(286 days)
The Lancer Pedicle Screw System is intended to provide immobilization 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: fracture, dislocation, failed previous fusion (pseudoarthrosis), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal deformations such as scoliosis or kyphosis and loss of stability due to tumors.
When used as a pedicle screw system, the Lancer Pedicle Screw 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 Lancer Pedicle Screw System is comprised of polyaxial pedicle screws, rods and crosslinks. The system consists of a variety of color coded top loading pedicle screws. The rods are Ø5.5mm and are available in straight and pre-lordosed (curved) configurations. The cross linkage assemblies fit over the rods to supply torsional stability to the construct.
The provided document is a 510(k) summary for the Lancer Pedicle Screw System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information you're asking for, which is typical for AI/ML device evaluations or drug trials (e.g., acceptance criteria tables with performance, sample sizes for test/training sets in an AI context, expert ground truth establishment for AI, MRMC studies, standalone algorithm performance, and training data details), is largely not applicable to this specific document.
However, I can extract the relevant "acceptance criteria" information in the context of what is provided in a 510(k) for a device like this, which primarily relates to non-clinical performance and substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
For a pedicle screw system, "acceptance criteria" are not reported as clinical performance metrics (like sensitivity/specificity for an AI model). Instead, acceptance criteria are met by demonstrating a device's substantial equivalence to predicate devices in terms of intended use, design, materials, and mechanical strength, along with meeting certain recognized standards for mechanical testing.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Lancer Pedicle Screw System) |
|---|---|
| Intended Use | Meets the same intended use as predicate devices: immobilization and stabilization of spinal segments for specific conditions (fracture, dislocation, spondylolisthesis, etc.) |
| Design | Polyaxial pedicle screws, rods (Ø5.5mm, straight & pre-lordosed), crosslinks. Design modifications (geometry of screw head, added screw/rod diameters, pre-bent rods, rod lengths) were compared to predicates. |
| Materials | Manufactured from titanium alloy (Ti 6Al 4V ELI) per ASTM F136. |
| Function | Provides immobilization and stabilization of spinal segments until fusion. |
| Mechanical Strength (per ASTM F1717) | Successfully underwent: |
- Static compression bending
- Static torsion
- Dynamic compression bending |
Study that proves the device meets acceptance criteria:
The study proving the device meets its "acceptance criteria" (i.e., demonstrates substantial equivalence and mechanical performance) is the non-clinical testing conducted in accordance with ASTM F1717. The document states:
- "The Lancer Pedicle Screw System is substantially equivalent to the predicate devices in terms of indications for use, design, material, function and strength."
- "The following tests were conducted per ASTM F1717: Static compression bending, Static torsion, Dynamic compression bending."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: This concept doesn't apply to this 510(k) in the way it would for an AI/ML device or clinical trial. The "test set" here refers to the actual physical devices (Lancer Pedicle Screw System components) that underwent mechanical testing. The specific number of physical samples tested is not reported in this summary, but device manufacturers typically test multiple units to meet ASTM F1717 standards.
- Data Provenance: Not applicable in the context of clinical data provenance. The data comes from in-vitro mechanical testing performed on the device components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable. There is no "ground truth" in the clinical AI sense for this device as no clinical data or image interpretation by experts was involved for regulatory submission. Mechanical tests are typically performed by engineers/technicians in a laboratory setting according to established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable. Adjudication methods are relevant for clinical endpoints, especially in situations involving human interpretation or subjective assessments. Mechanical tests are objective measurements.
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
- This question is not applicable. An MRMC study is a type of clinical study used to evaluate diagnostic imaging systems or AI devices. The Lancer Pedicle Screw System is a physical implant, not an imaging or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the mechanical performance of the device is defined by the acceptance criteria within the ASTM F1717 standard (e.g., minimum loads, fatigue life, etc.). The device passes if it meets or exceeds these pre-defined mechanical benchmarks, which are typically derived from historical data on predicate devices and clinical expectations for device durability.
8. The sample size for the training set
- This question is not applicable. There is no "training set" for physical mechanical devices in the context of this 510(k). The device's design and manufacturing process are informed by engineering principles and prior device knowledge, but not by a data-driven "training" process in the AI sense.
9. How the ground truth for the training set was established
- This question is not applicable.
§ 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.