Search Results

The HyperSound Group Auditory Trainer is indicated for use as a group auditory trainer or group hearing aid used to communicate simultaneously with one or more listeners with or without hearing loss and with or without the use of hearing aids in order to improve clarity and comprehension of sounds generated from sources such as a microphone, CD/DVD player, TV, Stereo System or other sound generation systems.

The HyperSound Audio System (HSS) utilizes a specially designed emitter (speaker) that delivers beamlike sound that is clear to the listener. The beamed audio content begins to demodulate in the air within six inches of the emitter and results in a cone-like transmission of sound waves that can be directed towards the listener. This device is intended for sale as an over-the-counter product and can be used with any sound source and at any distance from 3 feet to 50 feet or more from the emitters (speakers). Ultrasonic technology has been used for many years in industry and is also utilized in medical devices, such as ultrasonic nebulizers. The ultrasonic sound waves this product is based upon have also used in commercial and localized communications, and they are below the ultrasonic sound safety limits established by OSHA as required by OSHA Noise Standard, 29 CFR 1910.95. The device consists of an amplifier, software, and an emitter (speaker). No ear plugs or head phones are required to use this device. The device is distant from and does not touch the intended patient/user.

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

Acceptance Criteria and Device Performance

Note: The document focuses on demonstrating substantial equivalence rather than defining explicit acceptance criteria in a quantitative pass/fail manner. The reported performance metrics are used to support this claim of equivalence and clinical effectiveness.

Study Details

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

   • Sample Size: 10 adult patients with mild to severe hearing loss.
   • Data Provenance: Clinical study conducted at the California Hearing and Balance Center in La Jolla, CA (USA). Prospective data from a controlled audiology laboratory.

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

   • The document does not explicitly state the number or qualifications of experts establishing ground truth for the test set. However, a "controlled audiology laboratory" suggests that audiologists or similarly qualified professionals would have conducted and interpreted the speech tests.

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

   • Not specified. The study was a "single-blinded, randomized cross over clinical study," but no details on expert adjudication of results are provided beyond standard audiology testing procedures.

4. 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:

   • No. This device is not an AI-assisted diagnostic tool, but rather an auditory trainer. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable. The clinical study does compare the HSS system to conventional speakers, showing a significant improvement in speech understanding with the HSS.

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

   • Yes, for the non-clinical testing, "Equivalency testing to a predicate device was performed by an independent laboratory pursuant to ANSI S3.2-2009," which would be a standalone assessment of the device's audio output characteristics.
   • The clinical study assessed the device's performance directly with human users, but it's not an "algorithm only" test as the device itself is a physical auditory system.

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

   • The ground truth for the clinical study was established by standardized audiological speech tests: Modified Rhyme Test (MRT), Consonant-Nucleus-Consonant (CNC) in quiet, and AzBio in noise. These are objective measures of speech understanding, which serve as the "ground truth" for evaluating the hearing device's effectiveness.

7. The sample size for the training set:

   • This device is not an AI/ML model that requires a "training set." It is an auditory trainer employing ultrasonic technology. The design and performance are based on engineering principles and verified through bench testing and clinical studies, not machine learning training.

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

   • Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Sound Field wireless amplification systems are intended for use as group auditory trainers used to communicate simultaneously with one or more listeners with normal hearing or hearing impairments. The device is used with an associated transmitter microphone and speaker systems and does not provide coupling to the ear through either earphones or earmolds.

These systems use FM and/or infrared wireless technology which include receivers, transmitters, and strategic placement of high quality speaker systems and can be used with or without BTF hearing aids and/or personal FM devices. The talker's voice with or which bI E throughout the room to assist listeners, regardless of seating location, to consistently hear what the talker is saying.

Sound Field group amplification systems consist of FM or IR transmitters and microphone used by a speaker/instructor to send auditory signals to FM or IR receiver/amplifier which noreesses the voice signals and broadcast the signals through one or more loudspeakers. These systems are generally installed under the guidance of an audiologist or a sound contractor. Sound Field systems consist of an on/off switch and volume controls. Specifications and user guider in cre provided for Sound Field installation and use.

