(158 days)
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass of spinal segments in skeletally mature patients.
The ROCTM Lumbar System is intended for posterior, non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities: severe spondylolisthesis (grades 3 and 4), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis). The ROC Lumbar Plating System is indicated for placement in L3 - S1.
The ROC™ Lumbar System is a posterior system used to attain vertebral fusion and/or stabilization in L3-S1. The subject components of this submission are rods, rod connectors, and a rod connector adjustor.
The rods are manufactured from Ti 6Al-4V ELJ conforming to ASTM F136 or CP Titanium conforming to ASTM F67. The offset rod connectors are made of Ti 6Al-4V ELI conforming to ASTM F136 and come in a two sizes to accommodate the patient's anatomy and levels of fusion. The connectors will be used as part of the ROCTM Lumbar System
Here's an analysis of the provided 510(k) summary regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document describes the ROC™ Lumbar System as a spinal fixation device. For such devices, acceptance criteria typically revolve around mechanical strength, durability, and biocompatibility to ensure the device can withstand physiological loads and does not cause adverse biological reactions.
Based on the provided text, the specific acceptance criteria are not explicitly detailed in quantitative terms (e.g., minimum load-bearing capacity in Newtons). Instead, the criteria are implied through substantial equivalence to predicate devices and the performance of mechanical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability (Rod, Rod Connectors): | The ROC™ Lumbar System's rods and rod connectors, as part of a spinal construct, underwent mechanical and dynamic testing. The test results demonstrated that the mechanical performance of the ROC™ Lumbar System is substantially equivalent to those of the predicate devices: Moss Miami Spinal Fixation (K030383) and Synthes USS (K022949). |
| Material Biocompatibility: | Rods are manufactured from Ti 6Al-4V ELI conforming to ASTM F136 or CP Titanium conforming to ASTM F67. Offset rod connectors are made of Ti 6Al-4V ELI conforming to ASTM F136. These are standard, well-established biocompatible materials for implants. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample size (number of constructs or components) used for the mechanical and dynamic testing. It only states that the testing was performed.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that this is a 510(k) submission for a medical device in the USA, it is highly probable that the testing was conducted in a laboratory setting, likely in the US, according to recognized ASTM standards. This testing would be considered prospective for the purpose of the submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable to this type of device submission. For medical devices like the ROC™ Lumbar System, "ground truth" is established through engineering and biomechanical testing standards, not expert clinical assessment of outcomes for a test set in the way it would be for an AI/CAD diagnostic device. The ground truth here is the adherence to established mechanical performance benchmarks.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this is a mechanical engineering and materials science assessment, not a clinical study with human adjudication. The results are compared against predicate device performance and industry standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not performed. This type of study is used to assess the effectiveness of diagnostic tools or human-in-the-loop AI systems, which is not relevant for a spinal implant device focused on mechanical performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an algorithmic or AI device. The "performance" being evaluated is the mechanical integrity of the physical implant.
7. The Type of Ground Truth Used:
The ground truth used for this submission is based on established engineering and biomechanical performance standards for spinal fixation devices. Specifically, it relies on:
- ASTM F136 and ASTM F67 standards for material properties.
- Mechanical and dynamic testing results that demonstrate performance substantially equivalent to legally marketed predicate devices (Moss Miami Spinal Fixation and Synthes USS). The "ground truth" for acceptable performance is therefore inferred from the performance of these predicate devices, which have a history of safe and effective use.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical implant.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the same reason as point 8.
§ 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.