(403 days)
The INFINI Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
The INFINI Radiofrequency System includes the system main body, a handpiece equipped with disposable handpiece tips, footswitch, and an LCD touch screen control panel. The RF energy is delivered using disposable handpiece tip. The radiofrequency energy is delivered to the target tissue using a handpiece and disposable tip, the tip being placed in light contact with the epidermis, and the handpiece being held at right angles to the target tissue. As the RF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the MFR tip (Microneedle Fractional RF) the INFINI Radiofrequency System creates heat within the target dermal tissue via microneedles inserted from the MFR tip.
The INFINI Radiofrequency System is intended for use in electrocoagulation and hemostasis in dermatologic and general surgical procedures, and for the percutaneous treatment of facial wrinkles.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria or numerical performance metrics for the INFINI Radiofrequency System in a clear table format. Instead, it relies on the concept of "substantial equivalence" to a predicate device.
| Acceptance Criteria Category | Description | Reported Device Performance (Summary) |
|---|---|---|
| Safety | The device must demonstrate safe operation, including electrical and mechanical safety. It should also demonstrate that it delivers radiofrequency energy without causing unintended damage to surrounding tissues. | Bench testing, electrical and mechanical safety testing were performed. In an in vivo micropig model, it was demonstrated that the INFINI Radiofrequency System delivered radiofrequency energy at a depth in the dermis without causing any electrothermal damage to the epidermis. Non-clinical tests established substantial equivalence to the predicate device in terms of safety. |
| Effectiveness (General) | The device must be effective for its stated indications: electrocoagulation, hemostasis, and percutaneous treatment of facial wrinkles. Effectiveness is primarily demonstrated through substantial equivalence to a legally marketed predicate device. | The INFINI Radiofrequency System was determined to be substantially equivalent to the Primaeva Medical Miratone System (K082391) in terms of intended use, principles of operation, target population, and energy source. Clinical trials established substantial equivalence for the percutaneous treatment of facial wrinkles. |
| Effectiveness (Histology) | The device should produce similar histological effects (e.g., thermal coagulation zones) in target tissue as the predicate device when used for similar applications. | Histologically, the controlled creation of dermally located thermal coagulation zones by the INFINI System was shown to be substantially equivalent to the thermal coagulation zones by the predicate device. |
| Technological Equivalence | The device's technological characteristics should be similar to those of the predicate device, ensuring similar performance and safety profiles. This includes aspects like energy source, delivery method, and operating principles. | The INFINI Radiofrequency System is stated to be substantially equivalent to the predicate device in technological characteristics, such as intended use, principles of operation, target population, and energy source. Both are bipolar radiofrequency systems with delivery methods through optical fibers and handpieces, and both employ bipolar microneedle electrode systems. Any differences were deemed to have no significant influence on safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific numerical sample size (number of human subjects or cases) used for the clinical trials or the in vivo animal model. It mentions "clinical trials, conducted in two study centers" and "an in vivo micropig model."
- Data Provenance:
- Clinical Trials: "conducted in two study centers." The country of origin is not specified, but the submitter is Lutronic Corporation from the Republic of Korea, and the contact person is in the US. It is common for clinical trials for 510(k) submissions to include sites in the US or other regions with established clinical research infrastructure. The nature of the study (retrospective or prospective) is not explicitly stated, but clinical trials for demonstrating substantial equivalence are typically prospective.
- Micropig Model: "an in vivo micropig model" is mentioned, indicating an animal study. This is a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. It mentions "Histologically, the controlled creation of dermally located thermal coagulation zones by the INFINI System was shown to be substantially equivalent to the thermal coagulation zones by the predicate device." This implies histological assessment by pathologists or qualified personnel, but no specific numbers or qualifications are given.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set, as might be seen in diagnostic image analysis studies. The assessment of substantial equivalence appears to be based on the overall findings from the clinical trials and histological analyses comparing the new device to the predicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, or at least not described in this 510(k) summary. This type of study is more common for diagnostic imaging AI devices where human readers interpret images with and without AI assistance. The INFINI Radiofrequency System is a therapeutic device.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable in the typical sense for this device. The INFINI Radiofrequency System is a physical medical device that delivers energy, not a standalone AI algorithm that performs a diagnostic or prognostic task without human intervention. Its performance is inherent in its operation and effect on tissue, guided by a human operator. The "performance data" describes the device's ability to achieve its intended biophysical effects.
7. Type of Ground Truth Used
- Clinical Effectiveness (Facial Wrinkles): This would likely involve clinical assessments of wrinkle reduction, potentially using standardized scales or objective measurements, though not explicitly detailed. The "ground truth" here is the observed clinical improvement of facial wrinkles, as assessed in the clinical trials, demonstrating equivalence to the predicate.
- Histology: The ground truth for histological assessment was the physical observation and characterization of thermal coagulation zones in tissue samples, examined under a microscope by qualified personnel (presumably pathologists). This is a form of pathology ground truth.
- Safety: Ground truth for safety would be the absence of adverse events or unexpected tissue damage, as observed in both the animal model and clinical trials.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here as the INFINI Radiofrequency System is not an AI/ML algorithm that learns from data. It is a physical device.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no training set for this device in the context of AI/ML. The device's design and operating parameters are based on scientific and engineering principles of radiofrequency energy delivery, not on machine learning from a dataset.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.