(85 days)
The Life Spine SIMPACT Sacroiliac Joint Fixation System is intended for sacroillac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Life Spine SIMPACT Sacroiliac Joint Fixation System consists of fully threaded screws and partially threaded cannulated screws in various diameters and lengths to enhance sacroiliac joint fusion. The purpose of this submission is to add the Tri-Fin Screw to the SIMPACT Sacroiliac Joint Fixation System. All components are fabricated and manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine SIMPACT Sacroiliac Joint Fixation System components with components from any other system or manufacturer. The Life Spine SIMPACT Sacroiliac Joint Fixation System components should never be reused under any circumstances.
The provided text is a 510(k) summary for a medical device called the Life Spine SIMPACT Sacroiliac Joint Fixation System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing raw performance data or detailed study results for a new AI/software-as-a-medical-device.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, specifically concerning AI/ML performance, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies.
The performance data mentioned in the document is limited to:
- Engineering analyses
- Static Screw Pull-Out & Screw Driving Torque testing to ASTM F543 (A2 & A3)
This testing was done to demonstrate substantial equivalency in mechanical performance to the predicate device (Life Spine Sacroiliac Joint Fixation System (K141246)), not to assess the performance of an AI/ML algorithm or a diagnostic device.
To directly answer your request based on the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on showing mechanical/design equivalence to a predicate, not meeting specific performance metrics for an AI/ML or diagnostic device.
- Sample sizes used for the test set and the data provenance: Not applicable/not present. The testing mentioned (screw pull-out, torque) would have specific sample sizes for mechanical tests, but these are not for a "test set" in the context of AI/ML or clinical imaging data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not present. This is not an AI/ML or diagnostic device requiring expert-established ground truth from images or clinical data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not present.
- 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/not present. This device is a mechanical fixation system, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not present.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not present in the context of what you're asking. The "ground truth" for this device would be its mechanical properties matching the standard or predicate.
- The sample size for the training set: Not applicable/not present. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable/not present.
In summary, the provided document is a 510(k) for a mechanical spinal implant, not a software or AI-based medical device. Therefore, the detailed questions about AI acceptance criteria, ground truth, and study methodologies for AI/ML performance do not apply to the contents of this document.
§ 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.