Sound Field systems are assembled from standard electronic components widely used by Group Hearing Aid and Group Auditory Trainer manufacturers. Sound Field wireless ampification systems amplify and broadcast the speaker/instructor's voice through strategically-mnounted.will and/or ceiling loud speakers placed throughout the listening area to distribute the final moder want signal (sound) of the speaker/instructor and are not directly connected or coupled to the piroener.

Sound Field wireless amplification systems are intended for use as group auditory trainers used to communicate simultaneously with one or more listeners with normal hearing on he aring impairments. The device is used with an associated transmitter microphone and speakers systems and does not provide coupling to the ear through either earphones or earmolds.

These systems use FM and/or infrared wireless technology which include receivers, transmitters, and strategic placement of high quality speaker systems and can be used with or without BTE hearing aids and/or personal FM devices. The talker's voice is mildly amplified and dispersed throughout the room to assist listeners, regardless of seating location, to consistently bear what the talker is saying.

The provided text K043090 includes a 510(k) summary for Phonic Ear Sound Field Group Amplification Systems. However, it does not contain a study that proves the device meets specific acceptance criteria through performance metrics or statistical analysis.

Instead, the document states:

• "Many case studies, experiments, and trials exist that document the benefits and effectiveness of speech perception from Sound Field amplification." Crucially, it does not provide details of these specific studies that were conducted for this device to establish acceptance criteria and performance against them.
• "Field studies were conducted in accordance with ANSI S12.60 Acoustical Performance Criteria, Design Requirements, and Guidelines for Schools." Again, specific results, acceptance criteria, or performance data from these particular field studies are not included.
• "Test procedures to obtain FCC (Federal Communications Commission) approval are in accordance with good engineering practices and in accordance with FCC Rules, Part 15, Subpart A, 15, 19 (a) (3) and (C) Code of Federal Regulations (CFR 47)." This refers to regulatory compliance for radio frequency emissions, not clinical performance or efficacy.

Therefore, based solely on the provided text, it is not possible to complete most of the requested sections as the necessary information (specific acceptance criteria, detailed study results, sample sizes for test/training, ground truth establishment, expert qualifications, etc.) is absent. The submission relies on establishing substantial equivalence to predicate devices (K974287) and generally referencing existing literature and compliance with technical standards (ANSI, FCC) rather than presenting a novel performance study with defined acceptance criteria for the current device.

Here's a breakdown of what can and cannot be answered from the provided text:

Description of Acceptance Criteria and Device Performance Study (Based on Provided Text)

Unfortunately, the provided 510(k) summary for the Phonic Ear Sound Field Group Amplification Systems does not include specific acceptance criteria or a detailed study that measures the device's performance against such criteria. The submission focuses on establishing substantial equivalence to predicate devices and adherence to existing standards (ANSI S12.60 for acoustics and FCC for radio frequency emissions).

The document mentions that "Many case studies, experiments, and trials exist that document the benefits and effectiveness of speech perception from Sound Field amplification," and "Field studies were conducted in accordance with ANSI S12.60." However, it does not present the results of these or any new studies conducted specifically for this device against defined performance acceptance criteria.

Therefore, a table of acceptance criteria and reported device performance cannot be created from this document. The following sections are addressed where information is available, and marked as "Not provided in the text" otherwise.

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

   Acceptance Criteria	Reported Device Performance
   Not provided in the text	Not provided in the text

   • The document implies adherence to "ANSI S12.60 Acoustical Performance Criteria, Design Requirements, and Guidelines for Schools" and FCC regulations, but it does not specify quantitative acceptance criteria derived from these standards for the device, nor does it provide performance data to demonstrate compliance.

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 (Test Set): Not provided in the text.
   • Data Provenance: Not provided in the text. The document refers generally to "Field studies were conducted" but gives no details about the participants, methodology, or geographical origin.

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/Not provided in the text. The type of study described (adherence to acoustical standards, and general benefit of sound field amplification) does not typically involve expert "ground truth establishment" in the same way an AI diagnostic device would.

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

   • Not applicable/Not provided in the text. No details of a test set and associated adjudication method are present.

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 sound amplification system, not an AI diagnostic tool designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function and was not performed.

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

   • Not applicable. This device is an auditory trainer and amplifier, not a standalone algorithm. Its performance is inherently tied to its physical components and how it processes and broadcasts sound for human listeners.

