (e.g., frequency accuracy, intensity accuracy, stimulus distortion) are compared against the limits and criteria specified in these standards (e.g., IEC 60645, ANSI S3.6, etc.).
8. The Sample Size for the Training Set
Not applicable. This device is an audiometer, not an AI/machine learning algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is described for this device.
§ 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.