(13 days)
The uses for the legally marketed Osteonics® Spinal 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 Combination Screw Ring/Blocker incorporates the blocker into the design of the containment ring, resulting in a single, preassembled component. The blocker portion of the Combination Screw Ring/Blocker is preassembled in the factory to the containment ring via a snap-fit assembly process. The proximal portion of the existing Screw Blocker has been modified to include a proximal circular "lip". Two bars on the proximal side of the containment ring expand and retract to allow the snap-fit insertion of the proximal lip of the blocker component.
The locking mechanism and function of the Combination Screw Ring/Blocker is identical to that currently employed by the Long Arm Containment Ring and the Screw Blocker. The Combination Screw Ring Blocker is placed over the screw arms. The blocker is then tightened, which expands the proximal portion of the screw creating a friction-fit lock between the proximal screw and the containment ring portion of the Combination Screw Ring/Blocker. The screw arms are then broken off.
The provided document is a 510(k) Premarket Notification for the Osteonics® Combination Screw Ring/Blocker. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria and performance metrics in the same way a PMA (Premarket Approval) submission would.
Therefore, the document does not contain explicit "acceptance criteria" for device performance in the traditional sense (e.g., sensitivity, specificity, accuracy thresholds) or a "study" that directly proves the device meets such criteria based on a clinical outcome.
Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence in terms of intended use, material, and design, and confirming that the device functions identically to the predicate device. The "study" in this context is the comparison and analysis of the proposed device against the predicate devices.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Demonstrated Substantial Equivalence) |
|---|---|
| Intended Use: Identical to predicate devices. | The intended uses of the subject device (Osteonics® Combination Screw Ring/Blocker) are identical to the predicate Osteonics® Spinal System. |
| Material: Identical to predicate devices. | All components are manufactured from ASTM F-136-96 titanium alloy (Ti6Al-4V ELI), identical to the predicate devices. |
| Design/Function: Functionally identical to predicate devices when assembled. Changes should not raise new questions of safety or effectiveness. | The Combination Screw Ring/Blocker incorporates the blocker into the containment ring as a single, preassembled component via a snap-fit process. The design modifications (proximal circular "lip" on blocker, parallel bars on containment ring) allow for this preassembly. The locking mechanism and function are explicitly stated to be identical to that employed by the predicate Long Arm Containment Ring and Screw Blocker used together. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. This submission is based on a comparison to predicate devices, not on a clinical test set. No human or animal samples were used for testing in the provided summary.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. There was no "test set" requiring expert-established ground truth in this submission. The demonstration of substantial equivalence relies on engineering and design comparisons and functional identity to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as there was no test set or expert adjudication process for performance in this 510(k) submission.
5. 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 device is a mechanical spinal implant component, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate devices based on their prior marketing authorization. The new device demonstrates "substantial equivalence" to this established ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
§ 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.