(49 days)
To obtain an accurate imprint of an individual ear and ear canal.
Precise Impression Kit. Impression Kits, -- Substantially equivalent to the Silhouette™ Premium Impression System from Siemens Hearing Instruments, Inc. and the Matrics Impression System from Matrics, Inc.
The provided text describes a medical device called the "MAY - 2 1997 K970952 PRECISE IMPRESSION KIT." However, it is a 1997 510(k) submission, and the content focuses on establishing substantial equivalence to predicate devices for regulatory approval. This type of submission does not typically include detailed performance studies with acceptance criteria in the manner of modern AI/ML device evaluations.
Therefore, I cannot extract the information required in your request from the provided text. The document is about a basic impression kit and lacks any mention of AI, machine learning, or quantitative performance metrics for a "device" in the context of an AI/ML algorithm.
Here's why and what's missing:
- No AI/ML Component: The "Precise Impression Kit" is a physical product used to take ear impressions. There is no indication of any artificial intelligence or machine learning component.
- Regulatory Standard at the Time: In 1997, 510(k) submissions for devices like this focused on demonstrating substantial equivalence to existing legally marketed devices based on technological characteristics and intended use, not on rigorous statistical performance studies as would be required for a novel diagnostic or AI device today.
- Lack of Performance Metrics: The document lists features like "Smooth consistency, ease of insertion, non-allergenic properties, pleasant scent, quick drying time, easy clean up." These are descriptive characteristics, not quantitative performance metrics with associated acceptance criteria that would be evaluated in a study.
- No "Study" in the Requested Sense: The document describes the device and its intended use but does not present a "study" that proves the device meets acceptance criteria in the way you've outlined.
To answer your request, I would need a different type of document, specifically one that describes a performance study for an AI/ML-enabled medical device.
If you can provide such a document, I would be happy to analyze it against your criteria.
§ 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.