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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: Slight, Mild, Moderate, Severe, Profound
Configuration: High Frequency -Precipitously Sloping, Gradually Sloping, Reverse Slope, Flat, Other
Other: Low Tolerance to loudness

Sound F/XD Programmable Mini BTE Unitron Industries, Inc.

The provided document is a 510(k) clearance letter from the FDA for a hearing aid device, the Unitron Model Sound F/XD Programmable Mini BTE Hearing Aid (K974339).

This type of document primarily focuses on establishing "substantial equivalence" to a predicate device already on the market, rather than conducting a de novo study with acceptance criteria and detailed performance data like those for novel devices or AI/ML-based medical devices.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information.

The document indicates:

• Regulatory Class: I (21 CFR 874.3300/Procode: 77 ESD)
• Intended Use: To amplify sound for individuals with impaired hearing, for losses in slight, mild, moderate, and severe categories, with various configurations (high frequency-precipitously sloping, gradually sloping, reverse slope, flat).
• Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976.

The FDA letter explicitly states: "A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions."

For this specific clearance, detailed clinical studies with the requested metrics were not required for this type of Class I device seeking substantial equivalence. The focus was on demonstrating that the new device is as safe and effective as a legally marketed predicate device.

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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 ✓ 3. Moderate ✓ 4. Severe Configuration: ✓ 1. High Frequency -Precipitously Sloping ✓ 2. Gradually Sloping ✓ 3. Reverse Slope ✓ 4. Flat

Sound F/XP Programmble Mini BTE Hearing Aid

The provided text is a 510(k) premarket notification letter from the FDA regarding a hearing aid device (Unitron Industries, Inc. Sound F/XP Programmable Mini BTE Hearing Aid).

This document does not contain information related to acceptance criteria or a study proving device performance against acceptance criteria.

The letter is primarily a regulatory approval document stating that the device is "substantially equivalent" to legally marketed predicate devices for specific indications of use. It outlines general compliance requirements, potential future concerns regarding electromagnetic interference, and contact information for regulatory advice.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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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

Unitron Model Sound F/X Programmable Mini BTE Hearing Aid

This document is an FDA 510(k) clearance letter for the Unitron Model Sound F/X Programmable Mini BTE Hearing Aid. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the FDA has determined the device to be substantially equivalent to legally marketed predicate devices. This means that the device is considered as safe and effective as a device that was on the market before May 28, 1976 (the enactment date of the Medical Device Amendments) or a device that has been reclassified.

The focus of this type of submission is on demonstrating equivalence to an existing device, rather than providing a new study with specific acceptance criteria as might be seen for novel devices requiring Premarket Approval (PMA).

Therefore, I cannot extract the requested information from the provided text. The document does not describe:

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

The only "indications for use" information provided (in page 3) is a general table outlining severity and configuration categories for hearing loss that the hearing aid is intended to address, which is not specific technical performance criteria.

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To amplify and transmit sound via air conduction to the ear.

Completely-In-The-Canal Hearing Aid. Substantially equivalent to other Completely-In-The-Canal hearing aids. Features: Two channel wide dynamic range compression. Six adjustable parameters: Low-channel Gain, High-channel Gain, See-Saw, Cross Over Frequency, Threshold Knee-point and power. Twin average compression detectors. Class D Circuitry for excellent battery life. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical specifications comply with ANSI Standard S 3.22-1987. Controls: Screw set Volume Control, similar to other CIC devices. Power: Standard hearing aid battery - size 10A or 5A. A user's manual and other information is supplied with each hearing aid.

This document is a summary of safety and effectiveness information for a hearing aid from 1997. It describes the device's features and technical specifications but does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on describing the device itself and its equivalence to other devices, rather than presenting a performance study against specific acceptance criteria.

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To amplify and transmit sound via air conduction to the ear .

Sound F/X Programmable In-The-Ear Programmable Hearing Aid. Five programmable parameters: Low-channel Gain, High-channel Gain, Cross-over Frequency, Threshold Kneepoint, Power. Two channels with wide dynamic range compression circuitry independently adjustable for each channel. Twin average compression detectors. Class D circuitry for excellent battery life. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical Specifications comply with ANSI Standard S 3.22-1987. Volume Control, similar to other devices. Standard hearing aid battery size 13, 312 or 10A.

This document is a 510(k) summary for the Unitron Industries Sound F/X Programmable In-The-Ear Programmable Hearing Aid, dated April 24, 1997. It describes the device's intended use, features, and technical characteristics. However, it does not contain any information regarding clinical studies, acceptance criteria, or performance data.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. Method for establishing ground truth for the training set.

The document is purely a descriptive summary of the hearing aid's technical specifications and intended use for regulatory clearance, not a study report.

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To amplify and transmit sound via air conduction to the ear .

Behind-The-Ear Hearing Aids. Substantially equivalent to other behind-the-ear hearing aids. Features: Four fitter controls - Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier. Directional microphone. Assembled from standard components that are used by Unitron and other hearing aid manufacturers.

I apologize, but the provided text is a "Summary of Safety and Effectiveness Information" for a medical device (hearing aid) from 1996. It describes the device's intended use, features, technical characteristics, and assembly.

