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510(k) Data Aggregation
(100 days)
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.
-
The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). -
The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudoarthrosis).
-
In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:
a. Patients receiving autograft or allograft bone.
b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. -
The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral liac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. The Zodiac® Polyaxial Spinal Fixation System unplants are manufactured from Titanium Alloy conforming to ASTM F136 or ASTM F67, Stainless Steel conforming to ASTM F138 or ASTM F2229, or Cobalt Chrome conforming to ASTM F799 or ASTM F1537.
The Alphatec Spine, Inc. Zodiac® Polyaxial Spinal Fixation System received 510(k) clearance (K100685) in 2010. The clearance was based on demonstrating substantial equivalence to predicate devices through mechanical and dynamic testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria for Substantial Equivalence (Inferred from testing and FDA clearance process):
The primary acceptance criterion for this 510(k) submission was to demonstrate substantial equivalence to previously cleared predicate devices by showing comparable mechanical and dynamic performance. This is typically achieved by meeting or exceeding performance metrics established by relevant ASTM standards, specifically ASTM F1717 for spinal implant constructs.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Static compression values (ASTM F1717) equivalent to predicate devices. | Equivalent: "Static compression values are equivalent to the previously cleared legally marketed Alphatec Spine predicate devices." |
| Static torsion values (ASTM F1717) equivalent to predicate devices. | Equivalent: "Static torsion values are equivalent to previously cleared legally marketed Alphatec Spine predicate devices confirming substantial equivalence." |
| Critical dynamic compression run out value (ASTM F1717) identical to predicate devices. | Identical: "The critical dynamic compression run out value is identical to the previously cleared legally marketed Alphatec Spine predicate devices confirming substantial equivalence." |
| Torsional stability of Uniplanar screw (Simulated Derotation Testing) comparable to or better than predicate. | Improved: "Testing of the Uniplanar screws showed a much higher ultimate moment during torsional loading compared to the predicate." (This suggests the new Uniplanar screw design exhibited superior torsional stability, which would meet or exceed equivalence requirements). |
Note: The acceptance criteria are inferred based on common practices for 510(k) submissions of spinal fixation systems, where mechanical testing to established ASTM standards against predicate devices is the usual route to demonstrate substantial equivalence. The document explicitly states the conclusions of the testing in relation to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of devices or constructs tested for each mechanical test (e.g., number of samples for static compression, static torsion, dynamic compression, or simulated derotation). Mechanical testing for medical devices typically involves a specific number of samples as defined by the relevant ASTM standards to achieve statistical significance.
- Data Provenance: The data is from pre-clinical mechanical testing conducted by the manufacturer, Alphatec Spine, Inc. It is laboratory-generated data, not from human subjects or patient populations. There is no country of origin of data mentioned other than the company being located in Carlsbad, CA, suggesting the testing was performed within the US or under the company's purview. It is inherently retrospective in the sense that the testing was performed and then reported for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable. The "ground truth" for mechanical testing is based on objective measurements against established engineering standards (ASTM F1717) and direct comparison to the performance of predicate devices. It does not involve expert clinical judgment or consensus in the way a diagnostic AI device would.
4. Adjudication Method for the Test Set
This section is not applicable. As stated above, the "test set" here refers to mechanical test results, which are objectively measured against defined criteria, not human interpretations requiring adjudication.
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
This section is not applicable. This submission is for a spinal fixation system (a physical implantable device), not a diagnostic AI or imaging device that would involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Mechanical Performance Standards: Conformance to established ASTM F1717 physical and mechanical testing standards.
- Predicate Device Performance: Direct comparative performance against previously cleared, legally marketed predicate devices from Alphatec Spine, Inc. The predicate devices themselves represent "ground truth" in terms of acceptable mechanical performance for the intended use. These predicates are: K033090, K042673, K051286, K071890, and K093077.
8. The Sample Size for the Training Set
This section is not applicable. The concept of a "training set" applies to machine learning or AI models. This submission is for a physical medical device and relies on engineering principles and mechanical testing.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
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(29 days)
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.
