(28 days)
The Alpha Control Liner System is to be used exclusively for exoprosthetic fittings of the upper limbs.
The Alpha Control Liner System is an interface solution designed to provide the Complete Control System Gen2 with amputee muscle contraction signals needed for the pattern recognition algorithms. The Alpha Control System integrates electronics into a fabric covered elastomeric prosthetic liner to non-invasively detect muscle contractions and convert the signals into a digital format. The Alpha Control System is a substitute for the EMG Interface Cable currently provided with the Complete Control System Gen2. Patients can achieve control of their devices and benefit from quick donning and doffing of the prosthesis. The Alpha Control System simplifies electrode placement and allows a prosthetist to spend less time fabricating the prosthesis as well as adjusting system settings and configurations.
The Alpha Control System is used in conjunction with the Coapt Complete Control System Gen2 and does not require an additional battery.
The Alpha Control System contains the following components.
- Alpha Control Liner (gel-lined user interface)
- Alpha Control Module (re-packaged Complete CO-AMP consolidated EMG amplifier, Covered under 510(k) number K162891)
- Module Cap (secures the Module inside the Liner)
- Alpha Control Lock (socket suspension and connection to Complete Controller)
- Electrodes (Covered under 510(k) number K190416)
- Fabrication aids for the Lock
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) Premarket Notification from the FDA to Coapt Blair Lock for the Alpha Control Liner System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Coapt Complete Control System Gen2) through non-clinical performance data.
Here's an analysis of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several non-clinical performance tests that the Alpha Control Liner System passed, which can be interpreted as demonstrating the device meets internal requirements, national, and international standards. However, specific numerical acceptance criteria (e.g., "force must be > X Newtons") are not provided. The results are simply reported as "Pass".
| Test Name | Reported Device Performance |
|---|---|
| Electrical safety testing (IEC 60601-1) | Pass |
| Cytotoxicity testing (ISO 10993-5) | Pass |
| Skin irritation testing (ISO 10993-10) | Pass |
| Sensitization testing (ISO 10993-10) | Pass |
| Liner Thickness | Pass |
| Liner Doffing Force | Pass |
| Donning/Doffing Fatigue | Pass |
| Liner Umbrella Static Loading | Pass |
| Liner Umbrella Fatigue Loading | Pass |
| Lead Impedance Fatigue | Pass |
| Lead Impedance - Corrosion | Pass |
| Lock Body Static Loading | Pass |
| Lock Body Fatigue Loading | Pass |
| Liner High Pot Test | Pass |
| Module High Pot Test | Pass |
| Module Level Test | Pass |
| Coapt System Integration Testing | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for any of the non-clinical tests. It states that "validation testing was performed on the finished device," but does not detail the number of units or iterations. The provenance of the data is "internal" and "in-house performance testing" by Coapt LLC and WillowWood Global LLC. The document does not mention external (e.g., country of origin) or retrospective/prospective data for these tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided. The non-clinical tests are largely engineering and materials testing, which rely on established standards and protocols rather than expert medical interpretation for "ground truth" in the same way a clinical diagnostic test would.
4. Adjudication Method for the Test Set:
This information is not applicable and, therefore, not provided. The non-clinical tests do not involve human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The document explicitly states, "No human clinical testing was required to support the medical device as the indications for use is equivalent to the predicate device." This indicates that the evaluation was primarily based on non-clinical engineering and biocompatibility testing. The device is a "cutaneous electrode" for exoprosthetic fittings, not a diagnostic imaging or AI-driven decision support system that typically requires MRMC studies.
6. Standalone (Algorithm Only) Performance:
The device (Alpha Control Liner System) is described as an "interface solution designed to provide the Complete Control System Gen2 with amputee muscle contraction signals needed for the pattern recognition algorithms." It integrates electronics to detect muscle contractions and convert signals into a digital format. While it converts signals, it is a component for a pattern recognition algorithm (part of the predicate device, Coapt Complete Control System Gen2), not the algorithm itself or a standalone algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the loop performance)" is not applicable to this device description. The performance testing focuses on its physical and electrical integrity and its ability to integrate with the larger system.
7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" refers to established engineering standards, material specifications, and functional requirements. For example, "Liner Thickness" would be compared against a specified design tolerance, and "Biocompatibility" against the criteria outlined in ISO 10993 standards. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for these non-clinical tests.
8. Sample Size for the Training Set:
This information is not applicable and not provided. The Alpha Control Liner System is a hardware component that collects and processes sEMG signals. It does not inherently learn or require a "training set" in the context of machine learning. The pattern recognition algorithms are part of the predicate device, and details about their training are not discussed in this submission for the Alpha Control Liner System.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided, as the device itself does not use a "training set."
§ 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).