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510(k) Data Aggregation
(40 days)
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: Slight, Mild, Moderate, Severe. Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat. Other: Low Tolerance To Loudness.
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This document is a 510(k) premarket notification decision letter from the FDA for several hearing aid models (DB, DB2000, PH, ST, CI) manufactured by Magnatone Hearing Aid Corporation. It primarily states that the devices are substantially equivalent to legally marketed predicate devices and can proceed to market. It also includes "Indications For Use" forms for each model.
Based on the provided text, the acceptance criteria and study information are quite limited because this is a regulatory clearance document, not a detailed scientific study publication. The 510(k) pathway demonstrates substantial equivalence rather than requiring a full clinical trial meeting specific performance criteria in the way a PMA (Premarket Approval) would.
Here's an analysis based on the information provided, with an understanding of the limitations inherent in this type of document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or detailed performance metrics in the way a clinical study report would. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The "performance" described relates to the indications for use.
| Acceptance Criteria (Implied by 510(k) process) | Reported Device Performance |
|---|---|
| Substantial Equivalence to legally marketed predicate devices. | The FDA determined the devices are "substantially equivalent" to devices marketed prior to May 28, 1976, or to lawfully reclassified devices (Page 1). |
| Device must amplify sound for individuals with impaired hearing. | "The indication for use of the air conduction hearing aids in this submission is to amplify sound for individuals with impaired hearing." (Pages 3-7 for all models). |
| Device must be indicated for specific severities of hearing loss (Slight, Mild, Moderate, Severe, Profound). | All models (CI, DB, DB2000, LB, PH, ST) are indicated for "Slight", "Mild", "Moderate", and "Severe" hearing loss. The "Profound" category is generally unchecked, except for DB and DB2000 where it is also indicated "X" (Pages 3-7). |
| Device must be indicated for specific configurations of hearing loss (High Frequency, Gradually Sloping, etc.). | All models (CI, DB, DB2000, LB, PH, ST) are indicated for "High Frequency - Precipitously Sloping", "Gradually Sloping", "Reverse Slope", and "Flat" configurations (Pages 3-7). |
| Device may be indicated for "Low Tolerance To Loudness." | All models (CI, DB, DB2000, LB, PH, ST) include "Low Tolerance To Loudness" as an "Other" indication option (Pages 3-7). |
| Specific psychoacoustic indications (e.g., improved speech intelligibility in background noise) require clinical data support. | No specific psychoacoustic indications are checked or discussed. The forms explicitly state: "(Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)" This implies such claims were not made for these devices in this submission, or if they were, they needed separate clinical data, which is not included here (Pages 3-7). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on a test set sample size or data provenance (e.g., country of origin, retrospective/prospective). As a 510(k) submission, the primary evidence is typically technical specifications and comparison to a predicate device, not a new clinical study with a "test set" in the traditional sense of a clinical trial. The "clinical data" mentioned for specific psychoacoustic indications (if made) would typically be provided elsewhere, if at all.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The concept of "ground truth" established by experts for a test set is usually associated with clinical studies involving diagnostic or prognostic devices, where human expert labels are compared to device outputs. For hearing aids seeking 510(k) clearance, the "ground truth" for their substantial equivalence is the predicate device's established safety and effectiveness.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods (e.g., 2+1, 3+1) are relevant when multiple experts are interpreting data, and consensus is needed to establish ground truth for a clinical study. This document does not describe such a study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned or implied in this document. These types of studies are used to assess the performance of a device with human readers, often comparing human performance with and without AI assistance. This document is a regulatory clearance for a physical medical device (hearing aids), not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a hearing aid, which is a physical device used by a human, not a standalone algorithm. Its performance is directly tied to a human wearer.
7. The Type of Ground Truth Used
For the purpose of this 510(k) clearance, the "ground truth" essentially refers to:
- Predicate Device Performance: The safety and effectiveness of the legally marketed predicate device(s) to which the Magnatone hearing aids are compared. This is the cornerstone of substantial equivalence.
- Established Medical Understanding: The classifications of hearing loss severity and configuration (Slight, Mild, High Frequency, Flat, etc.) are based on established audiological standards and medical understanding.
There is no mention of pathology, expert consensus (beyond the regulatory review process), or outcomes data being used to establish ground truth for a novel study of these specific devices within this document.
8. The Sample Size for the Training Set
This information is not applicable/not provided. These are physical hearing aid devices, not AI/machine learning algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8.
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