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The hearing aid is intended to be used to amplify and transmit sound to the ear and thereby compensate for impaired hearing.

The hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is initially placed in the ear canal by an appropriately trained ENT physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. It is then replaced by a new device by the previously mentioned parties, or by an adult patient 22 years and older who have been wearing Lyric for a minimum period of 3 months under the direction and training of the ENT physician, Audiologist or Hearing Aid Dispenser. Upon device removal the hearing aid is discarded.

Lyric4 is a non-sterile, extended wear hearing aid that is worn 24 hours a day, 7 days a week for months-at-a-time. Due to the deep placement inside the ear canal, it is 100% invisible. For patients, Lyric4 is very easy to operate with no batteries to change, no ongoing maintenance required and no daily insertion or removal. Lyric4 takes advantage of the deep placement in the ear canal for natural sound quality and the natural directivity of the pinna. Lyric4 is designed for single insertion and is not reused once removed from the ear (single-use only).

Compared to the currently marketed Lyric4, there are no modifications to the technology (hardware and software), materials, or accessories when Lyric4 is used for self-replacement. Only the indications for use statement and labeling have been modified.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Lyric4 Hearing Aid (for self-replacement)

Clinical Study Objective: To demonstrate the effectiveness and safety of the HCP-guided Lyric4 self-replacement procedure compared to the commercially available HCP-replacement procedure.

1. Table of Acceptance Criteria and Reported Device Performance

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The Lyric 2 hearing aid is a disposable, extended-wear air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.

Lyric2 is a disposable, programmable, deep-canal, extended-wear, air conduction hearing device, It uses an analog, digitally programmable WDRC ("Wide Dynamic Range Compression") circuit with very low power consumption. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The amplification characteristics are contained in digitally programmable memory, and adjustment of device parameters is achieved through the proprietary Fitting System and Software.

The Lyric2 consists of:

• A programmable application specific integrated circuit ("ASIC") for analog signal processing. . An analog microphone receives sound waves that will be amplified and transmitted to the speaker.
• A custom made built-in battery to power the amplification circuit. .
• A magnetic sensor to program device parameters and to remotely control user settings (On/Off/Sleep/Volume).
• Mechanical components to protect the device from cerumen. .
• A removal loop to allow the user and/or professional to remove the device. .
• . Seals that allow the device to fit comfortably in the ear canal

Accessories available for Lyric2:

• User Remote Control
• . Device sizer to determine best device size
• Length sizer to determine insertion depth .
• . An insertion tool for insertion and removal of device and device sizers
• A dedicated software and programming interface to program the device with customer · ● specific settings

The Phonak's Lyric2 is a hearing aid, so the acceptance criteria would revolve around its acoustic performance, safety, and comfort, as well as its functional equivalence to the predicate device.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

• Appropriate device sizing
• Clinical assessments of gain
• Speech understanding
• Sound quality
• Length of device wear
• Patient ratings of comfort
• Proportion of eligible population meeting sizing parameters
• Post-removal health of the ear
• Usability evaluations by patients and audiologists | This is a broad claim of equivalence across multiple functional and clinical aspects. The details of "comparable" would be defined in the study protocol. |
  | Safety | Biocompatibility, electrical safety, and electromagnetic compatibility. | "Biocompatibility testing, electrical safety, and electromagnetic compatibility testing, has confirmed the equivalent performance of the modified Lyric compared to the cleared Lyric." | This indicates the device meets established safety standards and is comparable to the predicate for these aspects. |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the specific sample size(s) for the clinical testing. It refers to "clinical testing" and "post-market clinical testing" but doesn't quantify the number of participants.
• Data Provenance: The document does not specify the country of origin. It implicitly describes a prospective study ("Post-market clinical testing also confirmed the comparable performance..."). The phrase "Post-market clinical testing" suggests data collected after the original Lyric (predicate device) was on the market, but this specific study was for the Lyric2.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The evaluations involved "patients and audiologists." While audiologists are qualified professionals, the number and specific experience of those involved in establishing "ground truth" or performing assessments are not detailed.

