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The ORA-50 S AutoTemp ElectroThermal Generator ("ORA-50 S") and Accessories are intended to be used for general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes. The ORA-50 S ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The ORATEC Interventions ORA-50 S AutoTemp ElectroThermal Spine System ("ORA-50 S") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for the coagulation of soft tissue during a variety of spine procedures. The ORATEC ORA-50 S is specifically designed for use with ORATEC spine probe devices, although it may be used with any ORATEC electrosurgical or electrothermal probe.

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. A programmed temperature profile mode specifically designed for use with the ORATEC SpineCATH™ device ("SpineCATH Intradiscal Catheter", K974464) offers the convenience of selecting a treatment profile.

The provided text is a 510(k) summary for the ORA-50 S AutoTemp ElectroThermal Spine System. It focuses on establishing substantial equivalence to a predicate device based on intended use, operating principle, and hardware configuration. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions regarding studies, sample sizes, expert involvement, or ground truth. The document describes a regulatory submission for a medical device, which is different from a clinical study report.

The relevant information from the document is:

• Device: ORA-50 S AutoTemp ElectroThermal Spine System and Accessories
• Intended Use: For general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes.
• Predicate Device: ORA-50 S Programmable Spine System (K974464)
• Comparison: The ORA-50 S AutoTemp Spine System is a software modification of the predicate, sharing the same intended use, operating principle, and hardware configuration.

Missing Information:
All the specific points requested regarding acceptance criteria, device performance, study types, sample sizes, expert involvement, and ground truth are not present in the provided text. This document is a regulatory submission demonstrating substantial equivalence, not a detailed clinical study report.

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The ORA-50 S Programmable ElectroThermal Spine System and Accessories are intended to be used for general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes.

The ORA-50 S Programmable ElectroThermal Spine System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The ORATEC Interventions, Inc., ORA-50 S Programmable ElectroThermal Spine System generator is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for the electrocoagulation, cutting, and ablation of soft tissue during a variety of spine procedures. The unit is specifically designed to be used with ORATEC spine 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. A Programmed Temperature Profile mode specifically designed for use with the ORATEC SpineCATH™ device ("SpineCATH Intradiscal Catheter", K974464) is also included.

Accessories provided with the ORA-50 SP include:

• AC power cord ●
• Single-pedal foot pedal control

Each generator is also accompanied by Instructions for Use and a warranty registration card.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for a medical device (ORATEC® Interventions, Inc., ORA-50 S Programmable ElectroThermal Spine System and Accessories) and primarily focuses on:

• Device identification and contact details.
• Description of the device and its intended use.
• Comparison to a predicate device (ORATEC ORA-50 ElectroThermal Generator and Accessories) to establish substantial equivalence.
• FDA's response letter confirming substantial equivalence and clearance for marketing.
• Indications for use and contraindications.

The document details how the device is similar to and differs from its predicate device in terms of power, temperature/impedance monitoring, RF energy delivery, software control, and physical connections. However, it does not include any data from clinical trials, performance studies, or specified acceptance criteria with reported outcomes.

Therefore, I cannot fulfill your request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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