Search Results

Transcutaneous Electrical Nerve Stimulation (TENS):
The 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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

Electrical Muscle Stimulation (EMS):
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

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I am sorry, but the provided FDA 510(k) Clearance Letter for the "OTC 4-Channel Rechargeable TENS Unit" (K251429) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on the regulatory aspects of the clearance, such as:

• Device name and regulation
• Regulatory class and product code
• Substantial equivalence determination
• General controls and additional controls applicable to the device
• References to FDA guidance documents and regulations (e.g., Quality System regulation, UDI Rule)
• Contact information for the FDA

Specifically, the document does NOT include:

1. A table of acceptance criteria and reported device performance: This type of data would typically be found in the actual 510(k) submission, not the clearance letter.
2. Sample size used for the test set and data provenance: Again, this is detailed information from the testing portion of the submission.
3. Number of experts and their qualifications for establishing ground truth: Not mentioned in this regulatory letter.
4. Adjudication method: Not applicable or mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results: This applies to AI/CAD devices, and the TENS unit is a physical device, so such a study would not be relevant.
6. Standalone (algorithm only) performance: Not applicable for a TENS unit.
7. Type of ground truth used: Not applicable or mentioned.
8. Sample size for the training set: Not applicable for a TENS unit (unless it incorporates some form of adaptive AI, which is not indicated here).
9. How the ground truth for the training set was established: Not applicable for a TENS unit.

The provided text only states the Indications for Use for the TENS and EMS functions. To find the specific performance data and acceptance criteria, you would need to access the full 510(k) submission (if it were publicly available in that format, which it generally is not for the detailed technical reports). The clearance letter confirms that the FDA reviewed such data and found it adequate for substantial equivalence, but it does not reproduce that data.

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TENS: The 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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. The device is designed to temporarily increase local blood circulation in healthy leg muscles.

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The provided FDA 510(k) Clearance Letter for Shenzhen Yicai Health Technology Co. Ltd's Transcutaneous Electrical Nerve Stimulator (TENS) does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML medical device.

This document is a standard clearance letter for a physical medical device (TENS/EMS) and focuses on regulatory aspects like:

• Substantial equivalence to predicate devices.
• General controls (registration, listing, GMP, labeling, misbranding).
• Quality System (QS) regulation.
• Unique Device Identification (UDI) requirements.
• Indications for Use.

It does not detail performance studies conducted to establish effectiveness or safety beyond establishing substantial equivalence to a predicate. Specifically, it lacks any mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes for human readers.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or ground truth establishment for training.

Therefore,Based on the provided FDA 510(k) clearance letter, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested. The letter is for a physical medical device (Transcutaneous Electrical Nerve Stimulator) and outlines its regulatory clearance, not the details of a performance study, especially not one applicable to an AI/ML device as your detailed questions suggest.

The document does not contain any information related to:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This is a clearance letter for a device whose mechanism of action is electrical stimulation, not an AI/ML algorithm. The information you are seeking would typically be found in the 510(k) summary or the full submission, which are not included in this clearance letter.

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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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The BTL-199 is intended to stimulate peripheral nerves for relief of chronic intractable pain, post-traumatic pain, post-surgical pain and/or for relief of chronic painful diabetic peripheral neuropathy in the lower extremities. The BTL-199 is for use on patients 18 and older.

The BTL-199 is an electromagnetic stimulator that delivers brief, focused electromagnetic pulses to non-invasively stimulate peripheral nerves, providing pain relief.

The device consists of a main unit and specialized applicators, designed to deliver precise and effective therapy. The main unit is equipped with an intuitive color touch screen that provides step-by-step guidance for the operator throughout the therapy process. The device features a preset treatment protocol for ease of use, while also allowing operators to customize parameters to meet specific therapeutic needs. Adjustable parameters include frequency (up to 150 Hz), therapy time (up to 30 minutes), and intensity (0-100%). The interface displays detailed information about the therapy settings and session progress (i.e., treatment duration). The device uses a temperature sensor to monitor the temperature of the coil to ensure that the maximum permissible temperature of the applicator's contact areas (i.e., 43°C) are not exceeded. It also has an intensity predictor function that limits the maximum adjustable intensity of the device based on the therapy parameters set, so as not to overheat and damage the device.

