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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 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."

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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.

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