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510(k) Data Aggregation
(29 days)
GZJ
As a TENS device, the CP Relief Wand Rx - TENS/NMES is intended for use as an adjunctive therapy for pain management for medical purposes such as symptomatic relief of chronic intractable pain and relief of acute post surgical and post-traumatic pain.
As an EMS device, the CP Relief Wand Rx - TENS/NMES is intended for use for relaxation of muscle spasm, increasing local blood circulation, muscle re-education, prevention or retardation of disuse atrophy, prevention of venous thrombosis of the calf muscles immediately after surgery, and maintaining on increasing range of motion.
The CP Relief Wand Rx - TENS/NMES®("Wand") is a multitherapy medical device that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).
The CP Relief Wand Rx - TENS/NMES is portable with self-contained electrodes. The device is powered by a standard non-rechargeable 9-volt alkaline battery. A charger is not used due to the low current drain and long battery life of the low power circuitry.
In operation, the electrode end of the CP Relief Wand Rx - TENS/NMES is positioned to touch the skin. The electrical pulses travel from one electrode, through the skin, through the underlying tissue, and back through the skin to the other electrode. Controls on the unit are provided for power, intensity, pulse width, and pulse polarity.
This FDA 510(k) clearance letter pertains to a TENS/NMES device, not an AI/ML-driven medical device. Therefore, the information typically found in a study proving an AI/ML device meets acceptance criteria (such as performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment) is not present in this document.
The document discusses the substantial equivalence of the "CP Relief Wand Rx - TENS/NMES" to predicate devices based on regulatory parameters, specifications, and the leveraging of performance testing from the primary predicate. It does not describe a new study specifically designed to assess the performance of the device against acceptance criteria in the context of an AI/ML model.
Therefore, I cannot provide the requested information for acceptance criteria and study details as they relate to an AI/ML device, as this document does not contain that type of data.
The document primarily focuses on:
- Substantial Equivalence: Arguing that the new device is as safe and effective as previously cleared devices.
- Expansion of Indications for Use: Adding EMS functionality, which is justified by comparison to a second predicate device that already has EMS indications.
- Performance Data (Leveraged from Predicate): Citing existing standards compliance from the primary predicate device, rather than new performance studies on an AI/ML algorithm.
If you have a document describing an AI/ML device and its validation study, I would be happy to analyze it for the requested information.
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(382 days)
GZJ
TENS stands for Transcutaneous Electrical Nerve Stimulation. Unipro TENS is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
EMS stands for Electrical Neuromuscular Stimulation. Unipro EMS is indicated for:
- · Relaxation of muscle spasm
- · Increasing local blood circulation and muscle re-education
- · Prevention or retardation of disuse atrophy
- · Prevention of venous thrombosis of the calf muscles immediately after surgery
- · Maintaining on increasing range of motion
MIC stands for Microcurrent Stimulation. Unipro MIC is used to provide sumptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.
IFT stands for Interferntial Stimulation. Unipro IFT is indicated for symptomatic relief of chronic intractable pain.
Unipro is a non-invasive, non-sterile, reusable medical device which is intended to be used in both the hospital and home healthcare environment. It is a microprocessor controlled, non-implantable, portable neuromuscular electrical stimulator which is powered by a built in Li-ion rechargeable battery.
Unipro is a multitherapy unit that combines the treatment capabilities of TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscle Stimulation), MIC (Microcurrent Stimulation) and IFT (Interferential Therapy). The mode selection button on device will enable the user to switch between different modes (TENS, EMS II, EMS III, or massage). Each time the user changes the mode or program, the intensity level will revert to zero. This is a safety feature to alleviate any sudden feeling of a surge, as each program gives a different sensation.
Unipro Case L (large) features a white ABS case with a white silicone button pad and white power button. Power button is located on the right-hand side of the device. The hardware features a black perimeter border and black LCD display. Charging cable and lead inserts are located on the bottom of the device.
