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General Indications: A. The indication for use of the air conduction hearing aids in this submission is to amplify sound far 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, 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 psychoacuustic indications such as improved speech intelligibility in background noise, must be supported by clinical data.) - l. 2. - 3.

Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments

The provided text does not contain information about acceptance criteria or a study proving the device meets these criteria in the typical format of a medical device performance study (e.g., diagnostic accuracy, sensitivity, specificity).

Instead, the documents are a 510(k) Premarket Notification Summary for a hearing aid, the Phonak Novo Forte E3. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or performance against specific, quantifiable acceptance criteria through a clinical study.

Here's a breakdown of what the document does provide, and why it doesn't fit the requested format for acceptance criteria and study details:

• Device Description and Intended Use: The documents clearly describe the Phonak Novo Forte E3 as a "Programmable behind-the-ear hearing instrument" intended "To amplify and transmit sound to the ear."
• Technical Characteristics: It states that "Technical specifications comply with ANSI S3.22 - 1987." This is the closest thing to a performance standard or criterion mentioned, but it's a general compliance statement rather than specific device performance metrics.
• Substantial Equivalence: The FDA letter explicitly states, "we have determined the device is substantially equivalent...to devices marketed in interstate commerce prior to May 28, 1976." This is the core of a 510(k) submission.
• Indications for Use: Page 4 details the specific types and severities of hearing loss for which the device is indicated (Slight, Mild, Moderate, Severe; High Frequency, Gradually Sloping, Reverse Slope, Flat; Low tolerance to Loudness).

Answer based on the provided text:

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

Explanation: The document does not specify quantitative performance acceptance criteria (e.g., a required signal-to-noise ratio, hearing gain at specific frequencies, or distortion levels) or present performance data from a specific study against such criteria. The primary "acceptance" was the FDA's determination of substantial equivalence to a predicate device and compliance with ANSI S3.22 - 1987.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable/Not provided. The 510(k) summary does not describe a clinical performance study with a test set of patients or data.
• Data Provenance: Not applicable/Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. No test set or 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 applicable. 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 device is a hearing aid; it does not involve algorithms for standalone diagnostic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable/Not provided. No ground truth is established as no clinical performance study is described. The "ground truth" for the 510(k) application is the established safety and effectiveness of the predicate device to which the Novo Forte E3 is compared for substantial equivalence.

8. The sample size for the training set:

• Not applicable/Not provided. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable/Not provided. No training set is mentioned.

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The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)):
Severity: Slight, Mild, Moderate, Severe
Configuration: High Frequency - Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat
Other: Low tolerance To Loudness

Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments.
Features: Two programmable memories, 3 choices of signal processing, optional remote control
Assembly: Assembled from components available to hearing instruments manufacturer. Delivered completely assembled to the hearing aid dispenser
Technical Characteristics: Technical specifications comply with ANSI S3.22 - 1987
Audiometric Fit: Frequency response, gain, and output are fitted to the individual audiogram
Controls: Operated with remote control
Power Source: Standard hearing instrument battery, size 312

The provided documents describe a 510(k) premarket notification for the Phonak Epica E 2 hearing instrument. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data to prove novel acceptance criteria.

Therefore, the following information is either not applicable or not explicitly detailed in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance Study:
The document states that the "Technical specifications comply with ANSI S3.22 - 1987." This implies that compliance with this industry standard serves as the acceptance criterion for technical performance. However, specific numerical acceptance criteria (e.g., gain, output, frequency response ranges) and the corresponding reported device performance values against these criteria are not provided within the given text.

A standalone performance study, in the sense of a clinical trial to establish new performance metrics, is not detailed as the submission's goal is substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable/not specified. The 510(k) summary does not mention a specific test set or data provenance for a clinical study comparing the device against acceptance criteria.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable/not specified. No information regarding experts establishing ground truth is provided, as clinical efficacy data is not the primary focus of this 510(k) submission.

4. Adjudication Method:
Not applicable/not specified. No adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. MRMC studies are typically used in medical imaging to assess the impact of AI on human reader performance. This device is a hearing aid, and this type of study is not relevant to its regulatory pathway.

7. Type of Ground Truth Used:
Not applicable. Since the submission focuses on substantial equivalence to a predicate device and compliance with a technical standard (ANSI S3.22-1987), there's no mention of ground truth established through expert consensus, pathology, or outcomes data for clinical efficacy.

8. Sample Size for the Training Set:
Not applicable/not specified. There is no information about a training set or specific machine learning algorithms for this device.

9. How the Ground Truth for the Training Set was Established:
Not applicable/not specified. As with point 8, no training set or its ground truth establishment is discussed.

Summary based on the provided text:

The information primarily indicates that the device's technical characteristics comply with ANSI S3.22-1987, which serves as a key acceptance criterion for its fundamental performance. The 510(k) process is about demonstrating substantial equivalence, not conducting de novo clinical trials to prove new performance criteria.

