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The LUTRONIC GENIUS Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The LUTRONIC GENIUS Radiofrequency System consists of the system control module and RF power supply in a main body on locking castor wheels, a handpiece equipped with disposable handpiece tips with microneedle array, footswitch, handpiece hanger and holder, and an LCD touch screen control panel. The sterilized handpiece tips include the tip body containing the microneedle array and a protective cap. The treatment parameters are entered via a touchscreen console that also displays system output information during treatment. The microneedles come in light contact with the epidermis of the patient and minimally penetrate the epidermis during the treatment. Needle depth, Power level and Duration (Power x Duration = RF Energy), are userselectable via the GUI console. The RF Power output is controlled to insure for a given Duration that a determinate RF Energy is delivered to the 7x7 bipolar microneedle array of the handpiece tips. The handpiece is held at right angles to the target tissue. As the RF energy passes into the skin via the needles, it generates an electro-thermal reaction capable of coagulating the tissue surrounding the uninsulated portion of the needles.

The provided text describes the LUTRONIC GENIUS Radiofrequency System, a medical device, and its comparison to a predicate device for FDA 510(k) clearance. The focus of the study to prove the device meets acceptance criteria is primarily on demonstrating substantial equivalence to the predicate device, the INFINI Radiofrequency System (K121481), rather than a study against a pre-defined set of clinical performance metrics. Therefore, the information provided does not fully align with the typical structure of an AI/ML-based medical device performance study, especially concerning elements like multi-reader multi-case studies, ground truth establishment for a test set, and detailed acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity).

However, I can extract the relevant information from the document to describe the acceptance criteria and the study that proves the LUTRONIC GENIUS Radiofrequency System's equivalence to its predicate, as this is the primary method of acceptance described in the 510(k) summary.

Acceptance Criteria and Study for LUTRONIC GENIUS Radiofrequency System

The LUTRONIC GENIUS Radiofrequency System sought 510(k) clearance by demonstrating "substantial equivalence" to a legally marketed predicate device, the INFINI Radiofrequency System (K121481). The acceptance criteria were centered around demonstrating that the modified device's technological characteristics and performance are sufficiently similar to the predicate device such that it raises no new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

• Frequency: GENIUS: 460 KHz; INFINI: 1 MHz (Change, but deemed minor).
• Max Output Power: Both 50W.
• Operation Mode: Both Microneedle Fractional RF.
• Treatment Duration (Time): Both 10 - 1000 msec.
• Tip (Microneedle array, depth adjustment): Both 49 tip, 7x7 microneedles; 10x10 mm; depth 0.5 - 3.5 mm.
• Needle Diameter: Both 200 micrometers. Other differences in dimensions, electrical requirements, GUI, packaging, shelf life, and needle coating were evaluated. |
  | Performance Data: No significant differences in biological effects or safety outcomes. | Ex Vivo Animal Study Findings: Porcine tissue model. No statistically significant differences in the coagulation profiles (height, width, volume of thermal coagulative zones) between the two systems as per ANOVA and student t-tests. The LUTRONIC GENIUS fell within the 95% confidence interval of the INFINI for coagulation profile height, width, and volume at each setting.
  Additional Safety Data: Biocompatibility, Sterilization Validation, Electrical Safety & EMC, Software V&V, Cleaning & Disinfection Testing were all conducted and met relevant standards. |

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

• Test Set (Ex Vivo Animal Study): The document states "an ex vivo animal study utilized a porcine tissue model." It does not specify the exact number of porcine tissue samples or animal subjects used.
• Data Provenance: The ex vivo animal study was conducted to compare the LUTRONIC GENIUS with the INFINI Radiofrequency System. The data is prospective for this comparison study, specifically designed for this submission. The country of origin of the data is not explicitly stated, but the submitter is Lutronic Corporation, Republic of Korea, with a contact person in Massachusetts, USA.

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

• This question is not applicable in the context of this 510(k) submission as described. The "ground truth" for the performance comparison was the quantitative measurement of thermal coagulative zones in the ex vivo animal study, not expert consensus on medical images or patient outcomes. The evaluation involved scientific measurement and statistical analysis.

4. Adjudication Method for the Test Set

• This is not applicable. The ex vivo animal study data was quantitative (height, width, and volume of thermal coagulative zones) and analyzed statistically (ANOVA, student t-tests, 95% confidence intervals). There was no subjective assessment requiring adjudication.

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

• No Multi-Reader Multi-Case (MRMC) study was done. This device is a direct energy delivery system, not an AI-assisted diagnostic tool. Therefore, human reader improvement with AI assistance is not relevant to this submission.

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

• Not applicable. This is a hardware medical device, not an algorithm/software-only device intended for standalone performance evaluation in diagnosis or prediction.
• Software verification and validation testing were conducted, and the software was considered a "major" level of concern, indicating a thorough V&V process for the embedded software controlling the device.

7. The Type of Ground Truth Used

• The "ground truth" for the performance comparison was quantitative measurements of physical effects (height, width, and volume of thermal coagulative zones) on porcine tissue, obtained through standardized H&E staining techniques. This is a scientific and objective measure rather than expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set

• Not applicable. This device is a hardware medical device with embedded software. It is not an AI/Machine Learning device that undergoes a "training" phase on a dataset in the conventional sense. The "training set" concept is relevant for AI models, not for traditional medical devices undergoing performance testing for substantial equivalence.

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

• Not applicable. As stated above, there is no "training set" as this is not an AI/ML device in the context of data-driven model training.

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