(113 days)
The ReForm Pedicle Screw System is intended to provide immobilization and stabilization of spinal re relevels in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and obginonic in sittlies or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spiral tumor, and failed previous fusion (pseudarthrosis).
The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4 of the L5-S1 vertebra in skeletally mature patiently includion 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. It is also intended opine (Le to Gaeran) man reveal (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis) spinal tumor; pseudoarthrosis; and failed previous fusion.
The ReForm Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross links, locking cap screws. All of the components are available in a variety of sizes to match more closely the patient's anatomy.
The ReForm Pedicle Screw System is a medical device, and the provided text is a 510(k) summary for its clearance. Medical devices, especially implants like pedicle screw systems, typically demonstrate performance through mechanical testing rather than clinical studies or AI algorithm evaluations. Therefore, many of the requested categories related to AI performance, expert consensus, and human reader studies are not applicable to this device submission.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Type) | Reported Device Performance (Results) |
|---|---|
| Static compression per ASTM F1717 | Equivalent to predicate device(s) |
| Dynamic compression per ASTM F1717 | Equivalent to predicate device(s) |
| Static torsion per ASTM F1717 | Equivalent to predicate device(s) |
Note: The specific quantitative acceptance limits (e.g., minimum load, cycles to failure) are not provided in this 510(k) summary, but the general outcome is stated as "equivalent to predicate device(s)". Equivalence implies that the ReForm Pedicle Screw System achieved performance comparable to, or better than, the predicate devices in these mechanical tests.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. For mechanical tests, the "sample size" refers to the number of test specimens (e.g., screw constructs, rod-screw assemblies) subjected to testing. This information is typically found in the full test report, not usually in the 510(k) summary.
- Data Provenance: Not applicable in the context of geographical origin or retrospective/prospective clinical data, as this concerns mechanical testing of manufactured components. The data originates from non-clinical laboratory testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable. This device is evaluated using objective mechanical engineering tests (ASTM F1717). There is no "ground truth" in the sense of expert medical diagnosis or interpretation required for these performance assessments. The performance is determined by physical measurements and engineering standards.
4. Adjudication Method for the Test Set
- Not applicable. As the performance is determined by objective mechanical testing against engineering standards, there is no need for an adjudication method by medical experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC study was conducted.
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as this is a mechanical spinal fixation system, not an AI-driven diagnostic or assistive device for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This is a hardware medical device, not a software algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- Engineering Standards and Predicate Device Performance. The "ground truth" for this device's performance is established by its ability to meet standardized mechanical test requirements (ASTM F1717) and demonstrate equivalence to the performance of previously cleared predicate devices.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. Its design and materials undergo engineering validation.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this device does not utilize a "training set" in the context of AI/ML. The "ground truth" for its design and materials is established through engineering principles, material science, and compliance with relevant ASTM standards.
§ 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.