- The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
-
The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
-
In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:
a. Patients receiving autograft or allograft bone.
b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
- The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis,
kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
The provided document is a 510(k) summary for the Zodiac® Polyaxial Spinal Fixation System. It describes a medical device, not a diagnostic or AI-powered device. Therefore, the questions related to the performance of an AI/diagnostic device, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication, or MRMC studies, are not applicable.
The "Performance Data" section in the document states:
"Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use. The testing demonstrated that additional components are substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices."
This indicates that the device's performance was evaluated through mechanical and dynamic testing to demonstrate its substantial equivalence to previously cleared predicate devices. The acceptance criteria for such a device would typically involve meeting established engineering and biocompatibility standards for spinal implants, ensuring the device can withstand the physiological stresses of its intended use. However, the specific quantitative acceptance criteria (e.g., specific load capacities, fatigue limits, etc.) and the detailed results of these tests are not provided in this 510(k) summary.
Therefore, based solely on the provided text, I cannot answer the questions as they pertain to AI/diagnostic device performance because this document describes a physical spinal fixation system.
Ask a specific question about this device
(84 days)
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.
- The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
-
The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
-
In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:
a. Patients receiving autograft or allograft bone.
b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
- The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
This document, K093077, is for a medical device called the "Zodiac® Polyaxial Spinal Fixation System." It is a 510(k) submission, which means it seeks to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on comparative testing and engineering principles rather than clinical performance and diagnostic metrics typically associated with AI/ML devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide specific numerical acceptance criteria or performance metrics in a table format that would typically be seen for AI/ML device studies (e.g., sensitivity, specificity thresholds). Instead, it relies on substantiating equivalence to predicate devices through mechanical and dynamic testing.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Mechanical and dynamic performance comparable to predicate devices. | Mechanical and dynamic testing was performed. The testing demonstrated that additional components are substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes mechanical and dynamic testing, not clinical testing with patient data. Therefore, the concept of a "test set" from patient data, its sample size, or data provenance (country of origin, retrospective/prospective) is not applicable here. The "test set" would refer to the physical samples of the device components subjected to laboratory testing. The specific number of samples for mechanical and dynamic testing is not provided in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
As this is mechanical testing for a spinal fixation system, there's no "ground truth" in the diagnostic sense established by medical experts for a test set. Ground truth for mechanical testing would be defined by engineering standards, material properties, and regulatory requirements, typically evaluated by mechanical engineers or similar technical experts specialized in medical device testing. The document does not specify the number or qualifications of individuals who designed or oversaw this mechanical testing.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (e.g., 2+1) are used to resolve disagreements among human readers or experts when establishing ground truth for clinical data. This document describes mechanical testing, which would involve standardized procedures and measurements, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance and is relevant for diagnostic or interpretive AI/ML devices. The Zodiac® Polyaxial Spinal Fixation System is a physical implant, not a diagnostic tool requiring human interpretation supported by AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable. "Standalone performance" refers to the performance of an algorithm without human intervention, which is relevant for AI/ML diagnostic tools. The Zodiac® Polyaxial Spinal Fixation System is a physical medical device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
For the mechanical and dynamic testing, the "ground truth" is based on:
- Engineering Standards and Specifications: Performance parameters defined by recognized industry standards for spinal implants (e.g., ASTM, ISO standards, though not explicitly cited in this summary).
- Predicate Device Performance: The demonstrated performance of the legally marketed predicate devices (K033090, K042673, K051286, K071890). The new device components are shown to perform "substantially equivalent" to these established devices.
8. The Sample Size for the Training Set:
Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical medical device. The "training" for such a device would be its design and manufacturing processes, informed by engineering principles, material science, and prior device iterations.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no AI/ML training set. The "ground truth" in the broader sense for the design and development of the device (if considering a "training equivalent") would be based on:
- Biomechanical requirements of the spine.
- Material properties and strength requirements for permanent implantation.
- Clinical experience and performance data of existing spinal fixation systems (the predicate devices).