The device is equipped with three sets of applicators: AP-C-1, AP-C-2, and AP-C-4/5. Each applicator is intended for a different body area depending on the size and shape of the treated body part.

• Applicator AP-C-1 is intended for treatment of larger body areas, such as back, waist, thighs, etc.
• Applicator AP-C-2 is intended for treatment of smaller body areas, such as hands, arms, legs, etc.
• Applicators AP-C-4/5 (AP-C-4 and AP-C-5 - for each side of the body respectively) is primarily intended for treatment of waist and lower back.

The provided FDA 510(k) clearance letter and summary for the BTL-199 device does not include any clinical study data or describe acceptance criteria related to device performance in a clinical setting.

The submission is based on the device being "substantially equivalent" to predicate devices, which generally means that it has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. For devices like the BTL-199, classified as Class II, substantial equivalence can often be demonstrated through non-clinical testing (bench testing, electrical safety, biocompatibility, etc.) and a comparison of technological characteristics with predicate devices that have already been cleared.

The "Clinical Testing" section explicitly states "Not applicable," which confirms that a clinical study proving device performance against specific acceptance criteria (like accuracy, sensitivity, or improvement in patient outcomes) was not required or submitted for this 510(k) clearance.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the provided text, as such information is not present. The document focuses on demonstrating substantial equivalence for regulatory clearance, not on presenting performance data from a clinical trial.

If this were a device requiring clinical performance data (e.g., an AI-powered diagnostic device), the 510(k) summary would typically include a section detailing the clinical study, its methodology, and the results compared against pre-defined acceptance criteria. This is not the case for the BTL-199.

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1) TENS
The 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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

2) EMS
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "3 in 1 TENS UNIT" (K251187) does not contain any information about acceptance criteria or the specifics of a study proving the device meets those criteria, particularly not for an AI/ML medical device.

The document is a standard FDA clearance letter for a Class II medical device (Transcutaneous Electrical Nerve Stimulator For Pain Relief). It primarily covers:

• Device Identification: Trade name, regulation number, product code.
• Regulatory Status: Declaration of substantial equivalence to a predicate device.
• General Controls: Mentions requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding/adulteration.
• Additional Controls: Notes potential for special controls for Class II devices and references regulations like the Quality System (QS) regulation.
• Compliance: Reminds the applicant of various other FDA regulations (e.g., UDI Rule, MDR).
• Contact Information: Provides resources for further inquiries.
• Indications for Use: Describes the intended use for TENS (pain relief) and EMS (muscle performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The information you're asking for typically comes from the premarket submission itself (which might include detailed validation studies, performance data, and the methodology for establishing acceptance criteria), not from the FDA's clearance letter. This type of detail is particularly crucial for AI/ML-based devices, which this TENS unit is not described as.

If you have a document describing the actual performance study and acceptance criteria for this specific device, please provide it, and I would be happy to help analyze it.

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The MF SC GEN2 Facial Toning System is intended to stimulate the face. The device is intended for over the counter cosmetic use.

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The provided document is an FDA 510(k) clearance letter for the "MF SC GEN2 Facial Toning System." It confirms the device's substantial equivalence to legally marketed predicate devices for its stated indications for use.

Crucially, the document does NOT contain any information regarding acceptance criteria or a study proving the device meets these criteria.

This type of FDA letter is primarily a regulatory approval and does not detail the clinical or performance study data that the manufacturer submitted to support their 510(k) application. To provide the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.), one would need access to the actual 510(k) submission document itself, which is typically confidential business information and not released publicly by the FDA in detail.

Therefore,Based on the information provided in the FDA 510(k) clearance letter (K252218), it is not possible to describe the acceptance criteria and the study that proves the device meets these criteria.

