(115 days)
The TIGER™ Spine 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/iliac spine (TI Si/Ileum): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor, and failed previous fusion (pseudarthrosis).
The TIGER™ Spine System is composed of rods, connectors, and pedicle screws. It can be used for single or multiple level fixations.
The purpose of this premarket notification is twofold: 1) the addition of new components to the TIGER™ Spine System, 2) Size range expansion and 3) expand the Indications For Use statement to include Degenerative Disc Disease (DDD) for previously cleared components of the system.
The provided text describes a Special 510(k) Summary for the Tiger™ Spine System, which is a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness or safety through extensive clinical trials. Therefore, the information typically requested in your prompt (especially related to AI/algorithm performance, ground truth, and expert consensus for a separate study) is not applicable to this document.
However, I can extract the relevant information regarding the "acceptance criteria" and the "study that proves the device meets the acceptance criteria" as presented in this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Defined by ASTM Standards) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Static axial grip testing (per ASTM F1798) | Indicated equivalence to predicate device(s) via engineering rationale. |
| Static torsion grip testing (per ASTM F1798) | Indicated equivalence to predicate device(s) via engineering rationale. |
| Dynamic axial compression testing (per ASTM F1717) | Indicated equivalence to predicate device(s) via engineering rationale. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The tests were "non-clinical" and likely involved a number of manufactured devices/components for mechanical testing.
- Data Provenance: Not applicable in the context of clinical data. The tests were laboratory-based mechanical performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. The "ground truth" for mechanical testing is established by the specified ASTM standards and the physical properties of the materials and design. No humans were involved in interpreting data for ground truth in this context.
4. Adjudication Method
Not applicable. Mechanical tests have objective pass/fail criteria based on physical measurements against established standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document explicitly states, "No clinical studies were performed." and details non-clinical mechanical testing. MRMC studies are for evaluating human reader performance, often with AI assistance, which is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This document describes a physical medical device (pedicle screw system), not an algorithm or AI.
7. Type of Ground Truth Used
The "ground truth" for the non-clinical tests was established by the ASTM standards (ASTM F1798 and ASTM F1717) which define the test methodologies and acceptance parameters for spinal implant constructs. Equivalence was demonstrated through engineering rationale comparing the test results to the predicate device's performance, as per these standards.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See #8)
§ 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.