(59 days)
The Vitality® Spinal Fixation System implants 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 indicated for skeletally mature patients and for adolescent 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 sites), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vitality® Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition the Vitality® Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vitality® System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vitality® System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The use of the vitality Spinal Fixation System in skeletally mature patients may include the fixation of the Instinct® Java™ System hooks, APEX® System hooks, or fixation of the Universal Clamp® Spinal Fixation System to the Vitality Spinal Fixation System. The Vitality Spinal Fixation System may also be used in skeletally immature patients when connected with the Universal Clamp Spinal Fixation System.
In order to achieve additional levels of fixation in skeletally mature patients, the Vitality Spinal Fixation System may be connected to the Virage® OCT Spinal Fixation System* and the Instinct Java Spinal Fixation System offered by Zimmer Biomet Spine, using rod connectors.
The Vitality® Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy during surgery. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.
The system also includes instrumentation for insertion and securing of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.
The Vitality Spinal Fixation System is compatible with the Virage® OCT Spinal Fixation System Rods, Instinct® Java" Spinal Fixation System Rods and Universal Clamp® Spinal Fixation System.
The provided text describes a 510(k) premarket notification for the "Vitality® Spinal Fixation System" and its substantial equivalence to predicate devices. It focuses on mechanical testing to demonstrate substantial equivalence for a medical device (spinal fixation system), not an AI/ML powered device. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment, which are typical for AI/ML device evaluations, are not present.
However, based on the provided text, I can extract the following information regarding the performance study:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device functions as intended and demonstrates substantial equivalence to predicate devices | "In all instances, the modified device functioned as intended and demonstrated substantial equivalence to the predicate device(s)." |
| Meets ASTM standards for spinal implant mechanical testing (F1717 and F1798) | "Performance testing included tests per ASTM F1717 and ASTM F1798 which demonstrated the subject devices are safe and effective for use with pedicle screw fixation." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "mechanical testing of the modified screw implants" but does not quantify the number of screws or tests performed.
- Data Provenance: Not applicable in the traditional sense for AI/ML. The "data" here refers to the outcomes of physical mechanical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a mechanical device, not an AI/ML device requiring human expert ground truth. The "ground truth" is established by the predefined ASTM standards and the physical properties of the materials and design.
4. Adjudication method for the test set:
- Not applicable. As a mechanical device study, there is no expert adjudication process. The results are based on objective measurements against engineering standards.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in tasks like image interpretation, which is not the function of a spinal fixation system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of AI/ML algorithms. The device itself (the spinal fixation system) is standalone in its mechanical function, but "standalone performance" usually refers to an AI algorithm operating without human intervention.
7. The type of ground truth used:
- Engineering Standards: The ground truth for performance is based on established engineering standards (ASTM F1717 and ASTM F1798) for spinal implant mechanical testing. These standards define the acceptable performance parameters.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set in the machine learning sense. The device design and manufacturing processes are informed by engineering principles and previous designs, not by a data-driven training set.
9. How the ground truth for the training set was established:
- Not applicable. As there's no training set for an AI/ML algorithm, this question is irrelevant to this device.
In summary, the provided document describes a 510(k) submission for a spinal fixation system, focusing on demonstrating substantial equivalence through mechanical testing against established ASTM standards. It does not pertain to an AI/ML device, and thus, many of the questions related to AI/ML specific evaluation criteria are not applicable.
§ 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.