Search Results

Volnewmer™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis of soft tissue.

Volnewmer™ is a noninvasive monopolar radiofrequency (RF) therapy system. The radiofrequency output of the device is 6.78 MHz, and the maximum output power is 115 W.

• . Volnewmer™ delivers radiofrequency energy for selective coagulation of tissue while conductively cooling the epidermis.
• Volnewmer™ delivers energy from the disposable/reusable tip to the patient.
• . Volnewmer™ employs radiofrequency tuning to provide radiofrequency energy across a range of impedances for delivery to the patient through the disposable/reusable tip.
  Volnewmer™ consists of the following components:
• Console ●
• . Handpiece x2
• Treatment Tips ●
• Accessories:
  • Return Pad -
  • Return Pad Cable -
  • Coupling Gel -
  • Footswitch -

The provided text, K240248, is an FDA 510(k) clearance letter for the Volnewmer™ device, an electrosurgical cutting and coagulation device. It details the device's characteristics, its comparison to predicate devices, and a summary of non-clinical testing performed to demonstrate substantial equivalence.

However, the document specifically states "Summary of Non-Clinical Testing" and explains that "Verification/validation activities from non-clinical testing as described below demonstrate that the differences do not raise any new issues of safety or effectiveness of the subject device compared to the predicate device." It then lists tests like EMC, electrical safety, thermal effect & safety in-vivo test, bench testing, biocompatibility, and software verification/validation.

Crucially, the document does NOT contain information about acceptance criteria or specific studies that prove the device meets acceptance criteria related to a clinical performance study involving human subjects or AI performance. The questions you've posed, particularly those regarding sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone AI performance, and ground truth establishment for training/test sets, are typical for the evaluation of AI/ML-enabled medical devices or diagnostic devices with clinical performance claims. This document pertains to a Class II electrosurgical device that relies on non-clinical testing and comparison to predicates for substantial equivalence, not a device with such complex performance metrics.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's an attempt to address the points based only on the information available in the given document:

Acceptance Criteria and Device Performance (Based on provided Non-Clinical Testing):

Since this is a 510(k) for an electrosurgical device cleared based on substantial equivalence and non-clinical testing, the "acceptance criteria" discussed are largely related to safety and fundamental performance characteristics as demonstrated through engineering tests and comparison to predicates, rather than clinical efficacy metrics (like sensitivity, specificity, accuracy, or improvements from AI assistance) which would require clinical studies.

The document implicitly states that the acceptance criterion for the non-clinical tests was that the device performs as intended and meets design specifications and that the differences (from predicate) do not raise any new issues of safety or effectiveness.

Here's a table reflecting what can be inferred as acceptance criteria and reported performance from the "Summary of Non-Clinical Testing" section:

Since the document focuses on non-clinical testing for a device leveraging substantial equivalence, the following points address what is not present in the provided text:

1. Sample size used for the test set and the data provenance: Not applicable/not mentioned. The "test set" here refers to non-clinical tests (e.g., electrical safety tests, bench tests, in-vivo thermal tests on an animal model, likely, although not explicitly stated). No human patient "test set" data for clinical performance is provided.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This type of information is relevant for AI/ML or diagnostic devices where human expert consensus often forms the ground truth for clinical evaluation.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
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: No, an MRMC study was not done (or at least not reported in this document). This device is not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is not an algorithm-only device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not mentioned for clinical performance. For the non-clinical tests, the "ground truth" would be established by validated test methodologies and engineering specifications.
7. The sample size for the training set: Not applicable/not mentioned. This device is not an AI/ML device that requires a training set in the typical sense (e.g., for image recognition). Its software undergoes verification and validation, but not machine learning model training.
8. How the ground truth for the training set was established: Not applicable/not mentioned.

In summary, the provided FDA 510(k) clearance letter for the Volnewmer™ device focuses on non-clinical performance and substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating its efficacy or the performance of an AI/ML component. Therefore, the detailed questions regarding clinical test sets, expert ground truth, and AI training data are not addressed by this type of regulatory submission document.

Ask a specific question about this device

The SCIZER delivers high intensity focused ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue(SAT) to provide a non-invasive approach to achieve a desired aesthetic effect.

The SCIZER is specifically indicated for non-invasive waist circumference reduction.

The Subject Device consists of 2 handpieces, a control unit, a Touch LCD monitor, power supply unit for irradiation and for setting parameters after the main power and key switch is turned on.

