(71 days)
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portaREM-3000, PFS-6000
No
The description focuses on standard audiometry and hearing aid testing functionalities, with no mention of AI/ML terms or capabilities.
No
This device is described as a "portable hearing aid dispensing system" that functions to test hearing aids, conduct Real Ear testing, and In Situ Audiometry. It helps hearing health care professionals with hearing aid selection and fitting, but it does not directly treat a disease or condition itself.
Yes
The device is described as allowing a Hearing Health Care Professional to "test hearing aids to IEC/ANSI standards," "Real Ear testing," "In Situ Audiometry via the use of the probe microphone," and "Standard puretone measurement." These functions are diagnostic in nature, aiming to assess hearing aid performance and a patient's hearing. It also states "the 2cc coupler response desired can be determined from the audiogram," which implies using diagnostic data.
No
The device description explicitly lists multiple hardware components including electronic circuitry, a monitor, a printer, a loudspeaker, a disk drive, a test chamber, a battery simulator, serial ports, a probe mic, and a keyboard.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to test hearing aids, perform real ear testing, in situ audiometry, and standard puretone measurement. These are all related to assessing hearing and the performance of hearing aids in vivo (within a living organism), not on biological samples in vitro (in a test tube or other artificial environment).
- Device Description: The components described (electronic circuitry, monitor, printer, loudspeaker, test chamber, battery simulator, probe mic, keyboard) are consistent with a system for testing and fitting hearing aids, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, urine, tissue), reagents, or any other components typically associated with in vitro diagnostics.
The device is clearly designed for use by Hearing Health Care Professionals to assess hearing and fit hearing aids, which falls under the category of medical devices used for diagnosis and treatment related to hearing, but not as an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The portaREM-3000,PFS-6000 is a portable hearing aid dispensing system which allows the Hearing Health Care Professional to test hearing aids to IEC/ANSI standards. It also allows for Real Ear testing, and In Situ Audiometry via the use of the probe microphone, and offers a 2cc coupler conversion in which the 2cc coupler response desired can be determined from the audiogram. Standard puretone measurement is also available. With the PFS software, which will be standard with PFS-6000 and optional for the pR-3000, prescriptive formulas, matrix and hearing aid selection, order form printing, along with other optiions described in the user manual are available.
Product codes
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Device Description
The portaREM-3000, PFS-6000 is a portable hearing aid dispensing system. It features easy to use menu-driven software, connections for color monitor and external printer, complete 2cc coupler test according to IEC/ANSI, intermodulation distortion measurement, composite signals, Ear Canal Resonance(REUR), Insertion gain measurements(REIR), In Situ response(REAR), In Situ audiometry, Real Ear 2cc coupler conversion(NAL), Insertion gain with Prescription Rules and Articulation Index, Fitting prescriptions:NAL, POGO II, 1/2 Gain, 1/3 Gain, 1/3 Gain, and Berger. It has a 3.5 inch disk drive, built in Thermoprinter for hard copy, test chamber for hearing aid measurement, 4.7" color LCD monitor, battery simulator, two RS-232 serial port interfaces, and a real ear probe mic. Its display is a 4.7" LCD with 640*480 resolution, color monitor, and Thermoprinter. The loudspeaker has a minimum of 6W in 4 Ohms with a frequency range of 50 Hz-15,000 Hz. The keyboard is a fully functional PC style keyboard.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Hearing Health Care Professional
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.
0
JAN | 0 1997
SAFETY AND EFFECTIVENESS SUMMARY portaREM-3000, PFS-6000
NAME OF DEVICE: Rastronics portaREM-3000, Starkey PFS-6000
TYPE OF DEVICE: Hearing aid calibrator and analysis system
INTENDED USE: The portaREM-3000,PFS-6000 is a portable hearing aid dispensing system which allows the Hearing Health Care Professional to test hearing aids to IEC/ANSI standards. It also allows for Real Ear testing, and In Situ Audiometry via the use of the probe microphone, and offers a 2cc coupler conversion in which the 2cc coupler response desired can be determined from the audiogram. Standard puretone measurement is also available. With the PFS software, which will be standard with PFS-6000 and optional for the
pR-3000, prescriptive formulas, matrix and hearing aid selection, order form printing, along with other optiions described in the user manual are available.
FEATURES:Easy to use menu-driven software, connections for color monitor and external printer, complete 2cc coupler test according to IEC/ANSI, intermodulation distortion measurement, composite signals, Ear Canal Resonance(REUR), Insertion gain measurements(REIR), In Situ response(REAR), In Situ audiometry, Real Ear 2cc coupler conversion(NAL), Insertion gain with Prescription Rules and Articulation Index, Fitting prescriptions:NAL, POGO II, 1/2 Gain, 1/3 Gain, 1/3 Gain, and Berger. There is a 3.5 inch disk drive, built in Thermoprinter for hard copy, test chamber for hearing aid measurement, 4.7" color LCD monitor, battery simulator, two RS-232 serial port interfaces, real ear probe mic.
ASSEMBLY: Electronic circuitry all complies to IEC 601 and FCC part 15 class B. Display is 4.7" LCD 640*480 resolution, color monitor, Thermoprinter. Loudspeaker min. 6W in 4 Ohms, freq. range 50 Hz-15,000 Hz. All electrical components are of a standard, off the shelf variety.
TECHNICAL
CHARACTERISTICS: Technical specifications complies to IEC 601 and FCC part 15 class B, 2 channels, LCD monitor, Thermoprinter, single 3.5 in floppy drive, measurement circuits freq. range: 42 - 15600 Hz, dynamic range: 130 dB, dynamic resolution: 0.25 dB, accuracy: ±0.2dB, loudspeaker output: min. 6W in 4 Ω, freq. range: 50 - 15000 Hz, electrical THD: