(94 days)
Combo Stimulator MT9000
For TENS/IF/MIC mode
- Symptomatic relief of chronic intractable pain
- Post traumatic pain
- Post surgical pain
For EMS mode - Relaxation of muscle spasm.
- Increase of local blood flow circulation
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Combo Stimulator LT7102
For TENS/IF/MIC mode
- Symptomatic relief of chronic intractable pain
- Post traumatic pain
- Post surgical pain
For EMS/RUSS mode - Relaxation of muscle spasm.
- Increase of local blood flow circulation
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
TENS Stimulator Intensity 10
- Symptomatic relief of chronic intractable pain
- Post traumatic pain
- Post surgical pain
MT9000, LT7102 and Intensity 10 are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The 3 models MT9000, LT7102 and Intensity 10 have similar housing with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user.
The provided document is a 510(k) Summary for medical devices (stimulators) and does not contain information about acceptance criteria or a study proving device performance against such criteria for AI/ML-driven diagnostic devices.
The document details the substantial equivalence of new stimulator models (Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10) to previously marketed predicate devices. The "performance data" section covers biocompatibility, electrical safety, EMC, and software verification/validation, which are typical for this type of medical device submission, but do not involve acceptance criteria or studies related to AI/ML diagnostic performance metrics like sensitivity, specificity, or reader studies.
Therefore, I cannot provide the requested information, specifically:
- A table of acceptance criteria and reported device performance (for AI/ML diagnostic context)
- Sample size for the test set and data provenance
- Number of experts and qualifications for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study details (effect size)
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- Ground truth establishment for the training set
The document is primarily focused on demonstrating that the new devices have the "same intended use and technological characteristics" as existing devices, and that changes do not affect safety or effectiveness, as confirmed by regulatory compliance testing (e.g., IEC standards).
§ 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).