(189 days)
Cutting: Skin and Mucosal Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures; Blended Cutting and Coagulation: Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal Cell Carcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures, ENT procedures; Hemostasis: Control of Bleeding, Epilation, Telangicctasia; Bipolar: Pinpoint, Precise Cutting and Coagulation, Pinpoint Hemostasis in any field (Wet or Dry)
The @llman Surgitron Radiolase II is a high frequency, medium power output electrosurgical medical device. The design is similar to currently marketed electrosurgical generators and provides the essential operational modes that are most often used in medium power electrosurgical applications. The unit consists of both a nominal 50 Watt maximum output power in monopolar mode and a nominal 55 Watt maximum output power in bipolar mode, providing the capability of precision cutting, coagulation, and hemostasis in a four megacycle frequency electrical current. The unit is designed to comply with the international safety standards.
Here's a breakdown of the acceptance criteria and study information for the ellman Surgitron Radiolase II device, based on the provided 510(k) summary:
This document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It typically does not contain detailed primary study results, acceptance criteria, or comprehensive performance data as would be found in a full clinical study report. Instead, it focuses on demonstrating equivalence to existing devices.
Therefore, the information provided below will be based on what can be inferred from the 510(k) submission, particularly the comparison to predicate devices, rather than explicit statements of acceptance criteria and a detailed study proving performance against them.
Acceptance Criteria and Reported Device Performance
Note: The 510(k) summary does not explicitly state "acceptance criteria" in the typical sense of quantitative performance targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and safety standards. The reported device performance is described by its technical specifications and capabilities, which are compared directly to the predicate devices.
| Feature / Acceptance Criteria (Implicit) | Reported Device Performance (ellman SURGITRON RADIOLASE II) |
|---|---|
| Intended Use (Substantially Equivalent to Predicates) | Monopolar and/or Bipolar Electrosurgical Cutting, Blended Cutting and Coagulation, and Hemostasis. (Specific indications listed: Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, Skin Tags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthroscopic Procedures, Papilloma Keloids, Verrucae, Basal Cell Carcinoma, Fistulas, Epithelioma, ENT procedures, Control of Bleeding, Epilation, Telangiectasia.) |
| Monopolar Output Power (Equivalent or within acceptable range of Predicates) | 50 Watts |
| Bipolar Output Power (Equivalent or within acceptable range of Predicates) | 55 Watts |
| Output Waveforms (Similar to Predicates) | Monopolar and Bipolar - 4.0 MHz Sine-wave shaped, Fully Rectified, Partially Rectified. |
| Compliance with Safety Standards (Meeting or exceeding Predicate standards) | IEC 60601-1, 60601-2-2, BS 5724-1, Requirements of the Medical Device Directive 93/42/EEC. |
| Delivery System Configuration (Comparable to Predicates) | Monopolar and Bipolar Capability |
| Software Presence (Comparable to Predicates) | Device does not contain software. |
Study Information (Based on 510(k) Submission)
1. Sample size used for the test set and the data provenance:
- Test Set: Not applicable for this type of submission. A 510(k) premarket notification primarily relies on a comparison of technological characteristics and intended use to predicate devices, rather than a new clinical study with a "test set" in the sense of clinical data. The submission indicates that the "indications for use is identical to the Surgitron as a preamendment device".
- Data Provenance: The document does not describe specific clinical data or a test set. The provenance of the comparison data is the existing specifications and regulatory clearances of the predicate devices: ellman Surgitron Radiolase (K992382) and ellman Surgitron 4.0 Dual RF/120 IEC (K013225).
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set with human-established ground truth in this 510(k) submission. Ground truth would be derived from the established safety and effectiveness of the predicate devices.
3. Adjudication method for the test set:
- Not applicable, as no human expert adjudication of a test set is described.
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. This device is an electrosurgical unit, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation. Therefore, an MRMC study is not relevant here.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical electrosurgical unit. It does not contain an algorithm or AI component.
6. The type of ground truth used:
- For a 510(k) submission, the "ground truth" for demonstrating substantial equivalence is the established safety and effectiveness of legally marketed predicate devices, as determined by the FDA's original clearance of those devices. This includes adherence to recognized performance standards (e.g., IEC 60601-1, 60601-2-2).
7. The sample size for the training set:
- Not applicable. The device does not contain software or AI that would require a "training set."
8. How the ground truth for the training set was established:
- Not applicable, as no training set exists for this device.
§ 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.