(77 days)
The Spineology Threshold™ Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for 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; pseudoarthrosis; and/or failed previous fusion.
The Spineology Threshold Pedicular Fixation System consists of cannulated screws (titanium allov), curved and straight rods (titanium alloy), and adjustable Connector (titanium alloy), and fixed Connex Rod Connector (titanium alloy) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Threshold cannulated screws are available with or without a hydroxyapatite coating. The system is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine. The cannulated screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.
Spineology Connex Cross Connector devices are transversely-placed implants that are intended to connect the rod on one side of the spinal construct to the rod on the other side. These devices are manufactured from titanium alloy and are adjustable to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. ConneX Cross Connector devices are intended to be used with Spineology's Fortress™, Threshold V2™, and Palisade™ Pedicular Fixation Systems which are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Spineology Connex Rod Connector devices are implants that are intended to connect two rods in a spinal construct. These devices are manufactured from titanium alloy and the components allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. ConneX Rod Connector devices are intended to be used with Spineology's Fortress™, Threshold™, Threshold™ V2, and Palisade™ Pedicular Fixation Systems which are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
This document is a 510(k) premarket notification for a medical device, the Spineology Threshold™ Pedicular Fixation System. It focuses on demonstrating that new components (ConneX™ Cross Connector, ConneX™ Rod Connector, and 5.5 titanium Straight Rod devices) are substantially equivalent to previously cleared predicate devices. Therefore, the information provided primarily concerns non-clinical testing to support this substantial equivalence, rather than a clinical study evaluating the device's diagnostic performance for a specific condition.
Based on the provided text, here's a breakdown regarding acceptance criteria, study details, and related information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" in terms of specific performance metrics (like accuracy, sensitivity, specificity) for a diagnostic device, nor does it report "device performance" in similar terms. Instead, the "acceptance criteria" are implied by the performance standards outlined in ASTM F1717, ASTM F1798, and ASTM F2193 for mechanical testing, and ANSI/AAMI ST-72:2011 for bacterial endotoxin testing. The "reported device performance" is a statement that the devices were tested in accordance with these standards.
| Acceptance Criteria (Implied Standard) | Reported Device Performance (Compliance Statement) |
|---|---|
| Mechanical performance as defined by ASTM F1717 (Static Cantilever Bending) | Testing conducted in accordance with FDA Guidance: Spinal System 510(k)s (2004) and ASTM F1717-15. |
| Mechanical performance as defined by ASTM F1798 (Static Compression Bending) | Testing conducted in accordance with FDA Guidance: Spinal System 510(k)s (2004) and ASTM F1798. |
| Mechanical performance as defined by ASTM F2193 (Flexural Grip, Dynamic Compression Bending) | Testing conducted in accordance with FDA Guidance: Spinal System 510(k)s (2004) and ASTM F2193. (Specific tests mentioned: Flexural Grip, Dynamic Compression Bending). |
| Bacterial endotoxin limits as defined by ANSI/AAMI ST-72:2011 | Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST-72:2011. |
Note: The document states that these tests were performed and implies successful completion to demonstrate substantial equivalence, but it does not provide the raw data or specific quantitative results of these tests, which would typically be included in a full submission rather than this summary letter.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "sample size" in terms of individual patients or cases for diagnostic accuracy. Instead, it refers to "representative worst case" devices for mechanical testing. The number of devices tested for each mechanical or bacterial endotoxin test is not disclosed.
- Data Provenance: The data is from non-clinical (laboratory) testing, not from human subjects. Therefore, there is no country of origin or retrospective/prospective distinction for patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable as the document describes non-clinical mechanical and biological (endotoxin) testing of manufacturing components, not a clinical study requiring expert assessment for ground truth.
4. Adjudication Method for the Test Set
This section is not applicable as the document describes non-clinical mechanical and biological (endotoxin) testing.
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 reported in this document. This type of study is typically conducted for diagnostic or AI-assisted devices to evaluate human performance with and without AI. This submission is for surgical implants, and the testing focuses on the mechanical and biological safety of the components.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not reported. This device is not an algorithm or AI system, but rather physical implant components.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" (or reference standard) is the published performance specifications and methodologies within the cited ASTM standards. For bacterial endotoxin testing, the ground truth is the validated limits and methodologies within ANSI/AAMI ST-72:2011.
8. The Sample Size for the Training Set
This section is not applicable. This document describes the clearance of physical medical device components (implants), not an AI/ML algorithm that would have a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for an AI/ML algorithm.
§ 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.