Search Results

1. Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
2. Application of ultrasound for non-invasive reduction in abdominal circumference on adults with a Body Mass Index (BMI) of 25 or greater.

The Ultimate Contour is a medical device that combines the technologies of radio-frequency energy and ultrasound in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece of the appropriate energy intensity based on the settings selected.

Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.

Delivered ultrasound is accomplished with a piezo transducer located in the ultrasound handpiece that is bonded to the handpiece contact surface. The handpiece is applied directly to the patient skin at the abdominal area and the emitted ultrasound energy focuses within the subdermal fatty tissue, causing reduction in waist circumference.

The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos.

The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.

Here's an analysis of the provided text, focusing on acceptance criteria and the study proving device compliance, as requested:

Device: Ultimate Contour, Ultimate Contour Mini

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for performance in a tabular format. However, it implicitly defines the effectiveness acceptance criterion through the primary effectiveness endpoint of the clinical study.

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

• Sample Size for Test Set: 42 subjects completed the treatment regimen.
• Data Provenance: The study was a "single-site single-arm study." The country of origin or specific demographic details beyond "majority of study subjects were Caucasian females" are not explicitly stated. It was a prospective study as it involved treating subjects and then evaluating outcomes.

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

The document does not specify the number of experts used to establish a ground truth for the test set. For the primary effectiveness endpoint (waist circumference reduction), measurements were conducted by clinicians, but their specific qualifications or the number involved are not provided. The information only states: "Clinicians were blinded relative to measuring pre-treatment and post-treatment."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It states that "Clinicians were blinded relative to measuring pre-treatment and post-treatment," implying that a single clinician or a group of clinicians performed measurements, but there's no mention of a consensus or adjudication process if discrepancies arose.

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

No, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or reported in this document. The device is a direct treatment device (radiofrequency and ultrasound for aesthetic/therapeutic purposes), not an AI diagnostic or assistive tool for clinicians interpreting data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the device described. The "Ultimate Contour" is a physical medical device that applies energy (RF and ultrasound) directly to the patient, not an algorithm that functions standalone or with human-in-the-loop. Its performance is measured by its direct effect on the patient (e.g., waist circumference reduction).

7. The Type of Ground Truth Used

The ground truth for the effectiveness endpoint was established by clinically meaningful waist circumference reduction measurements. This was defined as "a value of at least 1 inch of waist circumference reduction of the treatment regimen," and this clinically meaningful value was "identified based on published studies utilizing other devices for the same purpose."

For safety, the ground truth was observed adverse events and serious adverse events reported by subjects and assessed by the study team.

8. The Sample Size for the Training Set

The document does not mention a training set in the context of device performance or clinical evaluation. The device is not an AI/ML product that typically requires a training set. The clinical study described involved direct treatment of subjects.

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

As no training set is mentioned as being applicable to this device or its evaluation, this question is not applicable.

Ask a specific question about this device

Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

The Ultimate Contour is a body sculpting device that combines the technologies of radio-frequency in one convenient unit. The Ultimate Contour utilizes a single power source and control circuitry that directs the emission of energy based on which operating screen is selected and which applicator handpiece is attached to the unit's delivery cable. Based on the attached handpiece, the Ultimate Contour delivers to the handpiece the appropriate energy intensity based on the settings selected. Delivered radio frequency energy is accomplished with the multi-nodal RF handpiece that contains RF energy to the treatment area and works to gently heat the tissue to induce collagen contraction and increase local circulation. The elevated temperature further works to provide temporary relief from pain and muscle spasms. The unit features an interactive color LCD touchscreen for adjusting device settings, as well as for viewing onboard tutorial videos. The device is presented as two model (005-00035) is an integrated free-standing system. The second model (005-00036) is a portable, table-top style units feature exactly the same internal electronics and components, the exact same software, the exact same attachments and accessories, and the exact same environment of use. The models differ only in the shape and dimensions of the mechanical enclosure of the control unit.

This document is a 510(k) Summary for a medical device called "Ultimate Contour" and "Ultimate Contour Mini." It does not describe an AI/algorithm-based device, but rather a physical device that uses radio frequency for therapeutic purposes.

Therefore, many of the requested criteria for AI/algorithm acceptance and study details (such as sample size for test/training sets, ground truth establishment for AI, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract information related to the device's performance testing and general acceptance criteria as described in the document.

Here's the closest interpretation of the requested information based on the provided document, with notes indicating why certain points are not applicable:

Device Name: Ultimate Contour, Ultimate Contour Mini
Regulation Number: 21 CFR 878.4400 (Electrosurgical Cutting and Coagulation Device and Accessories)
Regulatory Class: Class II
Product Code: PBX
Indications for Use: Application of non-thermal radio frequency for relief of minor muscle aches and pains, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

Acceptance Criteria and Reported Device Performance

The document describes performance testing rather than explicitly stating acceptance criteria in a quantitative sense for each indication. However, it implicitly aims to demonstrate the device's ability to achieve the stated therapeutic effects or safety parameters.

Table of Acceptance Criteria (Inferred from Performance Testing) and Reported Device Performance:

Study Details

Many of these points are not applicable as this is not an AI/algorithm-based device being submitted for a clinical study to prove algorithmic accuracy. It's a physical device seeking substantial equivalence based on technical characteristics and limited clinical performance testing.

1. Sample size used for the test set and the data provenance:

   • For Clinical Performance Testing (heating skin tissues): "a single-site study on 5 human patients with varying skin pigmentation".
   • Data Provenance: Not explicitly stated, but clinical testing implies prospective data collection from human subjects. The document is part of a US FDA submission, so the study would likely have been conducted, or data collected, in North America, but this is not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • N/A. This document describes a physical medical device. The "ground truth" for the clinical performance testing was the direct measurement of skin tissue temperature, not an expert assessment of an image or diagnostic output for an algorithm. There is no indication of experts establishing a "ground truth" label in the sense of an AI model's training or testing.

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

   • N/A. This concept applies to human reader studies often used to establish ground truth for AI algorithms or assess reader performance. The testing for this device involved direct physical measurements (temperature) and engineering verification (electrical safety, RF power), not qualitative assessments requiring adjudication.

4. 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:

   • N/A. This device does not involve AI or human-in-the-loop assistance for interpretation. It's a direct therapeutic device.

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

   • N/A. This is not an algorithm/AI device. The "standalone" performance here would refer to the device itself operating as intended. Bench testing and the limited clinical performance testing (heating tissues to a specific temperature range) serve this purpose for the physical device.

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

   • For the Clinical Performance Testing: The ground truth was direct physiological measurement (skin tissue temperature, measured to be within 40-45°C). It was not based on expert consensus, pathology, or broader outcomes data for the described study.
   • For other tests (electrical safety, RF power), the "truth" was compliance with engineering standards and design specifications.

7. The sample size for the training set:

   • N/A. This refers to AI/machine learning models. There is no mention of an AI training set for this device.

8. How the ground truth for the training set was established:

   • N/A. As there is no AI training set, this question is not applicable.

Ask a specific question about this device