(238 days)
Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for channel selection, patient cable, and electrodes applied to the skin. Various types of waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced system may have more than on output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.
The provided submission from KINGLY STAR INTL. TECHNOLOGY CO., LTD. for their KINGLY STAR Powered Muscle Stimulator, KS-138 (K062453), does not include acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for a medical device efficacy study.
Instead, this 510(k) submission relies on substantial equivalence to a predicate device, the TAI SHENG Powered Muscle Stimulator, TS-166 (K031310). The key 'study' referenced is a comparison to the predicate, focusing on technical specifications and safety standards rather than clinical performance metrics.
Here's a breakdown based on your request, highlighting what is and isn't present in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None explicitly stated for clinical efficacy. The submission focuses on technical and safety specifications being equivalent to the predicate device. | Demonstrated to be as safe and effective as, and function in a manner equivalent to, the predicate device: TAI SHENG Powered Muscle Stimulator, TS-166 (K031310). |
| Adherence to applicable standards for medical device electrical electromagnetic compatibility and safety (particularly for nerve and muscle stimulators). | Tested and found to be in accordance with these standards. Accessories (510(k) electrodes, shrouded patient cable connectors) also meet safety requirements. System-level testing, including waveform testing, performed. |
| Intended Use: Relaxation of muscle spasms, prevention or retardation of disuse atrophy, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, maintaining or increasing range of motion. | Stated to have the same intended uses as the predicate device, implying it performs these functions equivalently. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: None provided. No clinical test set data from human subjects is presented.
- Data Provenance: The document states "Non-Clinical Tests Submitted" and "Clinical Tests Submitted: None". The 'data' for demonstrating equivalence primarily comes from comparison of technical specifications and adherence to electrical safety standards. This is not human-centric data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. No clinical test set requiring expert ground truth was performed for this 510(k) submission. The equivalence is based on engineering and safety assessments.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No clinical test set requiring adjudication was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study would involve human readers (potentially radiologists or clinicians interpreting data) and is not relevant for a powered muscle stimulator cleared via substantial equivalence based on technical and safety data.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable. There is no AI component mentioned, nor is there a study involving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, in spirit, a form of "standalone" evaluation occurred, but not in the conventional sense of an algorithm's performance. The primary "standalone" assessment was of the device's adherence to electrical safety and electromagnetic compatibility standards, and its output waveforms, independently of a human user's performance. There is no algorithm in the device that would be evaluated for standalone predictive performance.
7. The Type of Ground Truth Used:
- Ground Truth: For the non-clinical tests, the "ground truth" was regulatory standards (e.g., medical device electrical and electromagnetic compatibility, specific requirements for nerve and muscle stimulators) and engineering specifications (e.g., waveform output). The device was tested to determine if it met these established objective benchmarks. For the intended use claims, the ground truth indirectly relies on the predicate device's established effectiveness for those indications.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" in a broad sense would be the engineering design and manufacturing processes, but not a data training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, there is no AI/ML training set for this device.
Summary of the Study (as described in the 510(k) submission):
The "study" described in this K062453 submission is a non-clinical comparison to a predicate device and adherence to recognized safety and electrical standards.
- Device: KINGLY STAR Powered Muscle Stimulator, KS-138
- Predicate Device: TAI SHENG Powered Muscle Stimulator, TS-166 (K031310)
- Methodology:
- Non-Clinical Tests: The KS-138 was tested against applicable standards for medical device electrical electromagnetic compatibility and safety, specifically "the particular requirements for safety of nerve and muscle stimulators."
- Accessories (electrodes and patient cables) were also assessed for safety requirements.
- System-level testing, including waveform testing, was performed.
- Comparison of the device's design, intended use, and technical specifications to those of the predicate device.
- Conclusion: The submission concludes that the KINGLY STAR Powered Muscle Stimulator KS-138 is as safe and effective as, and functions in a manner equivalent to, the predicate device TAI SHENG Powered Muscle Stimulator TS-166, thus establishing substantial equivalence.
- Clinical Tests: "None" were submitted.
In essence, this is a regulatory submission for substantial equivalence based on technical specifications and safety standards, not an independent clinical trial demonstrating efficacy against specific acceptance criteria for performance.
§ 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).