Unipro is supplied with self-adhesive electrodes which attach to the control unit via lead wires. A gentle electrical current is sent to underlying nerves and muscle groups via these electrodes applied on the skin to relieve pain. Placement of the electrode pads of the device depends on the selected device mode (TENS, EMS, IFT2, IFT4, MIC). For TENS, the easiest way is to apply the electrode pads around/near the source of the pain. For EMS, place two electrode pads over the bulk of the muscle, with one electrode over the muscle's motor point. For IFT2, electrodes should be placed either side of the area of pain and for IFT4, the pads need to apply in positions so that the signals from each channel cross over the point to be treated. Finally, for MIC, the electrode pads should be placed in such a way that a straight line between them passes through the problem area.
The TensCare Ltd Unipro (K232441) is a multi-therapy electrical stimulator combining TENS, EMS, MIC, and IFT functionalities. The submission claims substantial equivalence to the predicate device, Ultima NEO (K120054).
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided documentation does not explicitly list "acceptance criteria" for performance metrics in a pass/fail format. Instead, it compares the technical characteristics and indications for use of the Unipro to its predicate device, Ultima NEO, to demonstrate substantial equivalence. The "Comparison" column in the tables serves as a qualitative assessment of whether the Unipro's performance characteristics are similar enough to the predicate.
| Characteristic | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (Unipro) | Comparison |
|---|---|---|---|
| Indications for Use | Identical to Ultima NEO | TENS, EMS, MIC, IFT for pain relief and muscle stimulation (detailed in text) | Identical |
| Intended Population | Similar to Ultima NEO (Male and female patients over 18) | Male and female patients over 21 | Substantially Equivalent (difference in age: 21 vs 18) |
| Power Source | Similar to Ultima NEO (Li-ion rechargeable battery) | 3.7V 1500mAh Lithium-ion battery (rechargeable) | No substantial difference |
| Average DC current through Electrodes (no pulses) | 0 µA | 0 µA | Identical |
| Number of Output Modes | 4 (TENS, EMS, MIC, IFT) | 4 | Identical |
| Number of programs/modes | Similar to Ultima NEO (41 programs) | 76 | No substantial difference (Both comply with IEC 60601-1) |
| Number of Output Channels | 2 | 2 | Identical |
| Timer Range | Similar to Ultima NEO (10-90 minutes, constant) | 5-90 minutes, constant | No substantial difference (Unipro can be set lower) |
| Regulated Current or Voltage? | Current and Voltage | Current and Voltage | Identical |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Identical |
| Automatic No-Load Trip? | Not publicly available for predicate (implied: similar/present) | Yes (TENS/EMS) | - |
| Automatic Overload Trip? | Not publicly available for predicate (implied: similar/present) | No | - |
| Automatic Shut Off? | Not publicly available for predicate (implied: similar/present) | Yes | - |
| User Override Control? | Not publicly available for predicate (implied: similar/present) | Yes | - |
| Indicator Display | On/Off, Low battery, Voltage/Current level, Time to cut-off | Yes for all | Identical |
| Compliance Voluntary Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, etc. | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, etc. | Substantial equivalent |
| Compliance with 21 CFR regulations | Yes | Yes | Identical |
| Dimensions | Similar to Ultima NEO (123 x 61 x 22mm) | 125mm x 62mm x 29.6mm | Different, but does not affect safety/effectiveness |
| Weight | Similar to Ultima NEO (160g) | 128.5g | Different, but does not affect safety/effectiveness |
| Housing Materials | ABS 757 material | ABS 757 material | Identical |
| Sterilization | N/A | N/A | Identical |
