(111 days)
LineSider® Spinal System, with or without MIS instrumentation, is intended for posterior, non-cervical fixation in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (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; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor: pseudarthrosis; and/or failed previous fusion.
When used for posterior non-cervical pediction in pediatic patients, LineSider® Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis. Additionally, LineSider Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis; fracture caused by tumor and/or trauma. LineSider® Spinal System is intended to be used with autograft. Pediatric pediatic pediatic pedicle screw fixation is limited to a posterior approach.
The LineSider® Spinal System is a thoracolumbosacral pedicle screw system containing metallic implants intended to provide immobilization and stabilization of spinal segments. The system consists of a variety of screws, hooks, rods, set screws, crosslink connectors, rod-to-rod connectors, iliac connectors, and associated instruments. Components are offered in various shapes and sizes to meet the requirements of the individual patient anatomy.
This document describes the regulatory clearance for the LineSider® Spinal System, a thoracolumbosacral pedicle screw system. It is a 510(k) summary, which means the manufacturer is claiming substantial equivalence to previously cleared devices, not presenting novel clinical trial data for acceptance criteria. As such, the information you're requesting regarding acceptance criteria related to AI/algorithm performance, ground truth establishment, expert adjudication, MRMC studies, and sample sizes for training/test sets is not applicable to this type of medical device submission.
The document primarily focuses on bench performance testing to demonstrate the physical and mechanical equivalence of the new device to its predicates.
Here's a breakdown based on the provided text, highlighting what is available and what is not applicable:
1. A table of acceptance criteria and the reported device performance
The document lists the following bench performance tests and states that they were conducted in support of the submission. The acceptance criteria for these tests would typically be established by the relevant ASTM standards (e.g., meeting or exceeding certain load values, deflection limits, or fatigue cycles specified in the standard or observed in predicate devices). However, the specific quantitative acceptance criteria values and the reported device performance results are not detailed in this summary document. The summary only states that the tests were performed and conclude substantial equivalence.
| Test Type | Standard/Reference | Reported Performance (Qualitative) |
|---|---|---|
| Static Compression Bending | ASTM F1717-21 | Performance supports substantial equivalence |
| Static Torsion | ASTM F1717-21 | Performance supports substantial equivalence |
| Dynamic Compression Bending | ASTM F1717-21 | Performance supports substantial equivalence |
| Static Axial Grip | ASTM F1798-21 | Performance supports substantial equivalence |
| Static Torsion Grip | ASTM F1798-21 | Performance supports substantial equivalence |
| Static Flexion-Extension Bending | ASTM F1798-21 | Performance supports substantial equivalence |
| Static Axial Pull-Off | ASTM F1798-21 | Performance supports substantial equivalence |
| Static Axial Push-On | ASTM F1798-21 | Performance supports substantial equivalence |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: For bench performance testing, "sample size" refers to the number of physical device components or constructs tested. This information is not detailed in the provided 510(k) summary. These tests are typically conducted in a laboratory setting (e.g., in the US, given the company's location).
- Data Provenance: The data is from laboratory bench testing. Provenance (country of origin, retrospective/prospective) is not applicable in the same way it would be for clinical study data.
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 to this 510(k) submission. There is no AI or diagnostic algorithm involved that would require expert ground truth establishment for a test set. The "ground truth" for mechanical testing is based on engineered specifications and the ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as there is no diagnostic or image-based ground truth requiring adjudication.
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
An MRMC study is not applicable and was not done. This device is a physical pedicle screw system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. There is no algorithm for this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims relate to mechanical test standards (ASTM F1717 and ASTM F1798) and comparison to the performance of legally marketed predicate devices.
8. The sample size for the training set
This question is not applicable. There is no training set for an AI/algorithm as this is a physical medical device.
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.