The clearance letter primarily states that the device, "MF SC GEN2 Facial Toning System," is substantially equivalent to legally marketed predicate devices for its intended use (to stimulate the face, for over-the-counter cosmetic use). It does not contain the detailed performance data, study design, or acceptance criteria that would have been part of the manufacturer's 510(k) submission.

All sections of your request cannot be fulfilled as the necessary information is not present in the provided document.

To provide the requested details, one would need access to the full 510(k) submission document from Micro Current Technology, Inc., which is not publicly available in this correspondence.

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The StimTrial System is indicated for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for the StimRouter Neuromodulation System's permanent (long term) implant indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy used in a multidisciplinary approach and not intended to treat pain in the craniofacial region.

The StimTrial Neuromodulation System is to be used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant for a system indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy used in a multidisciplinary approach and not intended to treat pain of craniofacial nerve origin.

The StimTrial Neuromodulation System is intended to help determine patient candidacy for a permanent implant to help manage pain of peripheral nerve origin. The StimTrial System works by sending electrical impulses from an external stimulator to a lead that is percutaneously placed next to a target nerve. These impulses are intended to interrupt or change the pain signals, inducing the feeling of tingling or numbness (paresthesia), and possibly reducing or replacing the feeling of pain.

The StimTrial Neuromodulation System consists of three main parts - the percutaneous StimTrial Lead, the StimTrial Lead Adaptor Cable, and the StimTrial External Stimulator. The StimTrial Lead is percutaneously placed with the distal, stimulating end located at or near the targeted peripheral nerve and with the proximal end remaining outside of the body for the trial duration. The StimTrial Lead Adaptor Cable is an external cable that directly connects the StimTrial Lead to the StimTrial External Stimulator providing a direct electrical pathway from the External Stimulator to the Lead. The StimTrial External Stimulator is a device which, when connected to the Lead Adaptor Cable and the StimRouter Electrode (a hydrogel patch electrode) attached to the skin near the implant site, generates electrical stimulation pulses that travel to the StimTrial Lead. Accessories for the StimTrial System include the StimRouter Electrode (a disposable electrode patch, cleared most recently in K211965), the StimTrial Clinician Programmer with Software (CPS) and the optional StimTrial Mobile Application (MAPP) installed on a Smartphone.

The StimTrial System incorporates both commercially available and specially designed components. The materials used in the StimTrial Lead have a long history of use in implanted devices; the insertion tools are also constructed from materials with a long history of surgical use. Materials in the external accessories are commonly used in both medical and non-medical applications. The powered components of the StimTrial System use commercially available IEC and UL approval rechargeable batteries. There are no components which are plugged into a wall socket during the use of the system by the patient.

This document outlines the acceptance criteria and the study conducted to prove that the StimTrial Neuromodulation System meets these criteria, based on the provided FDA 510(k) Clearance Letter.

Summary of Device Performance Study Information:

The provided document details various performance tests conducted for the StimTrial Neuromodulation System, but it does not include a clinical study with specific acceptance criteria and reported performance metrics in the format typically used for demonstrating efficacy or performance against a clinical endpoint (e.g., accuracy, sensitivity, specificity, or improvement in patient outcomes).

Instead, the listed "Performance Testing" are focused on engineering, safety, and regulatory compliance aspects:

• Labeling Validation
• Software verification and validation (for External Stimulator, MAPP and CPS software devices)
• EMC, Wireless Co-Existence and Electrical Safety
• Usability testing (for Implanting Physician, Treating Clinician and Patient)
• Bench testing (Tests of the StimTrial Lead, External Stimulator, StimTrial System)
• Animal testing (Acute and Long-term studies in porcine animal model)
• Sterilization and Shelf Life (StimTrial Surgical Kit)
• Biocompatibility (for StimTrial Lead, Insertion Tools and External Stimulator)

This type of submission for a Class II device like a neuromodulation system for trial stimulation often relies heavily on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. The purpose of this "StimTrial System" is for trial stimulation to determine efficacy before a permanent implant, meaning its primary function in this context is to safely and effectively deliver electrical stimulation within defined parameters to aid in patient selection for a long-term device. It is not an AI/ML powered device, so many of the questions regarding ground truth, expert adjudication, MRMC studies, and training/test set sample sizes are not directly applicable in the typical sense of an AI/ML performance study.