4. Adjudication Method for the Test Set

• The document does not describe any adjudication method. Given the nature of the device (hearing aid) and the stated assessments (gain, speech understanding, comfort, etc.), it's more likely that direct measurements and patient/audiologist feedback were collected and potentially aggregated, rather than a consensus-based adjudication of a subjective "ground truth" in the typical sense (e.g., image interpretation).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study, in the typical sense for diagnostic devices, was likely not done. This type of study (comparing human readers with and without AI assistance on specific cases) is relevant for AI algorithms that aid in interpretation or diagnosis. For a hearing aid, the "effectiveness" is measured by direct device performance and patient outcomes, not by how humans interpret findings with or without the device's "AI."
• The study did compare the Lyric2 to the predicate Lyric (without AI, as AI in hearing aids was not as prevalent then) across various clinical parameters, but not in an MRMC paradigm comparing human reading performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, performance characteristics of the device itself were evaluated in a standalone manner. "The performance characteristics of the Lyric Hearing Aid have been evaluated in accordance with ANSI S3.22:2009, 'Specification of Hearing Aid Characteristics.'" This standard involves direct measurement of the device's acoustic output and characteristics, independent of a human ear. This represents the "algorithm only" or device-only performance.

7. The Type of Ground Truth Used

• The "ground truth" for the performance evaluation appears to be a combination of:
  • Objective Measurement Standards: The ANSI S3.22:2009 standard provides objective benchmarks for hearing aid characteristics.
  • Clinical Assessments/Patient Outcomes: For aspects like gain, speech understanding, sound quality, comfort, and ear health, the "ground truth" would be derived from clinical measurements and patient self-reports, compared against a baseline or a predicate device.
  • Expert Observations: Audiologists performed "usability evaluations" and clinical assessments which would form part of the "ground truth" for those specific metrics.

8. The Sample Size for the Training Set

• Not applicable / Not specified. This device is a hardware hearing aid with an analog, digitally programmable circuit. While it uses digital programming, it is not an AI/ML algorithm that requires a "training set" in the modern sense of supervised learning for classification or prediction tasks. The "training" here refers to the engineering design, calibration, and parameter setting, not data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

• Not applicable / Not specified. As explained above, there isn't a "training set" in the AI/ML context for this type of device. The "ground truth" for its design and programming would be based on established audiological science, hearing aid design principles, and engineering specifications.

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The Lyric Hearing Aid is a disposable, extended-wear, air conduction hearing aid, designed to be used and worn by hearing-impaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an appropriately trained ENT Physician, Audiologist or Hearing Aid Dispenser and can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal the hearing aid is discarded.

The Lyric Hearing Aid amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Lyric Hearing Aid:

The provided document, a 510(k) summary for the Lyric Hearing Aid, is quite limited in the type of information typically found in a detailed performance study report. It primarily focuses on establishing substantial equivalence to predicate devices and states that the device meets internal specifications.

Here's an attempt to extract the requested information, with notes on what is not available in the given text:

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)

• Sample Size: Not specified. The document states "The devices met all applicable specifications," but does not provide details on how many devices were tested or how many users were involved in any performance evaluations.
• Data Provenance: Not specified. It's unclear if the testing was done internally at Insound Medical, by a third party, or if it involved human subjects. The type of study (retrospective or prospective) is also not mentioned.

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)

• Number of Experts: Not applicable or not specified. This type of information is typically relevant for studies using expert assessment as a ground truth, often clinical trials or image interpretation studies. For a hearing aid, performance is often measured objectively against standards.
• Qualifications of Experts: Not applicable or not specified.

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

• Adjudication Method: Not applicable or not specified. Adjudication methods are typically used when multiple experts are determining a ground truth for qualitative assessments. The performance evaluation here appears to refer to objective measurements against a standard.

