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510(k) Data Aggregation
(227 days)
The Stackable Cage" System is indicated for use in the thoracolumbar spine (i.e., T1 to LS) to replace a diseased vertebral body resected or excised for the treatment of tumors, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
The Stackable Cage System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.
The Stackable Cage system is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Stackable Cage System include DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M-2, ISOLA, VSP, Moss Miami, TiMX, and Profile).
The Stackable Cage System consists of two componentsone or more stackable vertebral body replacement components (stackable cage implants) and a supplemental internal fixation system. The stackable cage implant is made of a polymer/carbon fiber composite material. One or more stackable cage implants may be stacked to the desired height, as determined by the surgeon. A titanium alloy screw can be passed through a center hole in the cages and with a nut provide a rigid and compressed assembly.
The structure of the stackable cage implants has been shown to support anticipated loads with a modulus of elasticity approximating that of cortical bone. The implants have ridges or teeth in both the anterior-posterior and mediallateral directions, which resist rotation and migration. The stackable cage implants have cavities to accept packing of bone graft. The entire structure is radiolucent so that healing can be assessed by normal radiographic methods. Additionally, radiotherapy can be performed immediately after surgery.
The provided text is a 510(k) summary for the Stackable Cage™ System, outlining its description, materials, indications, and substantial equivalence to a predicate device. It specifically mentions "Performance Data" which includes "Biomechanical testing, including static axial compression, torsional loading and cantilever beam testing, were conducted" and "Clinical data were provided to demonstrate the performance of the device in patients with spine tumors."
However, the document does not provide specific acceptance criteria or detailed results of these tests. It only states that these tests were conducted and that clinical data were provided to demonstrate performance. The document's primary purpose is to establish substantial equivalence for regulatory purposes.
Therefore,Based on the provided text, I cannot complete the requested tables and information. The document does not contain details about specific acceptance criteria, study methodologies (like sample sizes, ground truth establishment, expert qualifications, or adjudication methods), or outcomes (like reported device performance values) in the format requested.
The document states:
- Performance Data: "Biomechanical testing, including static axial compression, torsional loading and cantilever beam testing, were conducted. Clinical data were provided to demonstrate the performance of the device in patients with spine tumors."
This indicates that studies were performed, but no specifics are given regarding acceptance criteria or results.
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(47 days)
The TiMX Low Back System when used with pedicle screws, in skeletally mature patients, is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The TiMX Low Back System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The TiMX Low Back System, when not used with pedicle screws, is intended for posterior hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion surgery.
All implant components are manufactured of ASTM F-136 titanium alloy.
This document is a 510(k) summary for the Depuy AcroMed, Inc. ISOLA SPINAL SYSTEM Pedicle Screw Indications, also referred to as the TiMX Low Back System. It describes the device, its material, and the expanded indications for use regarding pedicle screws.
However, the provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. The document is a regulatory submission for expanding the indications of an existing device, focusing on its substantial equivalence to itself for the purpose of reclassification and adding indications. It states that the device design remains the same.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other study-related details based on the provided input.
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(47 days)
The VSP System is indicated for degenerative spondylolisthesis, in skeletally mature patients, with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.
The VSP System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
The primary purpose of this premarket notification is to add indications to the marketing clearance for the pedicle screws which may be used as a spinal anchor in the VSP System. All implant components are manufactured of either ASTM F-138 or F-1314 stainless steel or ASTM F-136 titanium alloy.
The provided text describes a 510(k) submission for the ISOLA SPINAL SYSTEM Pedicle Screw Indications (VSP System), which is an orthopedic device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy or safety through new clinical studies with defined acceptance criteria and performance metrics.
Therefore, the input does not contain information about:
- Acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document is a 510(k) summary and an FDA clearance letter, which means that the device's acceptable performance is demonstrated by its substantial equivalence to an existing, legally marketed device. The core of this submission is to add new indications for use for the pedicle screws within the VSP System, not to present new performance data from a clinical study.
Therefore, I cannot populate the requested table and answer the questions based on the provided text, as the information is not present.
The document states: "The VSP System manufactured from either stainless steel or titanium alloy is substantially equivalent, for purposes of this 510(k) adding indications, to itself. This 510(k) seeks to add labeled indications pursuant to a reclassification order. The device design remains the same." This explicitly indicates that no new performance data or studies defining acceptance criteria are being presented; rather, the focus is on regulatory reclassification and expanded indications for an existing, already cleared device.
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(15 days)
The AcroMed DOC™ Ventral Cervical Stabilization System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in whom stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.
Indications include symptomatic cervical spondylosis, trauma (including fracture), posttraumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.
The DOC Ventral Cervical Stabilization System, in its fully assembled form, consists of two laterally placed rods joined by platforms, or a plate, which lie on the anterior vertebral surface. The system is anchored to the vertebrae with screws. The implant provides supplemental stability to the cervical spine following anterior cervical fusion. Depending upon the implant configuration, it may serve as either a fixed (load-bearing) or unfixed (load-sharing) construct.
The following types of components are available in the system: Rods, Platforms, Plates Screws and Cross Connectors. All components are manufactured from implant grade Titanium alloy which conforms to ASTM F136 specifications. Assemblies are also available for convenience of the surgeon. These are pre-assembled partial constructs consisting of one Platform, one Cross Connector, two Rods and two Locking Screws.
An instrument set is available specifically designed for use with the DOC Ventral Cervical Stabilization System.
The document provided is a 510(k) summary for a medical device called the DOC Ventral Cervical Stabilization System. It details the device's description, components, intended use, and provides a letter from the FDA stating substantial equivalence to a predicate device.
However, the document does not contain acceptance criteria or a detailed study description that proves the device meets specific acceptance criteria.
The "PERFORMANCE DATA: Non-Clinical" section briefly mentions: "Static bending compression and torsion were performed on the system to characterize its mechanical properties. Additionally; testing was also performed to characterize fatigue life."
This statement confirms that some mechanical testing was conducted, but it does not provide:
- Specific acceptance criteria: What were the pass/fail thresholds for static bending, compression, torsion, or fatigue life?
- Reported device performance: What were the actual results of these tests? Did they meet the (unstated) acceptance criteria?
- Sample size: How many devices were tested for each type of mechanical test?
- Details about the study design: Where was the testing done? What standards (e.g., ASTM, ISO) were followed?
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Based on the available information:
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Table of acceptance criteria and the reported device performance:
Acceptance Criteria Reported Device Performance Not specified Not specified Not specified Not specified Not specified Not specified -
Sample size used for the test set and the data provenance: Not specified. The document only states "testing was performed."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to a clinical study with human data/diagnosis, not mechanical testing.
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Adjudication method for the test set: Not applicable. This refers to a clinical study.
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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 a medical device for spinal stabilization, not an AI diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
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The type of ground truth used: For mechanical testing, the "ground truth" would be the engineering specifications and established mechanical testing standards. The document does not explicitly state which standards were followed or the specific thresholds.
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The sample size for the training set: Not applicable, as this is a physical medical device, not a machine learning model requiring a training set.
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How the ground truth for the training set was established: Not applicable.
Conclusion: The provided 510(k) summary focuses on the description of the device and its substantial equivalence to a predicate device based on indications for use, rather than providing detailed acceptance criteria and study results for its mechanical performance. While it confirms non-clinical mechanical testing (static bending, compression, torsion, fatigue life) was performed, it does not include the specifics of these tests (criteria, results, sample sizes) as requested.
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