(65 days)
The DVX Spine System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal turnor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attaimment of solid fusion.
The DVX Spine System consists of four or more pedicle screws and two DVX solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The DVX rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The DVX Spine System is fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136 -02a, Standard Specifications for Wrought Titanium-6Aluminum-4VanadiumELI (Extra Low Interstitial) Alloy or Surgical Implant Applications (UNS R56401
The provided text describes a 510(k) submission for the DVX Spinal System, a medical device for spinal fusion. However, it does not include information about acceptance criteria or a study proving the device meets said criteria in the context of device performance, clinical efficacy, or AI system-specific metrics.
Instead, the document focuses on demonstrating substantial equivalence to previously cleared predicate devices (NFix Fusion System, K053623, and MEGA Spine System, K072436). The basis for substantial equivalence is the similarity in materials, design, indications for use, operational principles, and source manufacturer.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The submission does not detail specific acceptance criteria for a new performance study or report new device performance metrics. Its claim is based on substantial equivalence to predicate devices, implying that the predicate devices' performance (which met their own acceptance criteria) is sufficient.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new performance testing in a "test set" (clinical or otherwise) is described for the DVX Spinal System. The evaluation relies on the equivalence to existing devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No new test set requiring expert ground truth establishment is mentioned.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is mentioned.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No. The document does not describe any MRMC study, nor does it refer to an AI device that would typically be evaluated in such a study.
6. Standalone (i.e. algorithm only without human-in-the loop performance) Study
No. The document describes a physical medical device (spinal system) and does not refer to an algorithm or AI system for which a standalone performance study would be relevant.
7. Type of Ground Truth Used
Not applicable. Since no new performance studies are detailed, there is no mention of ground truth (expert consensus, pathology, or outcomes data) being used for the DVX Spinal System itself. The evaluation is based on the characteristics of the device and its predicate devices.
8. Sample Size for the Training Set
Not applicable. The DVX Spine System is a physical medical device. It does not involve machine learning or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is not relevant.
Summary of the Study (and its absence) described in the document:
The provided document describes a 510(k) submission for substantial equivalence. The "study" in this context is primarily a design and materials comparison between the DVX Spinal System and its predicate devices (NFix Fusion System and MEGA Spine System).
The key statement is: "No additional testing is required because the test results applicable to the N SPINE System and MEGA spinal system components are directly applicable to the DVX Spine System since they are virtually identical in design and materials. Designs are directly compared to demonstrate equivalence."
This means that:
- The acceptance criteria for the DVX Spinal System are implicitly those that were met by the predicate devices during their own clearance processes.
- No new study data is presented for the DVX Spinal System, as it is considered substantially equivalent based on design and material identity to already cleared devices.
§ 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.