| Waveform (TENS/EMS) | Bi-phase Symmetrical Rectangular, Asymmetrical Rectangular, Mono-Phase Symmetrical Rectangular (predicate) | TENS/EMS: Symmetrical Rectangular | No substantial difference |
| Waveform (Microcurrent) | Symmetrical Rectangular (predicate) | Continuous square unipolar, sawtooth unipolar, symmetrical balanced wave | No substantial difference (Both comply with IEC 60601-1) |
| Waveform (IFT) | Symmetrical balanced sine wave | Symmetrical balanced wave | Identical |
| Maximum Output Voltage (TENS/EMS) | 73.6V@500Ω, 120V@2 kΩ, 124V@10 kΩ (predicate) | 54V@500Ω, 114 V@2 kΩ, 116 V@10 kΩ | No substantial difference (lower, but proportional to current, complies with IEC 60601-1) |
| Maximum Output Voltage (Microcurrent) | 0.54V@500Ω, 2.12V@2 kΩ, 10.2V@10 kΩ (predicate) | 0.4V@500Ω, 1.56 V@2 kΩ, 7.8 V@10 kΩ | No substantial difference (lower, but proportional to current, complies with IEC 60601-1) |
| Maximum Output Voltage (IFT) | 17V@500Ω, 30V@2 kΩ, 32 V@10 kΩ (predicate) | 24V@500Ω, 34.4 V@2 kΩ, 40 V@10 kΩ | No substantial difference (complies with IEC 60601-1) |
| Maximum Output Current (TENS/EMS) | 147mA@500Ω, 60mA@2 kΩ, 12.4mA@10kΩ (predicate) | 108mA@500Ω (200μs), 80mA @500Ω (400μs), 57mA@2 kΩ, 11.6 mA@10 kΩ | No substantial difference (Unipro features amplitude modulation mode) |
| Maximum Output Current (Microcurrent) | 1.08mA, 1.06mA, 1.02mA (predicate) | 0.8mA, 0.78 mA @2 kΩ, 0.78 mA @10 kΩ | No substantial difference (Unipro MIC amplitude smaller, complies with IEC 60601-1) |
| Maximum Output Current (IFT) | 34mA@500Ω, 15mA@2 kΩ, 3.2mA@10kΩ (predicate) | 48mA@500Ω, 17.2mA@2 kΩ, 4mA@10 kΩ | No substantial difference (complies with IEC 60601-1) |
| Pulse Width (TENS/EMS) | 50-400µs (predicate) | TENS: 50-300 µs, EMS: 100-400 µs | No substantial difference (within recommended output, complies with IEC 60601-2-10) |
| Pulse Width (Microcurrent) | 2-200ms (predicate) | 10-200ms | No substantial difference (within recommended output, complies with IEC 60601-2-10) |
| Pulse Width (IFT) | 120-125µs (predicate) | 125 µs | No substantial difference (within recommended output, complies with IEC 60601-2-10) |
| Frequency (TENS/EMS) | 1-150Hz (predicate) | TENS: 2-150Hz, EMS: 10-120Hz | No substantial difference (Unipro's range is within recommended range, complies with IEC 60601-2-10) |
| Frequency (Microcurrent) | 1-150Hz (predicate) | 0.5Hz, 1Hz, 1.5Hz, 2Hz, 3Hz, 4Hz, 5Hz to 50Hz | No substantial difference (within recommended range, complies with IEC 60601-2-10) |
| Frequency (IFT) | 4000-4160Hz (predicate) | 2-160Hz (Carrier Frequency: 4000Hz fixed (CH1)) | No substantial difference (Predicate's higher frequency may not offer additional benefit, complies with IEC 60601-2-10) |
| Net Charge (µC per pulse) | 0.4µC@ 500 Ω (predicate) | 0.3µC@ 500 Ω | No substantial difference (Charge output dependent on current, complies with IEC 60601-1) |
| Maximum Phase Charge (µC) | TENS/EMS: 21.62μC@500Ω, Microcurrent: 220.8μC@500Ω, IFT: 5.16μC@500Ω (predicate) | TENS/ EMS: 22.76μC@500Ω, Microcurrent: 160μC@500Ω, IFT: 2.8μC@500Ω | No substantial difference (Charge used to set pulse width, complies with IEC 60601-1) |
| Maximum Current Density (mA/cm²) | TENS/EMS: 5.88mA/cm²@500Ω, Microcurrent: 0.022mA/cm²@500Ω, IFT: 1.65mA/cm²@500Ω (predicate) | TENS/EMS: 0.8mA/cm²@500Ω, Microcurrent: 0.008mA/cm²@500Ω, IFT: 0.82mA/cm²@500Ω | No substantial difference (both comply with IEC 60601-1) |
| Maximum Power Density (W/cm²) | TENS/EMS: 0.0086W/cm², Microcurrent: 0.012W/cm², IFT (predicate) | TENS/ EMS: 0.0076 W/cm2, Microcurrent: 0.0001049 W/cm2, IFT | No substantial difference (both comply with IEC 60601-1) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission indicates that "No clinical testing was considered necessary." Therefore, there is no sample size for a new test set or details on data provenance from a prospective or retrospective study involving the Unipro device. The equivalence claim is based on comparison to the predicate and literature review.