However, it does not contain any information regarding acceptance criteria, a study that proves device performance against acceptance criteria, or any of the specific details you requested (sample sizes, ground truth, expert opinions, etc.). This document is a regulatory filing, not a clinical study report.

Therefore, I cannot fulfill your request using the provided input. To answer your questions, I would need a clinical study report or a document detailing the validation of the device's performance.

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To amplify and transmit sound via air conduction to the ear.

Behind-The-Ear Hearing Aid. Substantially equivalent to other behind-the-ear hearing aids.

The provided document "K964511" is a 510(k) Premarket Notification for a hearing aid, dated November 27, 1996. This type of document is a submission to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device.

Critically, this document is a summary of safety and effectiveness information, not a detailed study report with specific acceptance criteria and performance data in the format requested. It focuses on demonstrating substantial equivalence to existing devices rather than presenting the results of a comprehensive study with quantitative performance metrics against predefined acceptance criteria for a novel AI/software-as-a-medical-device (SaMD) product.

Therefore, for the given input, most of the requested information cannot be extracted because it describes a hearing aid and not a software device that typically undergoes the kind of performance evaluation outlined in your request (e.g., AI performance metrics, ground truth establishment, expert adjudication, MRMC studies).

Here's an analysis of what can be inferred or stated about the provided document in relation to your request:

Analysis of K964511 within the context of your request:

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

   • Cannot be created. The document lists "Technical Characteristics" that "comply with ANSI Standard S 3.22-1987," but it does not provide specific numerical acceptance criteria (e.g., minimum gain, maximum distortion) and then report actual measured device performance against those criteria. It's a statement of compliance, not a detailed performance report.

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

   • Not applicable/Not mentioned. This document does not describe a "test set" in the context of evaluating an algorithm or AI. It's about a physical hearing aid.

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

   • Not applicable/Not mentioned. Ground truth establishment is typically for diagnostic/screening algorithms. This document doesn't involve that.

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

   • Not applicable/Not mentioned.

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-powered diagnostic tool requiring human reader studies.

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

   • Not applicable. This is a hardware device, not an algorithm.

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

   • Not applicable. This concept does not apply to a hearing aid's safety and effectiveness demonstration in this context. The "ground truth" for a hearing aid's basic function might be its physical performance characteristics measured against standards, but this is not the "ground truth" concept you're asking about.

8. The sample size for the training set:

   • Not applicable/Not mentioned. This information pertains to machine learning model development, which is not relevant to this 1996 hearing aid submission.

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

   • Not applicable/Not mentioned.

Summary specific to K964511:

The document K964511 for the Unitron Industries Sound F/XD hearing aid is a 510(k) Premarket Notification submitted in 1996. It aims to demonstrate substantial equivalence to existing, legally marketed Behind-The-Ear (BTE) hearing aids, rather than presenting a performance study against specific acceptance criteria for a novel device or AI.

The "acceptance criteria" for a 510(k) submission like this are generally satisfied by:

• Intended Use: Being the same as predicate devices ("To amplify and transmit sound via air conduction to the ear.").
• Technological Characteristics: Being "substantially equivalent" to predicate devices and complying with recognized standards (e.g., "Technical specifications comply with ANSI Standard S 3.22-1987"). The document states features like two-channel compression, Class D circuitry, telecoil, and directional microphone, implying these features are standard or comparable to devices on the market at the time.
• Safety and Effectiveness: Inferring from substantial equivalence that the device is as safe and effective as predicate devices.

No specific study with performance metrics against numerical acceptance criteria, as requested in your prompt, is described in this summary. The document's purpose is to summarize safety and effectiveness through equivalence, not to detail a novel performance study.

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To amplify and transmit sound via air conduction to the ear.

Behind-The-Ear Hearing Aid. Substantially equivalent Type of Device: to other behind-the-ear hearing aids. Features: Three fitter controls - Cross over frequency, low channel gain, and threshold knee point. Two channel compression circuitry. Class D circuitry for excellent battery life. Telecoil with pre-amplifier. Assembly: Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical Characteristics: Technical specifications comply with ANSI Standard S 3.22-1987. Fit: Hearing aid adjustment dictated by individual audiogram. Volume control, similar to other devices. Switch for Controls: selecting microphone, telecoil and off. Power : Standard hearing aid battery - size 13.

This document describes a hearing aid and focuses on its technical specifications rather than a study proving its performance against acceptance criteria. Therefore, I cannot extract the information you requested about acceptance criteria and a detailed study proving device effectiveness.

The document primarily provides:

• Device Name: Unitron Industries, Sound F/XP *4 Behind-The-Ear Hearing Aid
• Intended Use: To amplify and transmit sound via air conduction to the ear.
• Key Features: Three fitter controls (crossover frequency, low channel gain, threshold knee point), two-channel compression circuitry, Class D circuitry, telecoil with pre-amplifier.
• Technical Characteristics: States compliance with ANSI Standard S 3.22-1987.

Without a detailed clinical study report, it's impossible to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size, data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or 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.

