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When used as a pedicle screw fixation system in skeletally mature patients, the Modified VertiFlex® Spinal Screw System 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 neurological impairment, kyphosis, and failed previous fusion (pseudoarthrosis).

In addition, when used as a pedicle screw fixation system, the Modified VertiFlex® Spinal Screw System is indicated in patients who are receiving fusions with autogenous graft, who are having the device fixed or attached to the lumbar or sacral spine, and who are having the device removed after the development of a solid fusion mass.

The Modified VertiFlex® Spinal Screw System is, like the predicate VertiFlex® Spinal Screw System, a posterior, non-cervical instrumentation system consisting of both pedicle screws and connecting rods. Screws are of polvaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136-02, and are available in a range of diameters and lengths to accommodate anatomical requirements. Rods are available in rigid or semi-rigid forms, and are composed of titanium conforming to ASTM F67-06, or titanium alloy (Ti 6Al-4V) conforming to ASTM F136-02. Rods are available in both straight and curved styles, and in a range of lengths to accommodate both single-level and multi-level procedures. The Modified VertiFlex® Spinal Screw System may be implanted by either conventional surgical methods, or using minimally-invasive/percutaneous techniques. Manual instrumentation for implantation of the Modified VertiFlex® Spinal Screw System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile, and are intended to be sterilized by the user before use.

This document describes a 510(k) premarket notification for the Modified VertiFlex® Spinal Screw System. It is focused on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study evaluating the device's performance against specific acceptance criteria for a new medical AI device.

Therefore, many of the requested categories for AI device evaluation are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the information provided, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This is a submission for a spinal implant device, not an AI or diagnostic device that uses a test set of data. The "testing" refers to biomechanical bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. See point 2.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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 not an AI device.

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

• Not Applicable. This is not an AI device.

7. The type of ground truth used

• For the biomechanical performance, the "ground truth" would be established by the industry standard test methods (e.g., ASTM F1717) which define specific loads, cycles, and failure criteria for spinal implant constructs. The performance of the modified device was compared to predicate devices under these controlled conditions. The "ground truth" for substantial equivalence lies in meeting general device characteristics and performance benchmarks of commercially available predicate devices.

8. The sample size for the training set

• Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

Summary of the Study:

The study proving the device meets its acceptance criteria is primarily a non-clinical biomechanical study and a comparison of design characteristics and materials to legally marketed predicate devices.

• Study Type: Non-clinical (biomechanical studies and material/design comparisons). The document explicitly states: "No clinical testing was conducted to support this submission."
• Purpose: To demonstrate "substantial equivalence" of the Modified VertiFlex® Spinal Screw System to existing, commercially available predicate devices in terms of design, materials, indications, and performance.
• Methodology:
  • Material and Design Comparison: The device's materials (titanium alloy, titanium) and design features (posterior, non-cervical, pedicle screws, connecting rods, polyaxial/monoaxial, range of sizes, conventional/minimally-invasive implantation) were compared directly to those of listed predicate devices (e.g., VertiFlex® Spinal Screw System, Isobar® TTL System, Dynesys™ System, N Fix II (N Flex) System, CD HORIZON® System, AccuFlex™ (Protex™) System, ZODIAC® DYNAMO™ System).
  • Biomechanical Testing: Non-clinical tests, including those performed in accordance with recognized standards like ASTM F1717 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), were conducted. These tests would simulate physiological loads and assess the mechanical integrity and fatigue life of the implant constructs.
• Acceptance Criteria for Substantial Equivalence: The modified device was deemed substantially equivalent if its design, materials of composition, indications, performance (as demonstrated by biomechanical testing), and other features were comparable to the predicate devices. The specific quantitative acceptance criteria for the biomechanical tests are not detailed in this summary but would be defined within the ASTM F1717 standard and the company's internal testing protocols, ensuring the device performs similarly or superiorly to the predicates.
• Conclusion: The results of the non-clinical tests and comparisons demonstrated the "substantial equivalence" of the Modified VertiFlex® Spinal Screw System to the identified predicate devices, as stated in Section 5.9.

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When used as a posterior, noncervical pedicle screw system, the Extended VertiFlex® Spinal Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine:

• Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies;
• Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
• Degenerative spondylolisthesis; ●
• Trauma (i.e., fracture or dislocation); .
• . Spinal stenosis;
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
• Tumor , .
• Pseudoarthrosis; and/or .
• Failed previous fusion. .

