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Ask a specific question about this device

Ask a specific question about this device

truFlex is indicated to be used for:

• Improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen.
• Strengthening, toning and firming of arms, buttocks, thighs, and calves
• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• Increasing local blood circulation
• Muscle re-education
• Maintaining or increasing range of motion
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes
• To be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions

truFlex is an electrical muscle stimulator, which generates electrical impulses that are delivered through electrodes on the skin in direct proximity to the muscles to be stimulated. The device contracts muscles rhythmically to achieve the intended use.

truFlex consists of a console with a touchscreen control panel and eight handpiece pairs. All system functions are controlled through the console. During a treatment session, one or more handpiece pairs are secured to the patient using disposable hydrogel pads and transparent silicone belts, and electrical stimulation is delivered to the treatment area at the selected treatment mode and intensity.

The fundamental scientific technology has not changed in the modified device. Changes are solely considered for addition of indication for use. The modified device generates the same stimulation to contract the muscles rhythmically to achieve the intended use.

The clinician can increase or decrease the intensity as per the desired stimulation. While modified device, complete care and considerable measures have been taken to retain its safety and effectiveness. The truFlex device complies with voluntary standards.

The modified device, as described in this submission, have only addition of the indication for use and name the device

The device has two treatment types:

• Classic - In Classic mode, the treatment duration is 45 minutes.
• flex+ - In flex+ mode, the treatment duration is 15 minutes.

For ease of use and operation for the clinicians, we have 3 modes (suggestive):

• PREP mode creates a twisting motion to warm up and stretch the muscles and to slowly build a tolerance to muscle contractions. PREP mode is available for Classic treatments only.
• TONE mode contracts the muscles, holds it, and then relaxes to increase strength and muscle endurance. TONE mode is available for Classic and flex+ treatments.
• SCULPT mode uses fast, sequential contractions of the muscles which lead to toning and firming. SCULPT mode is available for Classic and flex+ treatments

Based on the provided FDA 510(k) Clearance Letter for the truFlex Muscle Stimulator, it's important to clarify that this document primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving specific clinical efficacy or performance through a traditional clinical study with defined acceptance criteria for de novo AI/ML devices.

The truFlex device is a Powered Muscle Stimulator, classified as Class II, and uses electrical muscle stimulation (EMS). Its clearance is based on the premise that its safety and effectiveness are "demonstrated by performance data and a comparison of technical characteristics between the modified device and the predicate device," as stated on Page 4 and Page 9. This means the acceptance criteria are largely met by showing the device performs similarly to or within the established safety and performance parameters of already cleared, similar devices (predicates).

Therefore, the requested information points (1-9) about acceptance criteria, test sets, expert ground truth, MRMC studies, etc., typically apply to the rigorous clinical validation studies for novel medical devices, especially AI-driven ones where performance metrics like sensitivity, specificity, or AUC are critical. For a 510(k) based on substantial equivalence to predicate muscle stimulators, the "study" is often a combination of non-clinical bench testing, electrical safety testing, electromagnetic compatibility (EMC) testing, and comparison of technical specifications to demonstrate that the new device is as safe and effective as the predicate.

Given this context, I will address your points as best as possible based on the provided document, acknowledging where the information is not directly applicable or explicitly stated as it would be for a typical AI/ML clinical validation study.

Acceptance Criteria and Study for truFlex Muscle Stimulator

The acceptance criteria for the truFlex Muscle Stimulator, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved by showing that the truFlex device has the same intended use, similar technological characteristics, and meets recognized safety and performance standards as its predicates, without raising new questions of safety or effectiveness.

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

Since this is a substantial equivalence submission for a traditional medical device (not an AI/ML diagnostic/therapeutic device), the "acceptance criteria" are generally that the device performs within the established safety and effectiveness profiles of the predicates. The "reported device performance" is demonstrated through compliance with voluntary standards and direct comparison of specifications.