HIFU energy is irradiated based on a linear scanning method through the handpiece depending on irradiation energy that is set in advance by the user. The Cartridge D13 used with the Subject Device focuses the HIFU energy from the transducer onto the fat layer at a depth of 13mm from the surface of the skin. The Cartridge can treat a region of tissue up to 46mm long and 46mm wide. The Cartridge can apply a maximum of 24 lines at a time. As a result, tissue temperature rises over 56°C and thermal coagulation occurs. Using thermal effects generated by the HIFU transducer, cellular disruption of the subcutaneous adipose tissue occurs. This thermal coagulation results in the contraction of the collagen and subsequently results in the destruction of the adipose tissue. The destroyed adipose tissue is cleared via an inflammatory response.

Immediately before the procedure, purified water was applied to the treatment area to promote the desired energy transmission of the ultrasound transducer. To minimize the pain from the thermal HIFU procedure, the cooling level was used through the GUI. It is recommended to use an ultrasound imaging system to visualize the sub-dermal regions of interest before treatment. It allows the physician to compile a precise view of the target treatment area.

The provided text describes the clinical study conducted for the SCIZER (SC1-M410) device to demonstrate its safety and effectiveness for non-invasive waist circumference reduction. This is a 510(k) submission, meaning the focus is on substantial equivalence to a predicate device, LipoSonix® system model 2.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The primary efficacy outcome serves as the key acceptance criterion.

Study Details

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

   • Sample Size: 20 study participants.
   • Data Provenance: Single-centered, single group, parallel clinical study. The country of origin is not explicitly stated in the provided text but "CLASSYS Inc, CLASSYS, 208, Teheran-ro, Gangnam-gu, Seoul, Republic of Korea" is listed for Classys Inc., implying the study might have taken place in South Korea. The study was prospective in nature, as it involved treatments and follow-ups.

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

   • The Global Aesthetic Improvement Scale (GAIS) was assessed by "three independent investigators (IGAIS)" and by the Subjects (SGAIS).
   • The specific qualifications of these investigators are not detailed beyond "independent investigators."

3. Adjudication Method for the Test Set:

   • For the Global Aesthetic Improvement Scale (GAIS), it was assessed by three independent investigators. The text states "All three independent evaluators observed a decrease in waist circumference during these evaluation periods," suggesting a consensus or agreement was reached, but no formal adjudication method (e.g., 2+1, 3+1) is explicitly described. For the primary efficacy outcome (waist circumference change), the data was objective measurements and statistical analysis was performed.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

   • No, a formal MRMC study comparing human readers (e.g., clinicians) with and without AI assistance was not performed. This device is a treatment device (HIFU) that directly reduces waist circumference, not an imaging or diagnostic AI-assisted device. The "investigator" evaluations were for aesthetic improvement, not for diagnostic performance of an AI.

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

   • This is not applicable as the device is a therapeutic device (HIFU system) and not an AI algorithm for diagnosis or image analysis operating standalone. Performance testing related to the device itself (electrical, EMC, acoustic power, beam profile, thermal evaluation, focal length) was done as standalone engineering/device performance tests (Section 5.7.2).

6. The Type of Ground Truth Used:

   • Primary Efficacy: Objective quantitative measurements: waist circumference reduction (in cm). The "ground truth" was established based on these direct physical measurements compared to a pre-defined threshold (2.45 cm reduction).
   • Secondary Efficacy: Included objective measurements (waist-hip ratio, weight, subcutaneous fat layer thickness via ultrasound, abdominal fat thickness via Caliper, abdominal fat area and height via CT) and subjective assessments (GAIS by investigators and subjects).
   • Safety: Blood tests, pain evaluation using NRS scale, and incidence of adverse events.

7. The Sample Size for the Training Set:

   • The provided text describes a clinical study for evaluation of the device's performance, which is typically linked to the test set for regulatory submission, not a separate "training set" for an AI algorithm. As this is a physical device without an explicit AI component described for its core functionality as typically defined in machine learning, there is no mention of a separate training set for algorithm development. The "training" for such a device would involve device design, engineering, and preclinical testing.

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

   • Not applicable as there is no mention of a "training set" in the context of an AI algorithm from the provided information. The "training" in the context of device development would involve iterative design, testing, and refinement, where "ground truth" for each iteration is established by engineering specifications, physical testing, and potentially animal studies (as mentioned in Section 5.8).

Ask a specific question about this device