(259 days)
The XIA® 3 Spinal System is intended for use in the noncervical spine. When used as an anterior/anterolateral and posterior, noncervical pedicle fixation system, the XIA® 3 Spinal System is intended to provide additional support during fustion using autograft in skeletally mature patients in the following acute and chronic instabilities or deformities:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- . Spondy lolisthesis;
- Trauma (i.e. fracture or dislocation); -
- Spinal stenosis: -
- . Curvatures (i.e. scoliosis, kyphosis, and/or lordosis)
- Tumor; •
- Pseudoarthrosis; and
- Failed previous fusion .
The Ø5.5mm rods from the Stryker Spinal System and Ø6.0mm 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 noncervical pedicle screw fixation in pediatric patients, the XIA® 3 Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The XIA® 3 Spinal System for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Stryker Spine XIA® 3 Spinal System is a noncervical pedicle screw system comprised of monoaxial and polyaxial bone screws, blocking mechanism), rods, hooks, and connectors. The implants are manufactured from Ti6Al4V alloy, CP Ti, and CoCrMo alloy (Vitallium).
Here's an analysis of the provided text regarding the acceptance criteria and study for the XIA® 3 Spinal System:
The provided document is a 510(k) Summary for the Stryker Spine XIA® 3 Spinal System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with specific acceptance criteria and performance metrics. Therefore, the information you're asking for, particularly quantitative acceptance criteria and detailed study designs involving human readers or standalone algorithm performance, is not present in this document.
Instead, the document focuses on:
- Indications for Use: What the device is intended to treat.
- Device Description: What the device is made of and its components.
- Predicate Devices: Other similar devices already on the market.
- Substantial Equivalence Justification: How the new device is similar to the predicates.
Let's break down what is available and what is not:
Acceptance Criteria and Reported Device Performance
This document does not provide a table of acceptance criteria with corresponding device performance metrics in the way one would expect from a performance study demonstrating efficacy (e.g., sensitivity, specificity, accuracy for a diagnostic device, or a specific functional outcome for a therapeutic device).
Instead, the "acceptance criteria" here implicitly revolve around demonstrating substantial equivalence to predicate devices. The performance is reported in terms of mechanical testing results that show compliance with established ASTM standards.
| Acceptance Criteria (Implicit from Substantial Equivalence and Standards) | Reported Device Performance (from K113666) |
|---|---|
| Mechanical integrity under static and dynamic compression bending (per ASTM F1717-04) | "Testing performed on XIA® 3 Spinal System indicates that the system is substantially equivalent to predicate devices. Mechanical testing of the system included static and dynamic compression bending testing..." |
| Mechanical integrity under static torsion (per ASTM F1717-04) | "...and static torsion testing per ASTM F1717-04..." |
| Interconnection strength (per ASTM F1798-97) | "...and interconnection strength testing per ASTM F1798-97..." |
| Equivalence in indications for use, design, function, and materials to predicate devices | "The XIA® 3 Spinal System was shown to be substantially equivalent to previously cleared devices with respect to its indications for use, design, function, and materials." |
| Dimensional comparisons and engineering analyses justifying equivalence | "The XIA® 3 Spinal System substantial equivalence determination to the predicate systems is based on dimensional comparisons and engineering analyses..." |
| Clinical literature analysis supporting equivalence | "...as well as, a clinical literature analysis." |
Missing Information (Not found in the provided document):
The following specific information about a study to prove the device meets acceptance criteria, particularly in the context of AI or diagnostic performance, is not present in this 510(k) submission:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set for a performance study is described. The "testing" refers to mechanical integrity and engineering analysis.
- 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): Not applicable, as this is a spinal implant for mechanical fixation, not a diagnostic device requiring expert consensus on ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a mechanical implant, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of a diagnostic or AI device. The ground truth for this device's performance would be successful mechanical integration and stability within the human body, which is assessed through long-term clinical outcomes (not detailed here, but likely referenced in the clinical literature analysis) and through pre-clinical mechanical testing standards.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
Summary:
The provided document is a 510(k) summary for a spinal implant system (XIA® 3 Spinal System). The goal of this submission is to demonstrate substantial equivalence to already cleared devices, not to establish novel safety and effectiveness through new clinical trials with detailed performance metrics characteristic of diagnostic or AI-driven devices.
The "study" that proves the device meets (implicit) acceptance criteria consists of:
- Mechanical testing: Static and dynamic compression bending, static torsion (per ASTM F1717-04), and interconnection strength (per ASTM F1798-97).
- Engineering analyses: Dimensional comparisons to predicate devices.
- Clinical literature analysis: To support the intended use and safety/effectiveness history of similar devices.
Therefore, the specific types of questions relating to AI performance, reader studies, ground truth establishment, and training/test sets are not relevant to this particular 510(k) submission for a mechanical spinal implant and are consequently not answered within the provided text.
§ 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.