(203 days)
The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes.
The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
Contraindications for Use:
The use of the VULCAN EAS ElectroThermal Arthroscopy System and Accessories are contraindicated, when in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.
The ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System generator is a single channel, 200-watt, electrothermal generator that offers finely controlled radiofrequency output for the electrocoagulation, cutting, and ablation of soft tissue during a variety of arthroscopic procedures. The unit is specifically designed to be used with ORATEC electrothermal, electrosurgical, and ablation probes. Temperature and impedance monitoring are provided to assist the surgeon by automatically adjusting energy delivery to maintain effective tissue heating during temperature controlled applications.
Accessories provided with the Vulcan EAS include:
- AC power cord .
- Probe extension cable .
- Dual-pedal footswitch control .
Each generator is also accompanied by Instructions for Use and a warranty registration card.
This document is a 510(k) summary for the ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System and Accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific device performance against acceptance criteria from a study.
Therefore, many of the requested sections about acceptance criteria, study details, and ground truth cannot be fully addressed from the provided text.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a specific study. The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, the ValleyLab Force FX Electrosurgical Generator. This means the "acceptance criteria" are implicitly met if the device is shown to be as safe and effective as the predicate.
Key points of comparison (which serve as the basis for "performance" as presented here):
| Feature/Aspect | ORATEC Vulcan EAS | ValleyLab Force FX (Predicate) | Substantial Equivalence Status |
|---|---|---|---|
| Intended Use | General surgical, orthopedic/arthroscopic, coagulation, ablation, hemostasis of soft tissues. | Similar (general electrosurgical purposes implied by comparison) | Equivalent |
| Applications | Coagulation (fulguration), cutting, ablation (dessication) of tissues. | Coagulation (fulguration), cutting, ablation (dessication) of tissues. | Equivalent |
| Electrosurgical Device Compatibility | Monopolar and bipolar electrosurgical devices. | Monopolar and bipolar electrosurgical devices. | Equivalent |
| Impedance Measurement for Power Control | Measures impedance (resistance) to control power output. | Measures impedance (resistance) to control power output. | Equivalent |
| Preset Temperature/Power Combinations | Offers preset temperature and power combinations. | Offers preset temperature and power combinations. | Equivalent |
| Neutral Electrode Monitoring Circuits | Offers neutral electrode monitoring circuits. | Offers neutral electrode monitoring circuits. | Equivalent |
| Software-Controlled RF Generator | Software-controlled RF generator. | Software-controlled RF generator. | Equivalent |
| Temperature Control | Offers temperature control. | Does not offer temperature control. | Difference |
| Auto Probe Recognition | Offers auto probe recognition. | Does not offer auto probe recognition. | Difference |
| Remote Control of Generator Settings | Offers remote control of generator settings. | Does not offer remote control of generator settings. | Difference |
| Remote Display of Generator Settings | Offers remote display of generator settings. | Does not offer remote display of generator settings. | Difference |
| Auxiliary Thermocouple Accommodation | Can accommodate an auxiliary thermocouple. | Cannot accommodate an auxiliary thermocouple. | Difference |
| Ultrasonic Surgery Capability | Designed for electrosurgery only. | Also capable of ultrasonic surgery. | Difference |
The differences highlighted are presented as features that the Vulcan EAS has and the Force FX does not, or vice-versa, but are argued not to raise new questions of safety or effectiveness, thus maintaining substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not describe a clinical study with a "test set" in the context of validating algorithm performance. This is a 510(k) for an electrosurgical generator, and the information provided focuses on the device's design, intended use, and comparison to a predicate, not performance derived from a diagnostic algorithm or image analysis. Therefore, there is no mention of sample size or data provenance for such a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This is not a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 is not a diagnostic AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for a 510(k) substantial equivalence submission for an electrosurgical generator is based on the functional and technical characteristics of the device being compared to a known safe and effective predicate, and potentially bench testing demonstrating its functionality as described. Specific clinical "ground truth" in the diagnostic sense is not typically used here.
8. The sample size for the training set:
Not applicable. This document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.