(43 days)
The intended use of the Scout Sport Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. This intended use is identical to that of the predicate device.
The Scout Sport is a small device measuring 8.5"x4"x2.5" (LxWxD) and weighing 1.45 lbs (0.65 Kg), which is connected to a PC computer through a standard RS-232 serial data communications cable. -The Sport contains a single printed circuit board with all electronics necessary for a complete, self-contained auditory testing system. Control commands are sent to this unit from the computer, and data is returned to the computer from the Sport device. The new Scout Sport OAE device duplicates the functions of the Ariel DSP board hardware and software in a different hardware package. The Scout Sport is battery-powered, using rechargeable batteries and an external charger connected to the AC power. In addition to the charger connector, there are two other connectors on the box. One connector is a 6-pin mini-din which allows for serial communication to the computer. The other connector is a 7-pin mini-din which connects to the Etymotic ER-10C ear probe. There is a single momentary pushbutton switch on the unit, used to perform a RESTART function by the user. A 2-row x 16-character LCD display on the Sport is used to communicate various operational messages to the user.
The provided document describes the Bio-logic Scout Sport OAE, a medical device for measuring otoacoustic emissions (OAE). The document asserts that the Scout Sport performs equivalently to its predicate device, the Bio-logic Scout (formerly EMAV) OAE Instrument (K944735), with some improvements. The primary focus of the document is to demonstrate the safety and effectiveness of the Scout Sport, particularly its equivalence to the predicate device despite hardware configuration changes.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a formal table of quantitative acceptance criteria with specific thresholds for performance metrics. Instead, it focuses on demonstrating equivalence to the predicate device and highlights areas of improvement.
| Parameter for Comparison | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to predicate device | No differences between Scout Sport and predicate. |
| Patient Population | Identical to predicate device | No differences between Scout Sport and predicate. |
| Hardware Configuration | Equivalent functionality, improved portability/compatibility | DSP board in separate enclosure, connected via serial cable. Allows use with virtually any computer, including notebooks. |
| Computer Control Software | Same test algorithms, adapted for new hardware | Only changes required to support new hardware; no differences in software test algorithms. |
| Ear Probe System | Identical to predicate device | Same Etymotic ER-10C probe used. Microphone preamplifier electronics moved into the Sport box. |
| Performance | At least equivalent to predicate, ideally improved | Average noise floor is improved (lower noise) in Sport, over that of Scout. Increased speed of testing. |
| Safety Characteristics | At least equivalent to predicate | No difference. No direct electrical connection to the patient. Maximum sound output is same as or less than Scout. |
| Environmental Conditions | Meet specified ranges for temperature, humidity, and flammability. Comply with EMC standards. | Temperature: Operating: 60-90°F, Storage: 50-110°F. Humidity: 8-80% (non-condensing). Flammability: UL94V-0. Electromagnetic Compatibility: Radiated Emissions CISPR 11 / EN55011, Electrostatic Discharge Immunity IEC 801-2, Radiated RF Immunity IEC 801-3. Battery/Charger Safety: UL/CSA listed external charger, current leakage < 100 microamps, max 12V DC, < 15W power. |
| Software Validation | Developed and tested according to standards (IEEE, internal policies) | System was validated in accordance with IEEE Standards for Software Engineering and Bio-logic internal policies. DSP program and PC software changes were developed and tested as specified. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a test set in the context of clinical performance or device accuracy. The "extensive testing" mentioned pertains to laboratory verification of hardware equivalence, software validation, and environmental compliance, not a clinical study on patient data. There is no information regarding data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided. The study described focuses on engineering verification and validation, not clinical performance requiring expert ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study is not mentioned. The study described is not a clinical study involving human readers or patient cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
The document reports on "Extensive testing" to demonstrate that the new Sport device duplicates the functions of the Ariel DSP board hardware and software. It states, "In all areas significant to the performance and quality of the OAE testing, these test results show significant correlation to Scout performance, with lower noise levels and increased speed of testing." This implies a standalone technical performance assessment comparing the Scout Sport's OAE measurements directly against the predicate Scout's measurements, independent of human interpretation of those measurements.
