(72 days)
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:
- 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.
- 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.
- 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.
- 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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| Equivalent to approved systems of the same type. | "The safety of this Infrared Amplification System is equivalent to approved systems of the same type." |
| Moderate sound pressure levels, adjustable by professional. | "While moderate sound pressure levels are produced by the PE600 Series receivers, this output can be limited to the output required by the user. Limiting can be accomplished by the setting of the volume controls in accordance with the tests made by a clinician, audiologist or hearing professional prior to use by the hearing impaired user." |
| User instructions for malfunction. | "Instructions for the user to follow, should the system not function as expected, are contained in the user information." |
| Technical specifications provided. | "Complete technical specifications are contained in the user information." |
| Distributed to qualified personnel. | "The systems are distributed directly to qualified dispensers or others who are trained in the proper fitting and use of the system." |
| Material safety (e.g., lack of side effects from casing). | "The system elements are housed in cases made of cycolac plastic which has few known side effects caused by the material." |
| Accessories description provided. | "A complete line of accessories to be used with the system elements are available from the manufacturer and a list of these accessories and a description of their use is contained in the user information." |
| Service information available. | "Addresses and telephone numbers of authorized service centers are available to the user should any questions arise about the function of the system." |
| Detailed use, maintenance, adjustment, and function descriptions. | "Detailed descriptions on the use, maintenance, adjustment and function of each element of the system are contained in the user information." |
| Low voltage, battery compartment security, fusing. | "The system elements are powered by low voltage batteries which are contained within battery compartments that are fitted with tight snap fitting covers to prevent inadvertent opening. The battery circuits are protected by fusing devices to prevent over heating should a short circuit occur." |
| Removable covers for hygiene. | "The user worn receivers are fitted with removable covers over the earphones that contact the skin and ears of the users, which can be removed for cleaning or exchange to prevent the spread or transmission of possible contamination." |
| Effectiveness: | |
| Equivalent to approved systems of the same type. | "The effectiveness of this Infrared Amplification System is equivalent to approved systems of the same type." |
| Clear reception from any angle. | "The infrared light gathering lenses on the receivers are designed to detect the sound signals from any angle providing for clear reception at any location within the installation." |
| Reduced size/weight without loss of features. | "The use of solid state surface mount components and integrated circuits allow the size and weight of the system elements to be reduced without the loss of any of the beneficial features provided in the design. Units are less obtrusive to the user because of the smaller size and easier to use because of the reduction in weight." |
| More natural sound with accessories. | "The use of several optional listening accessories provide a more natural sound to the user in different environments because the sounds are processed more like the sounds received by normal hearing persons." |
| Wide choice of fitting possibilities. | "The ability of the system elements to utilize a variety of listening accessories allow the user a wider choice of fitting possibilities to better meet their personal needs." |
| Battery charging indicator. | "The inclusion of a battery charging LED indicator on the PE600R receiver insures that the device's rechargeable batteries will receive a full charge by confirming to the user that a positive charging connection has been made." |
| Flexible power source options. | "The ability of the receivers to operate on either rechargeable or throw-away batteries allow the user to select the power source most beneficial to their use." |
| Selection of receiver types. | "The provision of optional receiver types provide the user with a selection which will best suit their own needs." |
| Easier installation and adjustment of emitter. | "The combining of the power and amplifier circuits with the infrared LED circuits into one unit, provide easier installation and adjustment of the infrared emitter PE600E." |
| Dual frequency operation (2.3/2.8 Mhz). | "The ability of the PE600E to operate on both 2.3 Mhz and 2.8 Mhz simultaneously provides greater flexibility for the use of the system. Either stereo or 2-channel programs can be transmitted by the same system." |
| Elimination of interference from electrical circuits/lighting. | "The use of the higher 2.3 Mhz and 2.8 Mhz transmission frequencies eliminates the interference which may be caused by electrical circuits and lighting, thus providing a clearer, interference free sound to the listener." |
| Flexible mounting options for emitter. | "The ability of the PE600E Infrared Emitter to be mounted in several ways provide more flexibility for use as either a small portable system or in permanently installed systems for large auditoriums." |
| Scalability for large installations. | "The ability of the systems to be enlarged by the addition of more infrared emitters provides full sound coverage even in very large installations." |
| Compatibility with tele-coils in hearing aids. | "The ability of the infrared receivers to power the tele-coil found in most hearing aids enables the users to utilize their own hearing aids which provide more convenience of use as well as allowing the user to hear the same sounds they would normally hear using only their hearing aid." |
| No dead spots or sound fade-outs. | "The design of the infrared detecting elements in the receivers allow the user to sit anywhere within the infrared environment without experiencing the dead spots or sound fade-outs usually found in most installations." |
| Increased speech understanding and word discrimination. | "The use of an Infrared Group Amplification System provides increased speech understanding and word discrimination for the hearing impaired in listening environments such as school classrooms, concert halls, theaters or other similar situations where noises, reverberation or poor acoustical treatment may be found. The use of these systems also reduce the detrimental effects caused by the distance between the speaker or sound source and the hearing impaired listener." |
| Dual-channel operation for language translation. | "The ability of the infrared system to operate on two channels simultaneously allows the system to be used for language translation thus integrating users of different languages into the same environment." |
| Adaptability for secure sound environments. | "The PE600 Infrared Systems are especially adaptable for use in installations where security of the sound is desired, such as in court rooms or jury deliberation rooms." |
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.
§ 874.3320 Group hearing aid or group auditory trainer.
(a)
Identification. A group hearing aid or group auditory trainer is a hearing aid that is intended for use in communicating simultaneously with one or more listeners having hearing impairment. The device is used with an associated transmitter microphone. It may be either monaural or binaural, and it provides coupling to the ear through either earphones or earmolds. The generic type of device includes three types of applications: hardwire systems, inductance loop systems, and wireless systems.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.