(121 days)
The Element system is intended to be used exclusively for myoelectric exoprosthetic fittings of the upper limb.
The Element system is a surface electromyography (EMG) electrode system that is to be used with upper limb prosthetic devices. Element outputs standard envelop EMG signals detected from EMG electrodes (IBT Electrodes) placed on the user's skin. These signals are used as inputs by connected prosthetic devices, such as hands, wrists or elbows. The Element system is an alternative to standard suction socket myoelectrodes, with the advantages of a lower profile, digital signal processing, and wireless gain adjustment. Element does not replace or modify any functionality of connected prosthetic components.
Element is compatible with most hands, wrists, and elbows that accept standard analog EMG electrode inputs. The Element system is typically sold with three-port kidney-style output connectors, however alternative connectors may be used to ensure compatibility with other terminal devices. The Element system accepts power from IBT's FlexCell Battery system and outputs control EMG signals to hands, wrists, or other prosthetic components. The Element system is installed in the prosthesis by a trained prosthetist and connected to prosthetic components selected to meet the needs of the individual user.
System components:
- IBT Electrodes (up to 2)
- Signal Processing Box
- Element Desktop Software
The provided document is a 510(k) summary for the Infinite Biomedical Technologies (IBT) Element System with IBT Electrodes. It outlines the device's characteristics, comparison to a predicate device, and the testing conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a table of acceptance criteria with corresponding pass/fail results for each criterion to demonstrate "device performance" in terms of clinical outcomes or specific quantitative metrics for the Element System's functionality as a myoelectric signal processor. Instead, it focuses on demonstrating safety and effectiveness through adherence to recognized standards and successful completion of various verification and validation tests.
However, we can infer acceptance criteria from the "Performance Data" section. The acceptance criterion for each test is generally "Pass," indicating that the device met the requirements of the specified standard or test protocol.
Here's a table based on the provided "Performance Data":
| Category | Test/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Safety | IEC/EN 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance | Compliance with standard | Equivalent (to predicate) |
| IEC 60601-1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | Compliance with standard | Predicate was not tested to this standard, implying the Element system does comply. | |
| Electromagnetic Compatibility | IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Compliance with standard | Equivalent |
| Biocompatibility | ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | Compliance with standard | Equivalent |
| ISO 10993-5: Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity | Compliance with standard | Equivalent | |
| ISO 10993-10: Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization | Compliance with standard | Equivalent | |
| Design V&V/Usability (Element System) | Compatibility with IBT Electrodes | Device is compatible | Pass |
| Simulated installation of Element | Successful simulated installation | Pass | |
| Simulated Use of Element Software and Electrode Placement | Successful simulated use | Pass | |
| Simulated Use with Commonly used Prosthetic Components | Successful simulated use | Pass | |
| Lifetime and Reliability Testing | Device meets lifetime/reliability requirements | Pass | |
| Testing Report Summary | Report deemed satisfactory | Pass | |
| Signal Performance during Simulated Use | Acceptable signal performance | Pass | |
| Simulated battery life with Element | Acceptable battery life | Pass | |
| Simulated use with Region Specific Noise | Acceptable performance in noise | Pass | |
| Packaging Drop Test | Packaging integrity maintained | Pass | |
| Simulated Installation of IBT Electrodes | Successful simulated installation | Pass | |
| Simulated Seal | Acceptable seal performance | Pass | |
| Simulated Cleaning | Device withstands cleaning | Pass | |
| FlexCell Battery Testing | IEC 60601-1: Medical electrical equipment Part 1: General requirements for basic safety and essential performance | Compliance with standard | Complies |
| IEC 62133: Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications | Compliance with standard | Complies | |
| UN38.3: Transportation Testing for Lithium Batteries | Compliance with standard | Complies | |
| FlexCell Major Component Test | Major components perform as specified | Pass | |
| FlexCell V&V Test Specification Plans | Plans are executed successfully | Pass | |
| FlexCell Charger Update V&V Test Plan | Plan is executed successfully | Pass | |
| FlexCell Charger IC Update V&V Test Plan | Plan is executed successfully | Pass |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample sizes used for the various verification and validation tests listed. It also does not provide details on data provenance (e.g., country of origin of the data, retrospective or prospective) for these tests. The tests mentioned are primarily laboratory-based simulations and regulatory standard adherence, not clinical trials with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The tests described are engineering and regulatory compliance validations rather than diagnostic or interpretative studies requiring expert ground truth establishment. For example, "Signal Performance during Simulated Use" would likely involve objective measurements against predefined specifications, not expert consensus on an interpretation.
4. Adjudication Method for the Test Set
This information is not provided and is generally not applicable to the types of engineering and regulatory compliance tests described. Adjudication methods (like 2+1, 3+1) are common in clinical studies where multiple human readers interpret data, and an agreed-upon truth is needed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done and is not applicable to this device. The Element System is a myoelectric signal processing unit for prosthetic control, not an AI-assisted diagnostic or interpretive tool that human readers would use. The document describes the system as an alternative to standard suction socket myoelectrodes, with advantages like a lower profile, digital signal processing, and wireless gain adjustment, but it doesn't involve "AI assistance" in the sense of improving human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The Element System itself is a standalone algorithm/device for processing myoelectric signals. The performance tests ("Signal Performance during Simulated Use", "Simulated battery life with Element", "Simulated use with Region Specific Noise") would effectively be standalone performance evaluations of the device's electrical and signal processing capabilities, without human user interaction as part of the performance measurement. However, its intended use is with a human user providing the EMG signals and benefiting from its processing for prosthetic control.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the specific tests mentioned, the "ground truth" would be established by:
- Regulatory Standards: For tests like IEC 60601-1, ISO 10993, and UN38.3, the ground truth is adherence to the requirements and specifications defined by these international standards.
- Engineering Specifications: For tests like "Compatibility with IBT Electrodes," "Signal Performance during Simulated Use," and "Simulated Seal," the ground truth would be predefined engineering specifications, performance tolerances, or established benchmarks for electrical signals and mechanical functions.
- Simulated Conditions: For tests involving "simulated use" or "simulated battery life," the ground truth is the controlled and measurable conditions established within the simulation.
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth in this submission, as it's not a diagnostic or treatment outcome-focused device.
8. The Sample Size for the Training Set
The document does not mention any training set size. As the Element System with IBT Electrodes is a device that processes myoelectric signals based on predefined algorithms and hardware, it is unlikely to involve "training" in the machine learning sense that would require a distinct training set. The "digital signal processing" and "signal smoothing" functionalities are described as inherent design features or adjustable parameters, rather than learned models.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied, the question of how its ground truth was established is not applicable.
§ 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).