(30 days)
The Firebird Spinal Fixation System is intended for posterior, non-cervical pedicle fixation. 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:
- degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis,
- trauma (i.e., fracture or dislocation),
- spinal stenosis.
- deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
- tumor,
- pseudoarthrosis, and
- failed previous fusion
The Firebird Spinal Fixation Screw System components are used with certain components of the Blackstone SFS system, including rods, rod connectors and cross-connectors.
The Firebird Spinal Fixation System is a temporary, titanium alloy, multiple component system comprised of a variety of non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine. The spinal construct is completed by connecting the screws with titanium alloy or cobalt chrome rods.
The document describes the K092624 premarket notification for the Blackstone Medical, Inc. Firebird Spinal Fixation System with the addition of a Cobalt Chrome Rod. This is a medical device submission, and as such, the concept of "acceptance criteria" and "device performance" as it might apply to software or AI algorithms is not directly applicable in the same way. Instead, the "acceptance criteria" for a medical device like this is typically demonstrating substantial equivalence to a predicate device, primarily through mechanical testing to ensure safety and effectiveness.
Here's a breakdown based on the provided text, adapted to the context of a medical hardware device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Study Results) |
|---|---|
| Same intended use as predicate device | The modified system has the same intended use as the predicate system. |
| Similar indications for use as predicate device | The modified system has similar indications for use as the predicate system. |
| Similar technological characteristics to predicate device | The modified system has similar technological characteristics and principles of operation as the predicate system. |
| Meets established mechanical testing standards | Mechanical testing was conducted in accord with ASTM standards. |
| Mechanical performance substantially equivalent to predicate | Mechanical testing demonstrates that the system with cobalt chrome rods is substantially equivalent to the predicate system when using titanium alloy rods. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact sample size for the mechanical testing. For medical devices, "sample size" in this context typically refers to the number of devices or components tested. ASTM standards for medical devices usually specify the required number of samples for each test type to achieve statistical significance.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given that the submission is to the FDA (USA), it is reasonable to infer the testing was likely conducted in the US or by a lab adhering to US standards. Mechanical testing on medical devices is inherently prospective, as it involves newly produced components subjected to defined test protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This question is not applicable. For mechanical testing of a medical device, "ground truth" is established by the specifications of the ASTM standards themselves and the objective measurements obtained from standardized testing equipment, not by a panel of human experts. Expert clinical opinion would be relevant in the initial design and indication definition, but not in validating the mechanical performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This question is not applicable. Mechanical testing of physical medical devices does not involve human adjudication in the way clinical studies or image analysis might. The results are based on objective physical measurements and adherence to pre-defined test protocols.
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. The device is a spinal fixation system (hardware), not an AI or imaging diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a spinal fixation system, which is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the mechanical testing of this device is established by objective physical measurements (e.g., force, displacement, cycles to failure) in accordance with recognized industry standards (ASTM standards). These standards define the criteria for acceptable performance (e.g., fatigue life, strength) for spinal fixation systems.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of mechanical testing for a medical device like a spinal fixation system. The device's performance is evaluated against engineering standards and comparison to a predicate device.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set 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.