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R-C1 TENS and EMS Stimulator

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 post-surgical stimulation of calf muscles to prevent venous thrombosis.
• R-E1 EMS Stimulator
• 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 post-surgical stimulation of calf muscles to prevent venous thrombosis.
• R-T1 TENS Stimulator
• 1. Symptomatic relief of chronic intractable pain;
• 2. Post traumatic pain;
• 3. Post surgical pain.

The RW Series A Electrical Stimulator, which includes models R-C1, R-E1 and R-T1, 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 electrodes 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 device unit of R-C1 was portable device, battery powered (6.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.

The stimulator is used with electrodes. For the electrodes are provided by the manufacturer Top-Rank Health Care Equipment Co. Ltd, cleared under K070612.

The three models of R-C1, R-E1 and R-T1 have the same appearance, structure, display, electrical principle and critical components, the main differences are software and color. The R-C1 have TENS mode (12 programs), EMS mode (9 programs). The R-E1 only have EMS mode (9 programs) and R-T1 only have TENS mode (12 programs). The R-C1 was combination the function of R-E1 and R-T1.

The provided document is a 510(k) summary for the Shenzhen Roundwhale Technology Co., Ltd. R-C1 TENS and EMS Stimulator, R-E1 EMS Stimulator, and R-T1 TENS Stimulator. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a novel device or algorithm.

Therefore, much of the requested information regarding acceptance criteria and studies (especially for AI/ML performance) is not applicable or cannot be directly extracted from this type of regulatory submission. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."

However, I can extract information related to non-clinical testing and performance standards used to demonstrate safety and performance.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are primarily compliance with recognized consensus standards for safety and performance. The performance reported is that the device "meets the requirements of its pre-defined acceptance criteria and intended uses."

Study Proving Acceptance Criteria

The study performed was a series of non-clinical safety and performance tests conducted on the subject device (RW series A Electrical stimulator: R-C1, R-E1 and R-T1). The document states: "All the test results demonstrate RW series A Electrical stimulator (R-C1, R-E1 and R-T1) meets the requirements of its pre-defined acceptance criteria and intended uses, and is substantially equivalent to the predicate devices."

The specific types of non-clinical tests mentioned are:

• Shelf life
• Software validation
• Electromagnetic compatibility and electrical safety (verified against IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10)
• Function test
• Usability (verified against IEC 62366-1)
• Risk management (verified against ISO 14971)

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated, however, for non-clinical engineering and performance testing as described, it typically involves a small number of devices (e.g., 3-5 units) undergoing specific tests to demonstrate compliance with standards. It does not refer to a "test set" in the context of clinical trials or AI/ML validation data.
• Data Provenance: The tests were performed on the devices manufactured by Shenzhen Roundwhale Technology Co., Ltd. The document refers to "non-clinical laboratory studies and safety testing data." This implies the data was generated internally as part of the device development and validation process, likely in China where the manufacturer is based. It is retrospective in the sense that these tests were performed on the final device design to support regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable. This submission relates to a physical medical device (electrical stimulator) which demonstrates safety and performance through engineering tests against recognized standards, not through clinical data where expert-established ground truth would be required.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable. This is not a clinical study involving ambiguity or subjective assessments. Compliance with engineering standards is typically determined by objective measurements and pass/fail criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This is not an AI/ML device or an imaging device for which an MRMC study would be relevant. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No. This is a hardware medical device; it does not involve a standalone algorithm for diagnostic or prognostic purposes.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" here is compliance with established international and FDA-recognized consensus standards (e.g., IEC 60601 series, ISO 14971, IEC 62304, IEC 62366-1) and internal design specifications for the device's electrical characteristics and functionality. These standards define the acceptable range of performance and safety parameters.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not use an AI/ML model that requires a training set.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable.

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R-C1 TENS and EMS Stimulator

TENS: This mode is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

EMS: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

R-E1 EMS Stimulator

This device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.

R-T1 TENS Stimulator

This device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

The RW Series A Electrical Stimulators, which includes models R-C1 TENS and EMS stimulator, R-E1 EMS stimulator and R-T1 TENS stimulator, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes 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 device unit of R-C1 was portable device, battery powered (6.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.

The electrode size is 50*50mm, the manufacturer is Top-Rank Health care Equipment Co., Ltd. The electrode is OTC use and cleared with 510(K), the cleared number is K132588. It has been evaluated and tested according to ISO 10993-1/-5 and -10 standards.

The three models of R-C1, R-E1 and R-T1 have the same appearance, structure, display, electrical principle and CDF, the main differences are software and color. The R-C1 have TENS mode (18 programs), EMS mode (15 programs). The R-E1 only have EMS mode (15 programs) and R-T1 only have TENS mode (18 programs). The R-C1 was combination the function of R-E1 and R-T1.

The provided document is a 510(k) Summary for a medical device (Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator). It describes the device, its intended use, comparison to predicate devices, and non-clinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document provides a table outlining compliance with recognized consensus standards for safety and performance (page 6). This effectively acts as the acceptance criteria for the non-clinical tests.

The document also provides a detailed comparison table (pages 8-9) with the predicate devices for various technical characteristics. For each characteristic, the comparison indicates "Same," "Different but does not adversely impact safety and effectiveness," or similar justifications, implying that these characteristics meet the acceptance criteria established by the predicate devices or are otherwise deemed safe and effective. Specific numerical values are provided for many parameters, such as maximum output voltage, maximum output current, pulse width range, and frequency.

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 explicitly states: "No clinical test data was used to support the decision of substantial equivalence." (page 6). The evaluation was based solely on non-clinical (laboratory) testing. Therefore, there is no sample size for an effectiveness test set, nor is there data provenance in the context of clinical studies.

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)

Since no clinical studies were performed and the substantial equivalence determination was based on non-clinical, laboratory testing and comparison to predicate devices, this information is not applicable. The "ground truth" for the device's acceptable performance was established by demonstrating compliance with recognized safety and performance standards (e.g., IEC standards) and showing equivalence to legally marketed predicate devices through technical specifications and testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring expert adjudication was used.

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

Not applicable. The device is an electrical stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is an electrical stimulator, not an algorithm. However, the non-clinical tests (e.g., electrical safety, performance, software validation) represent an evaluation of the device's standalone performance against established engineering and safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" for demonstrating safety and effectiveness was based on:

• Compliance with recognized international consensus standards: Such as IEC 60601 series, ISO 14971, and IEC 62304. These standards define the acceptable performance and safety characteristics for medical electrical equipment.
• Comparison to legally marketed predicate devices: The predicate devices (MT9001, LT3060; K130802) serve as the established "ground truth" for a device of this type being safe and effective for its indicated use. The extensive comparison table (pages 8-9) outlines how the new device's technical specifications either match or differ in ways that do not adversely impact safety and effectiveness compared to these predicates.

8. The sample size for the training set

Not applicable. The device is an electrical stimulator that performs physical functions, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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