(109 days)
The SmartLoc™ is a spinal fixation system intended to provide immobilization and stabilization of thoracic, lumbar, and sacral spinal segments as an adjunct to fusion. When used as posterior, pedicle screw fixation, the system is intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients. In addition, when used as a pedicle screw fixation system in the non-cervical posterior spine (T1 to S2), the system is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumor, pseudarthrosis and failed previous fusion in skeletally mature patients. When used as a posterior, non-cervical, hook and/or sacral/iliac fixation system (i.e., non-pedicle screw), the SmartLoc™ is intended for the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (as conformed by patient history and radiographic studies), spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, lordosis, spinal stenosis, spinal tumor, pseudarthrosis and failed previous fusion.
The SmartLoc™ consists of rods, monoaxial and polyaxial pedicle screws, hooks and transverse connectors with locking set screws. The components are available in various sizes to accommodate differing patient anatomy. Rods are available in one diameter and a variety of lengths. Monoaxial and polyaxial screws are available in a variety of diameter-length combinations. Hooks are offered in a variety shapes and sizes.
The provided text describes the SmartLoc™ spinal fixation system, a Class II medical device. However, the information available is limited to its regulatory clearance, intended use, and mechanical testing results. It does not present a study with acceptance criteria and reported device performance in the context of an AI/algorithm-based device and its clinical performance metrics.
Therefore, I cannot provide the specific details requested in your prompt regarding:
- A table of acceptance criteria and reported device performance (in the context of AI/algorithm performance)
- Sample sizes and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone (algorithm only) performance
- Type of ground truth used (clinical outcomes, etc.)
- Training set details (sample size, ground truth establishment)
Based on the provided text, the device is a physical spinal implant system, not an AI or algorithm-based diagnostic or assistive device. The "Performance Data" section describes mechanical testing of the physical components.
Here's what I can extract related to acceptance criteria and performance for this physical medical device:
Acceptance Criteria and Device Performance (for a Physical Spinal Fixation System)
The SmartLoc™ spinal fixation system underwent mechanical testing to demonstrate its performance. The acceptance criteria are implicitly tied to demonstrating performance "as well as or better than" predicate devices according to established industry standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | |
| Static Compression Bending | Performed as well as or better than predicate devices. |
| Static Torsion | Performed as well as or better than predicate devices. |
| Dynamic Compression Bending | Performed as well as or better than predicate devices. |
| Material Composition | Components manufactured from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 / ASTM F136. |
| Technological Characteristics | Possesses the same basic design (rod-based fixation, mono- and polyaxial pedicle screws, hook shapes/sizes), material (titanium alloy), sizes (rod/screw sizes comparable to predicates), and intended use as predicate devices. The fundamental scientific technology is the same as previously cleared devices. |
Study Information (Mechanical Testing):
- Test Set Sample Size & Data Provenance: Not explicitly stated as a "test set" in the context of clinical data. The study was a mechanical test (laboratory-based) performed on a "worst case SmartLoc™ construct." The data provenance is from the manufacturer's testing in support of their 510(k) submission.
- Number/Qualifications of Experts (Ground Truth): Not applicable for mechanical testing. Performance is evaluated against engineering standards.
- Adjudication Method (Test Set): Not applicable for mechanical testing.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This is a mechanical test of a physical device, not an AI-assisted diagnostic tool.
- Standalone (Algorithm Only) Performance: Not applicable. This is a physical device.
- Type of Ground Truth Used: The "ground truth" for mechanical performance is adherence to the specified ASTM F1717 standard and comparison against the performance of legally marketed predicate devices.
- Training Set Sample Size: Not applicable. This is not a machine learning device.
- How Ground Truth for Training Set Was Established: Not applicable.
Summary regarding your specific questions:
The provided document describes the regulatory clearance of a physical medical device (spinal fixation system), not an AI-based system. Therefore, most of the questions pertaining to AI/algorithm performance, training/test sets, expert adjudication, and MRMC studies are not applicable to this submission. The "Performance Data" provided is solely about the mechanical integrity of the implant system.
§ 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.