(30 days)
The Ruthless Spine RJB device is intended to measure the angle of surgical instruments in two planes relative to a vertical plumb line in line with gravity. It is indicated for use during lumbosacral pedicle screw implantation in conjunction with applicable spinal instrumentation and as an adjunct to fluoroscopy or intraoperative x-ray. The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.
The Ruthless Spine RJB device is an intraoperative surgical angle measurement guide that attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The device can measure the axial and sagittal angles relative to gravity. The RJB system only provides measurements for angles in two planes relative to the vertical gravitational plumb line. As such, the RJB device does not provide surgical assistance, guidance, or navigation against patient anatomy. The RJB device is not intended to replace a surgeon's clinical judgement and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed.
The RJB device is provided sterile for single use and utilizes Bluetooth Low Energy (BLE) to connect to a tablet computer and display the angle measurements via the RJB Application (App). A set of handles and instruments compatible with the RJB are provided with the device for use in lumbosacral pedicle screw placement. The following components are part of the RJB system:
• RJB Device
• Quick Connect Axial Ratcheting Handle
• Straight Probe
• Duckbill Probe
• RJB Application
Note, a Tablet Computer is required to operate the device. The Tablet is not provided to the end user.
The provided text describes a 510(k) premarket notification for the Ruthless Spine RJB device. It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a performance study with acceptance criteria and results.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment based solely on the provided text.
The document explicitly states:
- "The RJB device is not intended to replace a surgeon's judgment and has not undergone clinical evaluation. No clinical benefit has been demonstrated or is claimed." (Page 3, 5)
- "Performance Testing - Non-Clinical: There were no changes to the design, intended use, or principles of operation. Therefore, performance testing was not required. The predicate device performance data is applicable to the subject device." (Page 7)
- "Performance Testing - Clinical: Clinical testing was not applicable to support a substantial equivalence determination for the subject device." (Page 7)
This means the submission relies on the prior clearance of the predicate device (DEN230012 – Ruthless Spine RJB) and argues that since there are "no changes to the design, intended use, or principles of operation" (the only modification mentioned being the change of instruments from single-use disposable to reusable), no new performance data is needed for this specific 510(k) submission.
To answer your request, one would need the performance data and study details for the predicate device (Ruthless Spine RJB DEN230012). This document does not contain that information.
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