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

   • Not provided in the text. For a sound amplification system, "ground truth" would likely relate to objective acoustical measurements (e.g., sound pressure levels, speech intelligibility index, signal-to-noise ratio) and subjective listener perception. However, no specific ground truth methodology or data is detailed in the submission for this device's performance.

8. The sample size for the training set

   • Not applicable. This device is a hardware-based amplification system, not a machine learning algorithm requiring a "training set."

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

   • Not applicable. As above, this device does not use a training set for machine learning.

Ask a specific question about this device

to amplify and transmit sound to the ear.
The indication for use of the air conduction hearing aids for 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 √, 2. Gradually Sloping √, 3. Reverse Slope √, 4. Flat √, 5. Other:
Other: Low tolerance to Loudness
The Telex Select 1-40 BTE FM System is best suited for students of middle school age and older who have a moderate to profound hearing loss. It may be appealing to older students that have rejected FM amplification because of the stigma associated with body-worn auditory trainers.

assembled from standard components that are widely used by other hearing aid manufacturers.
Technical characteristics: technical specifications comply with S3.2-1987 ANSI standards.
Fit: frequency response per S3.2-1987 ANSI standard as shown on specification filed with 510(k).
Controls: Volume control, Mode Switch, Audiological Controls (output and tone).
Power: Standard hearing aid battery (675)

This document set contains a 510(k) Summary for the Telex Select 1-40 with Adaptive Compression® FM at-the-ear Auditory Trainer. It describes the device, its intended use, features, and technical characteristics, and compares it to a predicate device.

After reviewing the provided documents, I can tell you that this submission does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It highlights the device's technical specifications complying with S3.2-1987 ANSI standards and its fit matching the frequency response per the same standard. However, it does not explicitly define acceptance criteria for performance, nor does it present the results of a study to demonstrate compliance with such criteria.

The information you've requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and specific study types (MRMC, standalone) is typically found in detailed device validation reports or clinical study summaries, which are not part of this 510(k) summary.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

Ask a specific question about this device

The Model PE 600 Series devices form the Impaired Group Amplification System which is used by adults and children in public halls, theaters, churches, courtrooms and other public gatherings and provide auditory assistance to hearing impaired persons.

The Model PE 600 Series consists of:

1. The Model PE 600E is a power amplifier which is combined with an infrared LED array. Audio signals from a sound system are processed and broadcast into the listening area by means of infrared light.
2. The Model PE 600R is a body worn infrared receiver. It receives the infrared light signals from the PE 600E and converts these signals to high level audio signals required by the hearing impaired listener. The audio signals can be adjusted to meet the user.
3. The PE 601R is an Infrared Headset Receiver. It receives the infrared light signals from the PE 600E and converts these signals to audio signals required by the hearing impaired listener. This devise is capable of stereo reception so that different audio signals can be received simultaneously and fed to each ear separately.
4. The PE 602R is an Infrared Headset Receiver. It receives the infrared light signals from the PE 600E and converts these signals to audio signals required by the hearing impaired listener. The device is capable of receiving infrared light signals transmitted on two separate frequencies. A switch on the headset allows the user to select the program frequency desired. The selected program is heard in each ear.

The provided text is a 510(k) summary for the Phonic Ear Model PE600 Series Infrared Group Amplification System. This device is an auditory assistance system for hearing-impaired individuals in various public settings.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary primarily focuses on demonstrating substantial equivalence to previously approved devices of the same type, rather than setting out specific numerical acceptance criteria. The information provided is descriptive of the system's capabilities and its equivalence.

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

The provided 510(k) summary does not detail a specific test set, its sample size, or its data provenance (e.g., country of origin, retrospective/prospective). The document primarily cites clinical studies on FM Auditory Training Systems to substantiate the effectiveness claims related to increased speech understanding and word discrimination. It does not describe a new clinical trial specifically for the PE600 Series.

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

This information is not provided in the document. The substantiation for effectiveness claims references "many clinical studies" by specific researchers (Dr. David Hawkins, Dr. Mark Ross, Robert Benoit, M.A., and Dr. Thomas Giolas) but does not outline how ground truth was established within those studies or if they were done for the PE600 series directly.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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 section is not applicable to the Phonic Ear Model PE600 Series Infrared Group Amplification System. This device is a sound amplification system, not an AI-assisted diagnostic or interpretive tool that would involve "human readers" or AI assistance in the way typically seen in medical imaging or diagnostic studies.

