(65 days)
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System are intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/Ilium). Pedicle screw fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft. The device is indicated for all of the following indications:
a) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
b) spondylolisthesis,
c) trauma (i.e., fracture or dislocation),
d) spinal stenosis,
e) deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
f) tumor,
g) pseudoarthrosis, and
h) failed previous fusion
When used for fixation to the illum, the offset connectors of the Firebird Spinal Fixation System must be used in conjunction with pedicle screws placed at the S1 or S2 spinal level.
The Phoenix MIS Fixation System when used with the Firebird System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery.
The Firebird Spinal Fixation System and Phoenix MIS Spinal Fixation System components are used with certain components of the Orthofix Spinal Fixation System, including rods, rod connectors and cross-connectors.
When used for posterior non-cervical pedicle screw fixation in pediatic patients, the Firebird Spinal Fixation System implants are indicated as an adjunct to freat adolescent idiopathic scoliosis. The Firebird Spinal Fixation System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System (K151488, K130932) are temporary, multiple component systems comprised of a variety of non-sterile, single use components, made of titanium alloy or cobalt chrome alloy, that allow the surgeon to build a spinal implant construct. The systems are attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System consist of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks, iliac connectors and STERILE packed HA Coated bone screws. A subset of the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System components may be used in pediatric patients. These components consist of a variety of screws ranging in diameters from 4.0mm to 7.5mm and lengths ranging from 25mm to 60mm.
Here's an analysis of the provided text regarding the Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, focusing on acceptance criteria and supporting studies.
Based on the provided FDA 510(k) summary, the device is a spinal fixation system, and the submission is for modifications to previously cleared versions. The type of acceptance criteria and studies described are primarily focused on mechanical performance to demonstrate substantial equivalence to predicate devices, rather than clinical performance (e.g., diagnostic accuracy, treatment outcomes).
It's important to note that the provided documents are regulatory submissions for a Class III medical device (pedicle screw spinal system). For such devices, "acceptance criteria" and "study that proves the device meets the acceptance criteria" are typically related to:
- Benchtop Mechanical Testing: To ensure the device new modifications meet established standards (e.g., ASTM standards for mechanical strength, fatigue, etc.) or are at least as good as the predicate device.
- Biocompatibility Testing: To ensure the materials are safe for implantation.
- Sterilization Validation: To ensure the device can be properly sterilized.
The provided text focuses only on the mechanical testing aspects. Clinical studies involving human subjects with endpoints like "accuracy" or "effect size improvement" are not generally required for 510(k) submissions unless demonstrating a new intended use or significant change that impacts clinical performance in a way not covered by substantial equivalence. This submission is for modifications to existing cleared devices, asserting substantial equivalence.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Device Component/Modification | Acceptance Criteria (Standard & Performance Target) | Reported Device Performance |
|---|---|---|
| JANUS Midline Fixation Screw (Cannulated and Non-Cannulated) | Adequate Insertion Torque (Implicitly, to ensure proper screw placement and fixation, likely compared to predicate or established clinical ranges/requirements, though specific values are not explicitly stated as 'acceptance criteria' in this summary). | Insertion Torque Mechanical Testing (Non-Cannulated) was performed. (Results are not quantified in this summary, but the implication of substantial equivalence is that performance was acceptable and comparable to predicate). |
| Phoenix CDX MIS Spinal Fixation System Modular Mono-Axial Body with Extended Tab | Flexion-Bending tests per ASTM F1798-13. The device must meet or exceed the performance of the predicate device (K130932) with respect to static and fatigue properties of interconnection mechanisms and subassemblies. | Flexion-Bending tests per ASTM F1798-13 were performed. (Results are not quantified in this summary, but the implication of substantial equivalence is that performance was acceptable and comparable to predicate). |
| Firebird NXG Spinal Fixation System (Set Screw, Multi-Axial Screw Top-Loading Body, Low Profile Offset Body, and Set Screw) | Static and Dynamic Compression Bending, and Static Torsion tests per ASTM F1717-14. The device must meet or exceed the performance of the predicate device (K130932) in a vertebrectomy model. | Static and Dynamic Compression Bending and Static Torsion tests per ASTM F1717-14 were performed. Static Torsion tests were also performed. (Results are not quantified in this summary, but the implication of substantial equivalence is that performance was acceptable and comparable to predicate). |
| Modified Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System Bone Screws | No mechanical testing performed. The modification (increasing thread surface area at the distal tip) was not deemed to affect structural integrity, implying an acceptance criterion that the change should not degrade existing performance. | No mechanical testing performed, as the modification entailed increasing thread surface area at the distal tip with no changes to the structural integrity of the main threaded section or neck. (This implies it's "accepted" based on engineering assessment rather than new test data). |
Note on "Acceptance Criteria" and "Reported Device Performance": In this 510(k) summary, the specific numerical acceptance criteria (e.g., minimum load to failure, fatigue life cycles) and the exact numerical results obtained from the tests are not provided. The summary states that testing was "conducted" per the standards and that these tests form the "basis of substantial equivalence." This implies that the devices met the performance targets (typically, at least matching or exceeding the predicate device's performance as per the relevant ASTM standards). For a detailed understanding, one would need to review the full testing reports submitted to the FDA.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the exact sample sizes (number of screws, bodies, constructs tested) used for the mechanical benchtop tests. Specific sample sizes are typically detailed in the full mechanical test reports.
- Data Provenance: The data comes from benchtop mechanical testing performed by the manufacturer, Orthofix Inc. This is prospective data generated specifically for the 510(k) submission. It is not clinical or patient data and therefore has no country of origin in that sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this type of submission. This 510(k) is for a physical medical device (spinal fixation system) and relies on mechanical engineering principles and testing, not on interpretation of data by human experts to establish "ground truth" in the way an AI diagnostic device would. The "ground truth" here is the physical performance data against established engineering standards or predicate device performance.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1, 3+1) are for human-interpreted data (e.g., radiology reads, clinical outcomes) to establish a consensus ground truth. For mechanical benchtop testing, the "adjudication" is typically the comparison of test results against predefined (often standard-based) acceptance criteria by qualified engineers and statisticians.
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
This question is not applicable. An MRMC study is relevant for AI-powered diagnostic or interpretive devices that assist human readers. This submission is for a physical implantable device, not an AI diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This question is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical performance tests is established by:
- Mechanical Engineering Standards: Specifically, ASTM F1798-13 (Flexion-Bending) and ASTM F1717-14 (Static and Dynamic Compression Bending, and Static Torsion). These standards define the test methodologies and often provide guidelines for performance expectations.
- Predicate Device Performance: To establish substantial equivalence, the performance of the modified components is compared to the performance of the legally marketed predicate device (Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System, K130932) on which the modifications are based. The implicit ground truth is that the new device's performance must be at least equivalent or better than the predicate.
8. The Sample Size for the Training Set
This question is not applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for an AI/ML model.
In summary, the provided document describes a 510(k) submission for modifications to a spinal fixation system. The "acceptance criteria" and "studies" are primarily focused on benchtop mechanical performance testing to ensure the modified components continue to meet established engineering standards and are substantially equivalent to their predicate devices, thereby assuring their safety and effectiveness. The nature of the device means that many of the questions related to AI/ML or clinical ground truth are not relevant.
§ 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.