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510(k) Data Aggregation
(82 days)
THOR ANTERIOR PLATING SYSTEM
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).
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(69 days)
THOR ANTERIOR PLATING SYSTEM
The Stryker Spine THOR™ Anterior Plating System is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach below the bifurcation of the great vessels.
The Styker Spine THOR™ Anterior Plating System is intended for use in the lumbar and lumbosacral spine (L1-S1). 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:
- Degenerative disc disease (defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies);
- Pseudoarthrosis; .
- Spondylolysis; .
- Spondylolisthesis; .
- Trauma (i.e., fracture or dislocation); .
- Deformities (i.e., scoliosis or lordosis)
- Spinal Stenosis; and
- Failed Previous Fusion. ●
The Stryker Spine THORTM Anterior Plating System is designed for anterior and anterolateral stabilization of the lumbar and lumbosacral spine (L1-S1). The system consists of a variety of plates and bone screws manufactured from Titanium alloy. The plates have an anatomical shape design and are preassembled with rings to accommodate the insertion of bone screws.
The Stryker Spine THOR™ Anterior Plating System is a spinal fixation device, not an AI/ML powered device, therefore the information requested is not applicable in the context of AI/ML software. The provided text describes a 510(k) premarket notification for a medical device (spinal plating system), which is a physical implant, not a software algorithm. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to mechanical and biocompatibility testing against established standards and comparison to predicate devices, not performance metrics like accuracy, sensitivity, or specificity for an AI model.
Therefore, I cannot extract the requested AI/ML specific information from the provided document.
However, I can provide a summary of the provided information as it pertains to the device's regulatory review:
Summary of the Stryker Spine THOR™ Anterior Plating System 510(k) Submission:
The submission focuses on demonstrating substantial equivalence to predicate devices based on:
- Technological Characteristics: Mechanical performance (in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004) and material biocompatibility.
- Intended Use: The device is designed for anterior and anterolateral stabilization of the lumbar and lumbosacral spine (L1-S1) in skeletally mature patients for various conditions (Degenerative disc disease, Pseudoarthrosis, Spondylolysis, Spondylolisthesis, Trauma, Deformities, Spinal Stenosis, and Failed Previous Fusion).
Key Information from the Document (non-AI/ML):
- Device Name: Stryker Spine THOR™ Anterior Plating System
- Classification Name and Number: Spinal Intervertebral Body Fixation Orthosis, 21 CFR 888.3060
- Product Code: KWQ
- Predicate Devices:
- Device Description: Consists of various plates and bone screws made from Titanium alloy, anatomically shaped, and preassembled with rings for screw insertion.
- Summary of Technological Characteristics (Study Information):
- Testing was performed in compliance with FDA's Guidance for Spinal System 510(k)'s May 3, 2004.
- Demonstrated equivalent mechanical performance characteristics to Stryker Spine CENTAUR Spinal System and Stryker Spine Xia Stainless Steel System.
- Demonstrated equivalent material biocompatibility to the Stryker Spine CENTAUR Spinal System.
- Equivalent to the Synthes Anterior Tension Band System with respect to intended use.
- FDA Decision: Substantial Equivalence (K073437)
The document does not describe an AI/ML algorithm and therefore cannot provide data on sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance.
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