- Regulatory guidelines and standards for spinal implants.
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(76 days)
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.
- The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine,
b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
-
The Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
-
In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:
a. Patients receiving autograft or allograft bone.
b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
- The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).
The Zodiac Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
The provided document describes the FDA 510(k) summary for the Zodiac® Polyaxial Spinal Fixation System. This is a medical device, and the acceptance criteria and study described are for mechanical performance testing rather than an AI/ML-driven device with performance metrics like sensitivity, specificity, or AUC.
Therefore, the requested AI-specific information (like sample size for test/training sets, experts for ground truth, MRMC study, standalone algorithm performance, types of ground truth, etc.) is not applicable to this document.
Here's the information that can be extracted from the provided text regarding the device's acceptance criteria and the study proving it meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Safety and effectiveness for intended use | Mechanical and dynamic testing provides reasonable assurance of safety and effectiveness. |
| Compliance with recognized consensus standards | Performance testing was performed per recognized consensus standards and the guidance document, "Spinal System 510(k)s - Guidance for Industry and FDA Staff." |
| Adequacy of static performance characteristics | Testing documented static performance characteristics, clearly demonstrating that performance satisfies requirements of posterior lumbar fixation. |
| Adequacy of fatigue performance characteristics | Testing documented fatigue performance characteristics, clearly demonstrating that performance satisfies requirements of posterior lumbar fixation. |
| Substantial equivalence to predicate devices (mechanical performance) | The mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices (K033090, K042673, K051286, K071890). |
2. Sample size used for the test set and the data provenance
- Not Applicable: This document focuses on mechanical testing of a physical medical device, not a data-driven AI/ML model where test set sample sizes and data provenance are relevant in the same way. The "test set" would refer to the physical devices or components subjected to mechanical stress. The document does not specify the number of devices tested, but it implies standard engineering testing procedures.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: "Ground truth" in the context of AI/ML refers to accurately labeled data. For mechanical testing, the "ground truth" is established by adherence to engineering standards and validated testing methodologies, not expert labeling. The experts involved would be engineers and regulatory bodies evaluating the test results against established safety and performance benchmarks.
4. Adjudication method for the test set
- Not Applicable: Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert labeling for AI/ML ground truth. For mechanical testing, adherence to standards and test protocols is the primary method of validation.
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: MRMC studies are specific to AI/ML devices that impact human reader performance (e.g., diagnostic image interpretation). This document is about a physical spinal fixation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of an AI algorithm on its own. The Zodiac® system is a physical implant, not an algorithm.
7. The type of ground truth used
- Engineering Standards and Test Protocols: For mechanical devices, the "ground truth" is defined by established engineering and regulatory performance standards (e.g., ISO, ASTM, or FDA-recognized consensus standards for spinal implants) and rigorous test protocols. The device's performance is compared against these predefined physical limits and requirements.
8. The sample size for the training set
- Not Applicable: "Training set" refers to data used to train an AI/ML model. This is a physical device, so no training set in that sense is involved.
9. How the ground truth for the training set was established
- Not Applicable: As there's no AI/ML training set, this question is irrelevant.
Ask a specific question about this device
(106 days)
ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
It is intended that this device, in any system configuration, be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral-iliac screw indications are limited to the sacrum-iliac crest only.
- The Zodiac® Polyaxial Spinal Fixation System when used as a hook and sacral iliac screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine,
b. Patients having deformity (i.e. idioscoliosis, neuromuscular scoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis).
-
The Zodiac® Polyaxial Spinal Fixation System, when used a pedicle screw system in the thoraco-lumbo-sacral iliac region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudoarthrosis).
-
In addition, the Zodiac® Polyaxial Spinal Fixation System, when used as a pedicle screw system is intended for:
a. Patients receiving only autogenous bone graft
b. Patient having the device fixed or attached to the lumbar and sacral iliac spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
- The Zodiac® Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e. idioscoliosis, neuromuscular scoliosis, kyphoscoliosis or kyphoscoliosis with associated paralysis or spasticity),
c. Patients having spondylolisthesis (i.e. Isthmic spondylolisthesis, degenerative spondylolisthesis and acute pars fracture allowing spondylolisthesis).