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The indication for use of the air conduction hearing aids in this submission is to amplify sound far individuals with impaired hearing. The devices are indicated for individuals with losses in the following category(ies). (Check appropriate space(s)): Severity: X 1. Slight X 2. Mild X 3. Moderate X 4. Severe Configuration: X 1. High Frequency - Precipitously Sloping X 2. Gradually Sloping X 3. Reverse Slope X 4. Flat Other X 1. Low tolerance To Loudness

Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments

The provided document is a 510(k) premarket notification for the Phonak "MicroZoom P 2" hearing instrument. This type of submission focuses on establishing substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and detailed performance metrics as might be seen for novel, higher-risk devices.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance against such criteria, information on test sets, ground truth establishment, or multi-reader multi-case studies.

However, I can extract the relevant information that is present in the document.

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

The document states: "Technical specifications comply with ANSI S3.22 - 1987". This implies that the acceptance criteria for the device's technical characteristics are adherence to this engineering standard. The reported device performance is that it "comply[ies] with ANSI S3.22 - 1987".

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device, and typically does not include detailed independent test set data in this manner.

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):

This information is not provided in the document. There is no mention of a test set where experts establish ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided.

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:

This information is not provided. This device is a hearing aid, not an AI-assisted diagnostic tool, so such a study would not be applicable or expected for this submission type.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not provided. This device is a hearing aid; it is inherently a human-in-the-loop device for its function (wearing it).

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

The primary "ground truth" for this 510(k) submission is the technical specifications conforming to ANSI S3.22 - 1987 and the established safety and effectiveness of the legally marketed predicate devices to which it is substantially equivalent. No specific "ground truth" in the context of clinical study data is discussed.

8. The sample size for the training set:

This information is not provided. If any "training" occurred, it would be in the context of the device's design and manufacturing processes to meet the ANSI standard, not in the sense of an AI model's training data.

9. How the ground truth for the training set was established:

This information is not provided. As above, the concept of a "training set" and associated "ground truth" in the AI/clinical study sense is not applicable to this 510(k) submission for a hearing aid.

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To receive FM transmission from a same channel transmitter/microphone and feed it to the hearing aid. An example of such use would be a lecture hall setting with user receiving direct imput from the person lecturing.

Personal FM unit, operates only via audio input connection to Phonak BTE style hearing instruments. Substantially equivalent to other FM BTE systems.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study to prove meeting acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, or training set details.

The document is a summary of safety and effectiveness information for the Phonak MicroLINK FM Receiver, likely from a regulatory submission (K964035 DEC - 4 1996). It describes the device's name, type, intended use, features, assembly, technical characteristics, and power source. It does not contain the detailed study results or methodological information you are requesting.

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To amplify and transmit sound to the ear

Programmable in-the-canal hearing instrument. Substantially equivalent to other programmable in-the-canal hearing instruments

The provided text describes a hearing instrument, the Phonak Sona P2. However, it does not contain any information regarding acceptance criteria, device performance metrics, or study details such as sample sizes, expert involvement, ground truth establishment, or any comparative effectiveness studies.

Therefore, I cannot fulfill your request as the necessary information is not present in the input. The exhibit only provides a summary of the device's characteristics and intended use.

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To amplify and transmit sound to the ear

Programmable behind-the-ear hearing instrument. Substantially equivalent to other programmable behind-the-ear hearing instruments

This document (K961622) is a "Summary of Safety and Effectiveness Information" for a medical device submitted to a regulatory body (likely the FDA based on the K-number format). It outlines the device's characteristics and intended use.

However, the provided text does not contain any information about acceptance criteria, performance studies, or clinical evaluation data in the way you've requested for AI/ML device assessment.

Here's why and what's missing:

• Device Type: The device described, "Phonak Piconet2 P2 AZ," is a programmable behind-the-ear hearing instrument. This is a conventional medical device, not an AI/ML powered one. The regulatory submission process for such devices typically relies on demonstrating substantial equivalence to a predicate device and adherence to technical standards (like ASA/ANSI S3.2-1987, as mentioned).
• Content: The document focuses on:
  • Device name and type
  • Intended use
  • Key features
  • Assembly
  • Technical characteristics (compliance with a standard)
  • Fit (customization to audiogram)
  • Controls
  • Power source
    It explicitly states "Technical specifications comply with ASA/ANSI S3.2 - 1987," which is how its performance is likely "proven" for regulatory purposes, rather than through a dedicated performance study with acceptance criteria as one would conduct for an AI algorithm.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, or standalone performance for an AI/ML device because this information is not present in the provided text. The document describes a traditional hearing aid, not an AI-powered diagnostic or assistive tool.

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