(90 days)
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No
The summary provides no indication of AI/ML technology. The performance study references an ANSI standard, suggesting a traditional, non-AI/ML approach to testing.
No
The device is described as a "Wizard Loudness Growth Tester" and its performance meets "ANSI S3.6-1989" requirements. This standard refers to specifications for audiometers, which are diagnostic instruments for measuring hearing, not directly therapeutic devices.
No
The device is described as a "Wizard Loudness Growth Tester" and its performance meets "ANSI S3.6-1989" requirements, which is a standard for audiometers. Audiometers are used to measure hearing thresholds, which is a form of assessment or testing, but not typically considered a diagnostic device in the medical sense where it identifies a disease or condition. It rather measures a specific physiological output.
Unknown
The summary provides very limited information about the device. It only mentions a "Wizard Loudness Growth Tester" and a performance standard. There is no description of the device's components, how it functions, or if it includes any hardware. Therefore, it's impossible to determine if it's software-only.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
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Lack of IVD Indicators: The description does not mention any of the key characteristics of an IVD, such as:
- Intended Use/Indications for Use: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to diagnose, monitor, or screen for diseases or conditions.
- Device Description: "Wizard Loudness Growth Tester" sounds like a device related to audiology or hearing assessment, not laboratory testing of biological samples.
- Input Imaging Modality: Not applicable to IVDs in the traditional sense.
- Anatomical Site: Not relevant for IVDs which analyze samples from the body, not directly on a specific anatomical site.
- Performance Studies: While performance is mentioned, it refers to meeting an ANSI standard (likely related to acoustics or audiology equipment), not performance metrics typical for IVDs (sensitivity, specificity, etc.) which are based on clinical sample analysis.
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Device Name: "Wizard Loudness Growth Tester" strongly suggests a device used to measure or assess how a person perceives changes in loudness, a common test in audiology.
Conclusion:
The information provided points towards a device used for audiological testing, not for the in vitro analysis of biological samples. Therefore, it is not an IVD.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The design follows traditional principles of operation for Loudness Growth Testers. The device is manufactured and assembled with equivalent manufacturing practices and performance guidelines.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance of this instrument meets requirements specified by ANSI S3.6-1989.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Ethical Hearing Instruments 90 Fleet Street Portsmouth. NH 03801 603-430-1024 603-436-3220 (fax)
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AUG 21 1996
196201
Safety and Effectiveness DRAERD 510 (k) Summary/Statement Certification for Wizard Loudness Growth Tester
The summary of information, new product to present products demonstrates substantial equivalence as required by the "Safe Medical Devices Act (SMDA)" of 1990. The design follows traditional principles of operation for Loudness Growth Testers. The device is manufactured and assembled with equivalent manufacturing practices and performance guidelines. Performance of this instrument meets requirements specified by ANSI S3.6-1989. User controls and methods are similar to others currently being marketed.