(20 days)
The FIREBIRD SI Fusion System is intended for fixation of sacroiliac joint disruptions, and intended for sacroiliac joint fusion for conditions including;
· sacroiliac joint disruptions,
· degenerative sacroiliitis,
· to augment immobilization and stabilization of the sacroillac joint in skeletally mature patients undergoing sacropelvic
fixation as part of a lumbar or thoracolumbar fusion and
• Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
The FIREBIRD SI Fusion System is a temporary, multiple component system consisting of non-sterile instruments as well as both non-sterile, cannulated screws of various lengths and diameters with multiple fenestrations on their shafts. The FIREBIRD SI Screws are constructed from medical- grade titanium alloy (Ti-6Al-4V ELI). The 11mm and 12mm FIREBIRD SI Screws are 3D printed with a mid-shaft porous region. The porous titanium region has open macroscopic 3D pores with a microscopic roughened surface. The FIREBIRD SI Screw allows for packing of autograft and allograft materials.
FIREBIRD SI Fusion System consists of cannulated, fenestrated 9mm, 11mm, and 12mm diameter implants in lengths ranging from 25mm to 70mm. The 9mm diameter implant maintains a single pitch thread along the entire shaft of the 11mm diameter implant features a tapered proximal end and dual-pitch threads. The 12mm diameter implant maintains a single pitch thread form on the proximal and distal ends.
The principle of operation is based on the bone screw implants which are designed to prevent and minimize motion / micro motion of the sacroiliac (SI) joint, and thereby stabilize the joint or fracture. The mechanism of action is that the interference fit allows for fixation, stabilization and fusion.
The provided text is a 510(k) summary for the FIREBIRD SI Fusion System. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.
The 510(k) summary states that the device is identical to a previously cleared device, and therefore, its performance characteristics are the same. It does not contain a study proving the device meets new acceptance criteria. Instead, it relies on the predicate device's prior clearance to establish equivalence.
Therefore, I cannot provide the requested information from the given text as it does not contain a standalone study with acceptance criteria and reported device performance.
Here's why and what information is available:
- No Acceptance Criteria or Reported Device Performance: The document explicitly states, "The performance and technological characteristics of the subject device are unchanged as the subject 9mm FIREBIRD SI Screw is identical to the predicate FIREBIRD SI Fusion System 9mm FIREBIRD SI Screw (K203138) in terms of design, materials and performance characteristics." This means Orthofix is not presenting new performance data for this submission; they are asserting that its performance is equivalent to the predicate.
- No Test Set/Ground Truth Information: Since no new performance study is detailed, there's no information on sample size, data provenance, expert ground truth establishment, or adjudication methods for a test set.
- No MRMC or Standalone Performance Study: The document doesn't describe any studies involving human readers with or without AI assistance, nor does it detail a standalone algorithm performance study. This is expected as the device is a physical bone fixation system, not an AI/software device.
- No Training Set Information: Without a new performance study, there's no mention of a training set or how its ground truth would be established.
The core of this 510(k) submission is to demonstrate that the new version of the FIREBIRD SI Fusion System (specifically, the sterile-packaged 9mm screws) is substantially equivalent to an already cleared version. It relies on the prior approval and testing of the predicate device.
To answer your request, here's what the document does provide, although it doesn't directly address "acceptance criteria and a study that proves the device meets them" for this specific submission:
1. A table of acceptance criteria and the reported device performance:
Not available in the document. The document asserts equivalence to a predicate device, implying its performance is already known and accepted from the predicate's clearance.
2. Sample sized used for the test set and the data provenance:
Not available in the document. No new test set described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not available in the document. No new ground truth establishment described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not available in the document. No new test set described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No, this is not applicable. The device is a physical bone fixation screw system, not an AI/imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, this is not applicable. The device is a physical bone fixation screw system, not an algorithm.
7. The type of ground truth used:
Not applicable. No new ground truth described for this submission. The basis for clearance is substantial equivalence to a predicate device, which would have undergone its own testing based on engineering standards and clinical data for its intended use.
8. The sample size for the training set:
Not applicable. No training set is mentioned as this is not an algorithm-based device.
9. How the ground truth for the training set was established:
Not applicable. No training set is mentioned.
§ 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.