• Normal Condition: Less than 100µA (Predicate 1,2:

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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.

Not Found

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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RelieVRx is a prescription-use immersive virtual reality system intended to provide adjunctive treatment based on cognitive behavioral therapy skills and other evidence based behavioral methods for patients (age 18 and older) with a diagnosis of chronic lower back-pain (defined as moderate to severe pain lasting longer than three months). The device is intended for in-home use for the reduction of pain and pain interference associated with chronic lower back pain.

RelievRx is an immersive virtual reality (VR) system with preloaded software content on a proprietary hardware platform that delivers automated cognitive behavioral therapy (CBT) and other behavioral methods to patients diagnosed with chronic pain. The VR content is delivered while incorporating CBT to enable diaphragmatic breathing exercises and mindfulness strategies, and is intended to be self-administered, unsupervised in the patient's home while the patient is in a seated position. The device is powered by a rechargeable lithium battery. Each device is intended for a single patient. The medical device is meant for repeated use, does not include non-medical software, and is only effective when treating chronic pain.

It appears there's a misunderstanding in the request. The provided FDA 510(k) clearance letter for RelieVRx (Pico G3) does not contain any information about clinical performance studies, acceptance criteria, sample sizes, expert involvement, or ground truth for the device's efficacy in pain relief.

This 510(k) clearance is specifically for a minor modification – the addition of a Predetermined Change Control Plan (PCCP) to allow future hardware updates (specifically to the VR headset) without requiring a new 510(k) submission, provided these changes adhere to predefined criteria and do not alter the intended use or therapeutic content.

The letter explicitly states:

• "No new nonclinical performance testing was conducted to demonstrate substantial equivalence."
• "The only changes that have been made to the RelieVRx in the current submission are the addition of a Predetermined Change Control Plan to accommodate potential future updates to the device hardware."
• "Please refer to K243417 for a comprehensive description of non-clinical testing that has been completed to validate the device."

Therefore, the information regarding the device's performance in reducing pain and pain interference, and the study that would demonstrate it meets acceptance criteria for its therapeutic effect, would be found in the original 510(k) clearance for the predicate device (K243417), not in this document.

Since the provided document K251519 does not contain the requested information about clinical performance studies, I cannot fill out the requested table or answer most of the questions.

However, I can extract the relevant information from this document regarding the nature of the submission and what it does discuss:

Based on the provided FDA 510(k) Clearance Letter (K251519) for RelieVRx (Pico G3):

This 510(k) does not describe a study proving the device meets acceptance criteria for its direct therapeutic effect on pain. Instead, it's a submission for a Predetermined Change Control Plan (PCCP) to streamline future hardware modifications. Therefore, most of the requested fields related to clinical performance testing cannot be filled from this document.

Here's what can be gathered regarding the purpose of this specific 510(k) and how it addresses a "change":

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For this specific 510(k), the acceptance criteria are related to the Predetermined Change Control Plan (PCCP). The plan outlines that any future hardware modifications made under the PCCP must:
  • Maintain the same intended use and therapeutic content.
  • Meet predefined acceptance criteria aligned with "Table 6 of the PCCP" (which is not provided in this document). These criteria are for "safety, biocompatibility, and software performance" of the modified configurations.
  • Undergo specified verification and validation protocols (electrical and mechanical testing (IEC 60601-1/11), electromagnetic compatibility (IEC 60601-1-2), environmental and acoustic safety, performance benchmarking).
  • Be clearly communicated to users via updated labeling.
• Reported Device Performance (for this submission): No new clinical performance data is reported as "no new nonclinical performance testing was conducted to demonstrate substantial equivalence." The substantial equivalence claim is based on the subject device being identical to the predicate (K243417) in its intended use, indications, principles of operation, and technological characteristics, with the only change being the addition of the PCCP.

Therefore, a table describing "device performance" in terms of pain relief effectiveness cannot be constructed from this document. The "performance" discussed here is adherence to a change control plan.

