(121 days)
The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).
When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.
When used with the 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm Systems. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm Systems. When used with the 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems.
When used with the 3.5/6.0 mm and 4.0/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5/5.5 mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Matrix System.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors.
The Synthes Matrix System is an addition to Synthes' existing posterior thoracolumbar spine systems. The Matrix System consist of a family non-cervical spinal fixation devices intended for posterior pedicle screw fixation (TI-S2), posterior hook fixation (TI-L5) or anterolateral fixation (T8-L5). The implants include pedicle bone screws, polyaxial pedicle screws, monoaxial pedicle screws, polyaxial heads, reduction screws, reduction heads, locking caps, transconnectors, transverse bars, rods and hooks. The implants are primarily manufactured from titanium (ASTM F67-06), titanium alloy (ASTM F1295-05), cobalt-chromium-molybdenum alloy (ASTM F1537-08) or nitinol (ASTM F2063-05), similar to the predicates.
The Synthes Matrix System, a spinal fixation device, demonstrated substantial equivalence to its predicate devices through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets in the conventional sense. Instead, the performance data focused on demonstrating that the Synthes Matrix System performs "as well as or better than" the predicate devices in various biomechanical tests. The implied acceptance criterion is that the device's performance in these tests is comparable to or exceeds that of the predicate devices.
| Test Name | Standard Accordance | Reported Device Performance |
|---|---|---|
| Cantilever Bend in conjunction with Rod Push-through | ASTM F1798 – 97 | Performs as well as or better than predicate devices. |
| Static Compression Bend | ASTM F1717 – 09 | Performs as well as or better than predicate devices. |
| Static Torsion | ASTM F1717 – 09 | Performs as well as or better than predicate devices. |
| Dynamic Compression Bend | ASTM F1717 – 09 | Performs as well as or better than predicate devices. |
| Compress and Return Testing | ASTM F1717 – 09 | Performs as well as or better than predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes (e.g., number of implants tested) for each non-clinical test. The testing was conducted by Synthes, implying an internal or contracted laboratory setting, but the country of origin of the data is not explicitly stated. The nature of these tests (biomechanical/mechanical) means they are retrospective in the sense that they are conducted on manufactured devices in a controlled environment, not on live patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This question is not applicable. The study involved non-clinical biomechanical testing of medical devices, not evaluations by human experts to establish "ground truth" for clinical conditions or diagnoses. The ground truth for these tests is defined by the objective measurements obtained from the testing equipment according to the specified ASTM standards.
4. Adjudication Method for the Test Set:
This question is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert consensus in clinical or imaging studies, not for non-clinical mechanical testing where performance is determined by objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical data was not needed for this device." The evaluation was based solely on non-clinical performance data.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance):
This question is not applicable. This is a physical medical device (spinal fixation system), not a software algorithm or AI-powered system where "standalone" performance would be a relevant metric.
7. Type of Ground Truth Used:
The "ground truth" for the non-clinical tests was established by objective physical measurements obtained from testing the devices according to specific ASTM standards (ASTM F1798-97 and ASTM F1717-09). These standards define the methodology for evaluating the mechanical properties of spinal implants.
8. Sample Size for the Training Set:
This question is not applicable. There is no information about a "training set" as this is a physical medical device, not a machine learning model or algorithm. The non-clinical tests evaluate the physical properties and performance of the manufactured device.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable. As stated above, there is no "training set" in the context of this device.
§ 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.