(72 days)
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain with degeneration of the disc . confirmed by history and radiographic studies)
- spondylolisthesis .
- fracture ●
- spinal stenosis ●
- deformities (i.e. scoliosis, kyphosis, lordosis) ●
- tumors
- failed previous fusion (pseudoarthrosis) ●
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and ●
- have the device removed after the development of a solid fusion. .
In addition, the PLUS Pivot Link Universal 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
- failed previous fusion (pseudoarthrosis) ●
The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
This document is a 510(k) summary for the PLUS™ Pivot Link Universal System, a spinal instrumentation system. It's a premarket notification to the FDA for a medical device and, as such, focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving performance against specific acceptance criteria through a clinical study in the way modern AI/ML device submissions might.
Therefore, many of the requested numbered points are not directly applicable or available in this type of document. I will extract what is present and explicitly state when information is not provided.
Device: PLUS™ Pivot Link Universal System (Rod, Hook, and Screw Spinal Instrumentation)
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Key Performance Indicators) | Reported Device Performance |
|---|---|
| Substantial Equivalence: The primary "acceptance criterion" for a 510(k) application is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by comparing design, material, and intended use. | The document explicitly states: "The components of the PLUS Pivot Link Universal System are identical in design, material, and intended use to other spinal instrumentation system that have been cleared by FDA for posterior spinal use." |
| Mechanical Performance: Ensuring the device can withstand physiological loads without failure. | "Mechanical testing was performed to demonstrate the equivalence of the construct design to currently marketed spinal systems." (Specific performance metrics, such as fatigue life, pull-out strength, bending stiffness, or the comparative results, are not provided in this 510(k) summary. The summary only states that testing was performed to demonstrate equivalence.) |
| Biocompatibility: Materials are safe for implantation. | The materials used are specified (stainless steel according to ASTMs F138 and F1586, titanium alloy complying with ASTM-F136, and commercially pure Titanium complying with ASTM F67). Compliance with these standards implies biocompatibility was addressed, but no specific testing results are presented in this summary. |
| Sterilization: The device can be effectively sterilized. | Not explicitly mentioned in this summary, but a standard requirement for implantable devices. |
| Labeling/Indications for Use: Clear and appropriate for the device. | The indications for use are clearly listed for both posterior non-pedicle and pedicle screw applications (see pages 1-2 and 4). These align with predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a submission for a spinal implant, which relies on mechanical testing and material compliance, not clinical data in the sense of patient test sets.
- No "test set" of patient data is described for performance evaluation.
- The "testing" mentioned is mechanical testing of physical device constructs. The sample size for these mechanical tests (e.g., number of constructs tested) is not provided in this summary.
- Data provenance for mechanical testing (e.g., location of a lab) is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no patient-data-based "test set" or ground truth requiring expert consensus to establish. This is a physical device approval, not an AI/ML diagnostic or prognostic tool.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No patient-data-based "test set" or adjudication method 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 not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, "ground truth" is typically established through:
- Engineering Standards: Adherence to established ASTM standards for materials (F138, F1586, F136, F67).
- Biomechanical Testing Principles: Ensuring mechanical performance (fatigue, strength) meets or exceeds that of predicate devices, often based on recognized test methods.
- Predicate Device Performance: The primary "ground truth" for a 510(k) is often the demonstrated safety and effectiveness of an already legally marketed, substantially equivalent predicate device.
No medical expert consensus, pathology, or outcomes data is mentioned as a "ground truth" source in this summary for the purpose of device validation.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/ML algorithm.
§ 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.