(108 days)
The Santis Pedicle System is intended for immobilization and stabilization of the spine. The Santis Pedicle System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (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; pseudoarthrosis; and failed previous fusion.
The Santis Pedicle Screws Spinal Fixation is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, compression retaining assemblies, cross connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Santis system can be implanted either by an open procedure or percutaneous MIS approach, or a combination of both during the same procedure. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, or cobalt chrome per ASTM F1537.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Santis Pedicle Screw System, presented in the requested format:
Acceptance Criteria and Study Analysis for Santis Pedicle Screw System (K133063)
Important Note: The provided document is a 510(k) Summary for a medical device (pedicle screw system), which primarily focuses on demonstrating substantial equivalence to a predicate device. This type of submission usually relies heavily on mechanical testing rather than clinical efficacy studies, especially for Class III devices that are well-understood. Therefore, the "study" referred to here is pre-clinical mechanical testing, not a clinical trial with human subjects/data, or an AI-based performance study. The questions regarding human readers, ground truth for training/test sets, and AI-specific metrics are not applicable to this type of device submission.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a mechanical device, the "acceptance criteria" are typically defined by the performance standards outlined in relevant ASTM test methods. The "reported device performance" is a statement of compliance with these standards, indicating the device met or exceeded the requirements.
| Acceptance Criteria (Defined by ASTM Standard) | Reported Device Performance |
|---|---|
| ASTM F1717-10 (Static and Dynamic Compression Bending, Static Torsion, Static Tension Bending) | Device demonstrated compliance with the standard for these tests. |
| ASTM F1798-97 (Axial Grip Strength) | Device demonstrated compliance with the standard. |
| ASTM F543-07 (Three-Point Bend Test) | Device demonstrated compliance with the standard. |
| Overall Goal: Substantial Equivalence to Predicate Device (demonstrated through performance testing and comparison of features) | Lanterna concludes that the Santis Pedicle Screw System is substantially equivalent to the predicate pedicle screw system in regards to indications for use, materials, function, sizes, and mechanical test results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as "sample size" in the context of clinical data. For mechanical testing, the sample size refers to the number of individual components or assembled constructs tested for each specific condition. This detail is typically provided within the full test reports, which are not part of the 510(k) summary but would have been submitted to the FDA. However, ASTM standards usually specify minimum sample sizes for each test.
- Data Provenance: The data is generated from in vitro mechanical testing of the device components and assemblies. It is not derived from human patients or a specific country of origin in the way clinical data would be. It's pre-clinical, laboratory-generated test data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is not a study assessing diagnostic accuracy or human interpretation against a "ground truth" established by experts. The "ground truth" for mechanical performance is defined by the ASTM standards and the physical properties of the materials and design. The interpretation of the test results against the acceptance criteria is performed by qualified engineers/scientists conducting the tests and preparing the reports.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert interpretations of clinical data. This is mechanical testing, where the results are quantifiable measurements compared against predefined thresholds in the ASTM standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is a type of clinical comparative effectiveness study, typically used to compare the diagnostic performance of different methods (e.g., human readers with and without AI assistance). This submission is for a pedicle screw system, which is a physical implant, and relies on pre-clinical mechanical testing and comparison to a predicate device, not diagnostic imaging.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This device is a physical pedicle screw system, not an algorithm or AI system. Therefore, a standalone performance study in the context of AI is irrelevant.
7. The Type of Ground Truth Used
- Standardized Mechanical Performance Metrics. The "ground truth" or reference for the device's performance is established by the specified ASTM standards (e.g., F1717-10, F1798-97, F543-07). These standards define the test methodologies, failure criteria, and acceptable performance ranges for pedicle screw systems. Essentially, the "ground truth" is whether the device can withstand the forces and conditions defined by these rigorous engineering standards.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of mechanical testing for a physical implant. The design and manufacturing process are informed by engineering principles, material science, and previous product designs, but this isn't "training data" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set as understood in AI/clinical studies, there is no ground truth established for it. The development process for such a device is governed by engineering design principles, material standards, and iterative testing, not by a "ground truth" in the AI context.
§ 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.