(138 days)
The SEURAT™ Universal Pedicle Screw System is intended to provide immobilization of the spinal segments, (T1 - S2/ilium) or as an anterolateral fixation system (T8 - L5), in skeletally mature patients as an adjunct to fusion. The SEURAT™ Universal Pedicle Screw System is a posterior, non-cervical, pedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor, pseudarthosis; and failed previous fusion.
The SEURAT™ Universal Pedicle Screw System can be used in an open approach and percutaneous approach with MIS instrumentation.
The SEURAT™ Universal Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consists of pedicle screws, rods, set screws, hooks, connectors, and a transverse (cross) linking mechanism. Various sizes of these implants are available. SEURAT™ Universal Pedicle Screw System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion.
SEURAT™ Universal Pedicle Screw System can either be used in an open approach and/or a percutaneous with minimally invasive (MIS) surgical approach. The rods, screws utilized as part of the proposed system are identical to devices cleared previously via K120714, K132365, and K140219. The crosslinks and additional universal instrument components that may be utilized as part of the subject system were cleared previously via K120714, K121568, K132365, and K140219.
The fundamental scientific technology and intended use are unchanged from the legally marketed predicate pedicle screw systems. The proposed system will use a modified version of DALI Spinal Fixation System previously cleared via K121568, a modified version of RAPHAEL Pedicle Screw System previously cleared via K132365 and additional lengths for anatomically bigger patients, and a modified version of PICASSO-II MIS Spinal System previously cleared via K140219 predicate based on the K120714, PICASSO MIS Spinal System) and additional size and lengths for anatomically bigger patients. The modifications include additional hexalobe screw-head driver feature; screw thread profiles, sizes, and lengths; and/or Minimally Invasive Spine (MIS) screw housing tower ring enhancement which will accommodate wider range of surgeons' usage preference, anatomically bigger patients, and/or consolidation of similar sub-components throughout all CTL Medical's pedicle screw systems for manufacturing efficiency.
The provided document describes a medical device, the SEURAT™ Universal Pedicle Screw System, and the testing conducted to support its substantial equivalence to predicate devices. It is a 510(k) summary, which focuses on demonstrating equivalence rather than establishing novel claims of safety and effectiveness through extensive clinical trials.
Therefore, the information you've requested regarding AI algorithm performance, sample sizes for training/test sets in that context, expert adjudication, AI improvement effect size, and specific ground truth definitions for an AI system are not applicable to this document. The study described is a mechanical performance safety study, not a study of an AI device.
Here's the information relevant to the mechanical performance study, extracted and formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Compression Bending | Met acceptance criteria as per ASTM F1717 guidance. | "The results met all acceptance criteria" |
| Static Tension Bending | Met acceptance criteria as per ASTM F1717 guidance. | "The results met all acceptance criteria" |
| Static Torsional | Met acceptance criteria as per ASTM F1717 guidance. | "The results met all acceptance criteria" |
| Fatigue (Dynamic) Compression Bending | Met acceptance criteria as per ASTM F1717 guidance. | "The results met all acceptance criteria" |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text, but it would have been a number of device units tested according to the ASTM F1717 standard.
- Data Provenance: Not applicable as this is a mechanical testing study, not a study involving human or patient data. The testing was performed according to an industry standard (ASTM F1717).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is the physical performance of the device against a mechanical standard, not a clinical observation by experts. The standard (ASTM F1717) defines the testing methodology and performance benchmarks.
4. Adjudication method for the test set:
- Not applicable. Adjudication methods are relevant for clinical studies where multiple reviewers assess data. In mechanical testing, results are quantitative measurements interpreted against pre-defined acceptance criteria.
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 a study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a pedicle screw system, not an algorithm or AI.
7. The type of ground truth used:
- The "ground truth" for this study is defined by the acceptance criteria established by the ASTM F1717 standard. This standard specifies how pedicle screw systems should be mechanically tested and what performance metrics they must achieve to be considered safe and effective in terms of mechanical stability and durability.
8. The sample size for the training set:
- Not applicable. No training set is involved as this is mechanical testing of a medical device, not an AI or machine learning study.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.