(131 days)
The TIGER® Spine System is 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 thoracic. lumbar. and sacral spine (T)-S1/Ileum): degenerative disc discase (defined as discogenic back pain with degeneration of disc confirmed by history of and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment. fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The TIGER® Spine System is a multiple component, posterior spinal fixation system which consists of pedicle screws, cannulated pedicle screws, posted pedicle screws, rods, crossconnectors, locking cap screws, hooks, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from titanium alloy described by such standards as ASTM F136.
This document describes a 510(k) premarket notification for the TIGER® Spine System, a medical device for spinal fixation. Let's break down the acceptance criteria and the supporting study, focusing on the requested information.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes physical performance testing rather than algorithm-based acceptance criteria for a medical imaging device. However, we can infer the "acceptance criteria" as meeting the specified ASTM standards and the "reported device performance" as having been tested to those standards.
| Acceptance Criteria (Inferred from Study Type) | Reported Device Performance |
|---|---|
| Compliance with ASTM F1717-11a | TIGER® Posted Spine System constructs were tested in static axial compression, static torsion, and dynamic axial compression per ASTM F1717-11a. |
| Compliance with ASTM F1798-97 | TIGER® Spine System Hook constructs were tested in static axial and torsion grip per ASTM F1798-97. |
| Compliance with ASTM F1717-11a | TIGER® Spine System Cannulated Screw constructs were tested in static axial compression, static torsion, and dynamic axial compression per ASTM F1717-11a. |
| Substantial equivalence to predicate devices | "The overall technology characteristics and mechanical performance data lead to the conclusion that TIGER® Spine System is substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not available in the provided text. The document refers to mechanical testing of physical device components, not a study involving human subjects or image data. Therefore, concepts like a "test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are inapplicable in this context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable/available. The study described is mechanical testing of medical device components, not a clinical study involving experts establishing ground truth for diagnostic or prognostic purposes.
4. Adjudication Method for the Test Set
This information is not applicable/available as the study did not involve a test set requiring adjudication in the context of expert review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes mechanical performance testing of spinal fixation components, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone study in the context of an algorithm's performance was not done. This device is a physical spinal fixation system, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical performance testing was the engineering specifications and established test methods defined by ASTM standards (ASTM F1717-11a and ASTM F1798-97). The device components were tested to see if they met the performance requirements outlined in these standards for static axial compression, static torsion, dynamic axial compression, and torsion grip.
8. The Sample Size for the Training Set
This information is not applicable/available. The device is a physical product, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/available as there is no training set for a physical medical device like the TIGER® Spine 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.