(126 days)
The PerFect® TCS II is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity.
PerFect® TCS II is an electrosurge unit designed to appeal to both the new and experienced user of electrosurgery. PerFect® TCS II can simplify and enhance the results of a variety of everyday procedures performed by virtually every dentist, including the control of bleeding, gaining access to caries and aesthetic contouring of gingiva.
The PerFect® TCS II is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The radio-frequency energy used by PerFect® TCS II is able to sever and coagulate tissue because it focuses the heat energy at the small, active electrode. While the active electrode remains cold, sufficient heat energy is generated in its path to sever and coagulate effectively.
The high-frequency energy focused at the active electrode returns to the electrosurge through the large dispersive electrode, which is placed on the back of the dental chair against the patient's back during use. The PerFect® TCS II has two output modes: "Cut" and "Coag." The operator can adjust the intensity of these modes. When the power output is adjusted properly, the electrode cuts without resistance, permitting an extraordinary degree of control and precision.
The PerFect® TCS II is designed to use the Strobex (predicate) handpiece electrodes. These handpiece electrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturing process. In addition performance testing was conducted by UL that included functional testing of electrodes sterilized twenty times via the recommended cycle.
Here's an analysis of the acceptance criteria and supporting study for the PerFect® Tissue Contouring System II, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Device | "The PerFect® TCS II has demonstrated that it is equally effective as the predicate device and is in fact a safer device due to the fact it has been certified to comply to the requirements of the recognized standards by performance testing." |
| Compliance with Recognized Electrical Safety Standards | "The PerFect® Tissue Contouring System II (PerFect® TCS II) complies with IEC 60601-1:1988 + A1: 1991 + A2: 1995, IEC 60601-2-2, EN55011, Group1, EN60601-1-2 and EN60601-2-2 Clause 36." "The product was investigated to the following additional standards: EN 60601-1: 1990 + A1:1993 + A2:1995 + A13:1996, CAN/CSA C22.2 No. 601.1-M90 (R1997), CAN/CSA C22.2 No. 601.1S1-94, and CAN/CSA C22.2 No. 601.1B-90." |
| Functional Integrity of Re-sterilized Electrodes | "performance testing was conducted by UL that included functional testing of electrodes sterilized twenty times via the recommended cycle." |
| Biocompatibility Material Equivalence of Electrodes | "These handpiece electrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturing process." |
| Intended Use Equivalence to Predicate Device | "Same" as predicate device. |
| Indications for Use Equivalence to Predicate Device | "Same" as predicate device. |
| Electrode Equivalence to Predicate Device | "Same" as predicate device (in form/function, as the device uses the predicate's electrodes). |
| Absence of Software/Firmware (if predicate device also lacked) | "None" (matching predicate device). |
2. Sample Size Used for the Test Set and Data Provenance
The provided documentation does not specify a discrete "test set" sample size for a clinical or in-vitro study involving patient data or images. The performance testing primarily focused on engineering and electrical safety standards compliance rather than a typical clinical evaluation with a test set of cases.
The provenance of data is therefore not applicable in the usual sense of clinical trial data. The compliance testing was performed by Underwriters Laboratories Inc. Melville Division in the USA.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the study described is primarily an engineering and electrical safety compliance assessment, not a clinical study requiring expert labeling or adjudication of medical cases.
4. Adjudication Method
This information is not applicable for the same reason as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted. The submission focuses on demonstrating substantial equivalence through technical and safety performance, not on comparing reader performance with and without AI assistance. The device is an electrosurgical unit, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not conducted. The device is a physical electrosurgical unit, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was primarily defined by:
- Recognized International and National Electrical Safety Standards: Such as IEC 60601-1, IEC 60601-2-2, EN55011, EN60601-1-2, CAN/CSA C22.2 series. Compliance with these standards served as the basis for safety and performance "truth."
- Predicate Device Performance: The functional capabilities and safety profile of the Strobex Ultron Electrosurge Unit (K850666) served as the benchmark for demonstrating "equally effective" performance.
- Functional Testing Results: The ability of electrodes to maintain function after repeated sterilization cycles.
8. The Sample Size for the Training Set
This information is not applicable. The PerFect® TCS II is an electrosurgical unit, not a machine learning model, so there is no concept of a "training set" in this submission.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 872.4920 Dental electrosurgical unit and accessories.
(a)
Identification. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.(b)
Classification. Class II.