(140 days)
The ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- Spondylolisthesis (Grade 3 and 4) .
- Degenerative spondylolisthesis with objective evidence of neurological . impairment
- Trauma (i.e., fracture or dislocation) .
- Spinal stenosis .
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
- Tumor .
- Pseudoarthrosis
- Failed previous fusion
The ANAX™ 5.5 Spinal System is manufactured by U&I corporation. The ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobait-chromium-molybdenum alloy (ASTM F1537).
The provided text describes a medical device, the ANAX™ 5.5 Spinal System, and its substantial equivalence to predicate devices, focusing on mechanical performance. This document pertains to a 510(k) submission to the FDA, which is primarily concerned with establishing substantial equivalence for medical devices based on predicate devices. It does not contain information about studies involving AI, human readers, or image-based diagnostics.
Therefore, many of the requested categories are not applicable to the provided text.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not present:
ANAX™ 5.5 Spinal System - Acceptance Criteria and Performance
The ANAX™ 5.5 Spinal System is a mechanical spinal fixation system designed to provide immobilization and stabilization of spinal segments. The provided document details its substantial equivalence to predicate devices based on mechanical performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance | ANAX™ 5.5 Spinal System met the acceptance criteria established from the predicate devices. |
| Material Composition | Fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537), similar to predicate devices. |
| Design Features | Similar design features to predicate devices. |
| Indications for Use | Similar indications for use to predicate devices. |
| Basic Fundamental Scientific Technology | Similar to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The testing was "bench testing" on the device itself.
- Data Provenance: Not applicable in the context of clinical data/patient data. The testing was non-clinical bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This is not applicable. The ground truth for mechanical performance testing is based on established engineering standards (ASTM F1717) and comparison to predicate devices, not expert human interpretation for diagnostics.
4. Adjudication Method for the Test Set
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on diagnostic interpretations, not for mechanical bench testing.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs without AI Assistance
- This is not applicable. The device is a mechanical spinal fixation system, not an AI-assisted diagnostic tool or system designed to be read by human readers. Therefore, an MRMC study and AI improvement effect size is irrelevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a mechanical system, not an algorithm.
7. The Type of Ground Truth Used
- Ground Truth: Established engineering standards (ASTM F1717 for mechanical testing) and the performance characteristics of legally marketed predicate devices.
8. The Sample Size for the Training Set
- This is not applicable. There is no "training set" in the context of a mechanical device's 510(k) submission. This term applies to machine learning models.
9. How the Ground Truth for the Training Set was Established
- This is not applicable. There is no training set for this type of device.
§ 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.