(15 days)
A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). Severity: X 1. Slight X 2. Mild X 3. Moderate Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other 1. Low Tolerance To Loudness B. Specific Indications (Only if appropriate.) : (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)
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The provided document K973972 is a 510(k) clearance letter for the Perfect Ear/Mini Canal and Perfect Ear/CIC hearing aids. It makes a determination of substantial equivalence (SE) to a predicate device already on the market.
It is important to understand that a 510(k) summary for a substantially equivalent device generally does not contain detailed information about the acceptance criteria and the comprehensive study results of the type requested.
The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical studies similar to those for a PMA (Premarket Approval) submission.
Therefore, many of the requested details about specific acceptance criteria, detailed study designs, sample sizes for test and training sets, ground truth establishment, and MRMC studies are not available in this document.
However, I can extract the information that is present in the document which relates to performance and indications for use.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Indication) | Reported Device Performance (from "Indications For Use" - Page 3) |
|---|---|
| Amplifies sound for individuals with impaired hearing. | The indication for use...is to amplify sound for individuals with impaired hearing. |
| Effective for various severities of hearing loss. | Indicated for individuals with: |
- Slight, Mild, Moderate hearing loss (Severity categories). |
| Effective for various configurations of hearing loss. | Indicated for individuals with: - High Frequency, Gradually Sloping, Reverse Slope, Flat hearing loss (Configuration categories). |
| Compatibility with specific psychoacoustic indications (e.g., improved speech intelligibility in background noise) if supported by clinical data. | No specific psychoacoustic indications beyond general amplification are made in this document. The document explicitly states: "(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)" Since these are not listed under "Specific Indications," it implies such claims were not made or supported in this submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Not specified in this document. A 510(k) submission primarily relies on comparisons to a predicate device. If performance data was submitted, its details (sample size, provenance) are not included in this high-level summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not specified in this document. The concept of "ground truth" as typically applied to AI/diagnostic device validation where expert labeling is used is not directly relevant to this 510(k) for a hearing aid, which usually relies on established audiological metrics and comparison to a predicate device.
4. Adjudication Method for the Test Set
- Not specified in this document.
5. 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 and not specified in this document. An MRMC study is typically for evaluating diagnostic imaging or AI-assisted diagnostic tools. This device is a hearing aid, which is a therapeutic/assistive device. The document does not describe AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable and not specified in this document. This device is hardware (hearing aid) and its performance is evaluated in direct interaction with the user, not as a standalone algorithm without human-in-the-loop performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a hearing aid, the "ground truth" would generally relate to audiological measurements (e.g., audiograms, speech understanding tests) that define the patient's hearing loss and the device's ability to ameliorate it. The document does not detail the specific types of ground truth data used in the comparison to the predicate device, but it would indirectly involve these audiological assessments.
8. The Sample Size for the Training Set
- Not applicable and not specified in this document. This 510(k) for a hearing aid does not describe a machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set was Established
- Not applicable and not specified in this document. As there's no mention of a training set for an AI model, this question is not relevant to the information provided.
In summary: The provided document is a 510(k) clearance letter confirming substantial equivalence. It focuses on the general indications for use of the hearing aid. It does not contain the detailed study design, acceptance criteria (beyond general indications), or statistical results that would typically be associated with clinical trials or AI/diagnostic device validation studies.
§ 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.