Search Results

The Reaction™ system is intended for the treatment of the following medical conditions, using the B-contour and F-contour applicators for delivering non thermal RF combined with massage: - relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and - temporary reduction in the appearance of cellulite.

Using the ST applicator for delivering RF, the Reaction™ system is intended for the treatment of relief of minor musele aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.

The Reaction™ system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The Reaction™ treatment is indicated for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite

The Reaction™ system provides the treatments using 3 specially-designed applicators that treat various areas of the body, including large and small areas.

The system includes five core modules: the Console, the hand piece, and 3 treatment applicators: B-Contour, F-Contour and ST.

The Reaction™ console houses the following components:

• Power supply
• Hand piece
• Vacuum pump
• RF Generator
• Main CPU
• Display unit

The hand piece allows the operator to adjust the treatment parameters of the RF power and intensity of mechanical vacuum massage.

The applicators incorporate operator panels and are used to adjust the treatment parameters of the RF power and mechanical vacuum manipulation.

The provided text is a 510(k) summary for the Reaction™ System, which focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than on detailed clinical study results and acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly stated in this document.

However, I can extract the following based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria or detailed performance metrics. The claim of "substantial equivalence" implies that the Reaction™ System's performance characteristics are comparable to those of the predicate devices for the stated indications.

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

No clinical test set or study data is described that would involve a "sample size" in the context of efficacy or performance evaluation for this 510(k) summary. The submission is based on comparison to predicate devices, not on a new clinical study.

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

Not applicable, as no new clinical study data requiring ground truth establishment or expert adjudication is described in this document.

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

No MRMC study is mentioned. This 510(k) summary focuses on demonstrating equivalence to existing devices, not on comparing AI-assisted vs. non-AI-assisted human reader performance.

6. Standalone Performance:

Not applicable. The Reaction™ System is a physical device (combining RF technology with mechanical vacuum massage) and does not involve an "algorithm only" or "human-in-the-loop" AI performance as implied by this question. Its performance is inherent to its physical operation.

7. Type of Ground Truth Used:

Not applicable, as no new clinical study requiring ground truth is described. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate devices.

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

Not applicable. The Reaction™ System is not an AI/machine learning device that would involve a training set.

Ask a specific question about this device

Fracture reduction and external fixation for treatment of distal radius fractures.

The Agee-WristJack System is an external fixation system used for reduction and fixation of distal radius fractures. The system includes an adjustable reduction/fixation frame (fixator), application instrumentation and skeletal fixation pins.

The fixator element has multiple adjustments to aid in fracture reduction and stabilization of distal radius fractures. The device and instrumentation are constructed of polyetherimide resin, stainless steel and aluminum alloy. The fixation pins are constructed of implant grade 316 stainless steel per ASTM F138.

The provided text is a 510(k) summary for the Agee-WristJack Fracture Reduction System (sterile version). It mainly focuses on demonstrating substantial equivalence to a predicate device by highlighting that the only difference is the sterility of the new device.

Therefore, the document does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other details related to a performance study for this specific device.

The document states:

• "All the device components and materials of the Agee-WristJack Fracture Reduction System (sterile version) are identical to the device components and materials of the predicate device, except this device is delivered sterile. The predicate device requires customer sterilization prior to use."
• "No performance standards exist for this device."

This indicates that the submission relies on the established safety and effectiveness of the non-sterile predicate device, with the sterile aspect being the primary change, likely supported by sterilization validation studies, not clinical performance studies comparing the new device's efficacy.

Ask a specific question about this device