(102 days)
The STARFIRE™ Pedicle Screw System is 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 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;
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
- . tumor;
- pseudoarthrosis; and .
- . failed previous fusion
The Choice Spine STARFIRE™ Pedicle Screw System is a top-loading, polyaxial screw spinal fixation system including polyaxial screws, rods, and connectors. The components are provided clean and non-sterile. Various sizes of the implants are provided.
The following information is extracted from the provided text regarding the Choice Spine STARFIRE™ Pedicle Screw System:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Compression Bending | Equivalence in bending loads and stiffness to predicate systems. | Cannulated STARFIRE pedicle screw constructs were equivalent, with respect to bending loads and stiffness, to non-cannulated predicate pedicle fixation systems. |
| Compression Bending Fatigue | Equivalent or greater endurance strength compared to predicate systems. | Cannulated STARFIRE pedicle screw constructs had equivalent or greater endurance strength compared to non-cannulated predicate pedicle fixation systems. |
| Static Torsional | Ability to resist loads greater than the range required for the human lumbar spine. | Cannulated STARFIRE pedicle screw constructs, without cross-connectors, were able to resist loads greater than the range of resistance required for the human lumbar spine. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample size used for each specific test or the "data provenance" in terms of country of origin or retrospective/prospective nature. It refers to "Mechanical testing" and "Test results," which implies the testing was conducted on physical samples of the device and predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device. The "ground truth" for the performance tests of a pedicle screw system is based on objective mechanical testing data and established ASTM standards, not expert interpretations of clinical data or images.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are objective mechanical performance tests, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices where human readers interpret medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical pedicle screw system, not an AI or software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the STARFIRE™ Pedicle Screw System was established through objective mechanical testing according to the guidelines outlined in ASTM F1717-09 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model."
8. The Sample Size for the Training Set
This information is not applicable. This device is a physical medical implant, not an AI model or software that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device.
§ 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.