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

This section is not applicable as the device is not an algorithm, but a hardware-based amplification system.

7. The Type of Ground Truth Used

For the claims related to "increased speech understanding and word discrimination," the document states: "Effectiveness claims outlined in paragraph 16 have been NOTE: substantiated by the results of many clinical studies made over the years since the introduction of FM Auditory Training Systems. Three such study reports by Dr. David Hawkins, Dr. Mark Ross, Robert Benoit, M.A. and Dr. Thomas Giolas form a part of this 510(k) submission."

This indicates that the ground truth for effectiveness was established through prior clinical studies (outcomes data) on similar FM Auditory Training Systems, rather than a new, specific ground truth established for the PE600 series in this submission. The nature of these "clinical studies" would likely involve objective measures of speech recognition or discrimination in controlled listening environments.

8. The Sample Size for the Training Set

This information is not provided as this device does not involve a "training set" in the context of machine learning or AI models.

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

This information is not provided as it is not applicable to the type of device being described.

Summary of Limitations in the Provided Document for Your Request:

The document is a 510(k) summary from 1997 for an infrared group amplification system. Its purpose is to demonstrate substantial equivalence to predicate devices, not to present a detailed clinical study with quantifiable acceptance criteria, specific test/training sets, or AI performance metrics. Therefore, much of the information you requested (especially around sample sizes, expert qualifications, adjudication, MRMC studies, and AI-specific ground truth) is not present in this type of regulatory submission. The "study that proves the device meets the acceptance criteria" is broadly defined as prior clinical research on similar FM Auditory Training Systems, used to support the general effectiveness claims.

Ask a specific question about this device

This device is a receiver for an FM group auditory trainer. It is intended to be used with the Phonic Ear PE 571t group auditory trainer transmitter. Auditory trainers are used primarily in institutions (schools, churches, theaters, etc.) to allow teachers, ministers, etc. to communicate with individuals with hearing deficits.

This device can also be used with its built-in microphones or plug-in microphones as a stand alone assistive listening device.

This device is a receiver for an FM group auditory trainer. It is intended to be used with the Phonic Ear PE 571t group auditory trainer transmitter. The device is powered by low voltage batteries which are contained within a battery compartment that is fitted with a locking cover to prevent inadvertent opening. The battery circuit is fused to prevent over heating should a short circuit occur. The devices' plastic housing is made of Cycolac plastic. The device includes controls for maximum power output, sound pressure level of built-in receiver microphones and FM signal, CHG/LOW BATT LED, NO FM LED, enlarging lens for FM frequency channel number, a 3 position switch for operating modes, a 7 position FM level switch for each ear, a 7 position SSPL switch for each ear, a 7 position GAIN switch for each ear, a 7 position TONE switch for each ear, and a 2 position microphone switch. It uses solid state surface mount components and integrated circuits. The receiver's FM receiving frequency is controlled by 2 rotary switches accessible under a latching cover.

The provided document is a 510(k) notification for a medical device (Group Auditory Trainer, Model PE571R). It describes the safety and effectiveness of the device, but it does not contain the specific acceptance criteria or a study designed to prove the device meets these criteria in the typical sense of a clinical trial with predefined metrics.

Instead, the document focuses on demonstrating substantial equivalence to previously approved devices, a requirement for 510(k) submissions. The "effectiveness" section lists various features and functionalities of the device and how they contribute to its intended use. For these effectiveness claims, the document refers to existing clinical studies that support the general concept of FM Auditory Training Systems, rather than a single study specifically designed for this particular device model and its acceptance criteria.

Therefore, many of the requested information points cannot be directly extracted from this document in the way they would be from a clinical trial report.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly defined in terms of measurable performance metrics with thresholds (e.g., "sensitivity must be >X%"). The criteria for acceptance are implicitly that the device is safe and effective, and substantially equivalent to predicate devices.
• Reported Device Performance: The document describes various features and functionalities as contributing to the device's effectiveness. These are qualitative descriptions of performance rather than quantitative measurements against specific criteria. For example, "The maximum power output of the receiver can be set to the appropriate level required by the user and then locked at that level to prevent over amplification..." describes a safety/effectiveness feature without providing a specific quantitative performance value or an acceptance threshold for that value.

