(70 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 mm/6.0mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm 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 mm/6.0mm and 4.0 mm/6.0mm 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 mm/5.5mm and 4.0 mm/5.5 mm tapered rods, Matrix or MIRS can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Matrix System or MIRS.
In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea.
Synthes MIRS is an addition to Synthes' existing non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium). This system is comprised of polyaxial reduction screws, rods, and locking caps. This system is intended to facilitate minimally invasive spinal reduction. The components of this system are manufactured of TAN (Titanium-6 Aluminum-7 Niobium, per ASTM F1295-05), Titanium (Ti-4 per ASTM F67-06) and cobalt chrome (Cobalt- 28Chromium - 6Molybdenum per ASTM F1537 - 08).
Here's a breakdown of the acceptance criteria and study information for the Synthes MIRS device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Static Compression Bending | Equivalent or superior to predicate devices (ASTM F1717-10) | Performs equivalently or superiorly to the above-mentioned predicates |
| Static Torsion | Equivalent or superior to predicate devices (ASTM F1717-10) | Performs equivalently or superiorly to the above-mentioned predicates |
| Dynamic Compression Bending | Equivalent or superior to predicate devices (ASTM F1717-10) | Performs equivalently or superiorly to the above-mentioned predicates |
Note on Acceptance Criteria: The document directly states that the device "performs equivalently or superiorly to the above-mentioned predicates" for each test. This implies that the acceptance criteria were defined as achieving at least equivalence to the performance of the specified predicate devices when tested according to ASTM F1717-10.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given 510(k) summary. The document focuses on bench testing, not clinical studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the study was non-clinical bench testing. There was no ground truth based on expert clinical assessment.
4. Adjudication Method for the Test Set
This information is not applicable as the study was non-clinical bench testing. There was no clinical ground truth requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed. The document explicitly states: "Clinical data and conclusions were not needed for this device."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to this device. The Synthes MIRS is a pedicle screw spinal system, a physical medical device, not a software algorithm that performs diagnostic or assistive tasks.
7. Type of Ground Truth Used
The "ground truth" for this non-clinical study was the bench testing standards (ASTM F1717-10) and the performance of legally marketed predicate devices. The goal was to demonstrate mechanical equivalence or superiority.
8. Sample Size for the Training Set
This information is not applicable as the study was non-clinical bench testing. There was no "training set" in the context of an algorithm or machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the study was non-clinical bench testing.
§ 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.