(108 days)
The Interacoustics ASSR is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions.
The Interacoustics ASSR can be used as either simple screening device if used as part of a group of I audionettic tests. It is exceptionally useful in testing individuals for whom behavioural audiometric results are deemed unreliable; this would include infants, young children, cognitively impaired or uncooperative adults. It allows for the estimation of hearing threshold at various frequencies, through the use of ASSR (Auditory Steady-State Response) test protocols. It is designed to be used by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.
This system consists of a general hardware platform (ERA) and a software platform (ASSR). This may be installed into any external cabinet as required for proper use of the system. For this application the external cabinet used is the Eclipse. Other cabinets will be released in the future using the same hardware platform (ERA) and will allow software interchange ability between cabinets.
As stated before this device is based on a general hardware platform (ERA) which is designed to be able to perform different audiometric and ABR testing functions. This module has been previously approved per 510k #K052562, functions may be added to this platform in the future, each module will be re-applied for at that time.
A license system makes it possible to select which functionality the user wants to be incorporated in the system.
The specific functionality of the system is controlled by the ASSR software. This software is installed on the connected PC and the system uses a USB connection between the PC and the hardware
Test results and reports are formatted and printed by the ASSR software. A database containing test results and other patient information can be located and shared on the PC,
The Interacoustics ASSR, Eclipse System is based on substantial equivalence to a predicate device, the Bio-logic Master Evoked Response System (K021895). The submission states that the device meets "all specified requirements" for performance, which indicates that it has been evaluated against certain acceptance criteria. However, the specific quantitative acceptance criteria are not explicitly detailed in the provided document.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device (K021895) in recording and analysis of human physiological data for diagnosis of auditory and hearing-related functions. | "The performance data indicated that the Interacoustics ASSR – Eclipse System meets all specified requirements, and is substantially equivalent to the predicate device." |
| Indicated for estimating hearing threshold at various frequencies using ASSR test protocols. | The device is described as allowing for "the estimation of hearing threshold at various frequencies, through the use of ASSR (Auditory Steady-State Response) test protocols." |
| Designed for use by trained individuals (audiologists and physicians), for whom behavioral audiometric results are unreliable (e.g., infants, young children, cognitively impaired adults). | "It is designed to be used as a diagnostic test procedure by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians." It is "exceptionally useful in testing individuals for whom behavioural audiometric results are deemed unreliable." |
| Proper functioning of hardware (ERA) and software (ASSR) platform. | The system consists of a general hardware platform (ERA) and a software platform (ASSR), and its specific functionality is controlled by the ASSR software. The ERA module was previously approved per 510k #K052562. |
Study Details
The provided 510(k) summary does not contain detailed information about a specific study with sample sizes, data provenance, expert qualifications, or adjudication methods. The primary method for demonstrating device performance and meeting acceptance criteria appears to be a comparison of technological characteristics and a declaration of substantial equivalence to a predicate device.
Here's what can be extracted based on the input:
- Sample size used for the test set and the data provenance: Not specified. The document only states that "The performance data indicated that the Interacoustics ASSR – Eclipse System meets all specified requirements, and is substantially equivalent to the predicate device." This implies that some form of testing or comparison was performed, but the details of the test set are not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. Given that the submission relies on substantial equivalence and mentions "performance data" without detailing study specifics, there's no information about expert involvement in establishing a ground truth for a test set.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not specified.
- 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/Not specified. This device is an "Evoked Response Auditory Stimulator" and does not appear to involve AI or human "readers" in the context of image interpretation or similar tasks where MRMC studies are typically conducted. Its function is to record and analyze physiological data.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly stated as a separate standalone study. The device itself is described as a system (hardware and software) that records and analyzes data, and it is "designed to be used... by individuals who are trained in the performance and interpretation of evoked potentials." This implies a human-in-the-loop for interpretation and recommendations, but it does not specify a standalone algorithm performance study.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified.
- The sample size for the training set: Not applicable/Not specified. The device's approval is based on substantial equivalence, not on a machine learning model developed and validated with separate training and test sets in the typical sense.
- How the ground truth for the training set was established: Not applicable/Not specified.
Summary of Study Information:
The 510(k) submission for the Interacoustics ASSR, Eclipse System, relies on the concept of substantial equivalence to an existing predicate device (Bio-logic Master Evoked Response System, K021895). The document explicitly states: "A comparison of the technological characteristics of the Interacoustics ASSR - Eclipse System and the predicate device has been performed. The results of this comparison demonstrate that the Interacoustics ASSR – Eclipse System is equivalent to the marketed predicate device." And "The performance data indicated that the Interacoustics ASSR – Eclipse System meets all specified requirements, and is substantially equivalent to the predicate device."
Such submissions typically include engineering verification and validation testing to ensure the new device performs as intended and is safe and effective when compared to the predicate, but the detailed methodology, sample sizes, and expert adjudications of these tests are not present in the provided summary. The stated "performance data" presumably refers to these types of internal verification and validation activities rather than a large-scale clinical trial or comparative effectiveness study as might be seen for novel technologies or AI devices.
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).