(88 days)
The Xia® 3 Spinal System is intended for use in the non-cervical spine. When used as an anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation system, the Xia® 3 Spinal System is intended to provide additional support during fusion using autograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
· Degenerative Disc Disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- · Spondylolisthesis
- · Trauma (i.e. fracture of dislocation)
- · Spinal stenosis
- · Curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudarthrosis
- · Failed previous fusion
The 5.5 mm rods from the Stryker Spine Radius™ Spinal System and 6.0 mm Vitallium rods from the Xia® Spinal System are intended to be used with the other components of the Xia® 3 Spinal System.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Xia® 3 Spinal System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Xia® 3 Spinal System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Intended Use (Power):
To facilitate the placement of pedicle screws using the power technique (corded and cordless), the use of the Stryker Spine Power Adaptor is intended for exclusive use with the Stryker Instruments Hudson Modified Trinkle Reamer and the Stryker Instruments CD3 Cordless Driver 3 and the Stryker Instruments RemB Universal Driver. When the power adaptors are attached, the CD3 Cordless Driver 3 and RemB Universal Driver provide power (corded and cordless) to rotate screwdrivers for the insertion of pedicle screws.
Pedicle screws from select Stryker Spine implant systems may be implanted in the non-cervical spine using powered (corded and cordless) instrumentation. The systems included are the family of Xia® Spinal Systems (Xia® Stainless Steel, Xia® II, Xia® Anterior, and Xia® Precision), Xia® 3 Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux Spinal System, and the ES2® Spinal System.
The Xia® 3 Spinal System is an orthopedic spinal system comprised a variety of shapes and sizes of screws, blockers, and hooks that affix several different types of rods and connectors to vertebrae of the spinal column for the purposes of stabilization, or corrective action through the application of force. The system can be rigidly locked into a range of configurations specific to each patient. The Xia® 3 Serrato Line Extension introduces new dual lead screws, with an enhanced cutting flute (also referred to as serrations), offered in the following configurations: Polyaxial Screws, Medial BA Polyaxial Screws, Reduction Polyaxial Screws, and Cannulated Polyaxial Screws.
The Xia® 3 Spinal System, including the new Serrato bone screws, will continue to be used with the Stryker Spine Power Adaptor Accessory Instrument, Stryker Instruments Hudson Modified Trinkle Reamer, the CD3 Cordless Driver 3 System, and the RemB Universal Driver, to facilitate the insertion of the pedicle screws. The adaptors serve as a mechanical interface between the power drivers and screwdriver instruments. When the adaptor is attached to the Hudson Modified Trinkle Reamer, the RemB Corded driver or the CD3 Cordless Driver 3 provides appropriate power to rotate the screw drivers for the insertion of the pedicle screws. The accessory indications for use were updated to reflect the indications for use of the Xia® 3 Spinal System.
I regret to inform you that the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets them, particularly for a software/AI-based medical device.
This document is a 510(k) premarket notification for the Xia® 3 Spinal System - Serrato and Stryker Spine Power Adaptor Instrument Accessory. These are hardware medical devices (pedicle screw spinal systems and their associated instruments) used in spinal fusion surgery.
The information you've requested, such as sample sizes for test sets, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, standalone algorithm performance, and training set details, are typically relevant to the validation of software as a medical device (SaMD) or AI/ML-based algorithms.
Here's a breakdown of why the information is not present and what is discussed instead:
- Device Type: The devices described are mechanical implants and surgical instruments. Their substantial equivalence is based on material properties, design, and mechanical testing, not on AI/ML performance.
- Acceptance Criteria & Performance: The "acceptance criteria" here are implicitly related to the mechanical and biocompatibility standards required for spinal implants. The "reported device performance" refers to the results of mechanical testing demonstrating that the new components (Serrato screws) perform equivalently to the predicate devices under various loads (compression, torsion, bending, etc.).
- Study That Proves Device Meets Acceptance Criteria: The study mentioned is primarily "Engineering analysis and applicable ASTM testing," specifically citing ASTM F1717-15, F1798-13, F2193-14, and F543-13. These are standards for mechanical testing of spinal implant systems.
- Missing Information (and why):
- Table of acceptance criteria and reported device performance: While mechanical tests are performed, the document doesn't present them in a detailed table with specific pass/fail criteria and numerical results in this summary. It states compliance with "FDA's Guidance for Spinal System 510(k) May 3, 2004."
- Sample sized used for the test set and the data provenance: For mechanical testing, this would refer to the number of devices tested, but it's not detailed here. There's no "data provenance" in the sense of patient data because it's not an AI/ SaMD.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical devices is defined by engineering specifications and physical measurements, not expert consensus on data.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as there's no "reading" of data by human experts for an AI.
- Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as there is no algorithm.
- The type of ground truth used: For mechanical devices, ground truth is based on engineering specifications, material properties, and physical test results, not clinical pathology or outcomes data in the context of AI validation.
- The sample size for the training set: Not applicable, as there's no training set for a mechanical device.
- How the ground truth for the training set was established: Not applicable.
In summary, this document describes the regulatory submission for a physical spinal implant system and its accessories, not a software or AI-based medical device. Therefore, the information you're looking for regarding AI validation metrics is not present.
§ 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.