(85 days)
The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) spiral tumor, and/or (5) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD Polyaxial Fixation System is intended for the following indications: (1) degenerative disc disease (as defined by bark nin of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) turnor resection, and/or (7) failed previous fusion.
The LTD Polyaxial Fixation System consists of a variety of shapes and sizes of rods, screws and connecting components, sold with or without the surgical instrument tray. These components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The LTD Polyaxial Fixation System implant components are fabricated from medical grade titanium or titanium alloy described by such standards as ASTM F67 or ASTM F136 or ISO 5832-3 or 5832-2
The provided 510(k) summary describes the LTD Polyaxial Fixation System, a spinal implant system. It presents performance testing results without defining explicit acceptance criteria in a quantitative table. The primary method for demonstrating safety and effectiveness is through substantial equivalence to predicate devices, supported by mechanical testing.
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static Axial Testing (Compression Bending) | Complies with ASTM Standard F1717-01. Substantially equivalent in static strength to predicate devices. |
| Static Torsion Testing | Complies with ASTM Standard F1717-01. Substantially equivalent in static strength to predicate devices. |
| Cyclical Axial Compression Bending (Fatigue) | Maximum run-out load value at 5.0 x 10^6 cycles estimated. Complies with ASTM Standard F1717-01. Substantially equivalent in fatigue strength to predicate devices. |
Note: The document states "Results demonstrate that the LTD Polyaxial Fixation System complies with the recognized, voluntary performance standards for spinal implant systems." and "test results indicate that the LTD Polyaxial Fixation System is substantially equivalent in static and fatigue strength to predicate devices previously cleared by FDA." However, specific numerical acceptance thresholds (e.g., minimum load values, ranges) or direct comparison data to the predicate devices are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document refers to "testing" and "test results" without providing the number of units tested for each mechanical test.
- Data Provenance: The study is reported as laboratory mechanical testing. The origin of the device manufacturer (U.S. Spinal Technologies, Inc.) is Boca Raton, Florida, USA. As this is a 510(k) submission, the data is prospective for this submission, conducted to demonstrate equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable: This submission relies on mechanical laboratory testing of the device components, not on expert assessment of clinical data or images. Therefore, clinical ground truth establishment by experts is not relevant to this specific study as described.
4. Adjudication Method for the Test Set
- Not Applicable: As this involves mechanical testing following a standard protocol (ASTM F1717-01), there is no adjudication method in the sense of reconciling expert opinions. The validity of the test results would be determined by adherence to the standard and proper measurement techniques.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No: No MRMC study or any clinical comparative effectiveness study involving human readers is mentioned. The submission focuses on mechanical performance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable: The device is a physical spinal implant system, not a software algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Mechanical Performance Standards: The "ground truth" for this study is defined by adherence to a recognized, voluntary performance standard (ASTM F1717-01) for spinal implant constructs in a vertebrectomy model, and demonstrating substantial equivalence in static and fatigue strength to predicate devices. The properties of the materials (medical grade titanium or titanium alloy described by ASTM F67, ASTM F136, ISO 5832-3, or ISO 5832-2) also serve as part of the "ground truth" for material specifications.
8. The Sample Size for the Training Set
- Not Applicable: This is a mechanical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As there is no training set for an AI model, this question is not relevant.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.