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 on the device to establish a new ground truth. The basis of the submission relies on the established safety and effectiveness of the predicate device and the modes of therapy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical testing was performed that would require adjudication of a test set.
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 not an AI-assisted diagnostic or interpretative tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a direct-use electrical stimulator, not an algorithm. Its performance is evaluated through bench testing against established standards and comparison to a predicate device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the Unipro's substantial equivalence claim is based on the established safety and effectiveness of the legally marketed predicate device (Ultima NEO), and recognized international consensus standards (e.g., IEC 60601-1, IEC 60601-2-10). Additionally, it mentions a formal review of published research and clinical evaluation on the use of TENS, EMS, IFT, and MC for pain relief and muscle training, which serves as a form of expert consensus and outcomes data from the broader scientific community.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/machine learning device that requires a training set.
Ask a specific question about this device
(117 days)
GZJ
The TENSWave is indicated for management and symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "TENSWave," which is a Transcutaneous Electrical Nerve Stimulator for pain relief.
The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The letter primarily focuses on the device's substantial equivalence to predicate devices, its regulatory classification, and applicable general controls and regulations.
Therefore, an answer to the request to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be generated from the given text.
The provided information only states:
- Trade/Device Name: TENSWave
- Regulation Number: 21 CFR 882.5890
- Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
- Regulatory Class: Class II
- Product Code: GZJ
- Indications for Use: The TENSWave is indicated for management and symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.
To answer the user's request, information regarding performance testing, clinical study results, and defined acceptance criteria would be necessary, which is absent in this FDA clearance letter.
Ask a specific question about this device
(207 days)
GZJ
The Cure Trio MC-310A is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion
The Cure Trio MC-310B is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy
The Cure Trio MC-310C is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles
- [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy
The Cure Trio MC-310D is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain
The Cure Trio MC-310E is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
- [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain
The Cure Trio MC-310F is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2]Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy
The Cure Trio MC-310G is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] For prevention of retardation of disuse atrophy
The Cure Trio MC-310H is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
- [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties
The Cure Trio MC-310I is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance
The Cure Trio MC-310O is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, wast, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion
The Cure Trio MC-310P is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
- [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain
The Cure Trio MC-310Q is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
- [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain
The Cure Trio MC-310R is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremntes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion
The Cure Trio MC-310S is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion
The Cure Trio MC-310T is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
The Cure Trio MC-310U is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles [2] To stimulate healthy muscles in order to improve and facilitate muscle performance
The Cure Trio MC-310A is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion
The Cure Trio MC-310B is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy
The Cure Trio MC-310C is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles
- [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy
The Cure Trio MC-310D is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain
The Cure Trio MC-310E is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
- [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain
The Cure Trio MC-310F is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain [2]Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy
The Cure Trio MC-310G is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] For prevention of retardation of disuse atrophy
The Cure Trio MC-310H is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
- [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties
The Cure Trio MC-310I is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance
The Cure Trio MC-310O is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, wast, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To stimulate healthy muscles in order to improve and facilitate muscle performance - [3] To relax muscle spasm - [4] To increase blood flow circulation - [5] For prevention of retardation of disuse atrophy - [6] For muscle re-education - [7] For maintaining or increasing range of motion
The Cure Trio MC-310P is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
- [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities - (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain
The Cure Trio MC-310Q is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
- [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties - [4] Relief of post-surgical pain and post traumatic acute pain
The Cure Trio MC-310R is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: [1] Symptomatic relief and management of chronic, intractable pain
[3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremntes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion
The Cure Trio MC-310S is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis - [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremites - (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain - b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: - [1] To temporarily increase local blood circulation in healthy leg muscles - [2] To relax muscle spasm - [3] To increase blood flow circulation - [4] For prevention of retardation of disuse atrophy - [5] For muscle re-education - [6] For maintaining or increasing range of motion
The Cure Trio MC-310T is Transcutaneous Electrical Nerve Stimulation device(Only TENS) for pain management. It is intended to provide:
[1] Symptomatic relief and management of chronic, intractable pain [2] Relief of pain associated with arthritis [3] temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arms) and lower extremities (legs) due to strain from exercise or normal household duties
The Cure Trio MC-310U is electrical stimulator designed for pain management and neuro muscular stimulation.
