(111 days)
The Spineology Fortress™ Pedicle Screw System is intended for posterior, non-cervical fixation as an adjunct to fusion for the following indications: degenerative discase (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
The Spineology Fortress™ Pedicle Screw System consists of screws (titanium) and rods (cobalt chrome) to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The devices are provided sterile or non-sterile. The associated instruments are provided non-sterile.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what would typically be found in a medical device submission for performance:
The provided text describes a 510(k) submission for the Spineology Fortress™ Pedicle Screw System, a Class III medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device, which often involves mechanical testing rather than studies involving human participants or AI performance.
Therefore, many of the requested categories related to AI performance, human readers, ground truth for training data, and clinical study details are not applicable (N/A) to this specific submission.
Acceptance Criteria and Device Performance
The acceptance criteria for the Spineology Fortress™ Pedicle Screw System are established by demonstrating that its mechanical performance is equivalent or superior to the predicate devices when evaluated against recognized ASTM standards. These standards define the expected performance thresholds for pedicle screw systems.
| Acceptance Criteria (Standard) | Reported Device Performance (Summary from Text) |
|---|---|
| ISO 1798-97(2008) Flexural Grip | "Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008)" |
The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary, but in the full submission, these would demonstrate meeting or exceeding predicate device performance. |
| ISO 1798-97(2008) Torsional Grip | "Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008)"
As above. |
| ISO 1798-97(2008) Axial Grip | "Mechanical testing was performed as follows: flexural grip, torsional grip, and axial grip tests according to F1798-97(2008)"
As above. |
| ASTM F543-13 Axial Pullout | "axial pullout and torque to failure per ASTM F543-13"
The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary. |
| ASTM F543-13 Torque to Failure | "axial pullout and torque to failure per ASTM F543-13"
As above. |
| ASTM F1717-13 Static Torsion | "static torsion and static and dynamic compression bending according to ASTM F1717-13"
The text states these tests were performed, implying the device met the requirements of the standard for substantial equivalence. Specific quantitative results are not provided in the summary. |
| ASTM F1717-13 Static Compression Bending | "static torsion and static and dynamic compression bending according to ASTM F1717-13"
As above. |
| ASTM F1717-13 Dynamic Compression Bending | "static torsion and static and dynamic compression bending according to ASTM F1717-13"
As above. |
| Substantial Equivalence | "The device is shown to be substantially equivalent to the intended use, materials, configuration, and performance characteristics of the predicate products." and "The information submitted in this premarket notification supports a determination that the devices subject to this submission are substantially equivalent in technological characteristics and intended use to the predicate devices."
Overall conclusion based on all testing. |
Study Details (Mechanical Testing)
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided summary document. For mechanical testing, sample sizes are typically defined by the relevant ASTM standards to ensure statistical validity (e.g., n=6 for certain tests).
- Data Provenance: The testing was "performed" by the applicant, Spineology Inc., likely in a laboratory setting. This is not clinical data (e.g., country of origin for clinical data, retrospective/prospective). It refers to in-vitro mechanical testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Mechanical testing against ASTM standards does not involve "ground truth" derived from expert consensus in the same way clinical or AI studies do. The "ground truth" here is the defined performance requirement within the standard.
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Adjudication method for the test set:
- N/A. See point 2. The outcome is determined by adherence to the pass/fail criteria of the ASTM standards.
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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:
- No. This is a 510(k) for a physical implant (pedicle screw system), not an AI/software device. Therefore, no MRMC study, human readers, or AI assistance is involved.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical implant.
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The type of ground truth used:
- For this type of mechanical testing, the "ground truth" is adherence to the specified performance characteristics and thresholds defined within the referenced ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., acceptable flexural strength, pullout force, fatigue life). The comparison is made against predicate devices, demonstrating the new device performs at least as well.
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The sample size for the training set:
- N/A. This is mechanical testing of a medical device, not an AI algorithm. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- N/A. See point 7.
§ 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.