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To amplify and transmit sound via air conduction to the ear.

Behind-The-Ear Hearing Aid. Assembled from standard components that are used by Unitron and other hearing aid manufacturers.

This document is a 510(k) summary for a hearing aid, a medical device. It does not contain the type of information requested, which pertains to the acceptance criteria and study data for a diagnostic or AI-driven device. The provided text describes the device's features, intended use, and technical specifications, but it does not detail any performance studies, acceptance criteria, sample sizes, expert involvement, or ground truth establishment relevant to the requested questions about device performance and validation.

Therefore, I cannot provide the requested table and information based on the given document.

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To amplify and transmit sound via air conduction to the ear.

Behind-The-Ear Hearing Aids. Four fitter controls Power, Compression Limiting, active low cut tone, high cut tone. Class D circuitry for excellent battery life. Powerful telecoil with preamplifier. Assembled from standard components that are used by Unitron and other hearing aid manufacturers. Technical specifications comply with ANSI Standard S 3.22-1987. Volume control, similar to other devices. Switch for selecting microphone, telecoil and off. Standard hearing aid battery size 13.

The provided document "K9644504" is a 510(k) summary for a Unitron Industries ICON AoHPL +4 Behind-The-Ear Hearing Aid, dated November 27, 1996. This document is a premarket notification to the FDA, demonstrating that the device is "substantially equivalent" to legally marketed predicate devices.

Crucially, this document does not describe a study with acceptance criteria and reported device performance in the way a modern AI/ML device submission would. In 1996, and for this type of medical device (a hearing aid), the regulatory pathway focused on demonstrating substantial equivalence to existing devices, primarily through descriptive technical characteristics and compliance with established industry standards, rather than robust clinical trials with detailed performance metrics against acceptance criteria.

Therefore, I cannot provide the information requested in your numbered list directly from this document, as those types of studies and performance metrics were not required or reported in this format for this specific device at that time.

Here's an explanation of why the requested information cannot be extracted and what can be inferred from the document:

Why the requested information cannot be directly extracted from K9644504:

This document is focused on establishing substantial equivalence to predicate devices. For a hearing aid in 1996, this typically involved:

• Description of Intended Use: Matched that of predicate devices.
• Technological Characteristics: Showed that the device was similar in design, materials, and operation to predicate devices, or that any differences did not raise new questions of safety and effectiveness.
• Compliance with Recognized Standards: Meeting industry standards like ANSI S3.22-1987 was a key part of demonstrating safety and effectiveness.

It did not require or report:

• Clinical Performance Studies: No trials with human subjects to measure sensitivity, specificity, accuracy, or other performance metrics against specific acceptance criteria.
• AI/ML Specifics: No algorithms, training sets, test sets, or ground truth establishment as this is not an AI/ML device.
• Expert Consensus or Adjudication: These methods are used for establishing ground truth, typically in image analysis or diagnostic AI, which is not relevant here.
• Multi-Reader Multi-Case (MRMC) Studies: These are for evaluating human reader performance, usually with diagnostic tools, not for basic amplification devices.

What can be extracted or inferred from the document regarding "acceptance" in its historical context:

The "acceptance criteria" in the context of this 1996 510(k) are implicitly:

1. Safety and Effectiveness: Demonstrate that the device is as safe and effective as a legally marketed predicate device.
2. Compliance with Standards: Meet the specifications of recognized industry standards.
3. No New Questions of Safety and Effectiveness: Any technological differences compared to predicate devices do not raise new concerns.

The "study that proves the device meets the acceptance criteria" is the entirety of the 510(k) submission itself, where the manufacturer presents evidence (primarily descriptive comparison and standards compliance) that these implicit criteria are met.

Here's a breakdown of the requested points, with "N/A" for elements not present in the document and explanations where applicable:

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

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

• N/A. This document does not describe a test set or any clinical data. It is a technical description and comparison.

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)

• N/A. No ground truth was established for a test set described in this document. The "ground truth" for regulatory clearance was conformance to industry standards and similarity to existing devices.

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

• N/A. No test set or human adjudication was involved or described for this device's clearance.

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

• N/A. This device is a hearing aid, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.

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

• N/A. This is not an algorithm-based device. Its "performance" is its ability to amplify sound according to its design specifications (which includes features like compression limiting, tone controls), and this was largely demonstrated by compliance with ANSI standards, not standalone algorithmic evaluation.

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

• N/A (in the modern sense). The "ground truth" for this submission was implicitly:
  • ANSI S 3.22-1987 Standard: The device's technical specifications met or conformed to this recognized industry standard for hearing aid characteristics.
  • Predicate Device Characteristics: The device's features, intended use, and general technology were demonstrably equivalent to legally marketed hearing aids.

8. The sample size for the training set

• N/A. There is no training set for this type of device.

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

• N/A. There is no training set for this type of device.

In summary, the provided document reflects a regulatory submission from a different era and for a different type of medical device than what your questions implicitly assume (i.e., a modern AI/ML diagnostic tool). The "acceptance criteria" and "proof" were centered around substantial equivalence and compliance with established engineering standards.

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