The Zodiac® Polyaxial Spinal Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac® Polyaxial Spinal Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine.
This document describes a 510(k) submission for the Zodiac® Polyaxial Spinal Fixation System, which is a medical device. As such, the "acceptance criteria" and "device performance" are not related to diagnostic accuracy or clinical outcomes as would be the case for AI/ML devices. Instead, they refer to the device's mechanical properties and its substantial equivalence to previously approved devices. The "study" refers to mechanical testing.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical and dynamic performance per recognized consensus standards and FDA guidance for spinal systems. | "Mechanical and dynamic testing was performed which provides reasonable assurance of safety and effectiveness for its intended use." |
| Satisfaction of requirements for posterior lumbar fixation. | "This testing clearly demonstrated that the performance characteristics satisfy the requirements of posterior lumbar fixation." |
| Substantial equivalence to predicate Zodiac® Polyaxial Spinal Fixation System devices in terms of general design, intended use, and technological characteristics. | "The mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device. It is similar in terms of general design, intended use, and technological characteristics to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic device that uses data for testing. The "test set" would refer to the physical samples of the device undergoing mechanical testing. The document states "Mechanical and dynamic testing was performed," implying laboratory testing of device components.
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)
This information is not applicable. For mechanical devices, "ground truth" is established by engineering specifications, material properties, and standardized testing protocols, not by expert consensus on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are used for resolving discrepancies in expert interpretations of data, which is not relevant for mechanical testing of a spinal fixation system.
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
This information is not applicable. This is a physical spinal fixation device, not an AI/ML diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical spinal fixation device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For mechanical devices, the "ground truth" is typically derived from engineering specifications, material science principles, and established international and national consensus standards (e.g., ASTM, ISO standards for spinal implants) that define performance requirements for strength, fatigue life, and other mechanical properties. The document explicitly states, "Performance testing was performed per the recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff," indicating adherence to these established engineering "ground truths."
8. The sample size for the training set
This information is not applicable. This is a physical medical device. "Training set" refers to data used to train AI/ML models, which is not relevant here.
9. How the ground truth for the training set was established
This information is not applicable. As no training set is used for a mechanical device.
Summary of the Study:
The study described is a series of mechanical and dynamic performance tests conducted on the Zodiac® Polyaxial Spinal Fixation System and its additional components.
- Objective: To provide reasonable assurance of the safety and effectiveness of the device for its intended use and to demonstrate substantial equivalence to predicate devices.
- Methodology: Testing was performed according to "recognized consensus standards and per the guidance document, Spinal System 510(k)s - Guidance for Industry and FDA Staff." This involved evaluating both "static and fatigue performance characteristics."
- Results: The testing "clearly demonstrated that the performance characteristics satisfy the requirements of posterior lumbar fixation." Furthermore, the "mechanical performance of the Zodiac® Polyaxial Spinal Fixation System additional components is substantially equivalent to the predicate Zodiac® Polyaxial Spinal Fixation System device."
- Conclusion: The tests confirmed that the device's mechanical properties were comparable to previously approved predicate devices, supporting its substantial equivalence claim to the FDA.
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ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM
It is intended that this device, in any system configuration be removed after development of solid fusion mass. Hook component indications are limited to T7-L5. Sacral screw indications are limited to the sacrum only.