Given the information, a detailed table of "acceptance criteria and reported device performance" related to clinical efficacy or AI/ML performance metrics cannot be constructed from the provided text. The "acceptance criteria" for a 510(k) clearance in this context primarily revolve around demonstrating that the device is as safe and effective as its predicate devices, which is achieved through the enumerated non-clinical tests and technical comparisons.

However, answering the questions as best as possible based on the implied purpose of such a device and the provided text:

Implied Acceptance Criteria and Study to Prove Device Meets Criteria (Based on information provided)

The "StimTrial Neuromodulation System" is a medical device for trial stimulation. Its acceptance criteria are implicitly tied to demonstrating safety and performance characteristics that are substantially equivalent to legally marketed predicate devices, as this is a 510(k) submission. The study proving this typically involves a combination of bench testing, software validation, biocompatibility, and animal studies, rather than large-scale clinical trials for efficacy.

1. Table of Acceptance Criteria and Reported Device Performance:

Since the document focuses on demonstrating substantial equivalence through technical specifications and non-clinical testing rather than clinical performance metrics, a table of "acceptance criteria" for a clinical outcome (e.g., sensitivity, specificity, accuracy) is not present. The acceptance criteria relate to meeting specific engineering, safety, and biocompatibility standards, and these are largely reported as successful completion of the tests mentioned in Section VII.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document does not specify a "test set" in the context of a clinical study for performance evaluation (e.g., accuracy of diagnosis). The "tests" performed are largely engineering validations or animal studies.
  • For Animal Testing, "Acute and Long-term studies in porcine animal model" were conducted. The specific number of animals is not stated.
  • For Usability Testing, the number of "Implanting Physician, Treating Clinician and Patient" participants is not specified.
  • For Bench Testing, the number of units or tests performed is not specified, but it implies a sufficient number to validate performance.
• Data Provenance: Not explicitly stated for any clinical data as it's not a clinical performance study. Animal studies are typically conducted in a controlled lab environment.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable in the typical sense of AI/ML ground truth establishment. The "ground truth" for this device's performance would be established by objective measurements in bench testing (e.g., output electrical parameters matching specifications), and pathological/physiological observations in animal models (e.g., tissue response). These are based on established engineering and biological standards, not human expert consensus on interpretations of images or signals.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of human-interpreted data that would require an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance:

Not applicable. This device is a neuromodulation system, not an AI/ML algorithm for diagnostic or prognostic purposes, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical neuromodulation system with accompanying software for control, not a standalone algorithm for independent task execution (like image analysis). Its function inherently involves human-in-the-loop operation (clinician programming, patient use).

7. The Type of Ground Truth Used:

The "ground truth" for the various performance tests would be:

• Bench Testing: Engineering specifications and physical measurements (e.g., electrical parameter values, mechanical properties).
• Biocompatibility: ISO standards for medical device materials.
• Sterilization: Sterility assurance levels (SAL) based on validated methods.
• Animal Testing: Histopathological analysis of tissues, physiological responses, and adverse event monitoring.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a machine learning component that requires a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for an AI/ML model.

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CEC101 and EE0101:
Microcurrent Facial Device is intended for facial stimulation for over-the-counter aesthetic use.

EEI101:
Microcurrent Facial Device is intended for facial, neck and body skin stimulation for over-the-counter aesthetic use.

The Microcurrent Facial Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, membrane cloth, conductive gel and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.

The provided FDA 510(k) clearance letter and summary for the Microcurrent Facial Device (K244004) does not contain information on acceptance criteria for a clinical study or a study proving the device meets performance criteria beyond safety and electrical standards.

