(56 days)
The ARx Spinal System, is intended for posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ ilium) in skeletally mature patients and for pediatric patients to treat adolescent idiopathic scoliosis. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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 and spinal deformity (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (pseudarthrosis), (6) spinal stenosis, (7) spondylolisthesis.
In order to achieve additional levels of fixation in skeletally mature patients, the ARx Spinal System 5.5/6.0 rod system may be connected to the Solstice OccipitoCervicoThoracic Fixation System's 3.5mm rod.
The ARX Spinal System consists of screws and longitudinal rods intended to provide temporary stabilization and immobilization following surgery to fuse a portion of the thoracic, lumbar, and/or sacral spine. The ARX Spinal System consists of an assortment of rods and screws. The bone screw, head, and taper lock are assembled together during manufacturing to create the ARX Spinal System screw assembly component. The ARX Spinal System implant components are made from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537. Do not use any of the ARX Spinal System components with the components from any other system or manufacturer.
The provided text describes the 510(k) premarket notification for the ARx Spinal System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, primarily through materials and mechanical performance testing, rather than an AI/ML product. Therefore, much of the requested information regarding AI/ML device acceptance criteria and study details (like sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not present in the provided document.
The document primarily addresses the mechanical and material characteristics of the ARx Spinal System.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this specific device (ARx Spinal System) are implicitly tied to the performance standards outlined in ASTM F1717 for pedicle screw systems, and the reported device performance is that it met these mechanical tests and demonstrated substantial equivalence to predicate devices. However, no specific numerical acceptance thresholds or detailed performance figures are provided in this summary.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Static Axial Compression Bending (ASTM F1717) | Tested and demonstrated substantial equivalency to predicate. |
| Static Torsion (ASTM F1717) | Tested and demonstrated substantial equivalency to predicate. |
| Dynamic Compression (ASTM F1717) | Tested and demonstrated substantial equivalency to predicate. |
| Material Composition (ASTM F136 for Ti-6Al-4V ELI, ASTM F1537 for Co-28Cr-6Mo) | Device made from specified materials, same as predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of an AI/ML device. For mechanical testing, the "sample size" would refer to the number of physical devices tested, which is not specified in the document.
- Data Provenance: Not applicable in the context of an AI/ML device. This submission is about a physical spinal implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the device is a physical pedicle screw system, not an AI/ML diagnostic tool requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for a physical device's mechanical testing.
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
- Not applicable as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device would be established by established engineering principles and the performance standards outlined in ASTM F1717 for spinal implant mechanical characteristics. There isn't a "diagnostic ground truth" in the typical AI/ML sense.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what the document DOES provide:
- Device Name: ARx Spinal System
- Device Type: Thoracolumbosacral Pedicle Screw System (physical implant)
- Regulation Number: 21 CFR 888.3070
- Regulatory Class: Class II
- Product Code: NKB
- Indications for Use: Posterior pedicle screw fixation of the non-cervical posterior spine (T1 to S2/ilium) in skeletally mature and pediatric patients (adolescent idiopathic scoliosis). Adjunct to fusion for stabilization and immobilization in acute/chronic instabilities or deformities.
- Materials: Titanium alloy (Ti-6Al-4V ELI) and Cobalt Chrome (Co-28Cr-6Mo).
- Performance Data: Tested according to ASTM F1717 (Static Axial Compression Bending, Static Torsion & Dynamic Compression Testing) to demonstrate substantial equivalence to predicate devices.
- Predicate Devices: Life Spine Nautilus (K123373), Stryker Xia 3 Spinal System (K142381), Life Spine AR CoCr Pedicle Screw System (K200070).
In conclusion, the provided FDA clearance letter and 510(k) summary are for a traditional, physical medical device (spinal implant) and therefore do not contain the details typically required for an AI/ML-based device regarding acceptance criteria, study design, and ground truth establishment.
§ 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.