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The VertiFlex® Spinous Process Fixation Plate is a posterior, non-pedicle supplemental fixation device intended for use at a single level in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: Degenerative disc disease (defined as back pain of discogenic origin with degenerationof the disc confirmed by history and radiographic studies); spondylolisthesis; Irauma (i.e., fracture or dislocation); and/or tumor. The VertiFlex® Spinous Process Fixation Plate is intended for use with bone graft, and is not intended for stand-alone use.

The VertiFlex® Spinous Process Fixation (SPF) Plate is a one-piece bilateral locking plate device which attaches to the posterior non-cervical spine by securely grasping two adjacent spinous processes. The SPF Plate is available in multiple sizes to accommodate different anatomical requirements, and it is composed entirely of titanium 6AL-4V allov. The SPF Plate may be implanted by either conventional surgical methods, or via minimally-invasive techniques. Proprietary manual instrumentation for implantation of the SPF Plate is available for both conventional and minimally-invasive surgical procedures.

The provided text describes the VertiFlex® Spinous Process Fixation Plate, a medical device for spinal fixation. It details the device's indications for use, comparison to predicate devices, and a summary of non-clinical tests. However, it explicitly states, "No clinical testing was conducted to support this submission."

Therefore, the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically concerning performance metrics from clinical trials, a test set, ground truth, expert involvement, or AI-related data, is not available in the provided text.

Based on the document, here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific clinical study for device performance. The "acceptance criteria" for regulatory submission seems to be substantial equivalence to predicate devices, based on design, materials, indications, and non-clinical performance.
• Reported Device Performance:
  • Non-Clinical Tests: The device demonstrated "substantial equivalence... in terms of performance" to a commercially available predicate through tests conducted in accordance with ASTM F1717-12 (Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model), static pull-off testing in synthetic bone, and static dissociation testing. Specific performance values (e.g., load limits, displacement) are not provided.

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. No clinical test set data is provided. The non-clinical tests likely used test samples of the device and synthetic bone models.

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 and thus no ground truth established by medical experts for device performance are mentioned.

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

• Not applicable. No clinical test set is mentioned.

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. This device is a mechanical implant, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory pathway as described.

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

• No. This device is a mechanical implant. The concept of "standalone algorithm performance" is not applicable.

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

• Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be the engineering specifications and established performance characteristics of the predicate devices against which the VertiFlex® plate was compared for substantial equivalence.

8. The sample size for the training set

• Not applicable. No machine learning or AI training set is mentioned as this is a mechanical device.

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

• Not applicable. No machine learning or AI training set is mentioned.

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The VertiFlex® Direct Decompression System is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.

The VertiFlex® Direct Decompression System consists of a group of instruments intended to assist in the performance of lumbar decompression through a minimallyinvasive approach. The instruments include both reusable, and single-use disposable devices. In combination, these instruments include dilators and a cannula through which the user may gain access to the site of decompression, and several specialized instruments with which both bony and soft tissue may be removed to decompress the neural elements. The single-use disposable devices will be provided sterile, and the reusable devices will be provided non-sterile for sterilization by the user before use.

The provided text is a 510(k) summary for the VertiFlex® Direct Decompression System. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study designed to prove the device meets these criteria in the context of clinical performance or diagnostic accuracy.

The summary explicitly states:

• "No clinical testing was conducted to support this submission." (Section 5.8)
• Non-clinical tests included "simulated decompression surgery in human cadavers, conducted to validate the performance of the subject System." (Section 5.7)

Therefore, based on the provided text, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or expert involvement as typically requested for studies evaluating diagnostic or clinical effectiveness. The submission focuses on substantial equivalence based on design characteristics, materials, and indications to existing predicate devices.

Here's what can be extracted from the document regarding testing and its purpose:

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

• No specific acceptance criteria related to clinical outcomes or diagnostic performance are presented.
• No reported device performance metrics (e.g., sensitivity, specificity, accuracy, clinical success rates) are provided. The submission focuses on demonstrating substantial equivalence to predicate devices through design and intended use comparisons.

