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510(k) Data Aggregation
(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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