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

• Not applicable for this document. The safety and effectiveness claims are based on substantial equivalence to predicate devices and general understanding of FM Auditory Training Systems, supported by existing literature. There is no specific "test set" for this particular device's performance in a clinical study detailed here. The technical specifications were obtained by testing devices per ANSI Standard ANSI.S3.22-1987, which is a standard for hearing aid characteristics, not a clinical test set in the usual sense.

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. No specific test set with ground truth established by experts for this device is detailed in the submission. The acceptance of the device relies on its technical specifications meeting standards and its features aligning with established principles of FM auditory trainers, as judged by the FDA.

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

• Not applicable. No specific test set requiring adjudication is detailed.

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 an auditory trainer, not an AI-powered diagnostic tool for interpretation by human readers. It's designed to assist hearing, not assist interpretation.

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

• Not applicable. This is a hardware device with specific audio processing capabilities, not an algorithm in the sense of AI. Its "performance" is its ability to transmit and amplify sound according to its design, which is tested against engineering standards (like ANSI S3.22-1987).

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

• For the claims of improved word discrimination, reduced effects of distance/reverberation (paragraph 17), the document references "many clinical studies made over the years since the introduction of FM Auditory Training Systems." It specifically mentions "Three such study reports by Dr. David Hawkins, Dr. Mark Ross, Robert Benoit, M.A. and Dr. Thomas Giolas form a part of this 510K submission." These studies would likely use outcomes data (e.g., speech recognition scores in various conditions) as their ground truth for demonstrating the effectiveness of FM systems in general. However, the details of how ground truth was established in those specific studies are not provided in this document.
• For the technical specifications, the "ground truth" is adherence to the ANSI Standard ANSI.S3.22-1987, which defines objective measurement methods for hearing aid characteristics.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that would require a training set.

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

• Not applicable.

In summary, this 510(k) notification primarily relies on demonstrating that the device's design, features, and technical specifications are substantially equivalent to legally marketed predicate devices and adhere to relevant engineering standards. The effectiveness claims for FM auditory trainers in general are supported by existing clinical literature, rather than a new, dedicated clinical study specifically for this model with defined acceptance criteria and a test set.

Ask a specific question about this device

The indications for use of the assistive listening device in this submission is to amplify sound for individuals with impaired hearing. The device is indicated for individuals with hearing loss in the following category(ies). (Check appropriate space(s)): Severity: Slight, Mild, Moderate. Configuration: Gradually Sloping, Flat.
Specific Indications: FOR IMPROVED SIGNAL TO NOISE RATIO THROUGH PLACEMENT OF A REMOTE MICROPHONE NEAR A DESIRED SOUND SOURCE. SEVERE TO PROFOUND LOSS - USED IN CONJUNCTION WITH PERSONAL HEARING AID VIA TELECOIL OR DIRECT AUDIO INPUT.
To improve the signal to noise ratio for a listener in a variety of environments where background noise, poor acoustics, and distance from a desired sound source contribute to hearing difficulty.
Any hearing and speech condition that can be improved by maximizing the signal to noise ratio for the listener. This includes: Low gain amplification for Attention Deficit Disorders, Learning Disabilities, Central Auditory Processing Disorders, amplification for mild to moderate conductive and sensorineural hearing loss, and amplification moderate to severe conductive and sensorineural hearing loss when used in conjunction with a personal hearing aid.

HEARING HELPER PERSONAL FM SYSTEM Models PFM300 & PFM 358. WILLIAMS SOUND, HEARING HELPER PERSONAL FM SYSTEM, Model PFM 300 / PFM 350.

The provided text is a 510(k) premarket notification for a hearing assistance device, the Williams Sound, Hearing Personal FM System Model PFM 300/350. This type of regulatory submission historically focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria as one might find for a novel or high-risk device.

