(262 days)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.
The ARX® Spinal System, PILOT® Spinal System, PILOT® Posterior Lumbar Plating System, and CONQUEST® Spinal System, when properly used, are intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. They provide stabilization and immobilization of spinal segments as an adjunct to fusion.
When used as posterior spine thoracic/lumbar systems, the ARX Spinal System, PILOT Spinal System, PILOT Posterior Lumbar Plating System, and CONQUEST Spinal System are indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion, (6) pseudoarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The Life Spine Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to the spinous processes for the purpose of achieving, in conjunction with autogenous bone graft, single level supplemental fusion in the following conditions: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies), (2) trauma (i.e., fracture or dislocation), (3) spinal tumor, (4) spondylolisthesis. The Life Spine Interspinous Fixation System is not intended for standalone use.
The Life Spine Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). Implants are manufactured from titanium alloy per ASTM F136 and are available in a range of sizes to suit the individual pathology and anatomical conditions of the patient.
The implants are designed to sit between two spinous processes in order to maintain distraction between the vertebrae. There are plates on both sides of the spinous processes, and the plates are translationally adjustable to one another to accommodate different widths. The plates include spikes which anchor the implant to the spinous processes to prevent migration.
This is a 510(k) premarket notification for a medical device (Life Spine Interspinous Fixation System), not a study evaluating a device's performance against acceptance criteria in the typical sense of a clinical trial or AI/software validation study.
The acceptance criteria for this type of submission are not performance metrics like sensitivity or specificity, but rather demonstration of substantial equivalence to a legally marketed predicate device. The "study" proving this is a comparison of the new device to predicate devices across various attributes.
Here's the breakdown based on the provided text, reinterpreting the concepts for this type of regulatory submission:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (for Substantial Equivalence): The new device (Life Spine Interspinous Fixation System) must be substantially equivalent in:
- Design
- Materials
- Function
- Indications for Use
Reported Device Performance (against Substantial Equivalence criteria):
| Feature | Acceptance Criteria (Substantial Equivalence) | Life Spine Interspinous Fixation System Performance |
|---|---|---|
| Design | Equivalent to predicate devices | "equivalent, and in many cases superior" to predicate devices based on mechanical testing (Static Axial Compression, Static Torsion, Static Axial Pullout, Dynamic Axial Compression, Static Axial Grip Strength). Design description of two plates with translationally adjustable spikes to anchor to spinous processes, similar to predicate devices. |
| Materials | Equivalent to predicate devices | Titanium alloy 6AL-4V-ELI per ASTM F136 (same as predicates). |
| Function | Equivalent to predicate devices | Intended to stabilize and maintain alignment (similar to predicates); serves as a posterior, non-pedicle supplemental fixation device for single level supplemental fusion in specific conditions (similar to predicates). |
| Indications for Use | Equivalent to predicate devices | Indications for use are explicitly listed and largely align with those of the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a mechanical testing study on the device itself, not a clinical study with patients or data. The "test set" refers to the physical devices undergoing mechanical tests. The number of devices tested is not specified but would be typical for biomechanical evaluations.
- Data Provenance: Not applicable in the context of human data. The "data" comes from in vitro mechanical testing of the physical implants.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable. This is not a study requiring expert readers or interpretation of medical images/patient data to establish ground truth. The "ground truth" for mechanical testing is established by engineering standards (ASTM Standard F1717-04).
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No human adjudication of data is mentioned or required for in vitro mechanical testing against a standard.
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
- MRMC Study: Not applicable. This is a 510(k) submission for a physical implant, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for the mechanical testing is established by a modified version of ASTM Standard F1717-04. This standard provides the benchmark for acceptable biomechanical performance of spinal fixation devices.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning study.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. This is not a machine learning study.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.