(30 days)
The ST360° Spinal System is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (DDD) (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, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.
When used as a hook and sacral screw system, the ST360 Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined as chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic, deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the ST360° Spinal Fixation System are intended for the sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.
The ST36000 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V), conforming to ASTM F-136.
This document is a 510(k) summary for the ST360® Spinal Fixation System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance metrics in the way a new drug or novel high-risk device might.
Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets them, in the typical sense of a detailed performance study with statistical measures.
Here's why and what can be inferred:
- Type of Device and Submission: The ST360® Spinal Fixation System is a Class III spinal fixation system. This is a 510(k) premarket notification. For devices like this, the primary focus for FDA clearance is demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. This is often done through bench testing (mechanical properties, materials), design comparisons, and sometimes cadaveric studies, rather than large-scale human clinical trials with specific performance endpoints like accuracy, sensitivity, or specificity.
- Lack of Performance Metrics for AI/Algorithm: The questions provided are highly relevant to AI/ML-driven diagnostic or prognostic devices. This device is a physical implantable medical device (spinal fixation hardware), not a software algorithm or AI diagnostic tool. Therefore, concepts like "acceptance criteria" for accuracy, sensitivity, "MRMC comparative effectiveness study," "standalone algorithm performance," "ground truth" (especially in the context of expert consensus or pathology for diagnostic outcomes), "sample size for training set," etc., do not apply to this specific device or its regulatory submission.
Summary of missing information based on the prompt's categories:
- A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence to a predicate device through material, design, and intended use comparisons, not a new performance study with specific metrics.
- Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device testing. Any "testing" for this device would be mechanical or biomechanical, not based on a "test set" of patient data for diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no diagnostic "ground truth" established by experts for this physical device.
- Adjudication method for the test set: Not applicable.
- 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. This device is not an AI assistance tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable. This device does not use a training set in the AI/ML sense.
- How the ground truth for the training set was established: Not applicable.
What can be inferred from the document:
- Acceptance Criteria (Implied): The implied acceptance criterion is "substantial equivalence" to the predicate devices (ST360® Spinal Fixation System, K022374, K041925). This is a regulatory standard, not a performance metric for the device itself.
- Study Proving Acceptance (Implied): The "study" is the 510(k) submission itself, which argues for substantial equivalence by stating: "There are no changes to the material of construction or the mechanism of action to the ST360° Spinal Fixation System. The modified system has the same fundamental scientific technology and intended use and indications as the predicate device." This is a declarative statement of comparison rather than a report of specific experimental results.
- Regulatory Decision: The FDA's letter (K072183) confirms that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This is the "proof" that the regulatory acceptance criterion (substantial equivalence) has been met.
In conclusion, the input document is for a physical medical implant (spinal fixation system) seeking 510(k) clearance, which relies on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria typically associated with AI/ML or novel diagnostic technologies.
§ 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.