(432 days)
TENS Stimulator (Model no .: AK-10M) TENS Stimulator provides 5 types TENS output modes (P1-P5) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain
TENS and EMS Stimulator (Model no .: AK3-20 and AK3-25) TENS and EMS Stimulator provides 8 types output modes (P1-P8). TENS/EMS output modes (P1-P6&P8) and TENS output modes (P7) For TENS mode (1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain For EMS mode (1) Relaxation of Muscle spasm, (2) Increase of local blood flow circulation, (3) Prevention or retardation of disuse atrophy, (4) Muscle re-education, (5) Maintaining or increasing range of motion, (6) Immediate postsurgical stimulation of muscles to prevent venous thrombosis
TENS and EMS Stimulator (Model no.: AK3-50)
TENS and EMS Stimulator provides 10 types output modes (P0-P9). TENS output modes (P0-P4) and EMS output modes (P5-P9)
For TENS mode
(1) Symptomatic relief of chronic intractable pain, (2) Post traumatic pain, (3) Post-surgical pain For EMS mode
(1) Relaxation of Muscle spasm, (2) Increase of local blood flow circulation, (3) Prevention or retardation of disuse atrophy, (4) Muscle re-education, (5) Maintaining or increasing range of motion, (6) Immediate postsurgical stimulation of muscles to prevent venous thrombosis
The TENS stimulator and TENS and EMS stimulator, are Transcutaneous Electrical Nerve Stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulators send gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of devices are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The four models have similar housing in a molded plastic case with viewable LCD display, an accessible keypad, and accessible battery storage compartment. The LCD is used to display system information to the user. The device is equipped with a keypad composed of push buttons which are located below the LCD that control the program selection, strength, channel, and power.
The TENS and EMS Stimulator (Model No .: AK3-20, AK3-25 and AK3-50) is the comination unit with the TENS and EMS functions; the function can be selected by press buttons. The range of settings is identical in models AK3-20 and AK3-25 while model AK3-50 provides 10 types of output modes.
The provided text describes a 510(k) summary for a TENS and EMS Stimulator. The document states that no clinical test data was used to support the decision of substantial equivalence. Instead, the device's acceptance criteria are demonstrated through non-clinical testing, ensuring safety and performance.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical sense of a clinical or analytical study. Instead, it details that the device underwent a "series of safety and performance tests" to demonstrate substantial equivalence to a predicate device. The implied acceptance criteria for each test are that the device meets the requirements of relevant electrical safety and biocompatibility standards.
The "reported device performance" is implicitly that the device passed these tests and complies with the standards. The table titled "Basic Unit Characteristics" compares various technical specifications between the subject device (multiple models) and the predicate device, noting similarities and differences. The conclusion drawn is that despite some differences in specifications, all tested aspects comply with relevant standards.
Here's a summary of the non-clinical tests and the general outcome:
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance |
|---|---|---|
| Safety & Performance | Shelf life test | Meets requirements of pre-defined acceptance criteria |
| Software validation | Meets requirements of pre-defined acceptance criteria | |
| EMC and Electrical Safety test | Meets requirements of pre-defined acceptance criteria | |
| Performance test | Meets requirements of pre-defined acceptance criteria | |
| Regulatory Compliance | Compliance with IEC60601-1, IEC60601-1-2, IEC60601-2-10, ISO10993-1 | All models comply with these standards. |
| Compliance with 21 CFR898 | All models comply with 21 CFR898. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set in terms of the number of devices tested for non-clinical studies. It refers to a "series of safety and performance tests" conducted on "the subject device, TENS and EMS Stimulator, TENS Stimulator" (page 5). Typically, for non-clinical hardware testing, a small number of units (e.g., 3-5) are tested to demonstrate compliance.
The data provenance is from ASTEK Technology Ltd. in Taiwan, which submitted the 510(k). The tests are non-clinical (laboratory studies) and therefore are prospective in nature for the purpose of demonstrating compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not applicable. The ground truth for non-clinical safety and performance tests is established by adherence to recognized national and international electrical safety, EMC, and biocompatibility standards (e.g., IEC 60601-1, ISO 10993-1). These standards define objective pass/fail criteria. There isn't a "ground truth" derived from expert consensus in the way there would be for image analysis or diagnostic AI. The tests are purely engineering and regulatory compliance assessments.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically relevant for clinical studies or studies involving subjective interpretation (e.g., by multiple human readers). For non-clinical performance and safety tests, the results are objectively measured against predefined criteria in the standards.
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 MRMC comparative effectiveness study was done. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This device is not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical TENS and EMS stimulator, not a standalone algorithm. While it has software, the validation is for the device's overall operation and safety, not for an AI algorithm's standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As this is a non-clinical submission, the "ground truth" for demonstrating the device meets acceptance criteria is compliance with established international and national standards (e.g., IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility). The tests measure physical and electrical properties against the limits and requirements specified in these standards.
8. The sample size for the training set
This question is not applicable. There is no mention of a "training set" as this is a non-AI medical device submission based on non-clinical performance and safety testing against predicate devices and standards.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set mentioned or implied for this device and its submission.
§ 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).