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

• The "test set" described is simulated decompression surgery in human cadavers. The sample size for this test set is not specified.
• The data provenance is non-clinical (cadaveric testing). The country of origin is not specified, and it is inherently prospective in that novel testing was conducted with the device.

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

• This information is not provided as the cadaveric testing was for "performance validation" of the system, not for establishing clinical ground truth for a diagnostic or treatment outcome.

4. Adjudication method for the test set

• This information is not provided.

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 MRMC comparative effectiveness study was done. This device is a surgical instrument, not an imaging AI or diagnostic tool where such a study would be relevant.

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

• Not applicable. This is a surgical instrument system, not an algorithm.

7. The type of ground truth used

• For the non-clinical cadaveric testing, the "ground truth" would likely be the ability of the instruments to perform the intended surgical actions (e.g., removal of bony and soft tissue to decompress neural elements) without breakage or functional failure, as observed by the operating surgeon(s) during the simulation. This is performance validation, not clinical ground truth.

8. The sample size for the training set

• Not applicable. This device is a physical instrument, not an AI/ML algorithm that requires a training set.

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

• Not applicable.

In summary, the provided submission focuses on demonstrating substantial equivalence to legally marketed predicate devices for a surgical instrument system, rather than proving clinical effectiveness or diagnostic performance through specific acceptance criteria and clinical trials.

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When used as a vertebral body replacement: The Octane™ device is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral book due to tumor or trauma (i.e., fracture), to achieve anterior decompression of the spiral oord ard neural tissues, and to restore the height of a collapsed vertebral body. The Schnal Corner Tor device is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. The Octane™ device may be used with allograft or autograft.

When used as an intervertebral body fusion device: The Octane™ device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The Octane™ device is intended to be used with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.

Like the predicate Octane™ Vertebral Body Replacement System, or Octane™ VBR System, the Octane™ device that is the subject of this "Special" 510(k) submission is an implant composed of pure Poly(Etheretherketone), or PEEK OPTIMA®, Grade LT1, When used as a vertebral body replacement, the device is intended to serve as a partial or total replacement of a vertebral body that is collapsed, damaged, or unstable as a result of tumor or trauma (i.e., fracture). When used as an intervertebral body fusion device, the device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). As a vertebral body replacement, the device is intended for use with allograft or autograft, and as an intervertebral body fusion device, it is intended for use with autogenous bone graft.

Octane™ implants are available in a range of sizes and shapes, to accommodate different surgical approaches and anatomical needs, and may be implanted by cither conventional surgical methods, or via minimally-invasive techniques.

The provided document is a 510(k) PreMarket Notification for a medical device (Octane™ Vertebral Body Implant System) and primarily describes the device, its intended use, and its substantial equivalence to a predicate device. It explicitly states: "No clinical testing was conducted to support this submission."

Therefore, based on the provided text, I cannot answer the questions related to acceptance criteria and the study proving the device meets them, as no such study is described.

Summary of what can be extracted based on the prompt's questions:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states "all acceptance criteria were met" for non-clinical tests but does not specify the criteria or detailed performance.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method for the test set: Not applicable. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No. "No clinical testing was conducted."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant device, not an AI algorithm.
7. The type of ground truth used: Not applicable. No clinical test data or AI algorithm.
8. The sample size for the training set: Not applicable. No AI algorithm.
9. How the ground truth for the training set was established: Not applicable. No AI algorithm.

Additional Information (from the document):

• Non-Clinical Tests: "Such verification and validation tests as were identified as appropriate to address the results of a risk analysis for the subject Product Line Extension to the Octane™ VBR System were completed, and all acceptance criteria were met." However, no details on these tests or criteria are provided.
• Substantial Equivalence: The submission relies on demonstrating substantial equivalence to a predicate device (Octane™ Vertebral Body Replacement System - K070218) through rigorous design control processes and comprehensive risk analysis, rather than new clinical data.

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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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