a. When using Cure Trio to deliver Transcutaneous Electrical Nerve Stimulation (TENS Mode), it is intended to provide: - [1] Symptomatic relief and management of chronic, intractable pain - [2] Relief of pain associated with arthritis [3] Temporarily relieves pain associated with sore and aching muscles in the shoulder, waist, back, upper extremittes (arms) and lower extremities (legs) due to strain from exercise or normal household duties [4] Relief of post-surgical pain and post traumatic acute pain b. When using Electrical Muscle Stimulation (EMS Mode), Cure Trio is intended: [1] To temporarily increase local blood circulation in healthy leg muscles [2] To stimulate healthy muscles in order to improve and facilitate muscle performance
The provided document is a 510(k) clearance letter from the FDA for a device called "Electrical Neuromuscular Stimulator, Cure Trio Models MC-310A, MC-310B," etc. This document states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain any information about the acceptance criteria or a study proving the device meets acceptance criteria. It lists the indications for use for various models but does not delve into performance metrics, clinical study design, or results.
To answer your request thoroughly, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a substantial equivalence discussion document that typically accompanies 510(k) submissions.
Therefore, I cannot provide the requested information from the given text.
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(124 days)
GZJ
The Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, the TENS WMPS6-1 is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post-surgical and post traumatic pain.
Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. The device has 18 programs (13 standard programs and 5 editable programs), powered by 6 pieces of 1.5V batteries or AC 100-240V, comprising electronic stimulatory module and accessories of lead wires, electrodes. Six outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.
The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It details the device's technical specifications and a comparison to a predicate device to establish substantial equivalence for regulatory clearance. This document does not describe an AI-powered medical device or an associated study for complex acceptance criteria like those involving AI performance metrics (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts).
Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from the provided text. The device is a physical medical device (TENS) and the "study" referred to in the document is a series of non-clinical bench tests to compare it to a predicate device, and to verify safety and performance standards.
Here's a breakdown of why I cannot fulfill your request based on the provided text:
- No AI Component: The device is a Transcutaneous Electrical Nerve Stimulator, a physical product that applies electrical current. There is no mention of any AI or machine learning component.
- No Diagnostic/Interpretive Task: The device is for pain relief, not for image analysis, diagnosis, risk prediction, or any other task that would typically involve acceptance criteria like sensitivity, specificity, or the need for ground truth established by experts.
- No Human-in-the-Loop Study: Since there's no AI component, there's no MRMC (Multi-Reader Multi-Case) study described for human readers improving with AI assistance.
- No Standalone Algorithm Performance: There is no algorithm to assess in a standalone capacity.
- No Training Set/Test Set (in the AI context): The concepts of training and test sets as they apply to machine learning models are not relevant to the clearance of this physical device. The "test set" here refers to the device itself undergoing bench tests.
- No Ground Truth Establishment by Experts: Ground truth for AI models is often established by expert consensus (e.g., radiologists reviewing images). For this TENS device, "ground truth" would refer to its physical and electrical properties meeting specified standards, validated through engineering tests, not human interpretation.
