(240 days)
The Firebird Spinal Fixation System is intended for posterior, non-cervical 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 or allograft. 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) Tumors: g) Pseudoarthrosis, and h) Failed previous fusion When used for fixation to the ilium, 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 Spinal Fixation System is indicated to provide the surgeon with a minimally invasive approach for posterior spinal surgery. The Firebird 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 fusion to treat adolescent idiopathic scoliosis. The Firebird 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 is a temporary, titanium alloy, multiple component system 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 system is attached to the vertebral body and ilium by means of screw or hook fixation to the non-cervical spine. The Firebird Spinal Fixation System consists of an assortment of rods, multi-axial and mono-axial pedicle screws, set screws, lateral offsets, bone screws, screw bodies, hooks and iliac connectors.
The provided text describes a 510(k) premarket notification for the Firebird Spinal Fixation System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical or performance study in the way an AI/ML device would.
Therefore, much of the requested information (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, AI performance metrics) is not applicable to this document as it pertains to a mechanical spinal fixation system, not a software or AI/ML device.
However, I can extract the relevant information regarding performance data as presented in the document:
1. Table of Acceptance Criteria and Reported Device Performance
For this medical device (spinal fixation system), "acceptance criteria" are typically defined by the standard mechanical tests and their pass/fail requirements, demonstrating that the modified device's performance is equivalent to the predicate device.
| Test Characteristic | Standard / Test / FDA Guidance | Reported Device Performance (Summary) |
|---|---|---|
| Static Torsion Test | N/A (No change from predicate device) | This test was not performed on the subject device because there were no changes that would affect its static torsional properties. The device is considered substantially equivalent to the predicate device in this regard. |
| Static Axial Compression Bending Test | N/A (No change from predicate device) | This test was not performed on the subject device because there were no changes that would affect its static axial compression bending properties. The device is considered substantially equivalent to the predicate device in this regard. |
| Dynamic Axial Compression Bending Test | ASTM F1717-14 | Subject lined rods demonstrated substantial equivalence to the predicate device with respect to fatigue properties. |
| Axial Rod Gripping Test | ASTM F1798-13 | Subject lined rods demonstrated substantial equivalence to the predicate device with respect to static axial rod gripping properties. |
Explanation of "Acceptance Criteria" for this device: The primary "acceptance criterion" for this 510(k) submission is that mechanical testing demonstrates that the modified device (Firebird Spinal Fixation System with lined rods) is substantially equivalent to the predicate device (Firebird Spinal Fixation System K130932) and the other predicate (LDR Spine USA SpineTune TL System K120760) per the specified ASTM standards. The specific quantitative results (e.g., load-to-failure values, cycles to failure) are not provided in this summary, but the conclusion that equivalence was demonstrated indicates the acceptance criteria were met.
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not specify the number of samples used for each mechanical test.
- Data provenance: The data provenance is from the mechanical testing performed on the device components themselves, adhering to specific ASTM standards in a laboratory setting. This is not clinical data (retrospective or prospective from a country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device, and "ground truth" (in the context of expert consensus or pathology) is not established by human experts for mechanical performance testing. Ground truth for mechanical tests is the quantitative measurement of physical properties against engineering specifications and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review, typically in studies involving interpretation of medical images or clinical outcomes. Mechanical testing does not involve this type of 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. An MRMC study is relevant for diagnostic imaging devices involving human readers and AI. This document describes a spinal fixation system, which is a physical implant, not a diagnostic AI tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This refers to the performance of an AI algorithm without human involvement. This document describes a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For mechanical performance testing, the "ground truth" is defined by the measured physical properties and performance characteristics (e.g., stiffness, strength, fatigue life) as determined by standardized laboratory tests (ASTM F1717-14, ASTM F1798-13) against the established performance of predicate devices.
8. The sample size for the training set:
- Not Applicable. This is a mechanical device, not an AI/ML system that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set is involved for this type of device submission.
§ 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.