(60 days)
Sense System with IBT Electrodes is to be used exclusively for external prosthetic fittings of upper limbs.
The Sense System is a surface electromyography (EMG) electrode system designed to enhance control of upper limb prosthetic devices. The Sense System detects EMG signals using the IBT Electrodes (previously approved by the FDA under 510k, K173571). The electrode signals are then processed using a pattern recognition algorithm and translated to output signals that are standardized to be compatible with an array of connected prosthetic devices, such as hands, wrists or elbows. The Sense System does not replace or modify any functionality of connected prosthetic components.
The Sense System is compatible with most hands, wrists, and elbows that accept industry standard signals. It is typically sold with three-port kidney-style output connectors; however, alternative connectors may be used to ensure compatibility with other components. The Sense System accepts power from IBT's FlexCell Battery system and outputs control signals to hands, wrists, and other prosthetic components. The Sense System is installed in the prosthesis by a trained prosthetist and connected to prosthetic components selected to meet the needs of the individual user.
Sense System components:
- IBT Electrodes (up to 8)
- Signal Processing Box
- User Interface Software
- Fabrication dummies for electrodes and processing box
The provided text describes a 510(k) premarket notification for the "Sense System with IBT Electrodes." It focuses on demonstrating substantial equivalence to a predicate device ("COMPLETE CONTROL System") rather than providing detailed acceptance criteria and a study dedicated to proving the device meets those criteria in the way typically found for an AI/ML medical device's performance claims.
The document primarily addresses the technological characteristics, performance, and safety of the Sense System in comparison to a predicate device to establish substantial equivalence for regulatory clearance. It doesn't present a study aimed at validating distinct performance metrics against specific, predefined numerical acceptance criteria for an AI model's accuracy, sensitivity, or specificity.
However, based on the information provided, we can infer some "acceptance criteria" through the lens of safety and effectiveness equivalence, and summarize the supporting "study" as a series of verification and validation tests.
Here's an attempt to structure the answer based on your request, while acknowledging the limitations of the provided text for a typical AI/ML performance study description:
Device: Sense System with IBT Electrodes
Purpose of the "Study" (Verification & Validation Testing): To demonstrate the safety and effectiveness of the Sense System with IBT Electrodes and its substantial equivalence to the legally marketed predicate device, the COMPLETE CONTROL System (K162891).
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly tied to demonstrating the new device performs as safely and effectively as the predicate, and does not raise new or different questions of safety and effectiveness. The "reported device performance" is the outcome of various tests and comparisons confirming this equivalence. Specific quantitative performance metrics for a pattern recognition algorithm's accuracy (e.g., control accuracy rates) are not detailed in this document.
| Feature / Category | Implied Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Indications for Use | Same as predicate: "exclusively for external prosthetic fittings of upper limbs" and "prescription use". | Identical indications for use and prescription use. Minor semantic differences in wording. (Table 2) |
| Technological Characteristics | Demonstrate no new or different questions of safety/effectiveness despite differences from predicate (Wireless Communication, Input Voltage, Output Signals, Calibration Method, Electrode Material, Suction Seal Compatibility) | Detailed discussion provided arguing that differences do not impact safety or effectiveness. (Pages 6-8) |
| Wireless Communication | Safe and Stable; passes FCC requirements; no additional safety risks over predicate. | Uses Bluetooth®, identical to previously approved Element system (K123759), tested extensively and found stable, passed FCC requirements. (Page 6) |
| Input Voltage Compatibility | Compatible with intended power source (FlexCell battery); no impact on safety/effectiveness. | Range of 5-10V, compatible with 7.4V FlexCell battery and other systems; no impact on safety/effectiveness. (Page 6) |
| Output Signals | Compatible with industry standard prosthetic components; similar functionality to predicate's outputs. | 0-5V analog, 0-3.3V digital, 0-8.2V motor signals. Tested for compatibility; similar to predicate's output standards. (Page 7) |
