(17 days)
The subject Diapason Combo, like the predicate OSS Combination Screw Ring/Blocker, are intended for use only with the components of the commercially available Osteonics "Spinal System/ Diapason System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System. The uses for the legally marketed Osteonics® Spinal System/Diapason System are as follows:
As a posterior, non-pedicle screw system of the T4-S2 spine, the Osteonics® Spinal System is indicated for:
- Long and short curve scoliosis .
- Vertebral fracture or dislocation .
- Spondylolisthesis .
- Degenerative disc disease (defined as back pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies).
- Previously failed fusion
- Spinal tumor .
Pedicular Use:
- When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally . mature patients, the Osteonics® Spinal System is indicated for one or more of the following: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
- In addition, the Osteonics® Spinal System is indicated for pedicle screw fixation in skeletally . mature patients with severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, having fusions with autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (with pedicle placement at L3 and below) with removal of the implants after the development of a solid fusion mass.
The design change involves modifying the ring height, blocker height and assembly process of the predicate OSS Combination Screw Ring/Blocker. In addition, the submission covers use of predicate Xia 6 mm diameter Rods with the Osteonics Spinal System. The submission involves no change to the Xia rods themselves.
The subject component, a design modification to the Osteonics® Spinal System Combination Screw Ring/Blocker, is a single-use device which is sold non-sterile and is intended for use only with the other components of the commercially available Osteonics® Spinal System. The Rods from the Xia Spinal System are intended to be used with the components of the Osteonics® Spinal System.
This document describes a Special 510(k) submission for a device modification to the Osteonics® Spinal System, specifically for the Diapason Combo and the use of Xia 6mm diameter rods with the system. The submission does not contain information typically found in studies for AI/ML-based medical devices. Instead, it focuses on the mechanical performance of modified spinal implant components. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models) are not applicable to this submission.
The "study" referenced in this document is a series of mechanical tests designed to demonstrate the comparable performance of the modified components to their predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Comparable Static Mechanical Properties to predicate OSS Screw Blocker and Cap | Testing demonstrates comparable static mechanical properties of the subject Diapason Combo to the predicate OSS Screw Blocker and Cap. |
| Comparable Fatigue Mechanical Properties to predicate OSS Screw Blocker and Cap | Testing demonstrates comparable fatigue mechanical properties of the subject Diapason Combo to the predicate OSS Screw Blocker and Cap. |
| Acceptable Static Mechanical Properties of Xia rods with Osteonics® Spinal System/Diapason System | Testing demonstrates acceptable static mechanical properties of the subject Xia rods with the predicate Osteonics® Spinal System/Diapason System. |
| Acceptable Fatigue Mechanical Properties of Xia rods with Osteonics® Spinal System/Diapason System | Testing demonstrates acceptable fatigue mechanical properties of the subject Xia rods with the predicate Osteonics® Spinal System/Diapason System. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a number of "cases" or "patients" as this is a mechanical engineering study. The "sample size" would refer to the number of individual test specimens of the device components. This detail is not provided in the summary.
- Data Provenance: Not applicable. This is a laboratory study involving physical testing of materials/components, not patient data from a specific country or retrospective/prospective collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in this context refers to established mechanical engineering standards and measurements, not expert clinical interpretation of medical data. The "experts" would be the engineers and technicians performing and analyzing the mechanical tests, operating under established protocols.
4. Adjudication method for the test set
Not applicable. This is a mechanical testing study, not a clinical study requiring adjudication of expert opinions. The determination of "comparable" or "acceptable" performance would be based on engineering analysis and adherence to pre-defined test protocols and measurable criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- MRMC Study: No.
- Effect Size of AI: Not applicable, as this is not an AI-based device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI-based device.
7. The type of ground truth used
The "ground truth" for this engineering study is based on:
- Established Mechanical Engineering Principles and Standards: This includes accepted methods for static and fatigue testing of spinal implants.
- Performance of Predicate Devices: The key ground truth for comparison is the documented and accepted mechanical performance of the previously cleared Osteonics® Spinal System components (the OSS Screw Blocker and Cap) and the Xia 6mm diameter rods. The goal is to show "comparable" or "acceptable" properties relative to these established devices.
8. The sample size for the training set
Not applicable. This is a mechanical testing study, not a machine learning study that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not a machine learning study.
§ 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.