(72 days)
The SSCS is intended for use as a posterior spinal fixation device, with specific indications as follows:
- 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 TI 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 sacral/pedicle screw system, the SSCS is intended for patients:
a. Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint
b. Who are receiving fusions using autogenous bone graft only.
c. Who are having the device fixed or attached to the lumbar and sacral spine.
d. Who are having the device removed after the development of a solid fusion mass.
Although the levels of fusion may not go above the L5-S1 joint, the SSCS screws may be inserted into pedicles up to, but not above, L-3.
The SSCS (Segmental Spinal Correction System) is a spinal fixation system comprised of various types and sizes of components, including the SSCS Hinged Screw, that are implanted via a posterior surgical approach and assembled to create a spinal construct. The SSCS also includes instrumentation/accessories that aid in assembling and/or implanting the components. Like most other posterior spinal fixation systems, the SSCS is comprised basically of 1) bone screws for attachment of the device to the spine, 2) longitudinal rods which are attached to the bone screws and which transmit loads across the pathologic segments of the spine, and 3) optional transverse connecting elements which link the two longitudinal rods for added construct stability.
The provided text describes a medical device submission (K971289) for the SSCS (Segmental Spinal Correction System) with the addition of a Hinged Screw component. The acceptance criteria and the study proving it are related to the mechanical performance of the device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Characteristic) | Reported Device Performance (SSCS Hinged Screw constructs) |
|---|---|
| Bending-compression static strength | At least comparable to, if not better than, SSCS Rigid Screw constructs and/or other predicate devices. |
| Bending-compression stiffness | At least comparable to, if not better than, SSCS Rigid Screw constructs and/or other predicate devices. |
| Torsional stiffness | At least comparable to, if not better than, SSCS Rigid Screw constructs and/or other predicate devices. |
| Fatigue strength | At least comparable to, if not better than, SSCS Rigid Screw constructs and/or other predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical "sample size" in terms of how many individual screws or constructs were tested. It refers to "Mechanical testing of SSCS Hinged Screw constructs."
The data provenance is prospective as the testing was conducted specifically for this submission to demonstrate substantial equivalence. The country of origin of the data is not specified, but the applicant (Osteotech, Inc.) is based in Eatontown, NJ, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a mechanical implant, and its "performance" is assessed through biomechanical testing, not by expert interpretation of clinical data or images. Therefore, clinical "ground truth" established by experts in the traditional sense is not relevant for this part of the submission. The "ground truth" here is the physical measurement of mechanical properties.
4. Adjudication Method for the Test Set
Not applicable. As described above, the "test set" involves mechanical properties, not clinical assessment by experts requiring adjudication.
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. This type of study is relevant for evaluating diagnostic tools where human readers interpret data, typically with AI assistance. The submission concerns a mechanical implant, and its evaluation focuses on its physical properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an AI algorithm or software device. The "performance" is the mechanical integrity of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for this mechanical device is established through objective physical measurements derived from standardized mechanical testing. The testing was performed "in accordance with the ASTM Provisional Standard for testing spinal implant devices." This standard defines the methodology and parameters for measuring the mechanical properties.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not an AI model requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for a mechanical device.
§ 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.