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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.

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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.

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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.

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