(80 days)
The Proliant System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The Proliant system is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: (DDD) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis including severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).
The ChoiceSpine Proliant Posterior Pedicle Screw and Hook Fixation System is a toploading spinal fixation system including screws, rods, and connectors for fixation to the thoracic, lumbar, and sacral spine. Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136) and Cobalt Chrome (Co-28Cr-6Mo per ASTM F1537) in various sizes. The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.
This document is a 510(k) premarket notification for a Class II medical device, the ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System. It explicitly states that the device is substantially equivalent to a legally marketed predicate device (Exactech, Inc.'s Proliant® Pedicle Screw System, K102870).
A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device rather than conducting de novo clinical performance studies or establishing new acceptance criteria based on human reading performance. Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, human reader studies, or detailed AI/ML performance metrics.
The study described is a non-clinical mechanical and biomechanical performance test designed to show the physical properties of the new device are comparable to the predicate.
Here's a breakdown of why this document doesn't fit your prompt's scope and what it does provide:
Why the Document Does Not Contain the Requested Information:
- Device Type: This is a pedicle screw and hook fixation system, which is a physical implant, not an AI/ML diagnostic or image analysis device. Therefore, concepts like "multireader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "ground truth establishment based on expert consensus," or "effect size of human readers improving with AI assistance" are not applicable.
- Regulatory Pathway: A 510(k) typically relies on demonstrating substantial equivalence to an existing legally marketed device. This means the primary evidence revolves around comparing the new device's design, materials, indications for use, and non-clinical performance (e.g., mechanical testing) to a predicate, rather than generating new clinical performance data against specific acceptance criteria for a diagnostic task.
- Absence of AI/ML: There's no mention of any AI or machine learning component in this device.
What the Document Does Provide (Mapped to Closest Relevant Concepts where possible, but not a direct match to your prompt):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion is that the new device's mechanical and biomechanical performance must be comparable or superior to the predicate device to demonstrate substantial equivalence for its intended use. The document states: "The results of this non-clinical testing show the strength of the Proliant Posterior Pedicle Screw and Hook Fixation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
- Reported Device Performance (Test Modes):
- Static axial compression bending per ASTM F1717-14
- Static torsion per ASTM F1717-14
- Dynamic axial bending per ASTM F1717-14
- No specific numerical results are provided in this summary, only the types of tests performed and a general conclusion of sufficiency.
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Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated (for mechanical tests, this would refer to the number of test specimens).
- Data Provenance: Not applicable in the context of human data. These are laboratory mechanical tests, not clinical studies with patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to the physical properties measured in a lab, not expert consensus on medical images or diagnoses.
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Adjudication method for the test set:
- Not applicable. This refers to mechanical testing, not a human reader study.
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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, not done. This is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This is a physical implant, not an algorithm.
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The type of ground truth used:
- Physical measurement of material properties and mechanical integrity. The "ground truth" is established by adherence to recognized industry standards (e.g., ASTM F1717-14) for testing the strength and durability of spinal implants.
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The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires training data.
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How the ground truth for the training set was established:
- Not applicable. No training set is involved.
In summary, the provided document details a 510(k) submission for a physical medical device (spinal fixation system) and demonstrates substantial equivalence through non-clinical mechanical testing, rather than addressing AI/ML performance metrics, human reader studies, or associated acceptance criteria.
§ 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.