FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

When used as a pedicle screw fixation system the device system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.

Device Description

The Contour Spinal Fixation System consists of rods, hooks, screws, clamps, and plates designed for attachment to the noncervical spine to restore or maintain the normal alignment and assist in obtaining arthrodesis of abnormal vertebral motion segments. The implants are made of 22-13-5 stainless steel conforming to ASTM-138. Three types of rods pre-cut to a variety of lengths are provided. The first rod is a simple straight rod. The second has a right angle bend with a short arm on one end. The third has an expansion with a screw hole on one end. The system uses three types of clamps. One clamp consists of and eye-bolt-"C" shaped clamp combination which connects longitudinal rods with a crosslink rod. A second clamp is shaped like a "C" which encircles and is compressed to the rod by the proximal threads of a bone screw engaging and lagging the threaded side of holes placed through the ends of the "C". The third clamp is similar to the second clamp except the compressing screw is a simple screw which is also used to attach a crosslink plate. Extending from and incorporated as part of the third clamp is a short rod. which, when connected to a "C" clamp-bone screw combination, allows insertion of a bone screw in any horizontal or sagital angle or translational distance from a longitudinal rod. The system has two types of screws provided in a variety of lengths. One screw locks to the rod by engaging the threads of a rod with a threaded hole expansion at one end or by the proximal threads of the screw lagging and compressing a "C" clamp around a rod . The second screw is secured by an eye-bolt in the head of the screw. Two mechanisms are used for hook-rod connection. One locks to the rod with an eye-bolt. The second has a lateral facing "U" shaped opening for the rod entrance. The rod is pushed into and locked at the closed end of the "U" by a tapered locking screw.

AI/ML Overview

The provided text is a 510(k) summary for the Contour Spinal Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on existing clinical data and literature reviews. However, it does not contain acceptance criteria for device performance or a study demonstrating the device explicitly meets such criteria for the Contour Spinal Fixation System itself.

Instead, the document focuses on establishing substantial equivalence based on prior clinical experience with similar devices and literature reviews related to spinal fusion generally. The FDA's response further emphasizes the limitations of this substantial equivalence for pedicle screw fixation.

Therefore, many of the requested sections regarding specific acceptance criteria, performance metrics, and study details for the Contour Spinal Fixation System cannot be completed from the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated for this Device)	Reported Device Performance (Inferred from literature/predicate)
Not explicitly defined for the Contour Spinal Fixation System in this document. The document implies equivalence to predicate devices, whose performance would be assumed acceptable.	Fusion Rate Enhancement: Mardjeko et al. concluded instrumentation enhanced the fusion rate. Zdeblick et al. reported fusion rates of 65% (bone graft), 77% (Luque II), and 95% (TSRH pedicle screw).
Patient Satisfaction: Mardjeko et al. found patient satisfaction significantly enhanced by spinal fusion. Zdeblick et al. reported good to excellent patient satisfaction rates of 71% (bone graft), 89% (Luque II), and 95% (TSRH pedicle screw).
Clinical Results: Yuan et al. revealed a higher fusion rate and better clinical results with pedicle screw fixation compared to non-instrumented and conventional non-pedicle screw instrumented patients.
Safety: (Implied to be comparable to predicate devices and those studied in the literature)	Potential risks identified include device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury (stated as general risks for this device system but not specific performance data).

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. There is no specific "test set" for the Contour Spinal Fixation System described. The performance claims are based on literature reviews of other devices.
- Mardjeko et al. meta-analysis: 25 papers.
- Yuan et al. historical cohort study: 2,684 patients.
- Zdeblick et al. randomized study: 124 patients.
Data Provenance: The studies cited in the "Safety and Effectiveness" section are peer-reviewed publications (Spine, Clin. Orthop., J. Bone Joint Surg.). The countries of origin are not specified but are likely multinational or from highly developed medical research regions. The studies mentioned are retrospective (Mardjeko, Yuan) and prospective randomized (Zdeblick).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No specific "test set" for the Contour Spinal Fixation System is described where ground truth would need to be established by experts for this document. The document relies on published clinical outcomes from various studies.

4. Adjudication method for the test set

Not applicable. No specific "test set" for the Contour Spinal Fixation System is 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

Not applicable. This is a medical device (spinal fixation system), not an AI diagnostic tool that would involve multi-reader multi-case studies or AI assistance for human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the reported performance metrics (fusion rate, patient satisfaction, clinical results) in the cited studies would typically be clinical outcomes data (e.g., radiographic evidence of fusion, patient self-reported satisfaction scores, functional assessment scales) as collected and reported by the researchers in those respective studies.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or algorithms.

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

Not applicable.

Summary

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.