Based on the information provided, it is not possible to describe specific acceptance criteria and a study proving the device meets them in the way modern device submissions or clinical trials would. Here's why and what can be extracted:

• Type of Device and Submission: This is a Class II group hearing aid or group auditory trainer. The document is a 510(k) premarket notification, which primarily establishes "substantial equivalence" to a legally marketed predicate device. This process typically involves comparing technical characteristics and indications for use, rather than extensive clinical efficacy studies with predefined acceptance criteria and statistical power calculations.
• Date: The letter is dated January 10, 2017, but refers to the original 510(k) submission from 1997 (K970974) and a correction letter from 1997. Regulatory requirements and expectations for performance studies have evolved significantly since 1997.

Therefore, the following points address what can be inferred or what is not present in the provided text regarding acceptance criteria and a detailed study:

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

Here are the answers to the specific questions, based on the provided document:

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

• Sample Size for Test Set: Not mentioned. The document describes a 510(k) premarket notification for substantial equivalence, which typically relies on comparisons of technical characteristics and indications of use to a predicate device, rather than a clinical "test set" with human subjects. If any testing was done, it would likely be engineering bench testing for acoustic performance rather than human performance testing that would require a "test set" in the clinical sense.
• Data Provenance: Not mentioned. It's highly unlikely that clinical data from a human test set was a primary component of this 1997 510(k) submission for this type of device, given the regulatory landscape at the time and the nature of substantial equivalence.

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/Not mentioned. As there is no clinical "test set" described, there would be no ground truth established by experts in this context. The "ground truth" for a 510(k) is the predicate device's established safety and effectiveness.

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

• Not applicable/Not mentioned. No clinical test set or adjudication 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

• No. This is a hearing assistance device, not an AI-powered diagnostic tool, and the concept of "human readers" or "AI assistance" is not applicable here.

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

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

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

• For a 510(k), the "ground truth" for the submission is the established safety and effectiveness profile of the predicate device. The applicant demonstrates that their new device is "substantially equivalent" to this predicate, meaning it performs similarly and raises no new questions of safety or effectiveness. No specific clinical ground truth (like pathology or outcomes data) is typically required for this type of device and submission.

8. The sample size for the training set

• Not applicable/Not mentioned. This is a hardware device; there is no "training set" in the context of machine learning or AI.

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

• Not applicable, as there is no "training set."

Ask a specific question about this device

To assist in conversation, meetings and TV-listening by amplifying sound.
The indications for use of the assistive listening device in this submission is to amplify-sound for individuals with impaired-hearing. The device is indicated for individuals with hearing loss in the following category(ies).
Severity: Mild, Moderate
Configuration: Gradually Sloping, Flat

Air Conduction Assistive Listening Device. Personal Amplifier.
Features: Adjustable volume control, Microphone/Telephone/Off switch, Gain, Treble and AGC adjustment trimmers, Internal/External microphone switch.
Assembly: Assembled from standard components widely used in electronic products.
Technical Characteristics: Technical specifications comply with ANSI S3.22-1987.
Controls: Volume control, Microphone/Telephone/Off switch, Internal/External microphone switch and sound adjustment trimmers similar to those used on other assistive listening devices/Personal amplifiers.
Power: Standard alkaline AAA (or LR03) size battery.

Here's an analysis of the provided text to extract the requested information about the Bellman Response model 1050:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided summary does not mention a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective) for a study to prove the device meets acceptance criteria. The document appears to be focused on a 510(k) premarket notification for substantial equivalence, which often relies on comparison to predicate devices and technical standards rather than new clinical trials with a test set.

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

Not applicable. As no specific clinical study with a test set and ground truth establishment is described, there's no information about experts or their qualifications.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Improvement with AI vs. without AI Assistance

Not applicable. This device is an analog assistive listening device, not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. The Bellman Response model 1050 is an assistive listening device, not an algorithm. Its performance is inherent in its hardware and amplification capabilities, not in a standalone algorithm.

7. The Type of Ground Truth Used

Not applicable in the context of a typical clinical study requiring ground truth. The "ground truth" for this device's performance relies on its adherence to technical specifications (ANSI S3.22-1987) and its ability to amplify sound, rather than on expert consensus, pathology, or outcomes data from a clinical trial. The basis for its approval is substantial equivalence to legally marketed predicate devices, implying that their "ground truth" performance and safety were already established.

