(55 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 (4.75 systems only). 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), (7) spinal stenosis, (8) 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-6A1-4V 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 is a 510(k) summary for the ARx Spinal System, a medical device for spinal fixation. It details the device's characteristics and its equivalence to predicate devices, focusing on design, materials, indications for use, and mechanical performance.
However, the document does not contain information about acceptance criteria, clinical study details, sample sizes for test or training sets, expert qualifications, adjudication methods, or multi-reader multi-case studies typically associated with AI/ML device evaluations. This is a traditional medical device submission, where "performance data" refers to mechanical testing according to ASTM standards, not clinical efficacy or diagnostic accuracy as would be assessed for an AI/ML product.
Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria and the study proving the device meets them in the context of an AI/ML device. The document focuses on demonstrating substantial equivalence through mechanical testing and comparison to predicate devices, which is a different framework than evaluating an AI/ML system's diagnostic or predictive performance.
If you are looking for information regarding acceptance criteria for a traditional implantable medical device like this, it would involve demonstrating:
- Biocompatibility: Showing the materials are safe for implantation in the human body (often by referencing existing standards and predicate devices).
- Mechanical Strength and Durability: Demonstrating the device can withstand the expected physiological loads over its intended lifespan, without fracturing or loosening. This is what the ASTM F1717 and F1798 tests address.
- Design Equivalence: Demonstrating that the design is similar enough to predicate devices such that it performs in a similar, safe, and effective manner.
- Manufacturing Quality: Ensuring the device is manufactured consistently and meets design specifications (addressed by Quality System (QS) regulation, 21 CFR Part 820, mentioned in the letter).
The "study that proves the device meets the acceptance criteria" in this context refers to the mechanical testing described:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Device must meet or exceed mechanical performance standards outlined in ASTM F1717 & F1798. | The ARx Spinal System was tested according to ASTM F1717 & F1798, including: Uniplanar: Dynamic Axial Compression Bending, Static Axial Grip, Static Torsion Grip, Static Moment Bending, Static Axial Compression Bending, Static Torsion. Monoaxial: Dynamic Axial Compression Bending, Static Axial Compression Bending, Static Axial Grip, Static Torsion Grip. Performance was presented to demonstrate substantial equivalency to the predicate device (Life Spine Centerline K151196). |
| Device materials must conform to established standards for implantable medical devices. | Made from titanium alloy (Ti-6A1-4V ELI) as described by ASTM F136 and Cobalt Chrome (Co-28Cr-6Mo) as described by ASTM F1537, which are the same materials used in predicate devices. |
| Device must be substantially equivalent in indications for use, design, function, and materials. | "The ARx Spinal System was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance." |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated as "sample size" in the context of a clinical or data study. For mechanical testing, this refers to the number of device samples tested for each specific test (e.g., how many screws were subjected to axial compression bending). This detail is not provided in the summary.
- Data provenance: Not applicable in the context of a clinical dataset. The performance data comes from in-vitro mechanical testing conducted by the manufacturer, Life Spine, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is not an AI/ML device requiring expert-established ground truth on clinical data. Mechanical testing results are objective measurements from laboratory equipment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML device requiring expert adjudication of clinical findings.
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. This is not an AI-assisted diagnostic or therapeutic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an implantable medical device, not an algorithm.
7. The type of ground truth used
- Ground truth concept: In this context, "ground truth" for mechanical performance is established by the specified ASTM standards. The devices are tested against physical parameters and benchmarks defined by these standards.
- Type: Mechanical properties (e.g., force, displacement, wear, fatigue life) measured by laboratory instrumentation according to standardized test protocols.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary, the provided document is a regulatory submission for a spinal implant, focusing on its physical and material properties and substantial equivalence to existing devices, not the performance evaluation of an AI-powered 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.