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The ORION-I EMF System is intended to be used for general surgical purposes in coagulation, cutting and ablation of soft tissues, including but not limited to orthopedic, arthroscopic, spinal, and neurosurgical procedures. Arthroscopic procedures may include those on the shoulder, elbow, wrist, hip, knee, and ankle. The ORION-I EMF System is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The ORION-I EMF System consists of a radiofrequency generator and accessories, sterile, single-use hand-pieces and sterile, single-use electrodes. The generator is a line-voltage powered, bipolar radiofrequency generator capable of delivering up to 16 watts of power at the electrode tip. The ORION-I utilizes controlled radiofrequency energy to cut, coagulate and vaporization (ablation) of soft tissue during a variety of electrosurgical procedures in general surgical use, including orthopedic, arthroscopic, spinal, and neurosurgical procedures.

This 510(k) summary for the Ortho Development Corporation ORION-I EMF System describes the device and its intended use, but it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

The document is a premarket notification (510(k)) submission to the FDA for substantial equivalence. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It typically relies on comparisons to existing devices, safety testing, and performance specifications rather than a comprehensive clinical study to "prove" meeting acceptance criteria in the way a clinical trial might for a novel therapeutic.

Therefore, I cannot provide the requested information. The provided text primarily establishes:

• Device Name: ORION-I EMF System
• Submitter Details: Ortho Development Corporation
• Date Prepared: June 22, 2001
• Predicate Devices: Ellman Surgitron IEC II RF generator, ArthroCare System 2000 RF generator, Ellman Surgitron Hand-pieces, Kirwan Surgical Hand-pieces, Kirwan Surgical Electrodes.
• Device Description: A line-voltage powered, bipolar radiofrequency generator delivering up to 16 watts, used for controlled desiccation and vaporization (ablation) of soft tissue in various electrosurgical procedures.
• Intended Use: General surgical purposes in coagulation, cutting, and ablation of soft tissues (orthopedic, arthroscopic, spinal, neurosurgical procedures, including shoulder, elbow, wrist, hip, knee, and ankle arthroscopy). For use by qualified medical personnel.
• Contraindications: When an electrosurgical procedure is contrary to the patient's best interest, in the judgment of the physician.
• Comparison to Predicate Devices: No significant differences that would adversely affect the use of the device; comparable in design, function, materials, and indications for use.
• FDA Decision: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

To directly answer your request based only on the provided text, I must state that the information is absent.

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