(379 days)
The Orthobiom™ Spinal System is a posterior, non-cervical pedicle screw system indicated to treat pediatric scoliosis by (1) correction, (2) stabilization, (3) adjustment and (4) fixation of the scoliotic spine.
The Orthobiom™ Spinal System is intended to be used with bone graft.
The Orthobiom™ Spinal System is designed as a pedicle screw based system. The system consists of rods, pedicle screws, fixed connectors, and one cross connector. The Orthobiom™ Spinal System uses rods, screws, and/or hooks to achieve correction and subsequent maintenance of the corrected scoliotic spine and use fusion to maintain the corrected spine.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanically sound as predicate devices (Implied) | "Testing performed indicate that the Orthobiom™ Spinal System is as mechanically sound as predicate devices." |
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Sample size used for the test set and the data provenance: Not specified. This submission focuses on mechanical equivalency rather than clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for mechanical testing is based on established engineering standards and comparisons to predicate devices, not expert human interpretation.
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Adjudication method for the test set: Not applicable. This is not a study requiring adjudication of expert opinions.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device for spinal surgery, not an AI-powered diagnostic or interpretive tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used: Mechanical testing standards and performance data of existing predicate devices. The "ground truth" for this submission is the established mechanical performance of legally marketed predicate devices.
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The sample size for the training set: Not applicable. This submission describes testing for a physical device, not an AI or machine learning model.
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How the ground truth for the training set was established: Not applicable.
Study Proving Device Meets Acceptance Criteria:
The provided document, K071663, is a 510(k) premarket notification for the Orthobiom™ Spinal System. The primary method used to demonstrate that the device meets acceptance criteria is through performance testing showing its mechanical equivalence to predicate devices.
The document states: "Performance Standards: Testing performed indicate that the Orthobiom™ Spinal System is as mechanically sound as predicate devices."
While the specific details of these "testing" are not included in the provided text (e.g., what specific tests were performed, the number of samples, or the results in quantitative terms), the FDA's clearance (JUL - 2 2008 letter) indicates that they reviewed this testing data and found the device substantially equivalent.
The study is essentially a benchtop mechanical testing study comparing the Orthobiom™ Spinal System to its identified predicate devices: Harrington Rods (K781443), Synthes Small Stature USS (K994121), DePuy Spine Kaneda Spinal System (K974757), Acromed Pediatric ISOLA (K962984), and DePuy Spine Frontier Anterior Deformity System (K012916). The acceptance criterion is an implicit one: the Orthobiom™ system must demonstrate comparable mechanical properties (e.g., strength, fatigue resistance, torsional stability) to these predicate devices to be considered "as mechanically sound."
§ 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.