(216 days)
Spinal Fixation System is non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). All components in the system are limited to skeletally mature patients. These devices are intended as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or curvatures (i.e., scollosis, kyphosis, and/or lordosis); tumor; stenosis, and failed previous fusion (pseudoarthrosis)
The Spinal Fixation System is available in various lengths. This system is comprised of screws, set screws, rods, crosslinks, connectors and hooks. The screws are available from 4.0 mm to 10.5 mm diameters with lengths ranging from 20 mm to 150 mm. The rods are available from 5.0 mm, 5.5 mm, 6.0 mm and 6.35 mm diameter with lengths ranging from 40 mm to 600 mm. Both straight rods and curved rods have four types of design that consist of standard type, hex type, stopper type and double stopper.
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Important Note: The provided document is a 510(k) summary for a spinal fixation system, which is a medical device. It does not describe an AI/ML-based device or a study involving human readers and AI assistance. Therefore, many of the requested points related to AI/ML device performance, ground truth establishment for AI, and MRMC studies cannot be found in this document and will be explicitly stated as "Not Applicable (N/A)" or "Not mentioned in the provided text."
Device Acceptance Criteria and Performance Study Summary
The device in question is the LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System, which are non-cervical spinal fixation devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are focused on substantial equivalence to existing predicate devices, rather than specific performance metrics like sensitivity, specificity, or accuracy (which would be typical for an AI/ML device). The performance is demonstrated through the equivalence of design, materials, and intended use, along with mechanical testing data, which is here substituted from predicate devices.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The device (additional components) must be substantially equivalent to predicate devices in: |
- Design
- Materials
- Scientific Technology
- Indications for Use
- Performance (specifically mechanical testing) | The additional components of the LnK Spinal Fixation System and OpenLoc-L Spinal Fixation System are considered substantially equivalent to the predicate devices. The systems have the same design, materials, scientific technology, and indications for use. |
| Material Composition | Manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) or Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537). This must be the same material used in the predicate devices. | The devices are manufactured from Ti-6Al-4V ELI titanium alloy (ASTM F136) or Cobalt-28Chromium-6Molybdenum-4Vanadium ELI (ASTM F1537), which is the same material used in the predicate devices. |
| Mechanical Performance | The additional components do not require additional mechanical testing if they are not the "worst case" and can substitute mechanical test data from predicate devices. (Implicit criterion is that the mechanical performance is equivalent to cleared predicate devices). | Mechanical test data for the additional components are substituted with data from predicate devices (K120270, K143363, K171813, K183168) because the additional components are not the worst case. The conclusion states they "perform as well as the predicate devices." |
| Intended Use | Non-cervical spinal fixation devices intended for use as posterior pedicle screw fixation systems (T1-S2/ilium), or as an anterolateral fixation system (T8-L5). Limited to skeletally mature patients and intended as an adjunct to fusion for: degenerative disc disease, spondylolisthesis, trauma (fracture or dislocation), deformities or curvatures (scoliosis, kyphosis, lordosis), tumor, stenosis, and failed previous fusion (pseudoarthrosis). | The device's indications for use match the specified criteria and are consistent with the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This submission relies on substituting mechanical testing data from predicate devices and demonstrating material and design equivalence, rather than a new test set of patient data or images for performance evaluation.
- Data Provenance: Not applicable. The "data" here refers to the design, materials, and previous mechanical testing of predicate devices. The country of origin for the predicate device's data is not specified. The nature of the "data" is not retrospective or prospective in the sense of clinical study data for an AI/ML device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. As established, this is not an AI/ML device performance study requiring expert annotation for ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. No test set requiring adjudication of "ground truth" labels.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, not mentioned. This document does not describe an AI/ML device and therefore no MRMC study was performed or is relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an algorithm-based device. Its "performance" is mechanical and related to its physical properties and design.
7. The Type of Ground Truth Used
- Not Applicable. The "ground truth" for this device is effectively the demonstrated safe and effective performance of its predicate devices through their established properties (design, materials, mechanical testing results) that it is substantially equivalent to. There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device, and thus there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. No training set exists for this type of device.
§ 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.