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The CANNULATED SCREW Internal Fixation System is intended to be used for alignment and stabilization of small bone fractures. Specifically:

· Fixation of small bones, such as those in the foot, ankle, wrist, elbow and hand for treatment of fractures, non-unions, or mal-unions

· Ligament reconstruction

• Osteochondritis dissecans
  · Arthrodesis of the foot, ankle, wrist, elbow and hand

· Small bone osteotomies, including first metatarsal head osteotomies, phalangeal osteotomies, and carpal/metacarpal osteotomies

These procedures may be indicated as a result of trauma, deformity, osteoarthritis, and rheumatoid arthritis.

The Cannulated Screw Internal Fixation System is comprised of Cannulated Headed and Headless Screws and Hook Plates intended to align and stabilize small bone fragments around articular regions. It is fabricated and manufactured from titanium alloy (6AI-4V-ELI per ASTM F 136). Screws and hook plates offer a variety of sizes of non-sterile, single use implantable components. Longer pitched threads on the distal tip of the screw penetrates bone at a faster rate than the shorter trailing threads for headless screws, allowing interfragmentary compression as the screw is advanced and countersunk. The non-threaded portion facilitates compression of the joint surfaces through a lag technique. The low profile hook plate can provide interfragmentary compression and is well suited for areas of limited soft tissue coverage.

All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Cannulated Screw Internal Fixation System components with components from any other system or manufacturer. The Cannulated Screw Internal Fixation System components should never be reused under any circumstances.

The provided text describes a 510(k) premarket notification for the Life Spine Cannulated Screws. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with established acceptance criteria and detailed study results. Therefore, the information requested in your prompt related to acceptance criteria, specific study designs, sample sizes, expert ground truth, adjudication methods, and AI performance is not present in this document.

However, I can extract the information that is available regarding the device performance and comparison to predicate devices:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) submission, there are no explicit "acceptance criteria" in the traditional sense of a clinical study with predefined statistical targets. Instead, the performance data presented aims to demonstrate equivalence to predicate devices.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

No clinical test set or sample size is mentioned. The performance data consists of "Benchtop Testing" and "Finite Element Analysis." These are laboratory and computational studies, not human or animal studies. Therefore, data provenance related to country of origin or retrospective/prospective is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. There is no human-involved "test set" or ground truth establishment by experts for this type of mechanical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as there is no human-involved "test set" requiring adjudication.

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. This device is a surgical screw, not an AI-assisted diagnostic or therapeutic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a surgical screw, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the mechanical performance data, the "ground truth" is defined by established engineering principles and standards (ASTM F543) for material and device properties.

8. The sample size for the training set:

Not applicable. There is no "training set" for an AI algorithm or a clinical study in this context. The performance data is from mechanical testing.

9. How the ground truth for the training set was established:

Not applicable, as there is no "training set."

Summary of available information:

The document primarily focuses on demonstrating that the Life Spine Cannulated Screw System is substantially equivalent to existing legally marketed predicate devices (Biomet BioDrive Micro Screw, Synthes Cannulated Screw, ACE Medical Cortical Screw).

• Performance Data: The device underwent Static and Dynamic Compression and Torsion testing in accordance with ASTM F543, as well as Benchtop Testing and Finite Element Analysis. This data was presented to demonstrate the substantial equivalence of the mechanical properties.
• Materials: Manufactured from implantable grade titanium (Ti 6Al-4V ELI) per ASTM F136, matching the material of predicate devices.
• Conclusion: The manufacturer concluded that the device is substantially equivalent in indications for use, design, function, and materials.

In essence, this document is a regulatory submission for a physical medical device (a screw) and does not involve AI, clinical efficacy studies with predefined acceptance criteria, or expert-adjudicated ground truth as would be relevant for a diagnostic or AI-driven device.

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