Search Results

The indication for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.

Not Found

This is a medical device approval letter from the FDA to Bernafon-Maico, Inc. regarding their Maico MA42 audiometer. The letter states that the device is substantially equivalent to devices marketed prior to May 28, 1976, and can therefore be marketed.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. It is a regulatory approval document confirming substantial equivalence, not a detailed technical report on performance or testing.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone (algorithm only) performance was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document focuses solely on the regulatory approval process based on substantial equivalence, and does not delve into the specific performance metrics or studies you're asking for.

Ask a specific question about this device

The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.

Not Found

This document is an FDA 510(k) clearance letter for an audiometer (Maico MA53) from 1998. It does not contain information about specific acceptance criteria or study results because, for 510(k) clearances, the primary mechanism for demonstrating safety and effectiveness is substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as might be seen for PMA submissions or more recent AI/ML device clearances.

Therefore, I cannot provide the requested information based on this document. The document essentially states that the device is substantially equivalent to devices marketed before 1976 and is cleared for marketing.

To answer your request, I would need a different type of document, such as a summary of safety and effectiveness (SSE) for a more recent device, especially one involving AI/ML components, or a PMA (Premarket Approval) document.

Ask a specific question about this device

A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: X 1. Slight X 2. Mild 3. Moderate 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: 1. Low Tolerance To Loudness 2. 3.

OPUS 2 - COMPLETELY - IN - CANAL SERIES ( CIC ) Device Name:

This is a 510(k) premarket notification for a hearing aid, not an AI/ML medical device. Therefore, the information requested (acceptance criteria, study details, expert qualifications, etc.) related to AI/ML device performance is not applicable to this document.

The document discusses the substantial equivalence determination for the "OPUS 2 - COMPLETELY - IN - CANAL SERIES - CIC" hearing aid to legally marketed predicate devices, and its indications for use. It primarily concerns regulatory approval based on existing device classifications and general controls.

There is no information within this document about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test or training sets, or data provenance.
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes for AI assistance.
• Standalone algorithm performance.
• Types of ground truth used (e.g., pathology, outcomes data).
• How ground truth for a training set was established.

Ask a specific question about this device

• A. General Indications:
  The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories:

Not Found

The provided text is a 510(k) clearance letter from the FDA for a hearing aid device, the "Opus 2 - Full Concha Series - ITE." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

Instead, it is a notification of substantial equivalence to a predicate device, allowing the manufacturer to market the product. It states the indications for use and general regulatory information.

Therefore, I cannot provide the requested information from the given text.

To be clear:

• There is no table of acceptance criteria or reported device performance in this document.
• There is no information about sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a study in this document.

Ask a specific question about this device

A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight X 2. Mild X 3. Moderate X 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping 3. Reverse Slope X 4. Flat 5. Other Other: X 1. Low Tolerance To Loudness 2. 3.

OPUS 2 - CANAL SERIES ( ITC )

This document is a 510(k) clearance letter from the FDA for the Opus 2 - Canal Series (ITC) hearing aid and does not contain the specific information required to answer the prompt.

The letter acknowledges the device's substantial equivalence to previously marketed devices and outlines regulatory requirements. However, it does not include studies or data on acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies. These types of details would typically be found in the 510(k) submission itself, which is not provided here.

Ask a specific question about this device

A. General Indications: The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 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.

DUALINE 100 BTE

The provided document is a 510(k) clearance letter from the FDA for a hearing aid named "DUALINE DL100 BTE Hearing Aid" (K973948). It does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria in the way a modern AI/ML device submission would.

The letter explicitly states that the device is determined to be substantially equivalent to devices marketed prior to May 28, 1976. This means its performance is considered comparable to existing, legally marketed predicate devices, and a specific clinical study with detailed acceptance criteria and performance metrics (as requested in the prompt) is typically not required for such 510(k) clearances, especially for devices from 1997.

Therefore, I cannot extract the requested information from this document. The document describes the regulatory approval process based on substantial equivalence, not a detailed performance study against specific acceptance criteria.

Ask a specific question about this device

The intended use of this model hearing aid is to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing. This device is indicated for individuals with losses in the following categories: Severity: 1. Slight, X 2. Mild, X 3. Moderate, 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.

DUALINE 400 CIC

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets any acceptance criteria. The document is a 510(k) premarket notification letter from the FDA for a device named "Dualine 400 CIC".

This letter confirms that the FDA has reviewed the submission and determined that the device is "substantially equivalent" to legally marketed predicate devices. It lists the general indications for use of the hearing aid (to amplify sound pressure waves and transmit the signal to the external ear, through the medium of air, to compensate for impaired hearing), and then specifies categories for severity, configuration, and other factors for hearing loss.

The document does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for any test set or training set.
• Information on expert involvement, adjudication methods, or MRMC studies.
• Any standalone algorithm performance data.

The FDA 510(k) clearance process primarily establishes substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific acceptance criteria as might be seen for a Pre-Market Approval (PMA) pathway.

Ask a specific question about this device

The indications for use of the audiometer in this submission would be for the detection and diagnosis of a suspected hearing loss.

Not Found

The provided documents are a 510(k) clearance letter and an Indications For Use statement for the Maico MA52 device. These documents do not contain information about acceptance criteria, device performance studies, or details regarding ground truth establishment, expert qualifications, or sample sizes.

The 510(k) clearance letter (Document 0) states that the FDA has reviewed the submission and determined that the Maico MA52 is "substantially equivalent" to devices marketed prior to May 28, 1976. This determination indicates that the device met the regulatory requirements for showing substantial equivalence to a predicate device, but it does not delve into the specifics of performance criteria or clinical study results for the device itself.

The "Indications For Use" statement (Document 1) simply specifies that the device "would be for the detection and diagnosis of a suspected hearing loss."

Therefore, based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not available in the provided documents.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available.
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 available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available.
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 available. The device is an audiometer, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not available. The device is an audiometer, which typically involves a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

Ask a specific question about this device

Ask a specific question about this device