Search Results

Over-The-Counter Use:
a. Model R-C101C is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
b. Model R-C101D is indicated for OTC TENS. It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
c. Model R-C101F is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
d. Model R-C101G is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
e. Model F100 is indicated for OTC TENS and OTC EMS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. OTC EMS(NGX) This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
f. Model MINI-TENS-COMB is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
g. Model R-C101I is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.
h. Model TENS3500 is indicated for OTC TENS. OTC TENS(NUH) It is used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, back, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities.

Prescription Use:
a. Model R-C101D is indicated for Rx TENS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
b. Model R-C101G is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 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.
c. Model R-C101C, is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic rlief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 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.
d. Model F100 is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 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.
e. Model MINI-TENS-COMB is indicated for Rx TENS. 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
f. Model R-C101F is indicated for Rx TENS and Rx EMS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain; Rx EMS(IPF): 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.
g. Model R-C101I is indicated for Rx TENS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;
h. Model TENS3500 is indicated for Rx TENS. Rx TENS(GZJ) : 1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;

Combo Electrotherapy Device (Model:R-C101C,R-C101F,R-C101G,F100,MINI-TENS-COMB,R-C1011, TENS3500) are Transcutaneous Electrical Nerve Stimulator and muscle stimulator The Device feature two independent output channels and four self-adhesive electrode gel pads. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation.For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs. Software controls all controls and indicators. Software controls waveform characteristics. The 8 models have Similar housing with a viewable LCD display,an accessible keypad.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 device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is 3.7V D.C.,Li-ion batteries and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device. The Battery Charger is not provided in the package, but users will choose adapters that meet the IEC 60601-1 medical standard.

The provided document is a 510(k) Premarket Notification from the FDA, evaluating the substantial equivalence of the "Combo Electrotherapy Device" to existing predicate devices. It focuses on technical specifications and safety standards rather than clinical performance or acceptance criteria in the typical sense of a clinical trial. Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable or detailed in this type of regulatory submission.

However, I can extract information related to acceptance criteria as demonstrated by compliance with recognized standards and a comparison to the predicate devices' performance.

The primary acceptance criteria for this device are demonstrated through compliance with recognized electrical safety and performance standards, as well as showing substantial equivalence to existing predicate devices in terms of intended use and technological characteristics.

Here's a breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, "acceptance criteria" are generally met by demonstrating compliance with applicable safety standards and showing that any differences from predicate devices do not raise new safety or effectiveness concerns. The "reported device performance" is primarily presented as a comparison to the predicate devices' specifications, along with statements of compliance to relevant IEC standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size: Not applicable. For a 510(k) submission based on technical equivalence, bench testing and compliance with standards are typically performed on representative units of the device itself, not a 'test set' of patient data in the clinical sense.
• Data provenance: The tests performed are "Non-Clinical Data" and "Bench Testing," conducted to verify device specifications and compliance with standards. These are typically laboratory tests of the device. The manufacturing company is Shenzhen Roundwhale Technology Co., Ltd. in Longgang District, Shenzhen, China.

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)

• Not applicable. This is a technical and safety review of an electrotherapy device, not an image-based diagnostic or screening AI device requiring expert ground truth for a test set.

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

• Not applicable. As above, this type of adjudication is for clinical or diagnostic studies, not for the technical bench testing described.

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. This device is an electrotherapy device, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. The device is a physical electrotherapy device; its performance is independently verifiable through electrical measurements and safety standards compliance.

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

• The "ground truth" for this submission are the recognized international and national standards (e.g., IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2, IEC 60601-1-11, ISO 10993) and the specifications and performance of the legally marketed predicate devices. The testing confirmed that the subject device's performance aligned with these standards and was substantially equivalent to the predicate.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set of data.

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

• Not applicable. (See answer to point 8).

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The Neurological Theray Devices - Accessories including Garment electrodes which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.

