(83 days)
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal turnor, and/or (8) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) unsuccessful previous attempts at spinal fusion.
For anterior use only the TSRH® Spinal System has the additional indications of: (1) spinal stenosis and/or, (2) spondylolysis.
The purpose of this 510(k) submission is to incorporate additional TSRH®-3D components into the system.
The TSRH® Spinal System is intended to help provide immobilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.
The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, and connecting components. In addition, GDLH® rods, DYNALOK PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, and GDLH® and CD HORIZON® set screws and locking screws may be used with the TSRH® Spinal System.
The TSRH® Spinal System implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® connectors and TSRH-3D® screws are intended for posterior use only. All CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.
The TSRH® Spinal System components are fabricated from stainless st be fabricated from medical grade titanium alloy or medical grade titanium. The TSRH® Spinal System may be sold sterile or non-sterile.
Acceptance Criteria and Device Performance for TSRH® Spinal System
The TSRH® Spinal System did not directly present specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy, as this is a spinal implant system rather than a diagnostic device. Instead, acceptance for this type of device is primarily based on demonstrating substantial equivalence to a previously legally marketed predicate device, as well as meeting established performance standards for the mechanical integrity and biocompatibility of the implant components.
The study that proves the device meets the acceptance criteria is a series of mechanical performance tests and a demonstration of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device (a spinal implant), the "acceptance criteria" are derived from FDA's requirements for demonstrating substantial equivalence and ensuring mechanical and material integrity. The "reported device performance" refers to the results of the tests conducted to meet these criteria.
| Acceptance Criteria (Derived from FDA Requirements for Spinal Implants) | Reported Device Performance |
|---|---|
| Material Composition Equivalence | |
| (Components must be made of materials known to be safe, biocompatible, and mechanically appropriate for spinal implants.) | Met: Components are fabricated from stainless steel, medical grade titanium alloy, or medical grade titanium. These materials are well-established and commonly used in spinal implants. |
| Substantial Equivalence to Predicate Device | |
| (The device must be shown to be as safe and effective as a legally marketed predicate device, especially for the additional components and indications, through comparison of indications, technological characteristics, and performance data.) | Met: The subject TSRH®-3D components were declared substantially equivalent to the predicate TSRH®-3D Spinal System components manufactured by Medtronic Sofamor Danek. This was the primary conclusion of the 510(k) submission. |
| Mechanical Strength & Durability | |
| (Components must withstand forces and stresses expected in the human spine over time. Specific tests include static and fatigue testing.) | Met: Results from static axial grip, static torsional grip, and interconnection fatigue testing were provided in support of this application. While specific numerical outcomes are not detailed in the provided text, the successful completion of these tests suggests they met pre-defined thresholds for mechanical performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Mechanical Testing: Not explicitly stated. For mechanical tests like static axial grip, static torsional grip, and interconnection fatigue, multiple samples of each critical component (e.g., rods, screws, hooks, connectors) would be tested to ensure consistency and reliability. The specific number of samples would depend on the statistical power required and industry standards for medical device testing.
- Data Provenance: The mechanical tests (static axial grip, static torsional grip, and interconnection fatigue) would typically be conducted in a laboratory setting under controlled conditions. This is a prospective generation of data specifically for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not directly applicable in the traditional sense for a spinal implant's mechanical testing and substantial equivalence determination.
- "Ground truth" for mechanical testing is established by engineering specifications and recognized ASTM/ISO standards for spinal implants, which define acceptable load-bearing capacities, fatigue life, and other mechanical properties. The "experts" in this context would be the engineers and technicians conducting the tests and interpreting results against these standards. Their qualifications would involve expertise in mechanical engineering, materials science, and medical device testing protocols.
- "Ground truth" for substantial equivalence is established by the FDA's review team, who are experts in medical device regulations, clinical safety, and efficacy. They compare the new device to the predicate device based on submitted documentation, including design, materials, indications for use, and performance data.
4. Adjudication Method for the Test Set
Again, this is not directly applicable as it would be for a diagnostic device.
- For mechanical testing: Adjudication is based on whether the test results (e.g., ultimate load, cycles to failure) meet or exceed the predefined acceptance criteria specified in the test protocol, which are typically derived from industry standards (e.g., ASTM F1717 for Spinal Implant Constructs). Any discrepancies in test execution or interpretation would be resolved by the engineering team or reviewed by internal or external experts if necessary.
- For substantial equivalence: The FDA review process itself serves as the adjudication method. The FDA reviewers (experts) evaluate all submitted evidence to determine if the device is substantially equivalent to a predicate.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers (e.g., radiologists) interpret images or data, and the AI's impact on their performance is being evaluated. The TSRH® Spinal System is a physical implant, not a diagnostic tool or an AI-assisted interpretation system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone study (in the context of AI) was not done. This concept is only applicable to AI/ML-based diagnostic or therapeutic algorithms. The TSRH® Spinal System is a mechanical implant device.
7. Type of Ground Truth Used
- For Material Composition and Design: The ground truth is established by material specifications (e.g., ASTM F138 for stainless steel, ASTM F136 for titanium alloy) and engineering drawings/design specifications.
- For Mechanical Performance: The ground truth is established by recognized biomechanical testing standards (e.g., ASTM F1717 for static and fatigue testing of spinal implant constructs). The "truth" is whether the device can withstand the specified loads and cycles without failure.
- For Substantial Equivalence: The ground truth is the predicate device's established safety and effectiveness profile and the FDA's regulatory criteria for determining equivalence.
8. Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/ML algorithm for this mechanical spinal implant system. The development and testing of the TSRH® Spinal System rely on engineering design, material science, and mechanical testing, not a machine learning paradigm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to be established for it.
§ 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.