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

• MRMC Study: No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant to this submission. The device is a hearing aid.
• Effect Size: Not applicable.

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

• Standalone Performance: Yes, implicitly. The performance evaluation against ANSI S3.22-2003 and Insound Medical's design specifications would be considered standalone performance testing of the device itself, separate from its use by an individual. However, the exact methodology is not detailed.

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

• Type of Ground Truth: The "ground truth" for this device's performance is based on objective measurements against established engineering standards (ANSI S3.22-2003) and the manufacturer's own design input specifications. It is not based on expert consensus, pathology, or patient outcomes in the sense of a clinical trial proving efficacy for a disease. The efficacy of hearing aids in general for hearing loss is well-established, and this submission focuses on the device meeting performance requirements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a hardware product that amplifies sound; it does not involve machine learning algorithms that require a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML algorithm.

Summary of Limitations in the Provided Document:

The provided 510(k) summary is very concise and primarily aims to establish substantial equivalence. It does not contain the detailed performance study information (e.g., number of subjects, detailed methodology, specific quantitative results) that would typically be found in a full study report or a more comprehensive technical summary for a device with complex clinical endpoints or AI components. The performance data section is brief, stating compliance with an industry standard and internal specifications, without elaborating on the specific tests, results, or conditions.

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The InSound XT Hearing Aid is a disposable, extendedwear, air conduction hearing aid, designed to be used and worn by hearingimpaired persons. Hearing assistance is achieved through amplification of sound pressure waves, which are transmitted to the external ear canal via air conduction. The hearing aid is placed in the ear canal by an ENT physician and it can remain in the ear canal for up to 4 months or until the battery is depleted. Upon device removal, the hearing aid is discarded.

The InSound XT Series Hearing Device amplifies and delivers sounds via air conduction to the external ear of persons with hearing loss. The microphone transforms sound waves into electrical signals and delivers it to the hearing aid circuit, which is powered by the battery. The hearing device is extendedwear (up to 4 months) and disposable. It is placed deep in the ear canal by an ENT physician. The amplification characteristics are contained in digitally programmable memory and adjustment of device parameters is achieved through the proprietary HandFit™ Fitting System and Software.

1. Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the clinical trials or "test set." It only mentions "human subjects." The data provenance is described as "clinical trials" which are typically prospective studies. The country of origin of the data is not explicitly stated.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical trials. It does mention that the device is "placed deep in the ear canal by an ENT physician," suggesting that ENT physicians would be involved in the clinical setting and potentially in evaluating the device's performance and comfort.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set or clinical trials.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text, nor is there any discussion of an effect size for human readers improving with AI vs. without AI assistance. This is a hearing aid device, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was done as this is a physical medical device (hearing aid), not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for the clinical trials appears to be based on:

• Clinical observations and subject feedback: Assessed comfort, safety, and efficacy during extended wear.
• Hearing aid verification battery: Demonstrated user benefit during extended wear.
• Compliance with ANSI standards: Performance characteristics were evaluated against established engineering specifications.

8. Sample Size for the Training Set

The document does not mention a separate "training set" or its sample size. The clinical trials described appear to serve as the evidence for efficacy and safety.

9. How the Ground Truth for the Training Set was Established

As no separate training set is explicitly mentioned, the establishment of ground truth would refer to how the clinical trial outcomes were determined, as described in point 7.

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Ask a specific question about this device

This air conduction hearing instrument is intended to amplify sound pressure waves and transmit the signal to the external ear through the medium of air to compensate for hearing losses of mild to moderate degree.

Indications for use include persons with mild to moderate hearing impairment depending upon specific characteristics of the hearing loss and the patient's environmental situations.

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

The SONIC innovations Completely-in-the-Canal DSP Hearing Aid with Soft Shell is a programmable hearing aid with fully digital signal processing and full dynamic range multiband compression (multiplicative DSPTM) that allows independent adjustment of gain and compression characteristics within each frequency band from 250 to 8000 Hz. The SONIC innovations hearing aid provides database storage of patient information and hearing aid fitting parameters.