8. The Sample Size for the Training Set

Not applicable. This device is hardware for audio amplification. There is no concept of a "training set" as understood in machine learning or AI.

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

Not applicable. As there is no training set for this type of device, no ground truth was established for it.

Ask a specific question about this device

Moderate to severe conductive hearing losses. Particularly useful for conductive losses compounded by congenital or secondary obstruction of auditory air conduction mechanisms

The EC-1000 Second Ear ' is a bone conduction-type hearing aid. Unlike conventional products which depend upon acoustic coupling through air, the EC-1000 Second Earl is based on bone conduction technology. Sound is transmitted directly through the bones of the skull to the cochlea, bypassing the outer and middle ear.

The EC-1000 Second Ear offers an innovative tone control system, providing flexible audio control adjustments. Also, features such as a voice filter which when selected, reduces additional exterior sound. As an added feature an auxiliary input jack allows the user to connect Search Eas ® directly to TV, CD players, portable radios, tape players or even telephones.

State of the art nickel-metal-hydride rechargeable battery technology is used for maximum battery life while minimizing size and weight.

Transducer

The EC-1000 Second Ear consists of a transducer unit, a shirt pocket sized audio processor/driver module and a wire cable for connecting the transducer with the audio processor/driver. The transducer is a convenient sized unit that is held against the head and is driven electrically to transmit audio vibrations to the underlying bones of the skull. It is a lowimpedance device, similar to a loudspeaker.

Audio Processor/Driver

The audio processor/driver module connects the transducer through the wire cable and usually would be carried in the users pocket. The wire cable connecting the audio processor/driver and the transducer can be placed comfortably at sensitive location such as behindear.

The audio processor/driver module is completely self-contained and is battery powered. It also has a built-in microphone for picking up sound. A rechargeable battery pack is the power source.

Battery Pack

The battery pack can be charged in place in the unit or snapped out for easy exchanging. By purchasing a spare battery pack, the user can be using one battery while charging the other, guaranteeing uninterrupted use of the EC-1000. The user should be able to obtain 24 to 48 hours of operation in normal use from fully charged batteries. Volume setting and environmental conditions affect battery life.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Second Ear® Bone Conduction Hearing Aid (K953872):

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state formal acceptance criteria. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "acceptance criteria" are implicitly met if the device's characteristics and performance are comparable to the predicates, indicating it's as safe and effective.

The provided "FEATURE COMPARISON TABLE" serves as the primary evidence for this comparison.

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

The document does not describe a specific "test set" or a clinical study with real patient data used to demonstrate performance. The entire basis for establishing equivalence is through a comparison of technical specifications and features with already marketed predicate devices.

Therefore:

• Sample size for the test set: Not applicable (no test set described).
• Data provenance: Not applicable (no patient data used for comparison/testing). The data is derived from the technical specifications of the Second Ear® and its identified predicate devices.

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

Since no clinical test set or study is described, there's no mention of experts establishing ground truth in this context. The "ground truth" for substantial equivalence is effectively the established performance and safety profile of the predicate devices as determined by their prior FDA clearances.

4. Adjudication Method for the Test Set

Not applicable, as no test set or clinical study requiring adjudication is described.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this 510(k) summary. This type of study would involve human readers (e.g., audiologists, patients) assessing performance with and without the device, and potentially comparing it to other devices. This 510(k) relies purely on technical specifications.

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

The device is a hardware hearing aid; it does not involve an "algorithm only" component. Performance is inherent to the physical device. The document does not describe any standalone performance testing in the sense of a formal clinical trial or laboratory study with performance metrics beyond the technical specifications listed. The "standalone performance" is implicitly established by the technical specifications presented in the comparison table.

7. The Type of Ground Truth Used

The "ground truth" used for this 510(k) submission is the established performance and safety profiles of the legally marketed predicate devices. The new device's specifications are compared against these known, cleared devices to argue for substantial equivalence. There is no pathology, expert consensus, or outcomes data presented for the Second Ear® itself in this document.

8. The Sample Size for the Training Set

Not applicable. The device is a hardware hearing aid; there is no machine learning "training set" involved.

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

Not applicable, as there is no training set.

Ask a specific question about this device