(50 days)
The CSS cannulated bone screw is indicated for bone fractures, arthodeses, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
The Cannulated Screw System is designed for bone fracture, osteotomies, arthrodesis, osteochronditis and tendon reattachment. These screws are not intended for attachment or fixation to the posterior elements (pedicles) of cervical, thoracic, or lumbar spine.
The Cannulated Screw System implants are partially threaded devices offered in multiple lengths and diameter. The implants have a cruciate driver head. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. These screws are of self-tapping.
The provided document is a 510(k) premarket notification for a medical device called the "Cannulated Screw System". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study. Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for a study cannot be found in this document.
Here's an explanation based on the document's content:
- Substantial Equivalence: The FDA's 510(k) pathway is for devices that are "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use as the predicate and either has the same technological characteristics or, if it has different technological characteristics, the differences do not raise new questions of safety or effectiveness and performance data demonstrates that the device is as safe and effective as the predicate.
The document states:
- "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent..." (Page 1)
- "The Cannulated Screw System is technologically substantially equivalent to the predicate devices." (Page 3)
- "Testing rationales related to pull out, insertion, removal and ultimate torque were provided to support the substantial equivalence of the subject device and show that no new worst-case devices are introduced in this system." (Page 4)
- "The safety and effectiveness of the Cannulated Screw System is adequately supported within this premarket notification. Through the analysis of technical characteristics the new devices are substantially equivalent to the predicate devices." (Page 4)
- "(b)(2). Substantial Equivalence - Clinical Evidence N/A" (Page 4) - This explicitly states no clinical evidence (which would typically involve large-scale studies with acceptance criteria) was provided or deemed necessary for this submission.
The "testing rationales" mentioned for pull-out, insertion, removal, and ultimate torque are benchtop (non-clinical) tests used to show that the new device performs at least as well as the predicate devices in these specific mechanical properties, thereby supporting substantial equivalence. They are not framed as meeting specific clinical "acceptance criteria" through a clinical study as your request implies.
In summary, this document does not contain the details of a study that proves the device meets specific acceptance criteria in the way you've outlined because it's a 510(k) submission focused on demonstrating substantial equivalence through technical characteristics and bench testing, not clinical performance against defined acceptance metrics.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.