(179 days)
The COMPLETE CONTROL System is to be used exclusively for external prosthetic fittings of the upper limbs.
The COMPLETE CONTROL System is an advanced control solution designed to enhance the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System employs Pattern Recognition technology to acquire, non-invasively, the rich information in muscle signals to enhance the control of industry standard upper extremity prostheses. Patients can achieve intuitive control of their devices, eliminate control switching, and benefit from quick and powerful recalibration. COMPLETE CONTROL simplifies electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations.
The COMPLETE CONTROL System is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on. COMPLETE CONTROL does not require an additional battery.
The COMPLETE CONTROL System is an embedded system that is used in conjunction with an upper-limb prosthetic device. This device can include any combination of an elbow, wrist, hand or terminal device. It contains several modules, including one for processing surface EMG (CO-AMP), processing and translating the signals (CONTROLLER), along with a controlling training routine (CALIBRATE). Finally, a wireless adapter (COMMUNICATOR) is included with the system setup and is used to provision the entire system.
The COMPLETE CONTROL System contains the following components.
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- Device Interface Cable (clinician-specified termination type)
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- COMPLETE CONTROLLER main processor
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- COMPLETE CALIBRATE patient interface button
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- COMPLETE CO-AMP consolidated EMG amplifier
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- EMG Interface Cable
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- Fabrication aids for the COMPLETE CONTROLLER, COMPLETE CO-AMP, and COMPLETE CALIBRATE
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- Socket cut-out template for the COMPLETE CALIBRATE button
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- COMPLETE COMMUNICATOR USB dongle
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- COMPLETE CONTROLROOM software installation USB dongle
This document, a 510(k) summary for the "COMPLETE CONTROL System" by Coapt, LLC, outlines the device's characteristics and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. It focuses on non-clinical performance data.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision, latency) for the device's core function (pattern recognition for myoelectric control). Instead, the "acceptance criteria" are implied to be conformance to various standards and the successful completion of internal validation tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| I. Conformance to Standards | |
| Electrical safety per IEC 60601-1 | Passed |
| Electromagnetic Disturbance (EMD) per IEC 60601-1-2 | Passed |
| II. Internal Validation Testing | |
| Cabling Connection Test | Passed |
| Power On and Boot Test | Passed |
| Wireless Connectivity and Profile Test | Passed |
| Inputs Test | Passed |
| Outputs Test | Passed |
| Calibration and Pattern Recognition Test | Passed |
| Feature Extraction Test | Passed |
| File Save Test | Passed |
| Meets device specifications and requirements and operates as intended | Confirmed (through internal testing) |
| Meets design inputs and specifications | Confirmed (through internal testing and electrical safety) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention a test set with a specific sample size used for performance evaluation related to the device's primary function of pattern recognition for myoelectric control. The non-clinical performance data described relates to engineering verification and validation testing of the hardware and software components.
The data provenance for these engineering tests would typically be internal laboratory testing conducted by Coapt, LLC or a contracted testing facility. No information about country of origin of data or retrospective/prospective nature is provided for these engineering tests.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
This information is not applicable and not provided in the document because the performance evaluation relies on engineering tests and conformance to standards, not on clinical ground truth established by experts.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the document, as there was no test set requiring expert adjudication for clinical or performance outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done and is not mentioned in the document. The device is a "Cutaneous Electrode" (Class II, Product Code GXY) that enhances the control of existing prosthetic devices; it's not a diagnostic imaging device where MRMC studies are typically performed. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done
The document describes "Calibration and Pattern Recognition Test" and "Feature Extraction Test" which would involve the algorithm operating in a standalone manner, processing signals and performing its designated function. However, the exact methodology, metrics, and quantitative results of these algorithm-only tests are not detailed beyond stating they "Passed."
7. The Type of Ground Truth Used
For the engineering tests (e.g., cabling, power, wireless), the ground truth is simply the expected operational output or state of the system (e.g., cable connected correctly, power on, wireless connected). For the "Calibration and Pattern Recognition Test" and "Feature Extraction Test," the ground truth would be the expected or correct pattern recognition output based on the input EMG signals, but the specifics of how this ground truth was defined or evaluated are not elaborated. There is no mention of expert consensus, pathology, or outcomes data as ground truth for these tests.
8. The Sample Size for the Training Set
The document does not mention the sample size for a training set. While the device utilizes "Pattern Recognition technology," the details of its development and training, including the dataset size, are not provided in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. Given the use of "Pattern Recognition technology," a training set with associated ground truth (e.g., specific muscle movements or intentions linked to EMG patterns) would typically be required, but the document does not elaborate on this aspect of the device's development.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).