(56 days)
When used with pedicle screw fixation systems, the Annex® 2 Adjacent Level System is 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 disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
The Annex® 2 Adjacent Level System can be linked to 4.75 mm, 5.5 mm, and/or 6.0 mm diameter rods of the following systems: CapSure®, Sniper® or Salvo® Spine Systems.
The Annex® 2 Adjacent Level System consists of a selection of non-sterile, single-use locking screws, adjacent level devices, and connectors for attachment to an existing pedicle spinal fixation construct to extend a rigid spinal construct. The Annex® 2 Adjacent Level System components are provided in a variety of sizes and shapes to accommodate variations in anatomy and spacing between existing screw and rod hardware. The implant components of this system are manufactured from titanium (ASTM F67)), titanium alloy (Ti-6Al-4V ELI (ASTM F136)), and cobalt-chromium (CoCr (ASTM F1537)).
The provided FDA 510(k) clearance letter pertains to a medical device, the Annex® 2 Adjacent Level System, which is a physical implant, not an AI/ML-driven software device. Therefore, the information requested regarding acceptance criteria and study design for AI/ML performance metrics (such as test set size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not applicable to this document.
The document discusses non-clinical testing to support substantial equivalence for a physical medical implant. Here's a summary of the relevant information from the provided document:
1. A table of acceptance criteria and the reported device performance:
The document mentions that non-clinical testing was performed, but it does not explicitly state specific pass/fail acceptance criteria or quantitative performance results in the provided text. It generally concludes that the device is "substantially equivalent" based on these tests.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Summary) |
|---|---|
| Mechanical performance (e.g., strength, durability under axial compression bending, torsion) comparable to predicate devices. | Non-clinical testing (Static axial compression bending, static torsion testing, and dynamic axial compression bending testing per ASTM F1717) found "substantial equivalence" to legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the document.
- Data provenance: Not applicable in the context of clinical data for a physical implant. The testing described is non-clinical mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study involved non-clinical mechanical testing of a physical device, not expert interpretation of AI/ML output.
4. Adjudication method for the test set:
Not applicable as the study involved non-clinical mechanical testing of a physical device, not subjective interpretation requiring adjudication.
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, as this is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device, not an AI algorithm.
7. The type of ground truth used:
For mechanical testing, the "ground truth" would be established by standardized testing methods and material properties, rather than expert consensus, pathology, or outcomes data. The document states testing was performed "per ASTM F1717," indicating adherence to a recognized standard for spinal implant testing.
8. The sample size for the training set:
Not applicable, as this is a physical medical device, not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as this is a physical medical device, not an AI/ML system.
In summary, the provided document is a 510(k) clearance letter for a physical orthopedic implant system. The study mentioned (non-clinical testing per ASTM F1717) focuses on establishing mechanical and material equivalence to predicate devices, not on AI/ML performance metrics.
§ 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.