(219 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) fracture, (4) 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 bonc 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: { }) 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 (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
For anterior use only the TSRH® System has the additional indication of: spondylolysis.
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, rod/bolt connectors, Variable Angle Tbolts, set screws and locking screws; DYNALOK® PLUS bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, as well as CD HORIZON® rods, screws, 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 components are fabricated from stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. Never use stainless steel and titanium implant components in the same construct. The TSRH® Spinal System may be sold sterile or non-sterile.
The purpose of this submission is to add TSRH® Anterior L-Plates to the TSRH® Spinal System. Indications for the TSRH® Spinal System will be updated in this submission.
This document describes the TSRH® Spinal System, specifically focusing on the addition of TSRH® Anterior L-Plates. It is a 510(k) summary, which means it describes how the new components are substantially equivalent to previously cleared devices rather than providing a study for novel acceptance criteria.
Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance, as typically found in clinical validation studies for AI/software devices, is not applicable to this submission.
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices. This is achieved through engineering and preclinical testing to ensure the new components meet established performance standards for medical implants in terms of "Indications for Use" and "Technological Characteristics," typically through mechanical testing.
Here's how the document addresses the concept of "acceptance criteria" and "proof" in the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a spinal implant system component, the "acceptance criteria" are not reported as specific performance metrics and thresholds like sensitivity, specificity, or AUC, as would be the case for an AI/software device. Instead, the acceptance criteria are based on demonstrating that the TSRH® Anterior L-Plate and VANTAGE™ Screws are substantially equivalent to existing, legally marketed predicate devices.
The document states:
"Documentation, including mechanical test results, provided has demonstrated that the TSRH® Anterior L-Plate and VANTAGE™ Screws are substantially equivalent to similar previously cleared devices such as the TSRH® Spinal System (K072317 SE 9/18/07) and CD HORIZON® Spinal System (K042025 SE 8/25/04). The VANTAGE™ Screws were previously cleared in K023797 (SE 12/16/02)."
This implies that the acceptance criteria are met if the mechanical performance of the new components is comparable to the predicate devices. Specific quantitative values for these mechanical tests (e.g., fatigue strength, pull-out strength, bending stiffness) are not provided in this summary but would have been part of the full 510(k) submission.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Mechanical performance comparable to predicate devices (e.g., TSRH® Spinal System K072317, CD HORIZON® Spinal System K042025, VANTAGE™ Screws K023797) | Mechanical test results as submitted to the FDA demonstrate substantial equivalence. |
The Study that Proves the Device Meets Acceptance Criteria
The "study" undertaken is a preclinical engineering study (mechanical testing) comparing the new components to predicate devices.
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified in this summary. For mechanical testing of implantable devices, the sample size would typically be determined by engineering standards (e.g., ASTM, ISO) to ensure statistical significance for the performance characteristics being evaluated.
- Data Provenance: The data would originate from laboratory bench testing conducted by Medtronic Sofamor Danek USA. It is prospective in the sense that the tests were specifically conducted for this submission, but it's not "clinical" prospective data. The "country of origin" would be the manufacturing/testing location, likely the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: This is not applicable. The "ground truth" for mechanical performance of a medical device implant is established through standardized engineering tests, not expert consensus on clinical data. The tests are designed and interpreted by qualified engineers.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Mechanical test results are objective measurements against predefined engineering standards or comparative data from predicate devices. There is no expert adjudication process in this context.
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
- MRMC Study: No. This is a spinal implant, not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a spinal implant, not an AI/software device.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for this device's performance is based on objective mechanical measurements obtained from laboratory testing (e.g., strength, fatigue, material properties), demonstrating compliance with relevant industry standards and comparability to predicate devices.
8. The sample size for the training set
- Sample Size (Training Set): Not applicable. There is no "training set" in the context of a 510(k) submission for a mechanical implant. The design and manufacturing processes are informed by existing engineering knowledge, standards, and previous device experience.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. There is no "training set" or "ground truth" in the AI/ML sense for a mechanical implant. Device design and manufacturing follow established engineering principles and regulatory guidelines.
§ 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.