Assembled from standard hearing aid components mounted with custom microchips. The hearing aid soft shell is manufactured from biocompatible materials that have been used in other medical devices.

The Soft Shell is removable and/or replaceable, and can be cleared or replaced as needed. The shells are offered in a few basic sizes and selected by the hearing aid dispenser.

Except for the Soft Shell, the device is manufactured and delivered completely assembled to the hearing aid dispenser using materials and techniques widely used by other manufacturers of hearing devices.

Two versions of the Soft Shell are available, both made of biocompatible materials. The two versions of the shell are available in multiple sizes, the specific one being selected by the hearing aid dispenser as suitable for an individual patient.

The Soft Shell may be cleaned and/or replaced as needed by either the hearing aid dispenser or the individual patient.

The provided text for the Sonic Innovations CIC DSP Hearing Aid (K984518) does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) Premarket Notification summary that:

• Identifies the device.
• States its intended use and indications for use.
• Claims substantial equivalence to previously marketed devices.
• Lists technical characteristics in accordance with ANSI S3.22 1987.
• Describes the materials and features.

Crucially, it does not include any performance data, clinical trial results, or details of studies conducted to evaluate the device against specific performance benchmarks. The statement "Technical specifications are in accordance with ANSI S3.22 1987" implies compliance with a standard, but it doesn't provide the measured performance against that standard.

Therefore, I cannot fulfill your request for the tables and study details because the necessary information is not present in the provided text.

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A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss where the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are not an issue.

A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss when the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are an issue.

A hearing Aid and/or Tinnitus Masker/Habituator. No hearing loss or a mild to severe high frequency hearing loss where the patient exhibits a low hearing loss where the patient's response to tinnitus is characterized by intolerance to specifically the inability to cope with head noises, anxiety, depression or the inability to function in daily life activities. When cosmetics are a major issue.

Tranquil TRI-OE: I-T-E hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 312 battery.

Tranquel TRI-COE: I-T-C hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 10A battery.

Tranquel TRI-CIC: C-I-C hearing aid and/or tinnitus masker/habituator with Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable. Assembled from standard components. Technical specifications comply with S3 2-1987 ANSI Standards. Frequency response dictated by individual audiogram. Volume control mechanical or electronic. Standard Size 10A battery.

The provided text does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in such a study.

The documents are a 510(k) summary of safety and effectiveness information for the "Tranquil TRI-OB, TRI-COE & TRI-CIC Tinnitus Maskers / Hearing Aids". This type of submission is for demonstrating
substantial equivalence to a predicate device already legally marketed, rather than proving performance against novel acceptance criteria through a specific study.

Here's what the documents do provide:

• Intended Use: A hearing Aid and/or Tinnitus Masker/Habituator for patients with no hearing loss or mild to severe high-frequency hearing loss, where the patient's response to tinnitus is characterized by intolerance, specifically the inability to cope with head noises, anxiety, depression, or inability to function in daily life activities. The "Tranquil TRI-OE" is for when cosmetics are not an issue, "Tranquil TRI-COE" for when cosmetics are an issue, and "Tranquil TRI-CIC" for when cosmetics are a major issue.
• Technical Characteristics: "Technical specifications comply with S3 2-1987 ANSI Standards." This is the closest thing to an acceptance criterion mentioned, but it refers to a general standard compliance rather than specific performance metrics unique to this device.
• Device Features: Class A Noise Generator, Class D Noise Generator, DSD K-amp programmable or Intrigue Programmable.
• Assembly: Assembled from standard components widely used by other hearing aid manufacturers.
• Regulatory Classification: Class III, Procode: 77 KLW/77 ESD, under 21 CFR 874.3400/21 CFR 874.3300.
• Substantial Equivalence: The FDA letter (Document 3) explicitly states that the device is found to be "substantially equivalent" to predicate devices marketed prior to May 28, 1976. This is the basis for its clearance, not a new performance study.

