(24 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 body in the presence of incomplete bone healing.
The ARX® Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion.
When used as a posterior spine thoracic/lumbar system, the ARX® Spinal 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, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.
The Life Spine Cross Connector is a titanium alloy, multiple component system comprised of a variety of non-sterile single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the non-cervical spine.
The Life Spine Cross Connector is available in various sizes. This device is an addition to the current systems (K070995) and therefore is fully cross-functional within the current systems.
The provided text describes the 510(k) summary for the Life Spine Cross Connector, a medical device. Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (implied) | Biomechanical testing in accordance with ASTM F1717 was conducted. |
| Material Composition (implied) | Manufactured from medical grade titanium alloy described by ASTM F136 (Ti 6AL-4V-ELI) implant grade titanium alloy. |
| Substantial Equivalence (implicit regulatory standard) | The Life Spine Cross Connector was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used. |
Note: The document doesn't explicitly state numerical acceptance criteria (e.g., "must withstand X N of force"). Instead, it references performance standards (ASTM F1717) and general equivalence to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Biomechanical testing in accordance with ASTM F1717 was conducted." However, it does not provide details on the sample size used for the test set, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). The testing would typically involve laboratory specimens (e.g., synthetic bone models or cadaveric spines) rather than human patient data in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information is not applicable to this device and study. The study involves biomechanical testing, not clinical evaluation with human interpretation that would require expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the study is a biomechanical test, not a clinical study involving human readers or interpretation.
5. 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
This is not applicable. This document describes a medical device for spinal fixation, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document describes a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the biomechanical testing, the "ground truth" would be the physical measurements and observations of the device's mechanical properties (e.g., stiffness, fatigue life, failure load) as defined by the ASTM F1717 standard. This is an objective measurement in a laboratory setting, not subjective expert consensus or pathology.
8. The sample size for the training set
This is not applicable. This device is a physical implant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. As it's not an AI model, there is no training set or ground truth in that context.
§ 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.