Search Results

The Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic surgery in soft tissue where control of hemostasis and thermal spread is desired. The system is indicated for dissection, sealing, transection, otomy creation and transection/coagulation of vessels as indicated for each cutting and coagulation instrument used (consult the instructions for use provided with each instrument). The system can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpels.

The Prime™ Adaptive Ultrasonic Scalpel System has three major components: Generator (with footswitch), Transducer Handpiece and instruments (or blades). The Prime™ 6000 Generator provides input/output control and operation interface to automatically adapt the ultrasonic power output for the tissue load encountered.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. Instead, it is an FDA 510(k) clearance letter for the Prime™ Adaptive Ultrasonic Scalpel System, focusing on its substantial equivalence to predicate devices and adherence to various performance and safety standards.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
6. If a standalone performance study was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

The document primarily details:

• Device Name: Prime™ Adaptive Ultrasonic Scalpel System
• Indications for Use: Cutting and coagulation in open, laparoscopic, and endoscopic surgery where control of hemostasis and thermal spread is desired. Used for dissection, sealing, transection, and vessel coagulation. Can be an adjunct or substitute for electrosurgery, lasers, or steel scalpels.
• Key Components: Generator (Prime™ 6000), Transducer Handpiece, and Instruments/Blades.
• Technological Characteristics: Automatically adapts ultrasonic power output to tissue load, consistent vibration, non-sterile reusable blades validated for cleaning/sterilization, and a cable disconnect feature at the transducer handpiece for convenience.
• Predicate Devices: Ultracision® Harmonic Scalpel® series from Ethicon Endo-Surgery, Inc.
• Reference Device: Sonopet® Surgical Aspirator for its blue anodized blade tip surface.
• Standards Met: A comprehensive list of IEC, ISO, AAMI, CAN/CSA, and EN standards related to electrical safety, electromagnetic compatibility, biocompatibility, risk management, and software life cycle processes. These are general safety and performance standards for medical devices, not specific clinical performance criteria or results.

The document asserts "no new questions of safety or effectiveness" and concludes substantial equivalence, which is the basis for 510(k) clearance, rather than presenting a detailed clinical study demonstrating meeting specific performance criteria.

Ask a specific question about this device