7. The Type of Ground Truth Used:
The "ground truth" in this context is the performance and output of the predicate device (Bio-logic Scout). The Scout Sport was tested to demonstrate "equivalence" and "significant correlation" to the predicate's performance, as well as adherence to various safety and engineering standards.
8. The Sample Size for the Training Set:
Not applicable. This document describes the validation of a hardware and software system, not a machine learning model that would typically have a "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned.
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Image /page/0/Picture/0 description: The image shows the date "MAY 29 1996". The month is "MAY", the day is "29", and the year is "1996". The text is in bold and black.
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K961447". The characters are written in a bold, black font, and they appear to be slightly slanted. The string consists of one uppercase letter, followed by six digits.
Image /page/0/Picture/2 description: The image shows the logo for Bio-logic Systems Corp. The logo is in black and white. The word "Bio-logic" is in a bold, sans-serif font, and the words "SYSTEMS CORP" are in a smaller, sans-serif font below the first word.
One Bio-logic Plaza Mundelein, Illinois 60060-370C 1-800-323-8326 Fax: 847-949-8615
SECTION 2 : SUMMARY AND CERTIFICATION
510 (K) SUMMARY
SAFETY AND EFFECTIVENESS SUMMARY
Safety and effectiveness information concerning the Scout Sport OAE is summarized below
Because this is not a CLASS III device, the special certification defined for this section is not required.
(847) -949 -5200
| PREPARED BY: | Bio-logic Systems CorpOne Bio-logic PlazaMundelein, IL 60060 |
|---|---|
| -------------- | ---------------------------------------------------------------------- |
TELEPHONE :
CONTACT PERSON : Norman E. Brunner
DATE ON WHICH THE SUMMARY WAS PREPARED: April 15, 1996
NAME OF DEVICE:
Scout Spcrt_ - a Modification to the Scout (formerly EMAV) Otoacoustic Emissions (OAE) Test Instrument.
COMMON NAME : Otoacoustic Emissions Test Instrument
CLASSIFICATION NAME: Audiometer (per CFR 874.1050).
PREDICATE DEVICE: Bio-logic Scout (formerly EMAV) OAE Instrumert (K944735)
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Scout Sport - Modification to Scout Otoacoustic Emissions (OAE) Test Instrument
DESCRIPTION OF THE DEVICE:
The Scout Sport is a small device measuring 8.5"x4"x2.5" (LxWxD) and weighing 1.45 lbs (0.65 Kg), which is connected to a PC computer through a standard RS-232 serial data communications cable. -The Sport contains a single printed circuit board with all electronics necessary for a complete, self-contained auditory testing system. Control commands are sent to this unit from the computer, and data is returned to the computer from the Sport device.
The first Bio-logic product for Otoaccustic Emissions (OAE) testing is the Scout predicate device referenced above. In this system, the hardware and software to perform the CAE test is contained on a computer-installed DSP board made by Ariel Corporation. The DSP software program on the Ariel board is included in the Etymotic Research CUBeDIS OAE product (K930553), which was the predicate device for the Scout 510(k) application. The Ariel board (with DSP software) and ER-10C ear probe is purchased as a kit from Etymotic Research and used as the basis for the Scout product. The Scout PC computer software provides additional features and enhancements over the CUBeDIS product, as described in the Scout 510(k) application.
The new Scout Sport OAE device duplicates the functions of the Ariel DSP board hardware and software in a different hardware package. Because of the size of the Ariel board, and due to the fact that it has to be installed inside a PC computer, the need for a full-length, unobstructed slot in the computer limits the PC's that can accommodate the Scout system. Additionally, it precludes the use of a notebook computer unless a docking station is used to house the DSP board. The new Sport device allows virtually any computer to be used for OAE testing, even notebooks. It also provides simplified cabling arrangements and enhanced portability, which makes it practical to reliably move the test instrument from place to place within the hospital .
