(29 days)
The intended use of the UCR Spinal System is as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The intended use of the UCR Spinal System, when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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. The indications for use are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- 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 (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis,
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- spinal tumor.
- pseudoarthrosis, and/or
- failed previous fusion.
The intended use and indications of the UCR Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
- degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
- spondylolisthesis
- trauma (i.e., fracture or dislocation),
- spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudarthosis, and/or
- failed previous fusion.
The UCR Spinal System includes titanium alloy polyaxial and polyaxial reduction screw assemblies. Both screw types will be offered in numerous widths and lengths. The screw assembly is comprised of a screw body, washer, and housing. Both screws are designed to be compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The UCR Spinal System will also include titanium alloy cross links, crossbars, rods, and caps. The cross links will come in one size, the crossbars in five sizes, the rods in two diameters, and the caps in two sizes. The cross link assemblies are comprised of a nut and hook while the crossbar assemblies are made up of two bars, two locking screws, a coupler, and a pin. All of these devices are designed to be compatible with and work in conjunction with the components in the current UCR Spinal System. The product is supplied "NON-STERILE" and must be sterilized prior to use.
The UCR Spinal System will offer a wide variety of instruments that range from in-situ rod benders to modular taps. These various instruments will be made primarily from various grades of stainless steel with a few components made from aluminum, titanium alloy, Radel, and silicone. These items are supplied "NON-STERILE" and must be sterilized prior to use.
The provided document is a 510(k) summary for the UCR Spinal System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo study to establish new performance criteria. Therefore, the information you've requested regarding acceptance criteria, study details, expert involvement, and ground truth is generally not applicable in the context of this 510(k) submission.
Here's why and what information is available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: For a 510(k) submission like this, the "acceptance criteria" revolve around demonstrating that the new device shares the same fundamental scientific technology, has the same intended use, and is as safe and effective as a legally marketed predicate device. Specific quantitative performance metrics (like sensitivity, specificity, accuracy for an AI device) and their acceptance thresholds are typically not established or reported in this format. The primary acceptance criterion here is "Substantially Equivalent."
- Reported Device Performance: The document states that the new components of the UCR Spinal System are "Substantially Equivalent" to the current UCR Spinal System (predicate device) in terms of Intended Use, Indications for Use, Design, Screw Sizes, Cross Links, Crossbars, Rods, Caps, Material, Sterilization, and Method of Sterilization. For "Mechanical Strength," it states "See test results," implying that testing was done to ensure the mechanical properties are similar to the predicate, thus meeting the substantial equivalence requirement.
Table of Acceptance Criteria and Reported Device Performance (based on provided text):
| Feature | Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (New UCR Spinal System vs. Current UCR Spinal System) |
|---|---|---|
| Intended Use | Intended use should be similar to the predicate device. | Similar |
| Indications for Use | Indications for use should be similar to the predicate device. | Similar |
| Design | Design principles and components should be similar to the predicate device. | Similar |
| Screw Sizes | Dimensional specifications should be within the range or similar to those of the predicate device. | Similar (details in prints) |
| Cross Links | Dimensional specifications should be within the range or similar to those of the predicate device. | Similar (details in prints) |
| Crossbars | Dimensional specifications should be within the range or similar to those of the predicate device. | Similar (details in prints) |
| Rods | Dimensional specifications should be within the range or similar to those of the predicate device. | Similar (details in prints) |
| Caps | Dimensional specifications should be within the range or similar to those of the predicate device. | Similar (details in prints) |
| Material | Material should be the same or a comparable, biocompatible material to the predicate device. | Titanium alloy (Similar) |
| Sterile | Sterility status should be similar to the predicate device. | Non-sterile (Similar) |
| Method of Sterilization | Method of sterilization should be suitable and similar to the predicate device. | High-temperature steam (Similar) |
| Mechanical Strength | Mechanical strength should be comparable to or meet the safety requirements of the predicate device. | See test results (implies equivalence was demonstrated) |
The remaining points are largely not applicable because this is a 510(k) for a physical medical device (spinal system components), not an AI/software device or a clinical study establishing new performance benchmarks.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a submission for a physical implantable device (UCR Spinal System components). The "test set" in this context would refer to mechanical testing of the physical components, not a dataset of patient images or clinical data for an AI algorithm. The document states "See test results" for mechanical strength, indicating such testing was performed, but specific sample sizes and data provenance for these engineering tests are not detailed in this summary.
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. Ground truth, in the sense of expert consensus on clinical diagnoses or image interpretations, is not relevant for a 510(k) submission for a physical spinal implant. "Ground truth" for this device would relate to engineering specifications and material properties, validated by standard mechanical testing protocols (e.g., ASTM standards), not medical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations (e.g., in radiological reads for AI studies). This is not relevant for mechanical testing of a medical device.
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. MRMC studies are specifically for evaluating diagnostic accuracy with and without AI assistance in situations involving medical image interpretation. This submission is for a physical orthopedic implant, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical implant, not a standalone AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. As mentioned, "ground truth" for this device would be derived from physical and mechanical performance specifications and testing results, confirming that the new components meet established engineering standards and are substantially equivalent to the predicate device. It would not typically involve medical "ground truth" like pathology or outcomes data in the context of a 510(k) for device components.
8. The sample size for the training set
- Not Applicable. There is no "training set" in the context of a physical medical device submission like this. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set or associated ground truth for this type of device submission.
§ 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.