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

• Not applicable for this 510(k). This submission did not involve new clinical performance testing on a test set to prove therapeutic efficacy.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable for this 510(k). No clinical ground truth for therapeutic efficacy was established in this submission.

4. Adjudication Method for the Test Set:

• Not applicable for this 510(k).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, not for this 510(k). This submission focuses on a change control plan, not a comparative effectiveness study for therapeutic outcomes.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• No, not for this 510(k). This device is a preloaded VR system for patient self-administration, not an AI algorithm with standalone performance metrics.

7. The Type of Ground Truth Used:

• Not applicable for this 510(k). No new clinical ground truth was established for this submission. The device's foundational efficacy would have been established in the predicate device's clearance (K243417).

8. The Sample Size for the Training Set:

• Not applicable for this 510(k). This submission pertains to a hardware change control plan, not the training of a new therapeutic algorithm.

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

• Not applicable for this 510(k).

Summary of what K251519 is about:
This 510(k) (K251519) is a software modification 510(k), specifically for adding a Predetermined Change Control Plan, not a clinical efficacy study for a new device or significant modification to the therapeutic content. All discussions about performance and validation in this document relate to ensuring that future hardware changes will not adversely affect the device's safety or effectiveness, building upon the substantial equivalence established by its predicate (K243417).

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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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The device of this submission is designed to temporarily relieve muscle soreness and pain in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.

Not Found

The provided text is an FDA clearance letter for a medical device: "TENS and EMS Unit." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary.

The letter is a regulatory document stating market clearance and does not detail the technical performance or supporting studies for the device. Instead, it refers to the device's "Indications for Use" and mentions regulatory compliance.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the 510(k) summary or the full 510(k) submission for K251706, which would typically contain the performance data and details of any studies conducted.

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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.

Not Found

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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Compression Therapy Device (Model: LGT‐2210DS) is intended for Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post‐mastectomy lymphedema).

Compression Therapy Device (Model: LGT‐2210DS) is intended exclusively for use by medical specialists and is only allowed to be used by qualified and instructed medical persons in clinical and hospital. The compression Therapy Device (Model: LGT‐2210DS) is designed to be used in patients over 22 years old.

The LGT‐2210DS is a compression therapy device comprised of an intermittent pneumatic controller, sleeves with 6‐chamber, 4‐chamber combined and connectable hoses. The working principle is the air inflating and deflating the sleeve sequentially to develop the circulating pressure on the human body, squeezing the proximal and distal of the limbs to promote blood circulation lymphatic system and improve body microcirculation.

The provided FDA 510(k) clearance letter is for a Compression Therapy Device (LGT-2210DS). This device is a physical therapy device and not an AI/ML medical device. Therefore, the document does not contain the information required to answer questions related to AI/ML device testing, such as acceptance criteria, performance metrics (sensitivity, specificity, AUROC), sample sizes for AI model testing, expert involvement in ground truth establishment, MRMC studies, or training set details.

The document primarily focuses on establishing substantial equivalence to a predicate device (Compressible Limb Therapy System MK300L) based on:

• Intended Use: Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post-mastectomy lymphedema).
• Technological Characteristics: Intermittent pneumatic compression, compressor and valve system, sequential inflation.
• Safety and Performance Bench Testing: Service life, reliability, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), software V&V (specifically cybersecurity as the main software aspect noted), and biocompatibility (ISO 10993 series).

No AI/ML components are mentioned or implied in this 510(k) submission. The "Software Verification and Validation Testing" section explicitly states: "There is no wireless connection, Bluetooth, internet connection in the device, and Power socket is only for battery charging connection. The client information can be exported by entered Password with USB flash drive. Testing related to Cybersecurity was performed." This confirms the software involved is minimal and not AI-driven.

Therefore, I cannot provide a response to the prompt's specific requirements, as the provided document does not contain information about an AI/ML medical device.

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