(103 days)
To obtain an accurate imprint of an individual ear and ear canal.
The above mentioned impression kits are designed to provide the tools necessary for a Hearing Health Professional to obtain an accurate imprint of an individual ear and ear canal. The Hearing Health Professional receives materials in the form of a kit, and is responsible for any mixing of materials, or assembly of components for usage.
Analysis of Acceptance Criteria and Device Performance for Precise, Tympanette, and Xacto Impression Kits
Based on the provided documents (SUMMARY and SAFETY AND EFFECTIVENESS SUMMARY), the acceptance criteria and device performance are primarily established through a claim of "substantial equivalence" to existing, commercially available products (Audalin Liquid and Impression Polymer) that were exempt from a 510(k) process due to their pre-1996 commercial distribution.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documents do not detail specific quantitative acceptance criteria or a formal study with measured performance metrics against those criteria. Instead, the "acceptance criteria" are implied by the listed "Features" of the impression kits and the claim that these features are substantially equivalent to the Audalin products.
| Acceptance Criteria (Implied from "Features") | Reported Device Performance (Claimed) |
|---|---|
| Smooth Consistency | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Smooth Consistency." |
| Ease of Insertion | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Ease of Insertion." |
| Non-Allergenic Properties | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Non-Allergenic Properties." |
| Pleasant Scent | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Pleasant Scent." |
| Quick Drying Time | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Quick Drying Time." |
| Ease in Clean Up | Kits are "Substantially equivalent to Audalin Liquid and Impression Polymer," which also have "Ease in Clean Up." |
Note: The "Reported Device Performance" here is a direct reiteration of the claimed "substantial equivalence" rather than data from an independent performance study against these criteria. The documents state, "The material in the impression kits are substantially equivalent to Audalin Liquid and Impression Polymer."
Study Details: Substantial Equivalence Claim
The provided text describes a claim of "substantial equivalence" as the primary "study" or justification for meeting acceptance criteria. This is not a study in the traditional sense of a clinical trial or performance evaluation with a test set of data.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable. There is no mention of a "test set" of data in the provided documents. The claim relies on the similarity of the new products to established ones.
- Data Provenance: Not applicable. No data or specific studies are described. The foundation is the commercial distribution and properties of the Audalin products.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. No ground truth was established by experts for a test set in the context of the provided information.
4. Adjudication Method for the Test Set:
- Not applicable. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC comparative effectiveness study was not done. The document focuses on material properties and equivalence, not reader performance with or without AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is an impression kit, not an AI algorithm. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used:
- The "ground truth," in this context, is the established characteristics and historical safe and effective use of the predicate devices (Audalin Liquid and Impression Polymer). The new devices are deemed acceptable because their material properties and intended use are considered identical or highly similar to these predicates, which were already commercially distributed and presumably met implicit safety and effectiveness standards. There is no mention of a specific, new "ground truth" being established by pathology, outcomes data, or expert consensus for the new kits themselves beyond this equivalency claim.
8. The Sample Size for the Training Set:
- Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As noted above, this is not an AI/machine learning device.
§ 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.