Summary of what the document DOES describe in terms of performance and comparison:
The document describes acceptance criteria in the context of substantial equivalence to an existing predicate device and compliance with voluntary standards for electrical medical equipment.
-
Acceptance Criteria (Implicit via Comparison to Predicate and Standards Compliance): The acceptance criteria are primarily demonstrated by showing that the new device's specifications (e.g., power source, output channels, waveform, voltage, current, safety features) are either identical, similar with acceptable differences (justified by safety and effectiveness analyses), or meet the requirements of relevant electrical safety and performance standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10). The reported device performance is presented as compliance with these standards and the specific electrical output values listed in the comparison table.
-
Study That "Proves" Compliance: The "study" here is a series of non-clinical bench tests.
- Sample Size: This is not a study with a "sample size" in the statistical sense of patient data. It refers to testing the physical device itself.
- Data Provenance: Not applicable as it's not a data-driven AI study. The tests are bench tests performed on the device.
- Experts and Ground Truth: Not applicable in the way you've defined them for an AI study. Electrical engineers and regulatory compliance experts would be involved in setting and verifying the test standards.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: The "standalone" performance here refers to the device successfully passing all required electrical and safety tests independently (i.e., not reliant on human interpretation for its function).
- Type of Ground Truth: The "ground truth" is compliance with established engineering and medical device safety standards for TENS devices (e.g., maximum current density limits, electrical isolation, waveform characteristics).
- Training Set/Ground Truth for Training: Not applicable.
If you have a document describing an AI medical device, please provide that, and I will be able to answer your questions with the level of detail you are seeking.
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(392 days)
GZJ
The iRelieve Microcurrent Pain Relief System is intended to be used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain.
The iRelieve Microcurrent Pain Relief System is a microcurrent TENS device that operates by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help block the body's ability to send a pain message to the brain, thereby reducing the pain sensation. The iRelieve Microcurrent Pain Relief System is a single channel device that produces microampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 3.0 volts. It is controlled by analogue electrical parts (voltage regulator, frequency oscillator, multiple resistors, etc.) and a digital microprocessor chip that contains embedded programmed software (firmware) that generates a sequence of current flows and frequencies during the course of a single treatment session. The iRelieve Microcurrent Pain Relief System performs this sequence of current flows without user manipulation or device controls other than switching the device on after application of the device to the electrodes.
The provided text is a 510(k) Summary for the iRelieve Microcurrent Pain Relief System. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to clinical performance or efficacy.
Instead, the performance testing for the iRelieve Microcurrent Pain Relief System focuses on:
- Output Performance: Micro Current Stimulator Measurements, Validation of Electrodes, Output sequence with Oscilloscope captures.
- Device Integrity/Safety: Shelf-life testing, Packaging testing (ASTM D4169-16), Battery use life testing, Biocompatibility testing (leveraged from predicate), Electromagnetic compatibility (EMC) and electrical safety (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 standards).
- Software Validation: Software verification and validation per FDA guidance for Class B level of concern (IEC 62304).
The document explicitly states that the determination of substantial equivalence is based on the device having the "same intended use and similar technical characteristics, performance and applications" as the predicate device (Model 7500 Microcurrent TENS Device, Version MCT-F50, K013167), and that it "does not pose any new question of safety or effectiveness."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets clinical acceptance criteria because this information is not present in the provided document. The document details technical performance and safety testing to demonstrate substantial equivalence to a predicate device, not a new clinical efficacy study with acceptance criteria.
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(263 days)
GZJ
StimOn™ Pain Relief System (GM2439) is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain.
StimOn™ Pain Relief System (GM2439) is a hand-held stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves. It may be used as a TENS device to aid the blocking of pain signals traveling to the brain.
The document describes the StimOn™ Pain Relief System (GM2439) and its substantial equivalence to predicate devices, but it does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) for an AI/algorithm-based device, nor does it detail a study proving the device meets such criteria in terms of AI performance.