Therefore, based on the provided text, I cannot answer the questions about acceptance criteria, a specific study, sample sizes, ground truth, or expert involvement because this information is not present in a 510(k) summary demonstrating substantial equivalence. Such details would typically be found in detailed clinical trial reports or design verification/validation documents, which are not part of this submission.

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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 X, 3. Moderate X, 4. Severe X. Configuration: 1. High Frequency - Precipitously Sloping X, 2. Gradually Sloping X, 4. Flat X, 5. Other: steeply sloping X. Other: 1. Low Tolerance to Loudness X.

Programmable OnQue for HS, CCA, and CAMEO Models

The provided document is a 510(k) premarket notification letter from the FDA for a hearing aid device, not a study report. Therefore, it does not contain the detailed information about acceptance criteria or a study proving device performance as requested.

The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is a regulatory pathway for certain medical devices. It confirms that the device, "Programmable OnQue for HS, CCA, and CAMEO Models," is substantially equivalent to devices marketed prior to May 28, 1976.

While it mentions "indications for use" and lists categories of hearing loss the device is intended for, it does not provide acceptance criteria, performance metrics, study details, or data provenance normally found in a clinical study report.

Therefore, I cannot populate the requested tables and information based on the provided text.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory equivalence, not performance metrics like accuracy, sensitivity, or specificity.
2. Sample size used for the test set and the data provenance: Not present. No test set or clinical study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth or expert review is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not present. No 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 present. This document predates common AI applications in medical devices and there is no mention of such a study. The device is a hearing aid, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. The device is a hearing aid, which works with a human (the wearer). No standalone algorithm performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
8. The sample size for the training set: Not present. No training data is mentioned.
9. How the ground truth for the training set was established: Not present.

The document is a regulatory approval letter, not a scientific or clinical study report.

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The Sonix Hearing Aid Fitting and Programming System is a lightweight hand-held batterypowered device intended for use in fitting and programming Sonix hearing aids using individual patient audiogram and/or loudness data. It also provides database storage of patient identification information, audiogram, loudness information and hearing aid selection and fitting parameters.

The Sonix Hearing Aid Fitting and Programming System is a hand-held, battery-powered, portable device used to fit and program Sonix hearing aids and to store certain patient data.

The provided text is a very brief summary of safety and effectiveness for a 510(k) submission (K973880) for the Sonix Hearing Aid Fitting and Programming System. It states that the device is substantially equivalent to two predicate devices based on its intended use and general characteristics.

Crucially, the document does not contain any information about specific acceptance criteria or a study that proves the device meets those criteria. It only asserts substantial equivalence to existing devices.

Therefore, for the requested information, I have to state that it is not available in the provided text.

Here's how I would answer your request based on the provided input:

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

   • Not available. The provided document does not specify any quantitative acceptance criteria or report performance metrics for the Sonix Hearing Aid Fitting and Programming System. It only makes a claim of substantial equivalence to predicate devices based on shared intended use and general features.

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

   • Not available. The document does not describe any specific test set or clinical study data.

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. The document does not describe any process for establishing ground truth as no specific test set or study is detailed.

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

   • Not available. No test set or ground truth establishment method 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. The device described (a hearing aid fitting and programming system) is not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study with human readers. The document does not mention any AI components or MRMC studies.

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

   • Not available. The document does not describe any standalone algorithm performance studies. The device is a system for programming hearing aids, implying human-in-the-loop operation by a dispenser.

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

   • Not available. As no specific study or test set is described, the type of ground truth is not mentioned.

8. The sample size for the training set

   • Not available. The document does not mention any training set or machine learning components.

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

   • Not available. As no training set is mentioned, the method for establishing its ground truth is also not.

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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.

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