Search Results

IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

The IPC™ POWEREASE™ System is indicated for drilling, tapping and working end attachments during spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and rods.

Medtronic Reusable Instruments compatible with Medtronic's IPC™ The POWEREASE™ System are spine preparation instruments manufactured from materials commonly used in orthopedic procedures which meet available national or international standards specifications. The instruments may be connected to the POWEREASE™ Driver or used manually. These instruments are also compatible with various Medtronic spinal implant systems.

The provided text is a 510(k) Summary for the Medtronic POWEREASE™ System. It discusses the device's substantial equivalence to a predicate device, IPC™ POWEREASE™ SYSTEM (K111520), and outlines some performance data. However, it explicitly states that no new testing was performed for the subject devices, and instead relies on a "confirmatory validation" to ensure minor modifications do not introduce new safety or effectiveness issues.

Therefore, the document does not report on a study that establishes acceptance criteria and demonstrates that the device meets those criteria through new performance testing. Instead, it asserts substantial equivalence based on the device being identical to the predicate in key aspects.

Given this, I cannot fully answer all parts of your request as there isn't a detailed study report with new acceptance criteria and performance data in the provided document. I will fill in what can be inferred from the text.

1. A table of acceptance criteria and the reported device performance

Based on the provided text, no specific quantitative acceptance criteria or new device performance metrics are presented for the subject device. The document states that the subject instruments are "identical to the predicate devices in terms of fundamental technology, intended use and indications for use." The "confirmatory validation" is not described with numerical acceptance criteria or performance results.

Ask a specific question about this device