- The ZODIAC™ Polyaxial Spinal Fixation System when used as a hook and sacral screw fixation system (nonpedicle screw) is intended for:
a. Patients having fractures of the thoracic and lumbar spine.
b. Patients having deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolisthesis, and acute pars fracture allowing spondylolisthesis). - The ZODIAC™ Polyaxial Spinal Fixation System, when used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine is intended for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
- In addition, the ZODIAC™ Polyaxial Spinal Fixation System, when used as a pedicle screw fixation system is intended for:
a. Patients receiving only autogenous bone graft.
b. Patients having the device fixed or attached to the lumbar and sacral spine and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint. - The ZODIAC™ Polyaxial Spinal Fixation System, when used as a laminar hook and bone screw system is intended for:
a. Patients having fractures of thoracic and lumbar spine.
b. Patients having thoracolumbar deformity (i.e., idioscoliosis, neuromuscular scoliosis, or kyphoscoliosis with associated paralysis or spasticity).
c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis, degenerative spondylolistheses and acute pars fracture allowing spondylolisthesis).
The ZODIAC™ Polyaxial Spinal Fixation System is comprised of various types and sizes of implantable components that are assembled to create a rigid spinal construct. System components are manufactured from titanium alloy, Ti-6AI-4V ELI (ASTM F 136). System rods are available in titanium alloy or commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for a line extension.
The ZODIAC™ Polyaxial Spinal Fixation System is a device used in spinal surgeries. The provided text describes its substantial equivalence to other pedicle screw systems already on the market, rather than presenting a performance study with acceptance criteria and detailed results from a clinical trial or algorithm evaluation.
Here's a breakdown of the information that can be extracted, and what is not present based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Not Explicitly Stated, Inferred as "Comparable to Predicate Devices") | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Comparable to, or better than, predicate devices | "Demonstrated that the mechanical performance of the ZODIAC™ Polyaxial Spinal Fixation System is at least comparable to, if not better than, those of the predicate devices." |
| Dynamic Performance | Comparable to, or better than, predicate devices | "Demonstrated that the mechanical performance of the ZODIAC™ Polyaxial Spinal Fixation System is at least comparable to, if not better than, those of the predicate devices." (Implied for dynamic performance as well, as both are mentioned together). |
| Clinical Efficacy | (Not applicable, as this is a 510(k) for substantial equivalence, not a PMA) | Not assessed/reported in this document. |
| Safety | (Not applicable, as this is a 510(k) for substantial equivalence, not a PMA) | Not assessed/reported in this document. |
Note: The document explicitly states "Documentation was provided that demonstrates that the ZODIAC™ Polyaxial Spinal Fixation System is substantially equivalent to other pedicle screw systems currently on the market." This implies that the acceptance criteria for the mechanical and dynamic testing were based on demonstrating equivalence, or superiority, to established predicate devices in those specific performance metrics, rather than pre-defined absolute thresholds.
2. Sample Size and Data Provenance for Test Set
- Sample Size (Test Set): Not specified. The document only mentions "Mechanical and dynamic testing was performed." It does not detail the number of constructs, materials, or specific test configurations used.
- Data Provenance: Not specified. It's likely that the testing was conducted internally by Alphatec Manufacturing, Inc. or by a contract testing laboratory, but the country of origin or whether it was retrospective/prospective is not mentioned. This is typical for 510(k) submissions focusing on physical device performance testing.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Not applicable. This submission focuses on the mechanical and dynamic performance of the device itself, not on the interpretation of medical data by human experts to establish ground truth for a diagnostic or AI device.
4. Adjudication Method for Test Set
- Not applicable. As the "test set" refers to mechanical and dynamic testing of the device, there is no expert adjudication process involved. The results would be objective measurements from testing equipment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission is for a spinal fixation system, not a diagnostic or AI device.
6. Standalone (Algorithm Only) Performance Study
- No. This is not an AI/algorithm-based device. "Standalone performance" in this context would refer to the mechanical and dynamic performance of the implant itself, which was evaluated as described in #1.
7. Type of Ground Truth Used
- For the mechanical and dynamic testing, the "ground truth" would be the objective measurements obtained from laboratory testing (e.g., stiffness, fatigue limits, pull-out strength). These are compared against established industry standards or the performance of predicate devices. There is no biological or clinical "ground truth" established from patients or pathology in this type of submission for a spinal implant's physical performance.
8. Sample Size for Training Set
- Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How Ground Truth for Training Set Was Established
- Not applicable. As there is no training set.
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