(90 days)
Cutting: Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeeurotic Repair, Levator Resection, Arthroscopic Procedures.
Blended Cutting and Coagulation: Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.
Hemostasis: Control of Bleeding, Epilation, Telangiectasia
Surgitron Radiolase is a high frequency, medium power output electrosurgical device. The design is unique, simple, energy efficiency, safe, and user friendly. Furthermore, it equips the essential operational modes that are most often used in electrosurgical application. The unit has a maximum 50 watt output power and provides the capability of precision cutting, coagulating, and hemostasis in four megacycle frequency electrical current. It is designed to comply with international safety standards.
This document describes the Surgitron Radiolase, an electrosurgical device, and its substantial equivalence to predicate devices, not acceptance criteria for a study proving device performance in the context of AI/medical imaging or diagnostics.
Therefore, many of the requested elements (like "device performance," "sample size for test set," "number of experts," "adjudication method," "MRMC study," "standalone performance," "ground truth type," "training set size," and "ground truth for training set") are not applicable to this 510(k) summary. This document is focused on demonstrating that the new device is as safe and effective as previously cleared devices.
Here's a breakdown of what can be extracted or inferred from the provided text, aligning with the intent of the request as much as possible given the nature of the document:
Acceptance Criteria and Study for Surgitron Radiolase
The "acceptance criteria" in the context of this 510(k) summary are primarily based on demonstrating substantial equivalence to existing predicate devices in terms of intended use, technological characteristics, and safety standards. There isn't a "study" reported in the traditional sense of a clinical trial proving a specific performance metric against a numerical acceptance criterion. Instead, the "study" is the comparison made by Ellman International to show that the Surgitron Radiolase is similar enough to its predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on Predicate Devices) | Reported Device Performance (Surgitron Radiolase) |
|---|---|
| Intended Use: Identical to predicate devices (Cutting, Blended Cutting & Coagulation, Hemostasis). | Intended Use: "Same As New Device" (explicitly stated for predicate), confirming the new device meets the same broad range of electrosurgical applications. |
| Design Specification: Compliance with IEC 601-1 and 601-2-2, and CE aspects of Council Directive 93/42/EEC. | Design Specification: Complies with IEC 601-1 and 601-2-2, and CE aspects of Council Directive 93/42/EEC. |
| Output Energy: While the predicates have higher output (100W and 200W), the new device's 50W output is noted, implying it's acceptable for its intended use without being a safety concern. This is a difference but considered allowable given its overall equivalence. | Output Energy: 50 Watts (lower than predicates, but implies suitable for indicated uses). |
| Output Waveform(s): Similar waveform types to the IEC predicate (e.g., Sine-shaped, Fully Rectified, Partially Rectified). Frequencies differ but the type of waveform is comparable. | Output Waveform(s): 4.0MHz Sine-shaped, Fully Rectified, Partially Rectified. |
| Monopolar/Bipolar: Can operate in Monopolar mode (the new device is Monopolar only, which is a subset of the predicate capabilities). | Monopolar/Bipolar: Monopolar. |
| Standards Met: Compliance with IEC 601-1, 601-2-2, BSI5724:Section 2.2, and UL2601. | Standards Met: IEC 601-1, 601-2-2, BSI5724:Section 2.2, and UL2601. |
| Biocompatibility Tests: Monopolar electrodes identical to predicate device. | Biocompatibility Tests: Monopolar Electrodes identical to predicate device. |
| Sterilization Method(s): Identical to predicate device. | Sterilization Method(s): "Refer to Note II" (although Note II is not provided, the table indicates it's "Same As New Device" as the predicate). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is not a clinical study involving a test set of patients or data. The evidence for "performance" is based on technical comparison to predicate devices, compliance with standards, and the known safety/efficacy of the underlying technology (radiofrequency electrosurgery).
- Data Provenance: Not applicable. The data provided is a technical comparison of device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" established by experts in this context. The determination of substantial equivalence is made by the FDA based on the manufacturer's submission and comparison to predicate devices. The manufacturer's team (e.g., Frank Lin, Ph.D. Director of R&D Engineering) performs the comparative analysis.
4. Adjudication method for the test set
- Not applicable. There is no test set or adjudication process as typically understood in a clinical study. The FDA reviews the submitted technical data and makes a determination of substantial equivalence.
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
- Not applicable. This device is an electrosurgical unit, not an AI-powered diagnostic or imaging tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an electrosurgical unit, not an algorithm. The document explicitly states: "There is no software component in this new device."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the traditional sense of a clinical study. The "ground truth" for demonstrating substantial equivalence relies on:
- Pre-amendment device history / Established Clinical Practice: The safety and effectiveness of the technology (radiofrequency electrosurgery) and its indications for use are well-established through years of medical practice and prior FDA clearances. The predicate device "Surgitron IEC" is referenced as a pre-amendment device.
- Regulatory Standards: Compliance with recognized international safety and performance standards (IEC, UL, BSI).
- Technical Specifications: Direct comparison of physical and electrical characteristics with legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. There is no training set for an algorithm.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for an algorithm.
§ 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.