(117 days)
- Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are:
The HAIDER-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 fusion 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. - Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are:
The HAIDER-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 pseudarthrosis)
The new 5.5mm screw will be used in all UCR Spinal System applications where a smaller screw would be of benefit. Therefore, the mechanical properties and fatigue performance are important. The remainder of the UCR Spinal System components will remain unchanged. Other than the major and minor diameter of the cancellous portion of the shaft and threads, the new 5.5mm screws are similar to the existing screws. Spinal rod attachment method are the same as cleared previously.
The new 8.0mm Spinal Screws expand the options for screw insertion by providing an alternative to the smaller 6, 6.5 or 7.0mm pedicle screws of the available UCR Spinal System. This new screw diameter allows the surgeon to insert screws in cases where the spine deformity or the large size of the pedicle makes use of smaller diameter screws less desirable. The larger diameter of the 8.0mm Spinal Screws permits the surgeon to address the needs of an expanded patient population.
The provided document is a 510(k) Premarket Notification for the UCR Spinal System, specifically focusing on new 5.5mm and 8.0mm spinal screws. This document addresses the substantial equivalence of these new components to previously cleared devices.
Based on the provided information, the device is a pedicle screw Spinal System, which falls under Class II uses. The "studies" conducted are non-clinical bench tests focused on mechanical and fatigue performance to ensure the new screws meet established standards and are equivalent to the predicate device.
Here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard/Guidance) | Reported Device Performance |
|---|---|
| ASTM F-1717-96 guidance document | Both the 5.5mm and 8.0mm pedicular screws carry clinically useful loads out to the five-million cycle asymptotic endurance limit. |
| Compliance with material standards | Not explicitly detailed, but implied by "Titanium alloy" and "Identical" material comparison to predicate. |
| Compliance with mechanical testing standard | "Mechanical and fatigue testing were carried out" in accordance with ASTM F-1717-96. |
| Compliance with biocompatibility standard | Not explicitly detailed but is a general control for such devices. |
| Compliance with specified labeling requirements | Not explicitly detailed but is a general control for such devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact number of samples tested for the mechanical and fatigue testing. It only states "Samples were tested".
- Data Provenance: The data provenance is from non-clinical bench testing. The testing was conducted by SEASPINE, INC. The country of origin of the data would be the USA, where SEASPINE, INC. is located. It is prospective in the sense that the testing was performed specifically for this 510(k) submission, not gathered retrospectively from patient data.
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)
This is a non-clinical mechanical testing study, not a clinical study involving diagnosis or interpretation by medical experts. Therefore:
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
The "ground truth" here is the performance under defined mechanical engineering standards, which is established by the test methods themselves and interpreted by engineers.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since this is a non-clinical mechanical test, an adjudication method for human interpretation is not applicable. The results are quantifiable mechanical measurements.
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: No, an MRMC study was not done. This submission is for a medical device (spinal screws), not an AI/software device that assists human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: No, a standalone performance study in the context of an algorithm or AI was not done. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for this premarket notification is based on engineering standards and mechanical performance metrics. Specifically, the ability of the screws to "carry clinically useful loads out to the five-million cycle asymptotic endurance limit" as defined by the ASTM F-1717-96 guidance document.
8. The sample size for the training set
This is a non-clinical mechanical testing study for a physical device. There is no "training set" in the context of machine learning or AI. The tests are designed to validate the physical properties against established standards.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable. The "ground truth" for the device's performance is established by the specified mechanical testing methods and standards (e.g., ASTM F-1717-96).
§ 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.