(41 days)
The TriFix Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.
The Tri-Fix Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar. and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The posterior Tri-Fix Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The posterior Tri-Fix System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with mateautins and of the disc confirmed by history and radiographic studies), deformities (scoliosis, and kyphosis), tumor, fracture, and previous failed fusion surgery.
The Tri-Fix Spinal System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, plates, and accessory connection components.
The provided text describes a 510(k) premarket notification for the Tri-Fix Spinal Fixation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a new drug or a novel AI diagnostic device would.
Therefore, many of the requested elements (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific performance metrics with acceptance criteria) are not applicable to this document as it pertains to a traditional medical device (spinal fixation system) seeking 510(k) clearance based on equivalence to an existing device, not a novel AI/software medical device.
However, I can extract information related to the device's technical specifications and the comparison made to the predicate device, which serves as the "study" demonstrating its suitability for market.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, "acceptance criteria" are generally implicit in demonstrating substantial equivalence to the predicate device. The primary performance metric mentioned is Stiffness Range from Biomechanical Test Results.
| Acceptance Criteria / Comparison Point | Tri-Fix Spinal System Performance | Predicate Device (ISOLA Spinal System) Performance (Benchmark) |
|---|---|---|
| Indications for Use | See above (detailed in 7.7) | Identical |
| Materials | Titanium | Stainless Steel or Titanium |
| Product Labeling | Instructions for use and box labeling including all necessary warning statements | Instructions for use and box labeling including all necessary warning statements |
| Packaging/Sterilization | Non-sterile, single use only | Non-sterile, single use only |
| Biomechanical Test Results (Stiffness Range) | Within the range of ISOLA | Outside the range of TriFix (This means the TriFix system's stiffness range is shown to overlap or fall within the acceptable range demonstrated by the ISOLA system, even if the ISOLA's overall range might be broader and include values outside the TriFix's specific range.) |
2. Sample Size Used for the Test Set and Data Provenance
- Not applicable in the context of a 510(k) for a spinal fixation system. This document does not describe a clinical study with a "test set" of patient data or samples. The "test set" here refers to the biomechanical testing conducted on the device components.
- The biomechanical tests would have involved a certain number of device samples, but the specific sample size for these engineering tests is not provided in this summary.
- Data Provenance: The biomechanical testing would have been conducted by the manufacturer (Endius, Inc.).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This relates to clinical data analysis, which is not the focus of this 510(k) summary for a spinal implant. Biomechanical testing relies on engineering standards and measurement rather than expert interpretation of a "ground truth" in the clinical sense.
4. Adjudication Method for the Test Set
- Not applicable. This applies to clinical interpretation or consensus, not biomechanical engineering tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC study was not done. This type of study is specifically relevant to diagnostic imaging devices or AI-driven decision support systems where human readers interpret cases. This document concerns a physical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The Tri-Fix Spinal Fixation System is a physical medical device, not an algorithm or software. It does not have standalone "algorithm-only" performance.
7. The Type of Ground Truth Used
- For the biomechanical testing, the "ground truth" would be established by standardized engineering test methods and established biomechanical properties (e.g., stiffness thresholds) relevant to spinal fixation systems. The predicate device's performance (ISOLA Spinal System's stiffness range) serves as the primary benchmark for the "ground truth" of acceptable performance.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device. This concept applies to machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There is no "training set" for this device.
§ 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.