(68 days)
The ISOBAR Spinal System consists of pedicle screws, rods, nuts and crosslink members utilized 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The ISOBAR Spinal System consists of pedicle screws. rods, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6A1-4V) that conforms to ASTM F136.
This system consists of pedicle screws that required rod attachment directly over the top of the screw (U-Line Screws) and a combination of screws and clamps that allow the rod to be offset from the screw (Hemispherical Headed Screws).
The provided text is a 510(k) summary for the ISOBAR Spinal System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a rigorous standalone study in the way an AI/software device would.
Therefore, many of the requested elements for an AI/software device's acceptance criteria and study design are not applicable to this spinal implant device. The "performance data" section in this document refers to mechanical testing to ensure the device meets engineering standards, not clinical performance or diagnostic accuracy.
Here's an attempt to answer the questions based only on the provided text, highlighting where the information is not applicable (N/A) for this type of medical device submission.
Acceptance Criteria and Study Information for ISOBAR Spinal System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What standard needs to be met) | Reported Device Performance (How the device performed) |
|---|---|
| ASTM F1717-96: | |
| Static Compression Testing | Performed (Implied compliance, no specific numerical results provided) |
| ASTM F1717-96: | |
| Fatigue Compression Testing | Performed (Implied compliance, no specific numerical results provided) |
Note: The FDA established no performance standards applicable to pedicle screw spinal systems at the time of this submission. The testing conducted was to an industry standard. The document states "was performed according to ASTM F1717-96," which implies the device met the requirements of this standard, but no specific numerical performance data (e.g., maximum load, cycles to failure) is provided in this summary.
2. Sample size used for the test set and the data provenance
N/A. This device is a physical pedicle screw system, not an AI/software device that would have a "test set" of data. The "testing" refers to mechanical integrity testing of the implants themselves. Data provenance (country of origin, retrospective/prospective) is not relevant to this type of mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Ground truth and expert adjudication are not applicable to the mechanical testing of a physical implant device for this type of submission.
4. Adjudication method for the test set
N/A. Adjudication method is not applicable to the mechanical testing of a physical implant device.
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
N/A. This is a physical spinal implant, not an AI or diagnostic imaging device. MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical spinal implant, not an AI or diagnostic imaging device. Standalone algorithm performance is not relevant.
7. The type of ground truth used
N/A. This is a physical spinal implant. Mechanical testing relies on engineering specifications and measurements, not "ground truth" derived from clinical outcomes, pathology, or expert consensus in the diagnostic sense.
8. The sample size for the training set
N/A. This is a physical spinal implant. There is no "training set" in the context of AI/machine learning. If by "training set" it refers to the number of devices mechanically tested, that information is not provided in this summary.
9. How the ground truth for the training set was established
N/A. Not applicable, as there is no "training set" or "ground truth" in the AI/ML context for this 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.