(130 days)
The CB PROT II Posterior Spinal System is intended to provide immobilization and stabilization for posterior, noncervical, pedicle fixation of the thoracic, lumbar and sacral spinal elements (T1-S1) as an adjunct to fusion for the following indications:
- Trauma (i.e. fracture or dislocation).
- Spinal stenosis.
- Vertebral tumors.
- Pseudoarthrosis and failed previous fusion in skeletally mature patients.
- Scoliosis, kyphosis and lordosis, and severe spondylolisthesis (grade 3 or 4) of the T1-S1 vertebra.
The system is intended to be used with autograft or allograft to facilitate fusion.
The CB PROT II Posterior Spinal System consists of non-sterile rods, monoaxial and polyaxial pedicle screws. The thoraco-lumbar rods are available in a variety of lengths (one diameter). Screws are available in various lengths and diameters according to practical requirements.
This document is a 510(k) premarket notification for a medical device called the "CB PROT II Posterior Spinal System." It is a regulatory submission to the FDA to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.
The document does not describe an acceptance criteria or study for an AI/CADe/CADx device that relies on diagnostic performance metrics like sensitivity, specificity, or AUC, nor does it involve human readers, expert ground truth, or training sets in the typical sense of AI device evaluation.
Instead, this document describes the acceptance criteria and a study for a spinal implant system, which is a physical device subject to mechanical and material performance standards. Therefore, the questions in the prompt, which are tailored for AI/diagnostic devices, do not directly apply to this submission.
However, I can extract the information relevant to the device's "performance" and "acceptance criteria" in the context of this specific regulatory submission for a spinal system:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material: Components manufactured from medical grade titanium alloy (Ti6Al4V) meeting ASTM F136 & ISO 5832-3 standards. | Components are manufactured from medical grade titanium alloy (Ti6Al4V) that meets ASTM F136 & ISO 5832-3. |
| Mechanical Performance: Performance as well as or better than the predicate device (SmartLocTM spinal fixation system) in:Static axial compression bending testDynamic axial compression bending testStatic torsion test (All referring to ASTM F1717 standards). | The results represented that the CB PROT II Posterior Spinal System performs as well as or better than the predicate device in static/dynamic axial compression bending tests and static torsion tests, conducted referring to ASTM F1717. |
| Substantial Equivalence: Demonstrated substantial equivalence to predicate system with respect to technical characteristics, performance, and intended use. | The information provided within this premarket notification supports substantial equivalence of the subject device to the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a test set of images or patient data. For mechanical testing, the "test set" would refer to the number of physical device units tested. This specific number is not provided in the summary, but such tests typically involve multiple units to ensure statistical significance for mechanical properties. The provenance is implied to be from the manufacturer's internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/diagnostic device that requires expert review for ground truth in clinical data. The "ground truth" for this device relates to engineering specifications and mechanical performance standards.
4. Adjudication method for the test set
Not applicable. There is no adjudication method described as this is not a diagnostic performance study involving human reviewers.
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
Not applicable. This is not an AI-assisted diagnostic device, so no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm-based device. "Standalone performance" in this context refers to the device's ability to meet mechanical standards independently, which was indeed what the mechanical tests evaluated.
7. The type of ground truth used
The "ground truth" for this device's performance evaluation is based on established engineering and material science standards (ASTM F136, ISO 5832-3, ASTM F1717) and comparative performance against a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI device that requires a training set.
§ 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.