The Neurological Therapy Devices - Accessories -Conductive fiber(Model:Electrotherapy device Electrode for Knee, Electrotherapy device Electrode for Elbow, Electrotherapy device Electrotherapy device Electrode socks.Neurological physiotherapy devices-accessories), are conductive garments that are made from material which is knitted from primarily nylon yarn with minor amounts of lycra, spandex to achieve a stretch fabric for a snug garment fit polyester for tactile qualities and polyester sheathed carbon yarn and pure silver coated nylon fibers to provide conductivity. The knitting follows standard knitting procedures with the conductive knitted material being fabricated into Neurological Therapy Devices - Accessories garments which are provided in multiple sizes of various garment configurations including; gloves, bands, socks, and sleeves.

The Neurological Therapy Devices - Accessories-conductive silicone rubber(Model:Electrotherapy device Electrode belt for back of body, Electrotherapy device Electrode belt for Abdominal Muscle TrainerToning, Electrotherapy device Electrode belt for Body joints,Electrotherapy device Electrode belt for arm of body,Electrotherapy device Electrode belt for back of body,Electrotherapy device Electrode belt for shoulder of body,Neurological physiotherapy devices-accessories), is made of conductive silicone rubber coated in conductive garments material, has excellent conductive performance and good flexibility and plasticity, can adapt to the needs of different shapes and sizes of electrodes.

The stretch characteristics of the material provide sufficient elasticity to ensure firm surface contact with the skin. The design of the devices is such that they can be used skin by reversing the surface contacting the skin.

The Neurological Therapy Devices - Accessories utilize conductive silicone rubber as a conduit for current transmission. When current passes through the garment electrodes, the conductive silicone rubber transmit the current to the surface of the body, thus enabling the transmission of current. The entire surface of the Neurological Therapy Devices - Accessories is very conductive having a resistance of less than 7 ohms per inch. This provides low current density with uniform current distribution to enable efficient use of these Neurological Therapy Devices - Accessories for use in TENS (transcutaneous electrical nerve stimulators) and NMES (powered muscle stimulator devices).

The Neurological Therapy Devices - Accessories are non- sterile external devices which are designed for single patient, for multiple uses and are intended for Prescription Use and/or OTC use with FDA Cleared TENS and NMES class II devices.

The provided FDA 510(k) summary (K232995) describes the acceptance criteria and the study conducted to demonstrate that the Neurological Therapy Devices - Accessories meet these criteria.

Here's a breakdown of the requested information:

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

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document explicitly states "No clinical testing was performed" (Section 8). Therefore, there isn't a "test set" in the context of human subjects or clinical data. The performance was evaluated through non-clinical bench testing. The sample sizes for the materials tested in biocompatibility and electrical performance bench tests are not specified in this summary.
• Data Provenance: The company is Shenzhen Roundwhale Technology Co., Ltd. in China. The testing would presumably have been conducted in China or by laboratories contracted by the company, adhering to international standards. The data is non-clinical (bench testing).

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)

Not applicable. As no clinical testing was performed, there was no "test set" requiring expert ground truth establishment in a clinical context. The performance was assessed against technical specifications and international standards in a laboratory setting.

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

Not applicable. There was no clinical test set requiring adjudication.

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. This device is an accessory (an electrode) for electrotherapy devices, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant and was not conducted.

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

Not applicable. This is not an algorithm-only device. It is a physical accessory (electrode). The "standalone" performance refers to the device's electrical conductivity and biocompatibility, which were assessed via bench testing as described.

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

The "ground truth" for this device's performance is based on:

• International Standards: Specifically, ISO 10993 series for biocompatibility testing (ISO 10993-5, ISO 10993-10, ISO 10993-23).
• Technical Specifications: Defined electrical performance criteria (e.g., resistivity less than 7 ohms per inch).
• Comparison to Predicate Devices: Demonstrating similarity in design, materials, function, and performance to legally marketed devices.

8. The sample size for the training set

Not applicable. As this device is a physical cutaneous electrode and not an AI/machine learning model, there is no "training set."

