(294 days)
The DIPLOMAT® Spinal System, when used as a posterior 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 (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- Spondylolisthesis
- Spinal stenosis
- Fracture
- Dislocation
- Scoliosis
- Kyphosis
- Spinal tumor
- Pseudoarthrosis
- Failed previous fusion
In addition, the DIPLOMAT® Spinal System is intended for 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 lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
The DIPLOMAT® Spinal System is intended to be used with autograft and/or allograft.
The DIPLOMAT® Spinal System is a multiple component posterior spinal fixation system which consists of pedicle screws, rods, and connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are manufactured from Ti-6AL-4V ELI per ASTM F136 and cobalt chrome per ASTM F75. The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use with poor bone quality (e.g., osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye
This document is a 510(k) Premarket Notification for the DIPLOMAT® Spinal System, a medical device for spinal fixation. It describes the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Mode per ASTM F1717-14) | Reported Device Performance |
|---|---|
| Static Compression-Bending Test | Strength sufficient for intended use and substantially equivalent to legally marketed predicate devices. |
| Static Torsion Test | Strength sufficient for intended use and substantially equivalent to legally marketed predicate devices. |
| Dynamic Compression-Bending Test | Strength sufficient for intended use and substantially equivalent to legally marketed predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of human patient data or a clinical study. The performance evaluation is based on non-clinical mechanical testing. Therefore, information regarding human sample size and data provenance (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The study is a non-clinical mechanical testing study, not a study involving expert assessment of patient data.
4. Adjudication Method
This information is not applicable for a non-clinical mechanical testing study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document describes mechanical testing of a spinal implant, not a study evaluating human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. This document focuses on the mechanical performance of a physical medical device, not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for this study is established by engineering standards and specifications as defined in the ASTM F1717-14 test methodology. The performance of the DIPLOMAT® Spinal System is compared against the expected mechanical properties for devices of its type and against predicate devices.
8. Sample Size for the Training Set
This information is not applicable. There is no concept of a "training set" in a non-clinical mechanical testing study.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set mentioned in the context of this non-clinical mechanical testing.
§ 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.