This document primarily focuses on establishing substantial equivalence to predicate devices through technical comparisons, safety testing (biocompatibility, electrical safety, EMC), and software verification/validation. It explicitly states that "The following performance data were provided in support of the substantial equivalence determination," and lists the aforementioned safety and software tests.

The listed "Indications for Use" for this device are for "facial stimulation for over-the-counter aesthetic use" and "facial, neck and body skin stimulation for over-the-counter aesthetic use." These are aesthetic claims, not medical claims requiring clinical efficacy studies in the same way a device for diagnosing or treating a disease would.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance for clinical efficacy
• Sample size used for the test set and data provenance related to clinical efficacy
• Number of experts used to establish ground truth or their qualifications for clinical efficacy
• Adjudication method for a clinical test set
• MRMC comparative effectiveness study or effect size
• Standalone algorithm performance
• Type of ground truth used for clinical efficacy
• Sample size for the training set (for clinical efficacy)
• How ground truth for the training set was established (for clinical efficacy)

The document focuses solely on engineering and safety performance to demonstrate substantial equivalence, not clinical efficacy for aesthetic outcomes. The "performance data" section (Page 15) explicitly lists only biocompatibility, electrical safety, EMC, and software verification/validation as the bases for establishing substantial equivalence.

In summary, for K244004, the acceptance criteria and proof of meeting them are primarily related to safety and functional performance, not clinical efficacy for aesthetic outcomes, as it falls under the "Transcutaneous Electrical Nerve Stimulator For Pain Relief" product code (NFO) but is indicated for aesthetic use. The FDA clearance is based on the device being "as safe, as effective and performs as well as the legally marketed predicate devices" for its intended aesthetic stimulatory purpose, which is proven through the technical and safety evaluations outlined.

If this were an AI/ML medical device, the information requested would be crucial. However, for a microcurrent facial device, the regulatory pathway relies on different types of "performance data."

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Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) are intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.

The Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1 (herein collectively referred to as "Rapid2 Magnetic Stimulators") are computerized, electromechanical medical devices that provide brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older. The subject device is intended to be used in hospitals and clinics such as pain management clinics.

Rapid2 Magnetic Stimulators are integrated systems consisting of a combination of hardware, software, and accessories. Rapid2 Magnetic Stimulators are offered in multiple configurations:

• Rapid2
• Super Rapid2
• Super Rapid2 Plus1

All three configurations have identical intended use/indications for use, common specifications, equivalent performance characteristics and equivalent composition to each other. Specifically, Rapid2 and Super Rapid2 have received prior clearance under K051864 for Peripheral Nerve Stimulation (Product Code: GWF, Regulation 21 CFR 882.1870). All Rapid2 Magnetic Stimulators are made up of components that have received prior clearance under K051864 (e.g., the 3190-00, 3192-00 and 3193-00 coils) and components which have received prior clearance under K051864 but have received modifications due to aspects like obsolescence (Mainframe, Power Supply etc.).

All Rapid2 Magnetic Stimulators are composed from the following main components:

• Stimulating Unit & Power Supply
• User Interface
• Stimulating Coil
• System and Stimulating Coil Cart and Holding Arm

Rapid2 Magnetic Stimulators include temperature monitoring via two independent temperature sensors to ensure surfaces of the coils do not reach unacceptable levels. The cut-off is set to act at 40°C at which point the system will automatically be disabled. Over-temperature conditions are also communicated on the User Interface (UI) via a temperature gauge and alarm system. Rapid2 Magnetic Stimulators also includes the 3910-00 air-cooled coil to further mitigate any temperature conditions. The 3910-00 air-cooled coil comes with all 3 configurations (Rapid2, Super Rapid2 and Super Rapid2 Plus1) as standard.

The provided document is an FDA 510(k) Clearance Letter for the Rapid2 Magnetic Stimulators. It does NOT contain information about a study proving the device meets acceptance criteria related to its performance in pain relief. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of technical characteristics, safety standards compliance, and physical properties.

