(92 days)
Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the presence of incomplete bone healing.
The Modular Spinal Fixation System, when properly used, is intended for posterior pedicle screw fixation of the noncervical posterior spine in skeletally mature patients to treat adolescent idiopathic scoliosis (4.75 systems only). It provides stabilization of spinal segments as an adjunct to fusion. Pediatric pediatric pediatic pedicle screw fixation is limited to a posterior approach.
When used as a posterior spine thoracic/lumbar system, the Modular Spinal Fixation System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (8) spondylolisthesis.
In order to achieve additional levels of fixation in skeletally mature patients, the Modular Spinal Fixation System may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod. The Modular Spinal Fixation System is intended to be used with autograft or allograft.
The Modular Spinal Fixation System consists of an assortment of rods, modular screws, modular tulips, cross connectors and offset connectors. The head and taper lock are assembled together during manufacturing to create the modular tulip assembly. The cross connectors are also assembled during manufacturing. The Modular Spinal Fixation System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome (Co-28Cr-6Mo) per ASTM 1537.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Life Spine Modular Spinal Fixation System components with components from any other system or manufacturer.
The provided text (FDA 510(k) K183430 submission for the Modular Spinal Fixation System) describes the acceptance criteria and supporting studies for a spinal implant system, not an AI-powered medical device. Therefore, much of the requested information regarding AI device testing (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, ground truth establishment) is not applicable or cannot be extracted from this document.
The document focuses on demonstrating the substantial equivalence of the new spinal fixation system to existing predicate devices based on design, materials, indications for use, and mechanical performance through bench testing.
Here's the information that can be extracted or deduced from the provided document, focused on the acceptance criteria and the study that proves the device meets them, insofar as they relate to a medical implant:
1. Table of Acceptance Criteria and Reported Device Performance
For a spinal implant system like this, "acceptance criteria" primarily revolve around meeting established mechanical performance standards for spinal implants and demonstrating material biocompatibility, as well as being substantially equivalent to legally marketed predicate devices.
| Acceptance Criteria (Bench Testing Standards) | Reported Device Performance/Findings |
|---|---|
| Mechanical performance according to ASTM F543 (Standard Specification for Metallic Medical Bone Screws) | "Testing according to ASTM F543... was presented to demonstrate the substantial equivalency of the Life Spine Nautilus K140457." (Indicates testing was performed and results supported substantial equivalence, implying the device met the mechanical requirements of F543 relevant to its components). |
| Mechanical performance according to ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model) | "Testing according to ASTM... F1717 included Static Axial Compression Bending, Static Torsion, Dynamic Axial Compression Bending and Dissociation tests was presented to demonstrate the substantial equivalency of the Life Spine Nautilus K140457." (Indicates these specific tests were performed and results supported substantial equivalence, implying the device met the mechanical requirements of F1717). |
| Material Biocompatibility (as per ASTM F136 and ASTM F1537) | "The Modular Spinal Fixation System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and cobalt chrome (Co-28Cr-6Mo) per ASTM 1537. This is the same material used in the predicate devices." (Implies acceptance based on use of medical-grade, standard materials with established biocompatibility, identical to predicates). |
| Substantial Equivalence to Predicate Devices (in terms of design, materials, indications for use, function, and mechanical performance) | "The Modular Spinal Fixation System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance." "The information presented demonstrates the substantial equivalency of The Modular Spinal Fixation System." (This is the overarching conclusion of the submission, indicating all criteria for substantial equivalence, supported by the data, were met). |
| Single Use Only / No Reuse | "All implants are intended for single use only and should not be reused under any circumstances." "Do not use any of the Life Spine Modular Spinal Fixation System components with components from any other system or manufacturer." (These are labeling and use instructions, critical for safety, and form part of the required compliance for acceptance). |
| Indicated for specific anatomical regions, patient populations, and conditions (non-cervical posterior spine, skeletally mature, pediatric AIS) | The "Indications for Use" section (Page 2 and 4) explicitly states these. Acceptance implies the device attributes (dimensions, strength, etc.) are appropriate for these indications, which is supported by the mechanical testing and substantial equivalence argument. |
| Use with autograft or allograft | "The Modular Spinal Fixation System is intended to be used with autograft or allograft." (Part of the accepted indications for use, implying compatibility and intended surgical practice are recognized). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: This document does not specify exact sample sizes for the mechanical bench tests (e.g., number of implants tested). For mechanical tests per ASTM standards, a sufficient number of samples are typically tested to ensure statistical validity and representativeness of the product. The focus is on demonstrating "substantial equivalence" of the new device's mechanical properties to the predicate, rather than clinical performance on a "test set" of patient data.
- Data Provenance: The data is derived from bench testing (laboratory studies) of the physical implant components, not from patient data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
- This is not applicable as the "ground truth" for a mechanical implant is adherence to specified material and mechanical performance standards, not expert consensus on medical images or diagnoses. The "experts" involved would be engineers/technicians conducting the tests and interpreting the results against the ASTM standards.
4. Adjudication Method for the Test Set
- Not applicable for mechanical bench testing. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involve human interpretation of data where consensus is needed to establish a "ground truth" (e.g., reading medical images).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is relevant for AI-powered diagnostic or assistive devices where human readers (e.g., radiologists) interpret medical images. This document pertains to a physical surgical implant, not an AI device.
6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done
- Not Applicable. This is a surgical implant, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on adherence to standardized engineering specifications and mechanical performance criteria (e.g., ASTM F543, ASTM F1717) and the established material properties of the chosen medical-grade alloys (ASTM F136, ASTM F1537). This is a physical and engineering ground truth, not one derived from clinical outcomes, pathology, or expert consensus on patient data. The ultimate 'ground truth' for this submission is demonstrating substantial equivalence to existing, legally marketed predicate devices.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI device, so there is no "training set" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI model, this question is irrelevant to the device described.
§ 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.