(170 days)
The SICONUS™ SI Joint Fixation System is intended to provide fixation of large bones, including the sacrum and ilium. It is intended for use in skeletally mature patients as an adjunct to sacroiliac joint fusion in the treatment of degenerative sacroiliitis, or sacroiliac joint disruptions.
The Camber Spine Technologies Siconus™ SI Joint Fixation System is a partially threaded, fully cannulated, bone fixation device that has a threaded distal end with a buttress-style profile in order to secure the device in cancellous bone. The proximal head of the device has a conical shape that provides axial compression of the bones across the sacroiliac joint in order to promote fusion. The head of the device also contains a tapered that allows the device to advance into hard cortical bone by displacing material, while also maintaining compression and preventing movement of the device. The proximal head and distal thread is connected by a smooth shaft. In the large version of the device, this shaft contains a slot along the axis to permit packing with bone graft to facilitate fusion.
The provided text is related to a 510(k) premarket notification for a medical device called the "Siconus™ SI Joint Fixation System." This document primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than a clinical study evaluating an AI algorithm's performance.
Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for AI algorithms is not present in the provided text.
The text describes mechanical performance testing of the physical medical device (implants and screws) against predicate devices, but this is not an evaluation of an AI algorithm.
Here's an attempt to extract what is available, and clearly state what is missing based on your specific request for AI device evaluation:
The document describes the Siconus™ SI Joint Fixation System, a partially threaded, fully cannulated bone fixation device for sacroiliac joint fusion.
1. A table of acceptance criteria and the reported device performance:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Torsion | Not explicitly stated; implied to meet or exceed predicate device performance. | Performs equally or better as compared to the predicate devices. |
| Static Bending | Not explicitly stated; implied to meet or exceed predicate device performance. | Performs equally or better as compared to the predicate devices. |
| Dynamic Bending | Not explicitly stated; implied to meet or exceed predicate device performance. | Performs equally or better as compared to the predicate devices. |
| Screw Thread Pullout | Not explicitly stated; implied to meet or exceed predicate device performance. | Performs equally or better as compared to the predicate devices. |
| General | Equivalent to or exceeding performance of predicate devices per ASTM F2193-02 & F543-07 | Subject device is equivalent or exceeds the acceptance criteria defined by equivalent tests performed on the predicate devices. |
Important Note: The acceptance criteria are not explicitly quantifiable values in this document. Instead, they are defined relative to the performance of predicate devices and compliance with ASTM standards. The "device performance" refers to the mechanical performance of the physical implant, not an AI algorithm.
The following information is NOT available in the provided text as it pertains to an AI device evaluation, which is not the subject of this 510(k) document:
- 2. Sample sizes used for the test set and the data provenance: Not applicable to a physical implant's mechanical testing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on physical measurements and engineering principles, not expert human interpretation of data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI sense. Ground truth for mechanical testing would be the results of the physical tests themselves.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.