The Extended VertiFlex® Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy conforming to ASTM F136, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium conforming to ASTM F67, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimallyinvasive/percutaneous techniques, although the line extension which is a subject of this submission is designed specifically to facilitate MIS/percutaneous use. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. The modifications that are the subject of this submission consist of the addition of rod and screw components designed to more easily create multi-level constructs percutaneously, and screws having smaller diameters. Screws, rods, and instruments are offered non-sterile.

This 510(k) summary describes a spinal screw system, which is a physical device, not an AI/ML powered medical device. Therefore, the typical acceptance criteria and study design elements requested (such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) are not applicable in the context of AI/ML.

The provided document states:

• No clinical testing was conducted to support this submission. (Section 5.8)
• The determination of substantial equivalence was based on rigorous design control processes, comprehensive risk analysis, and non-clinical verification and validation tests. (Sections 5.6 and 5.7)

Therefore, I cannot provide the requested information related to AI/ML device acceptance criteria and studies, as this device is a traditional medical implant subject to different evaluation methods.

If you are looking for information about the non-clinical tests performed, the document generally states:
"Such verification and validation tests as were identified as appropriate to address the results of a risk analysis for the subject Extended VertiFlex® Spinal Screw System were completed, and all acceptance criteria were met." (Section 5.7). However, the specific acceptance criteria and detailed outcomes of these non-clinical tests are not provided in this summary.

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When used as a posterior, noncervical pedicle screw system, the VertiFlex™ Spinal Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine:

• Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies;
• Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
• Degenerative spondylolisthesis; .
• Trauma (i.e., fracture or dislocation); .
• . Spinal stenosis;
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ●
• Tumor: .
• Pseudoarthrosis; and/or .
• Failed previous fusion. .

The VertiFlex™ Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimally-invasive/percutaneous techniques. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile.

The provided document is a 510(k) summary for a medical device called the "VertiFlex™ Spinal Screw System." It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by your detailed questions.

This 510(k) pertains to a physical implantable device (pedicle screws) and its regulatory review for market clearance based on substantial equivalence to existing devices, not an AI or software as a medical device (SaMD). Therefore, many of your specific questions related to AI/algorithm performance metrics, training sets, expert ground truth, MRMC studies, and standalone performance are not applicable to the information contained in this document.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

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

• Not Applicable / Not Provided. The document does not define specific performance acceptance criteria in terms of quantitative metrics for a device (like sensitivity, specificity, accuracy, etc.) nor does it report performance against such criteria. This is a physical implant device, and its performance is assessed via non-clinical tests (mechanical/material properties) and comparison to predicate devices, not AI performance metrics.

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. No "test set" in the context of an algorithm's performance is mentioned. The document refers to "non-clinical tests" in accordance with standards like ASTM F1717-04 for spinal implant constructs in a vertebrectomy model. This implies mechanical testing of the physical device, not data analysis on a patient dataset. Therefore, there's no information on sample size for an algorithm test set, data provenance, or whether it was retrospective/prospective.

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 / Not Provided. As there is no algorithm requiring a "ground truth" to be established for a test set, there is no mention of experts or their qualifications in this context. The "truth" for a mechanical implant typically comes from engineering standards and physical measurements.

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

• Not Applicable / Not Provided. An adjudication method is used when multiple human readers disagree on ground truth. Since no human readers or ground truth establishment for a test set are mentioned, no adjudication method is applicable or 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

• No, not done. The document explicitly states: "No clinical testing was conducted to support this submission." Therefore, no MRMC study, AI assistance, or effect size is reported.

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

• No, not done. This device is a physical medical implant, not an algorithm. Standalone algorithm performance is not applicable.

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

• Not Applicable. For this physical device, "ground truth" would relate to its material properties and mechanical performance meeting engineering specifications and standards (e.g., ASTM F1717-04), rather than clinical outcomes or diagnostic accuracy. The document focuses on demonstrating "substantial equivalence" of the device's design, materials, and performance to predicate pedicle screw systems through non-clinical tests.

8. The sample size for the training set

• Not Applicable / Not Provided. There is no algorithm, and thus no training set or associated sample size for training data.

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

• Not Applicable / Not Provided. No training set means no method for establishing its ground truth is described.

Summary of what the document does provide regarding device performance:

The document states that non-clinical tests, including those conducted in accordance with recognized standards like ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, "have demonstrated the substantial equivalence of the subject device to commercially-available predicate devices in terms of performance."

This implies a comparison of the mechanical and structural performance of the VertiFlex™ Spinal Screw System against the performance of predicate devices, adhering to industry-accepted testing standards. The "acceptance criteria" here are effectively met by demonstrating that the VertiFlex™ system performs comparably to the predicate devices under these standardized non-clinical tests. However, the exact numerical results or specific pass/fail thresholds from these tests are not detailed in this summary.

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