(243 days)
TENS stands for Transcutaneous Electrical Nerve Stimulation. This TENS system is used to provide symptomatic pain relief for chronic, acute or post operative pain.
PMS/EMS stands for Powered Muscles Stimulator/Electrical Muscles Stimulator. This PMS/EMS system is indicated for:
- Relaxation of muscle spasm
- Increasing local blood circulation
- Muscle re-education
- Prevention or retardation of disuse atrophy
- 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.
Features:
· Innovative design
· Large LCD display
• Dual output channels
• 2 AA Alkaline Batteries
· Adjustable frequency, pulse width, and timing parameters
• 9 different modes
• Timer option
• Doctor lock/unlock facility
· Open circuit detectors
• Non-volatile
The EasyMed EMS/TENS Model NMS-28 is a medical device that combines the functions of a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief and a Powered Muscle Stimulator (PMS) or Electrical Muscle Stimulator (EMS) for muscle re-education.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document is a 510(k) summary for the EasyMed EMS/TENS Model NMS-28, which means it aims to demonstrate substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria in the same way a clinical trial would for a novel device. Therefore, a direct table of acceptance criteria and device performance based on quantitative metrics is not explicitly provided in the document.
Instead, the document asserts substantial equivalence based on:
- Identical intended use and indications for use as predicate devices.
- Technological comparison:
- For TENS function: The software for the TENS function is a "subset" of the predicate EasyMed TENS Unit TN-28C (K040253). The new device shares the same enclosure, circuit diagram, PCB layout, components, and working principle.
- For EMS function: The software for the EMS function is "very similar" to the predicate TensCare Ultima NMS/EMS Model XL-A3 (K023997), applying "similar control methods for muscle contraction-relaxation."
- Safety and reliability considerations from the TN-28C are incorporated into the EMS function.
- Safety information:
- Design complies with relevant safety and recognized consensus standards.
- Output energy is "well controlled" within safety and effectiveness ranges specified by FDA guidance.
- "Detailed and strict" testing has been carried out.
- Risk Analysis and FMEA (Failure Modes and Effects Analysis) show the unit is "safe with no any hazard."
- Mechanical integrity ensures only one function (TENS or EMS) can be selected at a time.
- Post-market experience (Europe): The device has been on the European market for two years, and a review of customer complaints, returned products, and post-market feedback demonstrated it "performed as Intended, to its Specified Requirements."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a specific clinical test set in terms of sample size or data provenance (e.g., country of origin, retrospective/prospective). The evidence supporting safety and effectiveness appears to be primarily based on:
- Bench testing and engineering analysis to verify compliance with standards and equivalence to predicate devices.
- Existing clinical evidence/regulatory filings for the predicate devices.
- Post-market surveillance data from the European market.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not provided as the submission relies on demonstrating substantial equivalence to pre-existing, legally marketed devices, rather than establishing a new ground truth through an independent expert panel for a novel clinical claim.
4. Adjudication Method for the Test Set:
This information is not applicable/provided, as no clinical test set requiring expert adjudication for ground truth is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC study is not mentioned in the document. This type of study (evaluating human reader performance with and without AI assistance) is typically performed for AI-driven diagnostic or screening tools. The EasyMed NMS-28 is a physical electrical stimulation device, not an image-based diagnostic AI, so an MRMC study would generally not be relevant to its regulatory submission.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
A standalone performance study focused on an algorithm's performance is not described. As mentioned, this is an electrical stimulation device, not an AI algorithm in the typical sense. The "software" mentioned as part of the technological comparison refers to the embedded firmware controlling the device's electrical output, not a diagnostic or decision-making AI. The "performance" assessment focuses on the device's electrical output parameters and safety through engineering tests and comparison to predicate devices.
7. Type of Ground Truth Used:
The "ground truth" for the submission is based on the established safety and effectiveness of the predicate devices (EasyMed TENS Unit TN-28C and TensCare Ultima NMS/EMS Model XL-A3) and the assertion that the new device is technologically similar and meets relevant safety standards.
8. Sample Size for the Training Set:
This information is not applicable/provided. The device does not employ a machine learning model that requires a "training set" in the conventional sense. The "software" referred to is programmed control logic, not a learned algorithm.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable/provided, as there is no training set for a machine learning model described.
§ 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).