(69 days)
When used as a pedicle screw fixation system of 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) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, 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) vertebral 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.
When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (l.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.
The TSRH® Spinal System is intended to help provide immobilization and stabilization 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, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.
Certain implant components from other Medtronic spinal systems can be used with the TSRH® Spinal System. These components include GDLH® rods, GDLH® rod/bolt connectors, GDLH® Variable Angle T-Bolts, GDLH® set screws and locking screws, DYNALOK® PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, set screws and locking screws.
The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3Dx™ connectors and TSRH-3D® and TSRH-3Dx™ 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 implant components are fabricated from medical grade stainless steel, medical grade titanium or titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy. Medical grade titanium, titanium alloy, and/or cobalt-chromium-molybdenum alloy may be used together. Certain TSRH® Spinal System components may be coated with hydroxyapatite. Never use titanlum, titanlum alloy, and/or cobait-chromlum-molybdenum alloy with stainless steel in the same construct.
The purpose of this submission is to add 3Dx Chromaloy Plus (cobalt-chromiummolybdenum alloy) Pre-Cut Contoured Rods to the TSRH® Spinal System.
Here's an analysis of the provided text regarding the acceptance criteria and study for the TSRH® Spinal System, specifically focusing on the addition of 3Dx Chromaloy Plus Pre-Cut Contoured Rods.
It's important to note that this is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical trial with "acceptance criteria" in the same way one might find for a novel device. The "acceptance criteria" here are implicitly tied to demonstrating mechanical safety and performance comparable to the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Performance (Fatigue Resistance): Comparable fatigue strength to predicate devices when subjected to relevant orthopedic loading. (Based on ASTM F2193-02) | The submission implies that the 3Dx Chromaloy Plus Pre-Cut Contoured Rods demonstrated mechanical performance (specifically Four Point Bending Fatigue) that does not introduce new issues of safety or effectiveness when compared to the predicate devices. The text states: "Medtronic believes that documentation provided demonstrates that the TSRH® 3Dx Chromaloy Plus Pre-Cut Contoured Rods do not introduce new issues of safety or effectiveness." |
| Mechanical Performance (Interconnection/Static & Fatigue): Comparable static and fatigue properties of interconnection mechanisms and subassemblies to predicate devices. (Based on ASTM F1798-97) | The submission implies that the 3Dx Chromaloy Plus Pre-Cut Contoured Rods demonstrated mechanical performance (specifically axial grip per ASTM F1798-97) that does not introduce new issues of safety or effectiveness when compared to the predicate devices. The text states: "Medtronic believes that documentation provided demonstrates that the TSRH® 3Dx Chromaloy Plus Pre-Cut Contoured Rods do not introduce new issues of safety or effectiveness." |
| Biocompatibility: Material (Cobalt-Chromium-Molybdenum Alloy) is medical-grade and suitable for implantation without adverse biological reactions. (Implied, as ASTM F1537 is a standard for this material) | The device uses "medical grade ... cobalt-chromium-molybdenum alloy" (ASTM F1537), suggesting it meets industry standards for biocompatibility. No specific test results for biocompatibility are detailed in this summary, but its use of a recognized medical-grade material implies compliance. |
| Dimensions and Form: Rods meet specified dimensions (5.5mm diameter, 30-120mm length, contoured shape) as intended. | The device consists of "precut, contoured 5.5mm diameter rods in lengths from 30mm to 120mm." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided summary. For mechanical testing, this typically refers to the number of test articles (rods) used per test condition.
- Data Provenance: This is a non-clinical study involving in-vitro mechanical testing. There is no "country of origin of data" in the typical clinical sense, nor is it retrospective or prospective clinical data. The data provenance is from laboratory testing performed according to recognized ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. This summary describes non-clinical mechanical testing, not a study requiring expert clinical "ground truth" establishment. The "truth" is established by adhering to widely accepted engineering standards (ASTM F2193-02 and ASTM F1798-97) for implantable devices.
4. Adjudication Method for the Test Set
- Not applicable. This is non-clinical mechanical testing, not a clinical study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document describes a medical device (spinal implant) and its mechanical testing, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a medical device (spinal implant) and its mechanical testing, not an algorithm.
7. The Type of Ground Truth Used
- For this non-clinical testing, the "ground truth" is established by the definitions and specifications outlined in the referenced ASTM standards (ASTM F2193-02 and ASTM F1798-97). These standards define how the tests should be conducted and what constitutes acceptable mechanical behavior for spinal implants. There is no pathology, outcomes data, or expert consensus in the clinical sense for this type of submission.
8. The Sample Size for the Training Set
- Not applicable. This is a non-clinical submission for a physical medical device. There is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set for this type of submission, there is no ground truth to establish 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.