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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). (Check appropriate space(s)): Severity: 2. Mild X, 3. Moderate X, 4. Severe X. Configuration: 1. High Frequency - Precipitously Sloping X, 2. Gradually Sloping X, 4. Flat X, 5. Other: steeply sloping X. Other: 1. Low Tolerance to Loudness X.

Programmable OnQue for HS, CCA, and CAMEO Models

The provided document is a 510(k) premarket notification letter from the FDA for a hearing aid device, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study proving device performance as requested.

The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a regulatory pathway for certain medical devices. It confirms that the device, "Programmable OnQue for HS, CCA, and CAMEO Models," is substantially equivalent to devices marketed prior to May 28, 1976.

While it mentions "indications for use" and lists categories of hearing loss the device is intended for, it does not provide acceptance criteria, performance metrics, study details, or data provenance normally found in a clinical study report.

Therefore, I cannot populate the requested tables and information based on the provided text.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory equivalence, not performance metrics like accuracy, sensitivity, or specificity.
2. Sample size used for the test set and the data provenance: Not present. No test set or clinical study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth or expert review is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No adjudication process is described.
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 present. This document predates common AI applications in medical devices and there is no mention of such a study. The device is a hearing aid, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. The device is a hearing aid, which works with a human (the wearer). No standalone algorithm performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
8. The sample size for the training set: Not present. No training data is mentioned.
9. How the ground truth for the training set was established: Not present.

The document is a regulatory approval letter, not a scientific or clinical study report.

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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). (Check appropriate space(s)):

Severity:

1. Slight
   X 2. Mild
   X 3. Moderate
   X 4. Severe
2. Profound

Configuration:
X 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
3. Reverse Slope
X 4. Flat
X 5. Other Steeply sloping

Other
X 1. Low tolerance To Loudness
2.
3.

B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.)

Argosy Dynameq Series Models: HS, CCA,Cameo, Passport, Passport Deluxe, Shado, Eclipse, CCAS, CCAS Deluxe, and CCA-Mini Canal

The provided text is a 510(k) clearance letter from the FDA for a series of hearing aids. It does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter primarily focuses on the device's substantial equivalence to previously marketed devices and general regulatory compliance. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test sets or data provenance.
• Information on experts used for ground truth or adjudication methods.
• Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies.
• Results from standalone algorithm performance studies.
• Details regarding the type of ground truth used.
• Information on the training set size or how its ground truth was established.

The document only states the general indications for use of the hearing aids, primarily for amplifying sound for individuals with impaired hearing across various severity and configuration categories of hearing loss. It also mentions a general caution about potential electromagnetic interference but does not present any study data related to this or any other performance aspect of the device.

Ask a specific question about this device

Ask a specific question about this device