(197 days)
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No
The summary describes a hearing aid that amplifies sound, which is a traditional function of such devices. There is no mention of AI, ML, or any related concepts in the provided text.
No
The device is described as amplifying sound pressure waves to compensate for impaired hearing, which makes it a hearing enhancement system rather than a therapeutic device that treats or cures a disease.
No
The intended use of the device is to amplify sound and transmit it to the external ear to compensate for impaired hearing, which is a therapeutic function, not a diagnostic one.
No
The device description refers to "Intrastar models" and mentions transmitting signals to the external ear, which strongly suggests a hardware component (a hearing aid). The summary does not explicitly state it is software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing." This describes a device that interacts with the physical world (sound waves) and the body (external ear) to provide a therapeutic benefit (hearing compensation).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such tests on biological samples.
- Device Description: The description focuses on amplifying sound and transmitting it to the ear, which aligns with the function of a hearing aid, not an IVD.
- Lack of IVD-related information: The document does not mention any aspects related to analyzing biological samples, detecting biomarkers, or diagnosing conditions based on in vitro testing.
Therefore, this device falls under the category of a hearing aid or similar assistive listening device, not an in vitro diagnostic.
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Intended Use / Indications for Use
The intended use of these models is to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for impaired hearing.
Product codes
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Device Description
Descriptions of the device functions, scientific concepts, and physical and performance characteristics of the above-mentioned Intrastar models are set forth in Attachments 1 and 2.
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
external ear
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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 874.3300 Air-conduction hearing aid.
(a)
Identification. An air-conduction hearing aid is a wearable sound-amplifying device intended to compensate for impaired hearing that conducts sound to the ear through the air. An air-conduction hearing aid is subject to the requirements in § 800.30 or § 801.422 of this chapter, as applicable. The air-conduction hearing aid generic type excludes the group hearing aid or group auditory trainer, master hearing aid, and the tinnitus masker, regulated under §§ 874.3320, 874.3330, and 874.3400, respectively.(b)
Classification. Class I (general controls). This device is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 874.9.
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