(29 days)
When used as a nonpedicle posterior system, the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosls deformities (i.e., scoliosis, kyphosis, lordosis) lumors pseudarthrosis failed previous fusion (pseudarthrosis)
When used as an anterolaterallanterior system the SCS system is indicated for patients with:
degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studios spondylolisthesis fracture spinal stenosls deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosls)
When used as a posterior pedicle svstem. the device is indicated for use in skeletally mature patients L3 & below who are:
having severe spondylollsthesis (Grades 3 and 4) at the L5-S1 joint
receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine
having the device removed after the development of a solid fusion mass.
Posterior pedicle systems are 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:
degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal turnor failed previous fusion (pseudarthrosis)
This new connector is called the “Omni Axial Connector.” The part number is 7T20-CO04. It is made from titanium alloy as defined by the ASTM and ISO standards indicated below, TA6V ELI ASTM F136-92 ISO 5832-3. The Omniaxial Connector facilitates pedicle screw insertion by providing a range of adaptability of the screw path in the three axist, axial, sagittal and coronal. The OmntAxtal Connector is intended to be a "standard" component of the SCS Spinal System. The OmniAxtal Connector attaches to the spinal rods using the same connecting screw (2TD1-VS53) as used in the existing SCS Spinal System.
Here's a breakdown of the acceptance criteria and study information for the ORTHOTEC, LLC. OmniAxial Connector, based on the provided document:
This document is a 510(k) premarket notification for a medical device connector. The acceptance criteria and the study presented are focused on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving absolute clinical effectiveness or diagnostic accuracy as seen in AI/CADe devices. Therefore, many of the typical questions for AI/CADe will not be directly applicable (e.g., ground truth for training set, MRMC studies, effect size of AI assistance).
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from Special Controls & Guidance) | Reported Device Performance | Comments |
|---|---|---|
| Material Standards: Compliance with ASTM F136-92 and ISO 5832-3 for TA6V ELI titanium alloy. | Device is made from TA6V ELI titanium alloy, compliant with ASTM F136-92 and ISO 5832-3. | Met. |
| Mechanical Testing Standard: (ASTM F-1717-96 guidance document used) | Mechanical and fatigue testing carried out using ASTM F-1717-96. Static testing demonstrated substantial equivalence to the predicate device. | Met. The tests demonstrated that the new connector performs equivalently to the previously cleared connector. |
| Biocompatibility Standard: (Implicit from the "Special Controls") | Not explicitly detailed in the provided text as a separate study result, but compliance with material standards (titanium alloy) generally implies biocompatibility for spinal implants. No adverse biocompatibility issues were reported for the predicate which implicitly carries over. | Assumed met through material selection and predicate equivalence. |
| Labeling Requirements: Compliance with specified labeling. | The 510(k) submission includes labeling information. The FDA's response confirms the device can be marketed. | Met. |
| Substantial Equivalence: The OmniAxial Connector performs essentially the same function as the original connector (SCS Spinal System, K983353). Basic design, dimensional tolerances, materials, and intended use are identical or equivalent. | Design: "SAME"; Sterile: "Non-sterile" (SAME); Sizes: "EQUIVALENT" (6-7mm dia. X 30-55mm length vs. predicate); Material: "SAME" (Stainless steel, titanium alloy, pure titanium); Manufacturer: "SAME"; Product Code: "SAME". | Met. The overall conclusion is substantial equivalence. |
| cGMP Regulations: Product manufactured in compliance with cGMP. | "The product is manufactured in compliance with cGMP regulations." | Met. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the mechanical and fatigue testing in terms of individual devices or components tested. It generally states that "Samples were tested."
- Data Provenance: Not applicable in the context of clinical data. The data provenance refers to mechanical and fatigue testing conducted by the manufacturer, ORTHOTEC, LLC. The testing is internal to the manufacturer for engineering validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For this type of device (spinal implant connector), "ground truth" is established through engineering specifications, material standards, and benchmark testing against a predicate device, rather than expert clinical consensus on patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints. This submission concerns mechanical performance. The "adjudication" is essentially the manufacturer's testing and a regulatory body's (FDA) review of that testing against established standards and predicate device data.
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:
- No. This is not an AI/CADe device. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The "standalone performance" is the mechanical performance of the component itself, which was tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" is defined by:
- Engineering Standards: ASTM F-1717-96 guidance document for mechanical and fatigue testing.
- Material Specifications: ASTM F136-92 and ISO 5832-3 for TA6V ELI titanium alloy.
- Predicate Device Performance: The mechanical and functional characteristics of the previously cleared SCS Spinal System connector (K983353).
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. It is a physical medical device.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an algorithm, there is no ground truth to establish for it.
§ 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.