The basic functionality of the Scout system is virtually unchanged with the addition of the Sport device. DSP functions within the Sport are designed to duplicate as closely as possible the functions performed by the Ariel board. Extensive testing has been performed to demonstrate this equivalence. In all areas significant to the performance and quality of the OAE testing, these test results show significant correlation to Scout performance, with lower noise levels and increased speed of testing. The Scout PC computer software programs were changed in areas necessary to accommodate the new Sport hardware. I/O port addresses, memory page requirements, and various hardware-related system calls were changed because of the movement of the hardware from the computer internal bus to the serial port.
The Scout Sport is battery-powered, using rechargeable batteries and an external charger connected to the AC power. În addition to the charger connector, there are two other connectors on the box. One connector is a 6-pin mini-din which allows for serial communication to the computer. The other connector is a 7-pin mini-din which connects to the Etymotic ER-10C ear probe. There is a single momentary pushbutton switch on the unit, used to perform a RESTART function by the user. This is necessary because the unit is batterypowered and will automatically shut down when not in use. A 2-row x 16-character LCD display on the Sport is used to communicate various operational messages to the user, such as "Low Battery", "Finished Calibrate", and "DPOAE Test in Progress".
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Section 2 - Page 3 Scout Sport - Modification to Scout Otoacoustic Emissions (OAE) Test Instrument
The intended use of the Scout Sport Otoacoustic INTENDED USE: Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. This intended use is identical to that of the predicate device.
PATIENT POPULATION: Adults, children and infants.
SAFETY AND EFFECTIVENESS:
Extensive laboratory testing was performed on the Scout Sport OAE Test Instrument to verify proper operation over a wide range of environmental conditions. The following tests were completed according to the corresponding standards or specifications:
| Temperature: | a.) Operating: | 60 to 90 degrees F |
|---|---|---|
| b.) Storage: | 50 to 110 degrees F | |
| Humidity: | 8% to 80% (non-condensing) |
Flammability: UL94V-0
Electromagnetic Compatibility: Radiated Emissions CISPR 11 / EN55011 Electrostatic Discharge Immunity: IEC 801-2 IEC 801-3 Radiated RF Immunity: Magnetic Fields Emissions: RE101 Magnetic Field Immunity: RS101
The Sport is battery-powered, using recharqeable batteries with an external charger connected to the AC power line. This external charger is UL/CSA listed with current leakage of 100 microamps are less. The actual power delivered by the charger to the Sport device is a maximum of 12 volts DC with a maximum power less than 15 watts.
To establish the safety and effectiveness of the software which controls the Scout Sport OAE Test Instrument, the system was validated in accordance with the IEEK Standards for Software Engineering, as well as Bio-logic internal software development policies and procedures modeled after the IEEE Standards. " The DSP program in the Scout Sport OAE Box, and changes to the standard Scout PC computer program necessary to accommodate the communication to and setup of the unit, were all developed and tested as specified in these procedures. The system, for which this application is submitted, was verified and validated; it was found to perform in accordance with specifications.
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Scout Sport - Modification to Scout Section 2 - Page 4 Otoacoustic Emissions (OAE) Test Instrument
The following comparison is provided as a summary of technological characteristics relative to the predicate device Scout (formerly EMAV). This is to demonstrate that the Scout Sport has no significant differences which would adversely affect product safety and effectiveness.
| Parameter for comparison. | Similarity or Difference. |
|---|---|
| Intended Use | No differences. |
| Population | No differences. |
| Hardware Configuration | Original Scout used DSP board insidecomputer, Sport uses DSP board housedin separate enclosure connected tocomputer via serial communicationscable . |
| Computer Control Software | Only differences are changes to Scoutsoftware required to support the newhardware configuration. Nodifferences in software testalgorithms. |
| Ear Probe System | No differences. Both systems useEtymotic ER-10C probe. Samemicrophone preamplifier electronicshoused in separate box for Scoutsystem is included within Sport box. |
| Performance | Average noise floor is improved(lower noise) in Sport, over that ofScout |
| Safety Characteristics | No difference. There is no directelectrical connection to the patientin either case. Maximum sound outputof Sport is same as or less thanScout |
§ 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.