Search Results

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.

Ask a specific question about this device

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, multi-operated 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 joint, 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 components of the Titanium Spinal Rod System are not designed to be used with any other system except the bolts of the UlTium Spinal Plating System. The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (TI-6Al-4V).

Based on the provided text, the "Aurora Titanium Spinal Rod System" is a spinal fixation device. The document is a 510(k) submission to the FDA, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device. This type of submission relies on comparison to existing devices rather than new clinical trials with acceptance criteria and performance metrics against ground truth.

Therefore, many of the requested elements for a study proving a device meets acceptance criteria are not applicable to this document as it describes a substantial equivalence determination based on predicate devices, material specifications, and intended use, not a clinical study with detailed performance data, sample sizes, and ground truth adjudication.

However, I can extract information related to the device's intended use and the specific conditions under which its pedicular screw system was deemed substantially equivalent.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For the pedicular screw system, the FDA's acceptance criteria for substantial equivalence are implicitly linked to the specific indications for use and warnings outlined in the letter. These are not performance metrics in the traditional sense (e.g., sensitivity, specificity) but rather conditions for marketing.
• Reported Device Performance: This document does not contain reported device performance data as would be found in a clinical study (e.g., success rates, complication rates, effectiveness outcomes). The 510(k) process primarily evaluates safety and equivalence, often through bench testing, material specifications, and comparison to predicates, rather than extensive clinical performance data against specific acceptance criteria.

No specific study proving the device meets these (implicit) acceptance criteria is described in detail within this document. The FDA's 510(k) clearance is a determination of substantial equivalence based on the submitted information, which typically includes bench testing, material characterization, and comparisons to predicate devices, rather than a prospective clinical trial.

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. This document does not describe a clinical "test set" or clinical study with patient data in the context of evaluation against acceptance criteria. The 510(k) submission relies on demonstrating equivalence to predicate devices, material specifications, and safety. Any testing would typically be bench testing on the device itself, not a patient study with a "test set."

3. 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. No clinical test set with ground truth established by experts is described.

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

• Not Applicable. No clinical test set with adjudication is described.

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 is a spinal implant, not an AI-assisted diagnostic device.

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

• Not Applicable. This is a spinal implant, not an AI algorithm.

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

• Not Applicable. No clinical ground truth data is described in this document. The "ground truth" for the 510(k) submission is the demonstration of equivalence to legally marketed predicate devices, adherence to material standards, and acceptable risk profiles based on design and proposed labeling.

8. The sample size for the training set:

• Not Applicable. No training set for an algorithm is discussed.

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

• Not Applicable. No training set or ground truth establishment for a training set is discussed.

Ask a specific question about this device

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.

Ask a specific question about this device