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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 ability. These devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: 1. Slight ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe ✓ 5. Profound Configuration: 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat ✓ 5. Other Other 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. To amplify and deliver sound to the ear via air conduction 2. 3.

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I'm sorry, but I cannot fulfill your request to describe the acceptance criteria and the study proving a device meets these criteria based on the provided text. The documents you've supplied are an FDA 510(k) clearance letter and an "Indications For Use" statement for the "Oticon DigiSound Compact" hearing aid from 1997.

These documents do not contain the detailed information you've requested, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or the number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study details, including effect size.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes, etc.).
• Sample size for training sets or how ground truth for training was established.

The FDA 510(k) clearance process, especially in 1997, for a hearing aid of this nature, primarily focused on substantial equivalence to existing predicate devices. This means the manufacturer demonstrated that their device was as safe and effective as a legally marketed device, often through engineering and performance testing rather than extensive clinical efficacy studies with the types of details you're asking for in the context of AI/ML performance.

The provided text only confirms that the device was found substantially equivalent and lists its general and specific indications for use, primarily relating to types and severities of hearing loss.

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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 ✓ 2. Mild ✓ 3. Moderate ✓ 4. Severe 5. Profound Configuration: 1. High Frequency - Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope 4. Flat ✓ 5. Other Other 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. To amplify and deliver sound to the ear via air conduction 2. 3.

Not Found

I am sorry, but I cannot answer your request as the provided text does not contain any information about acceptance criteria or a study proving that a device meets such criteria. The document is an FDA letter regarding the substantial equivalence of a hearing aid (Oticon DigiSound ITE Hearing Aid) to previously marketed devices. It primarily discusses regulatory classifications, general controls, and potential issues like electromagnetic interference, and provides indications for use for the device.

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To amplify and deliver sound to the ear

DigiFocus is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500 Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 42 dB HFA gain. Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm.

It appears the provided text is a summary of safety and effectiveness information for a hearing aid device called "DigiFocus ITE (DFI)". However, the information details the device's technical specifications, intended use, and features but does not contain any information about acceptance criteria, study data, or performance outcomes.

Therefore, I cannot provide the requested information, as the provided text lacks the necessary content to answer questions regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The text focuses on the device's technical characteristics and how it functions as a hearing aid, rather than a clinical study evaluating its performance against specific acceptance criteria.

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To amplify and deliver sound to the ear

DigiFocus Compact (DFC) is a seven band, two channel fully automatic hearing instrument which utilizes true digital signal processing (DSP). True DSP allows for precise, seven band frequency shaping and a unique and complex compression system utilizing syllabic compression in the lower frequency channel (below 1500Hz) and nonsyllabic compression in the higher frequency channel (above 1500Hz). 54 dB HFA gain. Assembled from standard electronic hearing aid components mounted together with custom microchips on flexfilm. Technical specifications are in accordance with ANSI Standards S3.22-1987. Frequency response, compression threshold and ratio, gain and SSPL 90 is dictated by individual audiometric and patient history data. All parameters are digitally programmed via software. The hearing aid has a manual OTM switch. Standard type 13 battery.

This document is a 510(k) summary for a hearing aid, not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, much of the requested information regarding AI/ML study specifics (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or cannot be extracted from the provided text.

Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

Study that proves the device meets the acceptance criteria:

The document states: "Technical specifications are in accordance with ANSI Standards S3.22-1987." This implies that the device was tested against these industry standards. However, no specific study details are provided within this summary for how this compliance was proven. It can be inferred that standard audiological testing and measurements were performed to verify performance against ANSI S3.22-1987, as this is typical for hearing aid clearance.

Regarding the AI/ML specific questions:

• 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • Not applicable. This is a traditional medical device (hearing aid), not an AI/ML device in the context of diagnostic or prognostic algorithms.
• 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 applicable. Ground truth for a hearing aid's technical specifications is typically based on objective measurements and established standards (like ANSI).
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable.
• 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.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
  • The "ground truth" for this device would be its objective technical performance as measured against established audiological standards (ANSI S3.22-1987).
• 8. The sample size for the training set
  • Not applicable.
• 9. How the ground truth for the training set was established
  • Not applicable.

In summary, the provided document is a 510(k) summary for a conventional hearing aid, not an AI/ML powered device. Therefore, most of the detailed questions pertaining to AI/ML study design are not applicable to this submission. The "study" proving the device meets acceptance criteria is an implicit reference to testing against ANSI Standards S3.22-1987, but no details of such a study are provided.

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