(28 days)
When used as a pedicle screw fixation system in the non-cervical posterior spine in skeletally mature patients, the TSRH® 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) turnor 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 add modified TSRH® Spinal System Screws to the TSRH® Spinal System.
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, 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.
The TSRH® Spinal System components are fabricated from stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The TSRH® Spinal System may be sold sterile or non-sterile.
The provided text is a 510(k) summary for a medical device (TSRH® Spinal System) and the FDA's clearance letter. This type of document is a premarket notification for devices that are "substantially equivalent" to an already legally marketed device. It does not typically contain information about formal acceptance criteria or detailed studies proving device performance against such criteria in the same way a new, high-risk device might.
Instead, the primary "study" and "acceptance criteria" here revolve around demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the provided text, highlighting what is and isn't present:
Acceptance Criteria and Device Performance Study (TSRH® Spinal System)
The regulatory pathway for the TSRH® Spinal System, as described in the 510(k) summary, is based on demonstrating substantial equivalence to a previously cleared predicate device. This means the "acceptance criteria" are intrinsically tied to showing that the new device shares similar technological characteristics and/or indications for use with the predicate, without raising new questions of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Technological Characteristics: Demonstrate similar materials, design, and operating principles to a legally marketed predicate device. | The TSRH® Spinal System consists of rods, hooks, screws, cross connectors, and connecting components, fabricated from stainless steel, medical grade titanium alloy, or medical grade titanium. These components are described as similar to the previously cleared TSRH® Spinal System screws. The 510(k) specifically adds "modified TSRH® Spinal System Screws" to the existing system, implying a direct comparison of these modifications to the predicate. |
| Indications for Use: Demonstrate similar intended uses as a legally marketed predicate device. | The indications for use for the modified TSRH® screws are identical to the previously cleared TSRH® Spinal System. These include: |
| As a pedicle screw fixation system (non-cervical, mature patients): Degenerative disc disease, degenerative spondylolisthesis with neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis). | |
| Additional pedicle screw indications (skeletally mature, L5-S1): Severe spondylolisthesis (Grades 3 and 4), fusions with autogenous bone graft only, device fixed to L3 and below, device removal after solid fusion mass. | |
| As a posterior, non-cervical, non-pedicle screw fixation system: Degenerative disc disease, spondylolisthesis, fracture, spinal deformities (scoliosis, kyphosis, lordosis), spinal stenosis, pseudarthrosis, tumor resection, unsuccessful previous attempts at spinal fusion. | |
| For anterior use only: Spinal stenosis, spondylolysis. | |
| Safety and Effectiveness: Demonstrate that the device is as safe and effective as the predicate device and does not raise new questions of safety or effectiveness. | The document explicitly states: "The subject TSRH® screws were demonstrated to be substantially equivalent to previously cleared TSRH® Spinal System screws manufactured by Medtronic Sofamor Danek. A risk analysis was provided in support of this application." This statement serves as the primary "proof" of meeting safety and effectiveness criteria relative to the predicate device within the 510(k) framework. No specific performance metrics (e.g., strength, fatigue life, biological response) are detailed in this summary, but these would have been part of the risk analysis and comparison to the predicate. |
2. Sample size used for the test set and the data provenance
The provided text does not include information about a "test set" in the context of clinical or performance data for the modified screws. For a 510(k) submission focused on substantial equivalence, the "test set" is often the comparison of the new device's specifications (design, materials, indications) against the predicate device's specifications.
- Sample Size for Test Set: Not applicable/not provided for a clinical or performance study. The "sample" here refers to the specific modified TSRH® screws being compared to the predicate.
- Data Provenance: Not applicable/not provided for a clinical or performance study. Comparisons would be based on internal design and testing data against predicate data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary. For substantial equivalence, the "ground truth" is largely established by regulatory precedent (the predicate device's clearance) and engineering/risk analysis rather than expert clinical consensus on a new test set.
4. Adjudication method
Not applicable/not provided. There is no mention of a human-reviewed test set or an adjudication process in this summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not reported in this 510(k) summary. MRMC studies are typically for evaluating the diagnostic performance of software or imaging devices, not for surgical implants like spinal systems.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a surgical implant, not an algorithm.
7. The type of ground truth used
The "ground truth" in this context is the established safety and effectiveness of the predicate device. The modified TSRH® screws are deemed safe and effective if they are "substantially equivalent" to this predicate, meaning they share the same fundamental characteristics and indications for use without raising new safety concerns.
8. The sample size for the training set
Not applicable. There is no training set in the context of an AI/algorithm. For a medical device implant, the "training" would be the development and testing data that led to the original TSRH® Spinal System, but this specific information is not in the summary for the modified screws.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned. The "ground truth" for the predicate device would have been established through its own 510(k) clearance or other regulatory pathways, which would have involved demonstrating its safety and effectiveness (e.g., through performance testing, biocompatibility, and potentially clinical data, although often not required for 510(k)). This information is not detailed for the predicate in this document.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.