(82 days)
When used as an anterior non-pedicle fixation system in the lumbar and lumbosacral spine (L1-S1), THOR Anterior Plating System is intended for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels. THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 1) Degenerative Disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies); 2) Pseudoarthrosis 3) Spondylolysis 4) Spondyloisthesis 5) Trauma (i.e. Fracture of Dislocation) 6) Deformities (i.e. Scoliosis or Lordosis) 7) Spinal Stenosis 8) Failed previous Fusion. When used as an anterolateral non-pedicle fixation system in the thoracic and thoracolumbar spine (T1-L5), THOR Anterior Plating System is intended to provide additional support during fusion using autograft or allograft in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 1) Degenerative disc Disease (defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies) 2) Trauma (i.e. Fracture or Dislocation) 3) Spinal Stenosis 4) Deformities (i.e. Scoliosis, Kyphosis and/or Lordosis) 5) Tumors 6) Failed Previous Fusion
The Stryker Spine THOR™ Anterior Plating System is designed for anterior and anterolateral stabilization of the thoracic, lumbar and sacral spine. The system consists of a variety of plates and bone screws manufactured from Titanium alloy. The plates are preassembled with locking rings to accommodate the insertion of bone screws.
The Stryker Spine THOR™ Anterior Plating System is a medical device for spinal stabilization. The provided text, a 510(k) Premarket Notification, describes the device and its indications for use, but does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through clinical data or algorithm-based evaluations.
The relevant section states:
"Testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was performed for the THORTM Anterior Plating System, and demonstrated equivalent mechanical performance characteristics to the Stryker Spine CENTAUR Spinal System [510(k) K994347, K001844] and Stryker Spine Xia Stainless Steel System [510(k) K012870]. The subject THORTM system demonstrated equivalent material biocompatibility and intended use as the Stryker Spine CENTAUR Spinal System and the previously cleared THORTM Anterior Plating System [510(k) K073437]."
This indicates that the device's substantial equivalence was established through mechanical testing and material biocompatibility testing, comparing it to predicate devices. This is a common approach for 510(k) submissions, where a new device demonstrates that it is as safe and effective as a legally marketed device.
Therefore, many of the requested details, particularly those related to clinical studies, AI performance, ground truth, and expert evaluation, are not applicable or not present in this type of regulatory document for this specific device.
However, based on the provided text, I can infer some aspects relevant to the "acceptance criteria" through the lens of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) premarket notification for a spinal implant, the "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence to existing predicate devices. The performance is reported in terms of equivalence rather than absolute metrics.
| Acceptance Criteria (Implied for 510(k) Submission) | Reported Device Performance |
|---|---|
| Mechanical Performance: Equivalent to predicate devices (Stryker Spine CENTAUR Spinal System, Stryker Spine Xia Stainless Steel System) | Demonstrated equivalent mechanical performance characteristics to the predicate devices. |
| Material Biocompatibility: Equivalent to predicate devices (Stryker Spine CENTAUR Spinal System) | Demonstrated equivalent material biocompatibility to the predicate devices. |
| Intended Use: Equivalent to predicate devices (Stryker Spine CENTAUR Spinal System, previously cleared THOR™ Anterior Plating System [K073437]) | Demonstrated equivalent intended use as the predicate devices. |
| Indications for Use: Matches or is a subset of predicate devices | The stated Indications for Use align with or are a subset of the Indications for Use of the predicate devices, as approved by FDA's substantial equivalence determination. |
2. Sample size used for the test set and the data provenance
The document specifies "Testing in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004 was performed." This testing would involve mechanical and material integrity tests on device samples, likely under laboratory conditions (e.g., fatigue testing, static strength testing).
- Sample size: Not explicitly stated in the document. For mechanical testing, this would typically be a statistically relevant number of physical device samples (e.g., N=5 or N=6 per test condition as per ISO standards commonly referenced in FDA guidance for implants).
- Data provenance: Laboratory testing (likely in-house or by a contracted lab for Stryker Spine). Not clinical or patient-derived data in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For mechanical and biocompatibility testing, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO standards) and FDA guidance for test protocols, rather than expert consensus on clinical cases. The experts involved would be engineers and material scientists designing and conducting the tests.
4. Adjudication method for the test set
Not applicable. Mechanical and biocompatibility tests have objective pass/fail criteria based on predefined stress, strain, force, or material interaction limits, often compared directly to predicate device performance or established safety thresholds.
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 device is a passive spinal implant (anterior plating system) and does not involve AI, image analysis by human readers, or diagnostic capabilities that would warrant an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical spinal implant, not an algorithm.
7. The type of ground truth used
The "ground truth" for this 510(k) submission relates to:
- Compliance with mechanical performance standards and FDA guidance for spinal implants.
- Material properties (chemical composition, biocompatibility) meeting established standards for medical-grade Titanium alloy.
- Functional equivalence to predicate devices.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of AI or machine learning. Its design, manufacturing, and testing follow engineering principles and regulatory standards.
9. How the ground truth for the training set was established
Not applicable (see above).
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.