Search Results

A. General Indications: The indication for use of the air conduction hearing aids in this submission is to amplify some indicated for individuals with impaired hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated for individuals with losses in hearing. The devices are indicated as and can and
Severity:
X 1. Slight
X 2. Mild
X 3. Moderate
X 4. Severe
5. Profound
Configuration:
X 1. High Frequency - Precipitously Sloping
X 2. Gradually Sloping
X 3. Reverse Slope
X 4. Flat
5. Other
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.)
1.
2.
3.

Not Found

This looks like a 510(k) clearance letter for a hearing aid, not a document describing a clinical study with acceptance criteria and performance data as typically provided for AI/ML-based medical devices.

Therefore, I cannot extract the requested information about acceptance criteria, device performance, study design, expert ground truth, or MRMC studies. This document is a regulatory approval notice, confirming substantial equivalence to a predicate device, and includes general indications for use, but no specific performance study details are present here.

To directly address the prompts based on the lack of this information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided in this document. This is a 510(k) clearance letter, not a performance study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided 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 provided in this document. This device is a hearing aid, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hearing aid, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in this document.
8. The sample size for the training set: Not applicable; this is a hardware device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

A. General Indications: The indication for use of the air conduction hearing aids in this The indication for use of the individuals with impaired The devices are indicated for individuals with losses in hearing. nearing. The devices are indicated appropriate space(s)): Severity: 2. Mild, Configuration: 1. High Frequency - Precipitously Sloping, 3. Reverse Slope, 5. Other, Other: 1. Low tolerance To Loudness, 2., 3.
B. Specific Indications (Only if appropriate.): (Most psychoacoustic indications such as improved speech (Most psychoacouscic Indications back as supported by clinical data.) 1., 2., 3.

Not Found

This document is a 510(k) premarket notification from the FDA for a hearing aid, which approves the device based on its substantial equivalence to previously marketed devices. It does not contain a study describing acceptance criteria or device performance in the way requested.

Therefore, I cannot extract the information to complete the table and answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria."

The document primarily focuses on:

• Regulatory approval: Stating that the Philips S1694, S1695 Body Worn Hearing Aids are substantially equivalent to devices marketed prior to May 28, 1976.
• General controls: Listing requirements like annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
• Electromagnetic interference (EMI): Warning about potential EMI from digital cellular telephones and encouraging labeling modifications, noting that claims of compatibility would require a new 510(k) submission with supporting data.
• Indications for Use: Specifying the general indications for use as "air conduction hearing aids" for individuals with "impaired hearing" and outlining the severity and configuration of hearing loss these devices are indicated for (slight, moderate, severe, profound range; gradually sloping, flat configurations).

To reiterate, there is no information about specific performance metrics, acceptance criteria, or a study demonstrating the device meets those criteria within this FDA letter.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device