Instead, the document focuses on the regulatory clearance of a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, primarily through comparison with existing predicate devices and compliance with relevant electrical safety and performance standards. The "performance testing" mentioned refers to these safety and electrical performance standards, not to clinical efficacy measured by AI performance metrics.
Therefore, many of the requested items regarding acceptance criteria and study details for an AI-based device's performance cannot be extracted from this document.
Here's the information that can be extracted, and where the document does not provide the requested information:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantified acceptance criteria for AI performance (e.g., sensitivity > X%, specificity > Y%). Instead, it discusses the device's technical characteristics and how they compare to predicate devices. The "performance testing" section refers to compliance with electrical safety and performance standards, not AI accuracy.
| Characteristic | Acceptance Criteria (Not explicitly stated for AI performance) | Reported Device Performance (from "Table 1. Comparison table" and subsequent descriptions) |
|---|---|---|
| Intended Use | Same as predicate devices | Symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical or post-traumatic pain. |
| Product Code | GZJ | GZJ |
| Power Supply | Not explicitly stated as acceptance criteria, but compared to predicates | One 3.7V, 125mAh rechargeable Lithium polymer battery |
| Treatment Timer Maximum | Not explicitly stated as acceptance criteria, but compared to predicates | 15 minutes |
| Number of Output Modes | Not explicitly stated as acceptance criteria | 1 (RF Mode) |
| Number of Waveforms | Not explicitly stated as acceptance criteria | 1 |
| Waveform | Not explicitly stated as acceptance criteria | Biphasic (Sine Wave) |
| RF Stimulation Mode | Not explicitly stated as acceptance criteria | Transcutaneous Pulsed Radio-frequency (PRF) mode |
| RF Frequency | Not explicitly stated as acceptance criteria | 500 kHz fixed |
| Burst Time | Not explicitly stated as acceptance criteria | 25ms |
| Burst Frequency | Not explicitly stated as acceptance criteria | 2Hz |
| Electrode Contact | Not explicitly stated as acceptance criteria | Hydrogel pad |
| Load Impedance | Not explicitly stated as acceptance criteria, but stated as a shutdown threshold | 1 k Ohm, Over this load, the system will automatically shut off. |
| Maximum Output Voltage | Not explicitly stated as acceptance criteria | 7.4 V+/-10% (6.6 V +/- 20% @@500Ω with Electrode Pad) |
| Maximum Output Current | Not explicitly stated as acceptance criteria | 14.8 mA (Peak)@500Ω (13.2 mA (Peak)@500Ω with Electrode Pad) |
| Maximum Average Current (Over primary phase) | Not explicitly stated as acceptance criteria | 9.43 mA (Peak)@500Ω (8.41mA(Peak)@500Ω with Electrode Pad) |
| Maximum Average Power Density (Smallest electrode area) “P” | Must be within value range of predicates | 112.81 µW/mm² @500Ohm with Electrode |
| Maximum Current (RMS) Density (mA/mm²) | Not explicitly stated as acceptance criteria | 0.0242 mA /mm² @500Ω with Electrode |
| Net Charge | Not explicitly stated as acceptance criteria | The theoretical value is 0. |
| Maximum average phase charge | Not explicitly stated as acceptance criteria | 0.00942μC |
| Electrical Safety & Performance | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, ANSI/AAMI NS4 | Device underwent testing and demonstrated compliance (implied by substantial equivalence). |
| Biocompatibility | Meet standards for electrodes leveraged from K180865 | Leveraged from cleared electrodes (K180865). |
| Usability | Compliance with IEC 62366: Medical devices Part 1: Application of usability engineering to medical devices | Device complies with IEC 62366 and is similar to K180943 (BioWaveGO) cleared for OTC use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The document states "No Human Clinical Performance Testing have been required" for this application. The performance testing refers to electrical and safety standards, not clinical performance data from a test set of patients/cases.