| Calibration Method | Safe and effective; no additional risks to patient safety. | PC-based User Interface for calibration, allowing more user options and pre-prosthetic practice. No additional risks. (Page 7) |
| Electrode Material & Biocompatibility | Safe, biocompatible, no increase in skin irritation or patient risks. | Titanium contacts (no nickel), plastic biocompatible. Passed biocompatibility tests. (Page 7) |
| Software Verification & Validation | Software meets design requirements and provides safe/effective operation. | "Passed Internal Testing Regimen," includes Software V&V and Design V&V. (Page 8) |
| Electrical Safety Standards | Compliance with relevant IEC standards for medical electrical equipment. | Certified to IEC/EN 60601-1 (2012/2006) and IEC 60601-1-11 (2010). (Page 8) |
| Electromagnetic Compatibility | Compliance with relevant IEC standards. | Certified to IEC 60601-1-2 (2007). (Page 8) |
| Design Verification & Validation Tests | Successfully demonstrate intended use safely and effectively. | All listed tests (Simulated installation, User Interface Use (IBT, Practitioner, Patient), Simulated Use with Prosthetic Components, Lifetime and Reliability, Battery Life, Packaging Drop Test) passed. (Page 9) |
| FlexCell Battery Testing | Safe and effective; compliance with relevant safety and transportation standards. | Passed all listed tests (Major Component, V&V Test Plans, Charger Update V&V) and certified to IEC 60601-1, IEC 62133, and UN38.3. (Page 10) |
2. Sample Size and Data Provenance
The document does not specify a "sample size" in the context of a dataset for an AI model's performance evaluation (e.g., number of patient cases). Instead, it refers to various engineering and functional tests.
- Test Set Sample Size: Not applicable in the context of a test set for an AI model's performance on patient data. The tests described are functional, electrical safety, usability, and design verification tests.
- Data Provenance: Not explicitly stated as retrospective or prospective clinical data. The testing appears to be internal validation and verification, simulating use and testing components as per regulatory standards. No country of origin for specific "data" (apart from the manufacturer being in Baltimore, Maryland, USA) relating to patient cases is mentioned.
3. Number of Experts and Qualifications for Ground Truth
The document does not describe a process for establishing ground truth through expert review of patient data, as would be typical for an AI diagnostic device. The "ground truth" for this device's performance appears to be established by engineering specifications, safety standards, and functional requirements. For the "Practitioner Use of UI" and "Patient Use of UI" tests, it can be inferred that prosthetists and patients were involved, but the number and their specific qualifications for establishing ground truth are not detailed.
4. Adjudication Method for the Test Set
Not applicable. The tests described are engineering and functional validation, not clinical review of cases requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. The device is a control system for prosthetics, where the "human-in-the-loop" is the user of the prosthetic. The document does not evaluate how human readers (e.g., radiologists interpreting images) improve with AI assistance.
6. Standalone (Algorithm Only) Performance
The sense system is described as using a "pattern recognition algorithm" to process EMG signals (Page 4). However, the document does not report standalone performance metrics (e.g., accuracy, sensitivity, specificity) for this algorithm in isolation. The evaluation focuses on the entire "Sense System" as a functional unit to ensure safety and effectiveness for controlling prosthetic devices.
7. Type of Ground Truth Used
The "ground truth" for this device's clearance is based on:
- Engineering specifications and design requirements.
- International standards for medical electrical equipment (IEC/EN 60601 series) and battery safety (IEC 62133, UN38.3).
- Functional performance (e.g., proper signal output, compatibility with prosthetic components).
- Usability testing, which would involve observing user interaction with the system.
It is not based on expert consensus on patient cases, pathology, or outcomes data in the typical sense of a diagnostic AI device.
8. Sample Size for the Training Set
Not applicable. The document does not describe the specifics of the pattern recognition algorithm's training, including its training data size. The focus is on the integrated system's safety and effectiveness.
9. How the Ground Truth for the Training Set Was Established
Not applicable. The document does not provide details on the training process or ground truth establishment for the internal pattern recognition algorithm.
§ 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).