The document does not describe an AI/ML-driven device, nor does it present results from a clinical study with patients or human readers using AI. The acceptance criteria and performance metrics described are related to physical and electrical characteristics of the magnetic stimulator, not diagnostic accuracy or clinical effectiveness in a traditional sense of "performance" as one might expect for an AI diagnostic device.

Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC study, standalone performance, ground truth type) cannot be answered based on the provided text, as they pertain to clinical or AI/ML performance evaluation, which is not the subject of this 510(k) summary.

However, I can extract information related to the technical acceptance criteria and how they align with the device's measured performance as described in the summary:

Acceptance Criteria and Device Performance (Based on Technical and Safety Equivalence)

The acceptance criteria for the Rapid2 Magnetic Stimulators are primarily based on demonstrating substantial equivalence to the predicate device (MagVenture Pain Therapy) in terms of technical characteristics, safety, and effectiveness for the stated indications for use. The "performance" reported is adherence to these characteristics and safety standards.

Regarding the specific questions that cannot be answered from the provided text:

2. Sample sizes used for the test set and the data provenance: Not applicable or provided. The "test set" here refers to non-clinical testing of device characteristics, not a clinical study on patients or data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context would implicitly be engineering specifications, laboratory measurements, and standard compliance testing, not expert clinical assessment of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided. No adjudication process detailed for establishing technical specifications.
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 is not an AI/ML device, nor is it a diagnostic device being evaluated for reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance evaluation is based on engineering specifications, direct physical measurements (e.g., of magnetic fields, temperatures, electrical properties), and compliance with international safety and performance standards (e.g., IEC 60601 series, ISO 10993).
8. The sample size for the training set: Not applicable or provided. This device does not use a "training set" in the machine learning sense.
9. How the ground truth for the training set was established: Not applicable or provided.

In summary, the provided document details the 510(k) clearance process for a non-AI/ML magnetic stimulator for pain relief. The "acceptance criteria" and "performance" are framed around demonstrating substantial technical and safety equivalence to a legally marketed predicate device, rather than clinical efficacy data from patient studies or AI algorithm performance metrics.

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EMS is used for:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis

TENS is used for:

• Symptomatic relief and management of chronic, intractable pain
• Post-surgical acute pain
• Post-trauma acute pain

EVE Synergy has Synergy handpiece (1EA), Pro handpiece (2EA), Micro cable, Tip (Ball type, T type, COMB type) and Power adaptor & cable.

EVE Synergy has Synergy mode and Pro mode.

Synergy mode has radio frequency and low frequency functions using a synergy handpiece. The Synergy handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43℃.

Pro mode has low frequency function that uses the Pro handpiece with tip.

It should be noted that the device has radio frequency (RF Mode) indicated for relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. This RF mode was previously reviewed by the FDA under K212253 and was cleared under regulation 21 CFR 878.4400 (Product code PBX). In the subject submission, there are no changes being proposed related to the RF Mode, and, hence, the review of the RF Mode is not within the scope of the subject 510(k) submission.

The provided text is a 510(k) clearance letter and an accompanying 510(k) summary for the EVE Synergy (EVE-20M) device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than proving the device meets specific acceptance criteria through a comparative effectiveness study involving AI assistance or human-in-the-loop performance.

Therefore, many of the requested details regarding acceptance criteria for AI performance, specific study designs (MRMC, standalone), ground truth establishment for AI training/test sets, and sample sizes for these, are not present in this type of regulatory submission. This document primarily describes the physical and electrical characteristics of the device and compares them to predicate devices, along with standard electrical safety, EMC, and software validation testing.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

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

The document does not present "acceptance criteria" in the traditional sense of a specific performance metric (like accuracy, sensitivity, specificity) for a clinical outcome or an AI model's performance. Instead, it demonstrates compliance with safety and performance standards and similarity to predicate devices.

The "acceptance criteria" are implicitly met by showing:

• Compliance with various IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 62304) for electrical safety, EMC, and software.
• The device's technical specifications (e.g., output voltage, current, pulse width, frequency, power density) are comparable to or within the safe limits established by the predicate devices.

Table of Performance (extracted from comparison tables):

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