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 / Not provided. No clinical test set requiring expert ground truth was used for assessing the device's efficacy, as per the submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No clinical test set requiring 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 / Not provided. This device is a Transcutaneous Electrical Nerve Stimulator, not an AI-assisted diagnostic or interpretative device that augments human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. This device is hardware for pain relief, not an algorithm/AI system in the sense of a diagnostic or predictive tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. No clinical ground truth was established for "performance" as it relates to AI or clinical efficacy. The "performance testing" was for electrical safety, electromagnetic compatibility, and biocompatibility, which rely on technical standards and laboratory measurements.
8. The sample size for the training set
- Not applicable / Not provided. Not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. Not an AI/algorithm-based device requiring a training set.
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(86 days)
GZJ
The Transcutaenous Electrical Nerve Stimulator (Model RJTENS-1) is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and 4x1.5V AAA alkaline batteries. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K213879), Size 50*50mm.
The provided text describes the 510(k) summary for the Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1). Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly derived from its substantial equivalence to the predicate device (K202893). The "Comparison" column in the table indicates "Same" or "Similar" for most parameters, meaning the new device's performance aligns with the established performance of the predicate. Note 1 explicitly addresses the difference in deviation from amplitude, frequency, and pulse width.
| Parameter | Acceptance Criteria (Predicate Device K202893) | Reported Device Performance (Model RJTENS-1) |
|---|---|---|
| Indications for Use | Same as predicate | Same as predicate |
| Type of Use | Prescription use | Prescription use |
| Power Source(s) | 1.5Vx4 AAA alkaline battery | 1.5Vx4 AAA alkaline battery |
| Method of Line Current Isolation | N/A | N/A |
| Patient Leakage Current - Normal Condition | 2μΑ | 2μΑ |
| Patient Leakage Current - Single Fault Condition | NA | NA |
| Average DC current through electrodes |
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(60 days)
GZJ
TENS device-EmeTerm 2 is a wearable device for the treatment of nausea and vomiting caused by motion sickness and pregnancy.
TENS device-EmeTerm 2 is a single-patient use wearable device, rechargeable, non-invasive device that is worn on the wrist like a watch. It is a non-invasive device that is indicated for the over-the-counter use in the relief of mild to moderate nausea and vomiting, motion sickness, mild to moderate nausea and vomiting associated with pregnancy.
TENS device-EmeTerm 2 includes a Rubber wristband with two electrodes must be placed at the center of the inner wrist, about 2 to 3cm from the wrist crease. The electrodes in the wristband provide relief of nausea and vomiting through electrical stimulation of the median nerve on the ventral side of the patient's wrist.
This is a submission for a TENS device, which is not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, human reader performance, ground truth, and training set information is not applicable in this context. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data and adherence to recognized standards.
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(263 days)
GZJ
The Transcutaneous Electrical Nerve Stimulator is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment of post surgical and post traumatic pain.
Transcutaneous Electrical Nerve Stimulator is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The device has standard programs and edit programs. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and battery. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.
This document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this submission is to demonstrate that the new device, "TENStem eco basic," is substantially equivalent to a legally marketed predicate device (K112288), also a TENS device manufactured by the same company, Wuxi Jiajian Medical Instrument Co., Ltd.
Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the parameters of the predicate device (K112288) and the relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10). The reported device performance is presented as a comparison between the proposed device ("Modified Device") and the predicate device in the "Substantially Equivalent Comparison Conclusion" table.
| Parameter | Acceptance Criteria (Predicate Device K112288) | Reported Device Performance (TENStem eco basic) | Remark (Meeting Criteria) |
|---|---|---|---|
| Intended Use | Same | Same | Met |
| Type of Use | Prescription use | Prescription use | Met |
| Power Source(s) | 9V Battery type 6F22 | 1.5Vx4 AAA alkaline battery | Similar (Note 1) |
| Method of Line Current Isolation | NA | N/A | Met |
| Patient Leakage Current - Normal Condition (μΑ) | 2μΑ | 2μΑ | Met |
| Patient Leakage Current - Single Fault Condition (μΑ) | NA | NA | Met |
| Average DC current through electrodes when device is on but no pulses are being applied (μΑ) |
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