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The Vertebron PSS Pedicle Screw System is intended for non pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (2.0. , fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The Vertebron PSS Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The device consists of a system of implantable rods, screw and hooks for the purpose of aiding in spinal fusion. The system also includes various hand tool used to assist in implantation of the rod system. Implantable components are composed of titanium alloy meeting the requirements of ASTM F136-98. The device is supplied non-sterile and is intended for sterilization by hospital personnel.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets those criteria in the way typically found for AI/ML-based medical devices.

The document K033352 is a 510(k) summary for a non-AI/ML medical device, specifically a Spinal Rod System (Vertebron PSS Pedicle Screw System). This device is a traditional hardware implant for spinal fusion.

Therefore, many of the requested points, such as sample sizes for test/training sets, expert ground truth establishment for AI, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this type of device and are not present in the provided submission.

Here's a breakdown of the information that is available based on the request:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: The submission states that the device was tested "in accordance with the requirements prescribed in ASTM F1717." ASTM F1717 is a standard specification for spinal implant constructs in a vertebrectomy model, which outlines mechanical testing protocols (e.g., static and dynamic compression bending, torsion). The specific quantitative acceptance criteria (e.g., maximum deflection, fatigue cycles survived, failure load) are not detailed in this summary.
• Reported Device Performance: "The device was found to perform comparably to other spinal rod systems." This is a qualitative statement of performance relative to predicate devices, but specific quantitative results against the ASTM F1717 criteria are not provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. For a physical implant, testing involves mechanical samples of the device itself, not patient data in the typical sense of an AI/ML ground truth test set. The number of physical units tested is not specified.

3. 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 testing is established by engineering standards and measurement instruments, not by medical experts interpreting data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This relates to human interpretation of data, which is not relevant for mechanical device testing.

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 study design is specifically for evaluating the impact of AI on human interpretation of medical images/data. This device is a physical implant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. There is no algorithm; this is a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for this device would be its mechanical properties and performance as defined by the ASTM F1717 standard. This is based on engineering specifications and physical measurements, not clinical or pathology data.

8. The sample size for the training set

• Not applicable. There is no "training set" for physical mechanical testing.

9. How the ground truth for the training set was established

• Not applicable.

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When used as an anterolateral/anterior system, the levels of attachment are the lumbar, thoracic, and cervical spine. The points of attachment are screw fixation into the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5) and anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

When used as a nonpedicle, posterior system consisting of hooks, crosslinks, and sacral/iliac screws, the levels of attachment are the lumbar, thoracic, and cervical spine and the sacrum and ilium. The indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

When used as a pedicle screw system in the non-cervical spine of skeletally mature patient, the system is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of solid fusion mass.

In addition, when used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the system is intended to provide immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Surgical Dynamics Spiral Radius 90-D Rodding System is to be used in conjunction with the SDRS Spinal Rods, SDRS Spinal Rod with Sacral Eye and the SDRS Locking Screw.

The Spiral Radius 90-D Rodding System consists mainly of 1) screws and hooks that are implanted in vertebral bodies and 2) rods that fit into and are locked upon the screw heads using a locking cap. The system also includes crossbars that connect 2 parallel-running rods, offset screws and clips that allow a rod to be placed in certain situations where a direct connection to the vertebrae would cause excessive bending of the rod, and rod-to-rod connectors that allow a construct to be extended. All components of the system are composed of Ti-6Al-4V which conforms to ASTM F136.

The provided text describes the 510(k) summary for the "Spiral Radius 90-D Rodding System," a spinal fixation device. The focus of the provided document is on the regulatory submission for this medical device, including its description, indications for use, and a statement on substantial equivalence to predicate devices.

However, the provided text does not contain any information about acceptance criteria, device performance metrics (e.g., sensitivity, specificity, accuracy), or any details regarding a study that would prove the device meets specific acceptance criteria.

The "TESTING" section (marked as {1} in your input) briefly mentions:

"Mechanical testing was performed, including static and dynamic compression testing and static torsion testing."

This indicates that some form of testing was done to ensure the physical properties of the device. However, it does not provide:

• Specific acceptance criteria: What were the pass/fail thresholds for the compression and torsion tests?
• Reported device performance: What were the actual values obtained from these tests?
• Comparative data: How did these results compare to the predicate device or established standards?
• Study design details: No information about sample sizes for these mechanical tests, data provenance, ground truth establishment, or any clinical study involving human readers or AI algorithms is present.

Therefore, I cannot fulfill your request for a table of acceptance criteria, reported device performance, or details about studies involving human readers, AI, or specific ground truths, as this information is not present in the provided document.

The document's primary purpose is to establish substantial equivalence to a predicate device based on its design, materials, and intended use, rather than to report on detailed performance studies against quantitative acceptance criteria for software or diagnostic performance.

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The components of the Surgical Dynamics Rodding System are indicated for spinal fixation.

When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the confirmed by history and radiographic studies, disc spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudarthrosis).

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and illium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), turnors, pseudoarthrosis, or failed previous fusion (pseudarthrosis).

When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the SDRS is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; {c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, in the noncervical spine of skeletally mature patients, the SDRS is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The components of the Surgical Dynamics Rodding System are indicated for spinal fixation. The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (Ti-6Al-4V).

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is a 510(k) premarket notification for the "Surgical Dynamics Rodding System," which details the device's intended use, indications for use, and a letter from the FDA confirming its substantial equivalence to predicate devices. It does not contain any performance data, clinical study results, or specific acceptance criteria for the device's functionality or safety.

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The components of the Titanium Spinal Rod System are indicated for spinal fixation.

When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine(T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, multioperated back or revision of previous surgery.

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, multi-operated back or revision of previous surgery.

When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. The device system using pedicle screws is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 ioint, the levels of pedicle screw fixation may be L3-S1.

The components of the Titanium Spinal Rod System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. When used as a posterior pedicle system consisting of hooks, crosslinks, sacral/iliac screws, pedicle screws and connectors the levels of attachment are lumbar, thoracic and cervical spine and the sacrum and ilium. These device components are for single use. Cementless or cement fixation is not applicable to these components. The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (Ti-6Al-4V).

The provided text is a 510(k) Pre-Market Notification for the Aurora Titanium Spinal Rod System. It describes the intended use, materials, and regulatory clearance of the device. However, it does not contain information about acceptance criteria, device performance studies, sample sizes for test or training sets, expert qualifications, or ground truth establishment.

This document is a regulatory submission for a medical device (spinal rods and screws) and primarily focuses on demonstrating substantial equivalence to previously cleared devices. It outlines the specific indications for use and identifies the materials used. The FDA's response clarifies the limitations and warnings associated with pedicle screw use in particular.

Therefore, I cannot provide the requested table and study details as this information is not present in the provided text.

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