(77 days)
The SSCS (Segmental Spinal Correction System) is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracic-lumbo-sacral portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the SSCS are dependent in part on the configuration of the assembled device as described below.
When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: scoliosis; kyphosis; spinal fractures; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); tumors; stenosis; spondylolisthesis; pseudoarthrosis; previously failed attempts at spinal fusion.
When used as a pedicle screw system in the thoracolumbosacral region of the spine, the SSCS is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
In addition, when used as a pedicle screw system, the SSCS is intended for patients:
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- Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint
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- Who are receiving fusions using autogenous bone graft only.
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- Who are having the device fixed or attached to the lumbar and sacral spine (level of attachment: L3 and below).
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- Who are having the device removed after the development of a solid fusion mass.
The SSCS (Segmental Spinal Correction System) is a spinal fixation system comprised of various types and sizes of components, that are implanted via a posterior surgical approach and assembled to create a spinal construct. Like most other posterior spinal fixation systems. the SSCS is comprised basically of 1) bone screws and hooks for attachment of the device to the spine, 2) longitudinal rods that are attached to the bone screws and hooks either directly or indirectly by means of lateral connectors, and that transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements that link the two longitudinal rods for added construct stability.
This document describes a 510(k) submission for a medical device, the SSCS (Segmental Spinal Correction System), which is a posterior spinal fixation device. For spinal fixation devices, the "acceptance criteria" and "device performance" are typically defined by mechanical testing standards rather than diagnostic accuracy metrics seen in AI/imaging devices.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Study Details for the SSCS (Segmental Spinal Correction System)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Required Performance) | Reported Device Performance |
|---|---|
| Mechanical performance characteristics: | The test results demonstrated that the mechanical performance characteristics |
| - Bending-compression static strength | (bending-compression static strength and stiffness, torsional stiffness and |
| - Bending-compression static stiffness | fatigue strength) of SSCS constructs are at least comparable to, if not better than, those of the predicate devices. |
| - Torsional stiffness | |
| - Fatigue strength | |
| Standard: In accordance with the ASTM Standard for testing spinal implant devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for the mechanical testing. It mentions "SSCS constructs," implying multiple test specimens were used, but the exact number is not provided.
- Data Provenance: The document does not explicitly state the country of origin for the data or whether the study was retrospective or prospective. Mechanical testing of a device itself is not typically classified as retrospective or prospective in the same way clinical trials are.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This question is not applicable in the context of this device. The "ground truth" for a spinal fixation device's mechanical performance is defined by established engineering test standards (ASTM standards), not by human expert consensus or clinical evaluations.
4. Adjudication Method for the Test Set:
This question is not applicable. Mechanical testing results are objective measurements based on standardized protocols, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This submission concerns a physical implantable device, and its performance is evaluated through mechanical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, in spirit. The mechanical performance testing of the SSCS constructs is a standalone evaluation of the device itself, without human intervention affecting the measurement of its mechanical properties. The "algorithm" in this context is the physical device's design and material properties.
7. The Type of Ground Truth Used:
The ground truth used for evaluating the SSCS device's performance is established engineering standards and objective mechanical measurements. Specifically, the "ASTM Standard for testing spinal implant devices" serves as the reference for acceptable performance. The comparison also references the performance of legally marketed predicate devices.
8. The Sample Size for the Training Set:
This question is not applicable. There is no "training set" for the mechanical testing of a physical medical device. This concept applies to machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable for the same reasons as #8.
§ 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.