(90 days)
For the TENS function: TENS is used for the relief and management of symptomatic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post traumatic acute pain.
For the EMS function: The Ultima NMS/EMS is indicated for: Relaxation of muscle spasm. Prevention or retardation of disuse atrophy. Increasing local blood circulation. Muscle re-education. Prevention of venous thrombosis of the calf. muscles immediately after surgery. Maintaining or increasing range of motion.
For the TENS function: A portable TENS device for pain relief.
For the EMS function: A portable EMS device for the re-education of muscles.
The Ultima NMS/EMS (the "New Device") brings together TENS and Powered Muscle Stimulator functions from two previously cleared for market devices; namely the Ultima TENS (K020846) for the TENS functions and the TensCare XL-Y3 (K011543) for the Powered Muscle Stimulator functions.
The electrical. EMC and software technologies used in the Ultima NMS/EMS (the 'New Device'), are identical to the Ultima TENS (the Predicate device - (K020846), in that the same CPU series is utilised (the difference being that the variant used has increased memory capacity).
In addition, the "New Device" uses the same passive and active electrical components and PCB layout, as the Predicate devices.
The Powered Muscle Stimulator functions are derived from software programmed into the CPU device and are based on and virtually identical to the Predicate device.
The TensCare Ultima NMS/EMS has a Doctor Important anti-Misuse feature: Lock facility, which means that at the Treating Physician's discretion, the patient has no control over the devices outputs; the Programs are pre-set by the Treating Physician.
The use of 'shrouded patient cable connectors' to comply with FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables" is utilised to further ensure no hazards exist.
Acceptance Criteria and Device Performance for TensCare Ultima NMS/EMS
This document summarizes the acceptance criteria and supporting study information for the TensCare Ultima NMS/EMS device based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided text does not contain explicit, quantitative acceptance criteria for the TensCare Ultima NMS/EMS device in the form of a table. Instead, it relies on demonstrating substantial equivalence to predicate devices and performance in the European market.
The primary "acceptance criteria" appear to be:
- Substantial Equivalence: The electrical, EMC, and software technologies, as well as the passive and active electrical components and PCB layout, are identical or virtually identical to the predicate devices.
- Safety and Effectiveness: Bench testing, VVT (Verification, Validation, and Testing), and Risk Analysis (including FMEA) demonstrate that the device performs as intended with no harm to the user. Also, the device prevents simultaneous use of TENS and EMS functions.
- Post-Market Performance (EU): Review of customer complaints, returned products, and post-market feedback from over two years in the European market (in its TENS form) demonstrates performance as intended.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Technological Substantial Equivalence to Predicate Devices: | The electrical, EMC, and software technologies (CPU series, passive/active electrical components, PCB layout) are identical or virtually identical to the TensCare Ultima TENS (K020846) for TENS functions and TensCare XL-Y3 (K011543) for EMS functions. EMS functions are software-derived and virtually identical. |
| Output Characteristics Substantial Equivalence to Predicate Devices: | Bench testing demonstrates that the output characteristics of the TensCare Ultima NMS/EMS are substantially equivalent to those of the two predicate devices. |
| Safety of Combined Functions: | Bench Testing, VVT, and Risk Analysis (including FMEA) demonstrate that the device performs as intended with no harm to the user. It is not possible to use TENS and EMS functions simultaneously due to mechanical integrity. The device includes 'shrouded patient cable connectors' for safety. |
| Patient Control Restriction Option: | The device has a Doctor Important anti-Misuse feature: Lock facility, allowing the Treating Physician to pre-set programs, preventing patient control over device outputs. |
| Post-Market Performance (European Market - TENS form): | Over two years of data from the European market (for the TENS form) including customer complaints, returned products, and post-market feedback, demonstrated that the product performed as intended to its specified requirements. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of an AI/algorithm-based device as this device is a physical medical stimulator. The "testing" primarily involved bench testing, VVT, risk analysis, and post-market surveillance.
- Data Provenance:
- Bench Testing, VVT, Risk Analysis: Likely internal company data.
- Post-Market Feedback: European Market data from the TENS form of the product over two years.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. The product is a physical device, and its safety and effectiveness were assessed through engineering comparisons, bench testing, and review of existing market performance, rather than through expert-driven ground truth establishment for an AI algorithm.
4. Adjudication Method for the Test Set:
Not applicable. This is not an AI/algorithm-based device requiring an adjudication process for ground truth.
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:
No, an MRMC comparative effectiveness study was not done. The text explicitly states: "Clinical Testing was not necessary as no new or innovative aspects have been introduced." This indicates that the device's performance was not evaluated in a clinical trial comparing it against human performance or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical medical stimulator, not an algorithm.
7. The Type of Ground Truth Used:
For the TensCare Ultima NMS/EMS, the "ground truth" for its safety and effectiveness was established through:
- Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the two predicate devices (TensCare Ultima TENS (K020846) and TensCare XL-Y3 (K011543)). The new device's equivalence to these legally marketed devices forms the basis of its clearance.
- Bench Test Results: Objective measurements of electrical output characteristics.
- VVT (Verification, Validation, and Testing): Standard engineering validation processes.
- Risk Analysis (FMEA): Identification and mitigation of potential hazards.
- Post-Market Surveillance Data: Real-world performance data (customer complaints, returned products) from the European market for the TENS functions.
8. The Sample Size for the Training Set:
Not applicable. This is a medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As noted above, this device does not involve a "training set" for an AI algorithm.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).