(26 days)
The ORA-50 ElectroThermal System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues. The ORA-50 ElectroThermal System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.
The ORATEC Interventions ORA-50 ElectroThermal System ("ORA-50") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for use during a variety of arthroscopic procedures. The ORATEC ORA-50 is specifically designed for use with ORATEC cutting and temperature controlled probes.
Temperature and impedance monitoring are provided to assist the physician by automatically adjusting energy delivery to maintain effective tissue heating during temperature-controlled applications. Preset temperature and power settings in the generator software offer the convenience of quickly configuring the generator for use.
The provided text describes a 510(k) submission for the ORATEC Interventions ORA-50 ElectroThermal System and Accessories. The submission focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria, test results, or detailed performance metrics.
Therefore, many of the requested details about acceptance criteria and study methodology are not available in the given document. The document primarily details the device's intended use, description, and comparison to a predicate device to argue for substantial equivalence.
Here's an analysis based on the provided text, highlighting what is and is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in terms of quantitative performance metrics for a new study. The primary "acceptance criteria" for a 510(k) in this context is demonstrating substantial equivalence to a predicate device. | The document states: "Based on the data and information presented here, the modified ORA-50 System and Accessories are substantially equivalent to the ORA-50 ElectroThermal System and Accessories currently manufactured and distributed by ORATEC Interventions, Inc." This indicates the device met the substantial equivalence requirement. |
| For an electrothermal system, typical performance aspects might include power output accuracy, temperature control precision, impedance monitoring accuracy, and safety features. However, specific thresholds or measured values for these are not provided in this summary. | No specific quantitative performance data (e.g., actual power output, temperature ranges maintained, impedance accuracy) is reported in this 510(k) summary for the new device or in comparison to the predicate. |
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 test set or clinical study with a sample size. The filing is for substantial equivalence based on hardware and software modifications.
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. No ground truth establishment for a test set is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is described.
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 system, not an AI diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an electrosurgical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The submission is based on engineering principles and comparison to a legally marketed predicate device, not on establishing ground truth for a clinical condition.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning 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.