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

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

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Model:R-C101W:

• For TENS/IF/MIC mode
• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain
• For EMS/RUSS 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 muscles to prevent venous thrombosis

Model:R-C101A

• For TENS/IF mode
• 1. Symptomatic relief of chronic intractable pain.
• 2. Post traumatic pain.
• 3. Post surgical pain.
• For EMS/RUSS mode
• 1. Relaxation of muscle spasm.
• 2. Increase of 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 muscles to prevent venous thrombosis

Model:R-C101B
For TENS/IF mode

• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain
• For EMS/RUSS 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 muscles to prevent venous thrombosis

Model:R-C101E
For IF mode

• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain
     For RUSS 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 muscles to prevent venous thrombosis

Model:R-C101H
For TENS and IF mode

• 1. Symptomatic relief of chronic intractable pain.
• 2. Post traumatic pain.
• 3. Post surgical pain.

Model:R-C101D
For TENS mode

• 1. Symptomatic relief of chronic intractable pain
• 2. Post traumatic pain
• 3. Post surgical pain

Model:R-C101G
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 muscles to prevent venous thrombosis

The Combo Electrotherapy Device (Models: R-C101W, R-C101B, R-C101E, R-C101H, R-C101D, and R-C101G) is a Transcutaneous Electrical Nerve Stimulator. The device features two independent output channels and four selfadhesive electrode gel pads. The stimulator sends a gentle electrical current to the underlying nerves and muscle groups via electrodes applied on the skin. Users can choose from pre-set programs or specify their own to suit their individual needs. All controls and indicators are controlled by software which also controls waveform characteristics. The 7 models have similar housing with a viewable LCD display and an accessible keypad. The LCD is located on the upper half of the rectangular face of the device above the keypad. It is used to display system information to the user. The device is battery-powered but can be connected to an external power supply its internal battery which is a non-user serviceable or accessible 3.7V D.C., Li-ion battery. There are only two external connections on the device - power input and electrode connector - with no connection to any other devices. The Battery Charger is not included in the package; however, users can choose adapters that meet IEC 60601-1 medical stardards.

The provided document is a 510(k) Premarket Notification for a "Combo Electrotherapy Device." It establishes substantial equivalence to a predicate device, K171978. The document primarily focuses on non-clinical performance and safety data, as no clinical data was performed.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely based on demonstrating equivalence to the predicate device (K171978) in technical characteristics and compliance with relevant safety standards. The reported device performance is presented as a comparison to the predicate device.

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Self-Adhesive Electrode is intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e.TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF or IFC(Interferential current) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.

Self-Adhesive Electrode are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Roundwhale are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:

1. Top layer: Fabric/Foam/ Tan fabric
2. Middle layer: Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film)
3. Bottom layer: Biocompatible self-adhesive conductive hydrogel
4. Connection: Leadwire/snap button/magnetic button
5. double sides adhesive tape: Which is used for attaching the non-woven fabrics and conducting film
6. Release film: Release film is a protective layer for the hydrogel.
   The electrodes are designed for single-patient/multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
   For the electrical connection, Roundwhale provides lead wire type and snap button/Magnetic button type:

• Leadwire assembly: The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer.
• Snap button/Magnetic button assembly: With 2.5~5mm diameter male socket.

This document is an FDA 510(k) summary for the Shenzhen Roundwhale Technology Co., Ltd. "Self-adhesive Electrode" device. It outlines the device's indications for use, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This document pertains to a cutaneous electrode, which is a relatively simple medical device. Therefore, the "acceptance criteria" and "study" described are focused on physical and electrical performance and biocompatibility, not on complex diagnostic accuracy metrics like those for AI-powered imaging devices (e.g., sensitivity, specificity, AUC). The request's points regarding MRMC studies, expert concensus for ground truth, and training data are typically applicable to AI/ML device submissions, which are not relevant to this electrode device.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on established industry standards and comparisons to legally marketed predicate devices. The "reported device performance" demonstrates that the proposed device meets or is comparable to these criteria.

Table of Acceptance Criteria and Reported Device Performance:

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Over-The-Counter Use:

TENS mode::

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

EMS mode:

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

Prescription Use:

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.

Not Found

This document is a 510(k) clearance letter from the FDA for a Combo Electrotherapy Device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way a clinical study report for an AI/ML device would. The letter primarily confirms the device's substantial equivalence to predicate devices and lists the indications for use.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies from the provided text. This document is a regulatory clearance, not a performance study report.

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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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