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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. Vertebral staples are limited to use with 5.5mm and larger monoaxial screws only.

1. The ZODIAC™ 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).
2. The ZODIAC™ 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).
3. In addition, the ZODIAC™ 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 (L3-S1) and having severe spondylolisthesis grade 3 or 4 at the fifth lumbar-first sacral (L5-S1) vertebral joint.
4. The ZODIAC™ 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 scolliosis, or kyphoscoliosis with associated paralysis or spasticity).
   c. Patients having spondylolisthesis (i.e., isthmic spondylolisthesis).
5. When used as an anterior fixation system, the ZODIAC Spinal Fixation System intended for degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture, pseudarthrosis, tumors and/or failed previous fusion.

The ZODIAC™ 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 allov or commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for a line extension.

The provided document describes a medical device, the ZODIAC™ Spinal Fixation System, and its clearance through the 510(k) pathway. This pathway relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than explicit performance against predefined acceptance criteria from a clinical study.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable as this submission is for a spinal fixation system, which typically involves mechanical and biocompatibility testing, not diagnostic performance studies with human readers.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Not applicable for a 510(k) for a spinal fixation system that relies on mechanical testing and substantial equivalence. The "test set" in this context refers to the samples used in mechanical and dynamic testing of the device hardware, not a clinical data set. The document does not specify the number of individual implants or components tested.
• Data Provenance: The testing was presumably conducted by the manufacturer, Alphatec Manufacturing, Inc., or a contracted lab. The document does not specify the country of origin of this testing data. It is a retrospective summary of testing performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. This is a hardware device (spinal fixation system), not a diagnostic algorithm where expert ground truth is established for a test set. The "ground truth" here would be the physical properties derived from mechanical testing specifications and comparison to predicate devices, which are assessed by engineers and regulatory bodies.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no human readers or expert consensus involved in establishing a ground truth for a diagnostic test set in this context, there is no adjudication method.

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

• No, an MRMC study was NOT done. This device is a spinal fixation hardware system, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with or without AI assistance is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

• No, a standalone (algorithm only) performance study was NOT done. This device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

• Engineering specifications and performance of predicate devices. For a device like the ZODIAC™ Spinal Fixation System, the "ground truth" for its performance evaluation in a 510(k) is based on:
  • Mechanical and Dynamic Testing Standards: The device's physical properties (e.g., strength, fatigue resistance) are tested against established engineering standards and specifications.
  • Predicate Device Performance: The central claim of a 510(k) is substantial equivalence. The "ground truth" for this claim is a comparison of the device's design, materials, and performance (including mechanical testing) to that of legally marketed predicate devices, which are already considered safe and effective for their intended use.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware device, not an AI/ML algorithm. There is no concept of a "training set" in the context of this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

• Not Applicable. As there is no training set for this device, there is no ground truth established for it.

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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.

1. The ZODIAC™ 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).
2. The ZODIAC™ 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).
3. In addition, the ZODIAC™ 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.
4. The ZODIAC™ 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™ 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 offered in titanium alloy, Ti-6Al-4V ELI (ASTM F 136). System rods are also available in commercially pure titanium, CP Grade 4 (ASTM G67). This submission seeks clearance for stainless steel (ASTM F 138) system components.

The ZODIAC™ Spinal Fixation System is a medical device, and the provided text is a 510(k) summary for its clearance. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with acceptance criteria and device performance metrics in the way a diagnostic AI device might.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable in this context. The "study" here is primarily a performance data study to characterize the physical properties of the device, specifically the stainless steel components, and show they are equivalent to the previously cleared titanium alloy version.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified in the summary. This would refer to the number of components or constructs tested in engineering bench studies, not patient data.
• Data Provenance: Not applicable in terms of country of origin for patient data. The "data" are results from mechanical and material testing conducted on the device components. This would typically be laboratory data.
• Retrospective or Prospective: Not applicable. This refers to engineering test data, not clinical patient data collection.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Number of Experts: Not applicable. Ground truth in this context refers to established material science and biomechanical engineering standards used to evaluate device performance.
• Qualifications of Experts: Not applicable. Evaluation would be against established engineering standards and specifications.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Decision-making is based on comparing test results against established engineering standards and specifications for substantial equivalence.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This is a medical device for spinal fixation, not a diagnostic imaging or AI-assisted interpretation device. The study type is focused on mechanical and material properties.
• Effect Size of Human Readers Improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study: Not applicable. There is no algorithm or AI component to this physical medical device. The "performance data" refers to the mechanical and material testing of the physical components.

7. Type of Ground Truth Used:

• Ground Truth: Engineering and material science standards, biomechanical testing criteria, and established performance characteristics of the predicate titanium alloy ZODIAC™ Spinal Fixation System. The "ground truth" for the new stainless steel components is that their performance must meet or exceed the performance of the predicate device to ensure substantial equivalence.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. There is no AI or machine learning component requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

• How Ground Truth Was Established: Not applicable. No training set is involved.

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