(77 days)
The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:
- The UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The intended use and indications when used as a Pedicle Screw Spinal System are: - The UCR 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 neurological impairment,
- fracture,
- dislocation,
- scoliosis,
- kyphosis,
- spinal tumor, and
- failed previous fusion (pseudoarthrosis).
The indications for use as a Hook Spinal System are limited to T1-L5 and are: - degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history ad radiographic),
- spinal stenosis,
- spondylolisthesis,
- spinal deformities (scoliosis, kyphosis, and/or lordosis),
- fracture,
- pseudarthosis,
- tumor resection, and/or
- failed previous fusion.
The UCR Spinal System cross links and their components include variable and fixed cross links, fixed cross link bars, link bars, rounded links, screws, coupler, and an instrument. The variable cross links will be available in sizes ranging from 23 to 75mm and the fixed cross links and fixed cross link bars in sizes between 20 and 36mm. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The provided text is a 510(k) summary for the UCR Spinal System, specifically focusing on its cross links. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device efficacy through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, many of the requested categories related to clinical studies, ground truth establishment, expert adjudication, and comparative effectiveness are not applicable or not detailed in this document.
However, I can extract the information relevant to acceptance criteria in the context of a 510(k) (i.e., comparison to the predicate device) and provide available details about the comparative study conducted.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
In a 510(k) submission like this, "acceptance criteria" for substantial equivalence are generally met by demonstrating that the new device has the same technological characteristics, intended use, and indications for use as a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness. Mechanical testing is typically performed to demonstrate equivalent performance.
| Feature / Acceptance Criterion (for Substantial Equivalence) | Predicate Device Performance / Characteristic | UCR Spinal System Cross Link Reported Performance / Characteristic | Substantially Equivalent? |
|---|---|---|---|
| Intended Use (Overall design & function) | See Instructions for Use | Identical | Yes |
| Indications for Use | See Instructions for Use | Identical | Yes |
| Design and Scientific Technology | Titanium cross bar which clamps onto spinal rods to reduce the chance of movement to aid fusion. Uses a 3mm manual hex driver to lock the device. | Identical | Yes |
| Sizes | 60, 70, 80 mm | See prints (with additional sizes beyond predicate) | Yes, with additional sizes |
| Material | Titanium alloy | Identical | Yes |
| Sterile | Non-sterile | Identical | Yes |
| Mechanical Strength | Similar | See test results (implicitly "Similar" as per "Substantially Equivalent" column) | Yes |
Note: The "acceptance criteria" here are defined by the predicate device's characteristics and the requirement for "substantial equivalence." The "reported device performance" is the comparison against those characteristics.
2. Sample size used for the test set and the data provenance
The document refers to mechanical strength testing ("See test results"), but does not specify the sample size (number of devices tested) for these mechanical tests, nor does it provide data provenance (e.g., country of origin, retrospective/prospective nature) for any specific testing data. Mechanical testing in a 510(k) is typically conducted in a lab environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this 510(k) submission. No clinical study with expert-established ground truth is described or referenced. The "ground truth" for a 510(k) for a device like this relies on engineering principles and comparison to the predicate device's established performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication process for a test set is 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 a medical device for spinal fixation, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted 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 a physical implantable device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:
- The established intended use and indications for use of the predicate device.
- The design, material, and dimensional specifications of the predicate device.
- Mechanical engineering principles and testing standards to ensure that the new device's mechanical strength is comparable to the predicate.
8. The sample size for the training set
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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.