(59 days)
The SpineTune™ TL Spinal System is a posterior, noncervical pedicle fixation system indicated to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:
- Spondylolisthesis (Grade 3 and 4) .
- Degenerative spondylolisthesis with objective evidence of neurological . impairment
- Trauma (i.e., fracture or dislocation) .
- Spinal stenosis .
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
- . Tumor
- . Pseudoarthrosis
- Failed previous fusion .
The SpineTune™ TL Spinal System is a top-loading multiple fixation system which consists of pedicle screws, straight rods, curved cods, connectors and set which of polyaxial pedicle screw design and additional sizes of the straight and curved rods are an addition to the previously cleared SpineTune™ TL Spinal System (K100575).
The provided text describes a 510(k) summary for the LDR Spine SpineTune™ TL Spinal System. This document focuses on the mechanical testing of a physical medical device (spinal fixation system), not a software or AI-powered medical device. Therefore, the specific information requested about acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, as typically applied to AI/software for medical image analysis or similar diagnostic tools, is not present in the provided text.
The "study" described is non-clinical performance testing of the device's mechanical properties to demonstrate substantial equivalence to a predicate device, rather than a clinical study involving human subjects or an evaluation of an algorithm's diagnostic accuracy.
Here's a breakdown of what can be extracted and why other requested information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested) | Reported Device Performance (Outcome) |
|---|---|
| Static compression bending (according to ASTM 1717) | Cannulated polyaxial screw addition is substantially equivalent to predicate device |
| Static torsion (according to ASTM 1717) | Cannulated polyaxial screw addition is substantially equivalent to predicate device |
| Axial compression fatigue testing (according to ASTM 1717) | Cannulated polyaxial screw addition is substantially equivalent to predicate device |
Reasoning for table content: The document explicitly states: "The outcomes of non-clinical testing performed (static compression bending, static torsion, and axial compression fatigue testing) according to ASTM 1717 indicate that the cannulated polyaxial screw addition to the SpineTune™ Spinal System is substantially equivalent to the predicate device." The acceptance criterion is implicit in meeting the ASTM 1717 standards and demonstrating substantial equivalence.
Address for Missing Information:
The following requested information is not applicable or not present in the provided 510(k) summary because this document pertains to the mechanical testing of a physical implantable device, not an AI/software medical device:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for mechanical testing of a spinal system. The "test set" would be the number of screws/rods tested, but this detail is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering principles and ASTM standards, not expert medical opinion on images or diagnostics.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 for AI/software in diagnostic settings.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the ASTM 1717 standard's pass/fail criteria for the physical properties of the materials and design.
- The sample size for the training set: Not applicable (no AI/ML model for training).
- How the ground truth for the training set was established: 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.