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The antero-lateral plate Sphynx™ is designed for use during surgery on the thoraco-lumbar area of the spine (T1-L5). The device is to be used only on one side and placed in such a manner as to be as far away from blood vessels and nerve roots as possible.

This implant is intended to provide stabilization until a solid spinal fusion develops, in the treatment of the following indications:

• Tumor of the vertebral body
• Fracture of the anterior spine (trauma)
• Degenerative disc disease, compatible with a ventral approach (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.)
• Pseudoarthrosis
• Spondylolysis
• Spondylolisthesis
• Scoliosis
• Lordotic deformities of the spine
• Spinal stenosis
• Failed previous spine surgery

The Sphynx is an implant device made from a titanium alloy Ti-6AI-4V ELI. It is to be implanted from the anterior-lateral approach. The Sphynx™ implant is an antero-lateral plate aimed at performing internal fixation of the thoraco-lumbar area of the spine (T1-L5), in addition to a solid intervertebral arthrodesis. The Sphynx™ instrumentation is composed of plates with anatomical conformation for cyphosis and lordosis. These plates are available in lengths 45-135mm increasing increments of 10mm. The fixation screws also consist of a variety of lengths and diameters. The safety screw is a 5mm diameter screw available in lengths starting at 24mm increasing in increments of 5mm to an overall length of 55mm. The two other fixation screws are available in diameters of 6mm and 7mm starting at 25mm and increasing in increments of 5mm to an overall length of 60mm.

This document describes the premarket notification (510(k)) for the Sphynx™ antero-lateral plate device, intended for spinal fixation. It establishes its substantial equivalence to previously marketed predicate devices primarily through mechanical testing.

Here's an analysis of the provided text in relation to the requested information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample size (number of devices/tests) used for the mechanical testing.
Data provenance: The testing was performed according to ASTM F1717-14, which is a standard specifying in-vitro mechanical testing methods for spinal implant devices. There is no information provided regarding the country of origin of the data, and it is in-vitro mechanical testing, not clinical data, so 'retrospective or prospective' does not apply.

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 section is Not Applicable as the study involved mechanical testing of a medical device, not a diagnostic algorithm that requires expert ground truth.

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

This section is Not Applicable as the study involved mechanical testing, not human-read diagnostic interpretation.

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. The submission is for a physical spinal implant device, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant to this submission.

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

This section is Not Applicable. The submission is for a physical spinal implant device, not a software algorithm.

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

The "ground truth" in this context is the standards set by ASTM F1717-14 for static compression bending, static torsion bending, and dynamic compression bending. The device's performance was measured against these engineering standards.

8. The sample size for the training set

This section is Not Applicable. This is an evaluation of a physical medical device based on mechanical testing, not a machine learning model.

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

This section is Not Applicable. As above, this is not a machine learning model requiring a training set with established ground truth.

Study Proving Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as mechanical testing.

• Study Name/Type: Mechanical testing
• Standards Met: ASTM F1717-14 (Static Compression bending, Static Torsion bending, and Dynamic Compression bending).
• Conclusion: The tests demonstrated that the Sphynx™ device's mechanical performance and fatigue endurance meet the original performance requirements of the specified ASTM standard, leading to the conclusion of "substantial equivalence" to predicate devices.
• Clinical Testing: The document explicitly states: "No clinical testing was performed."

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The Giza® Vertebral Body Replacement is intended for use during open surgical procedures in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (e.g. fracture). The Giza® Vertebral Body Replacement is intended to be used with supplemental internal spinal fixation systems that have been labeled for use in the thoracic and lumbar spine (i.e. posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The use of allograft with the Giza® Vertebral Body Replacement device is optional.

The Giza® is a thoracolumbar vertebral body replacement device. The Giza is comprised of a variety of implant sizes to accommodate various patients' anatomy and pathology, and associated instrumentation. The devices are available in three diameters, 14mm, 21mm and 27mm. The Giza® device can accommodate lordosis from 2-12 degrees and from18 mm to 90mm in height. . All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI).

The provided document is a 510(k) summary for the Giza® Vertebral Body Replacement. This type of regulatory submission is for a medical device that demonstrates substantial equivalence to a legally marketed predicate device, rather than proving novel clinical efficacy. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for device performance, clinical study results, expert adjudication, MRMC studies, standalone algorithm performance, number of experts, and training set details) is not relevant or present in this document.

Instead, the submission focuses on bench testing to demonstrate that the Giza® device performs comparably to its predicate devices in specific mechanical aspects.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance (Bench Testing):

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

• Sample Size: Not specified for the bench tests.
• Data Provenance: The tests are "pre-clinical testing" and "bench testing," meaning they were conducted in a laboratory setting. There is no mention of human data, country of origin, or whether it was retrospective or prospective, as it's not a clinical study.

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

• This is not applicable to bench testing. The "ground truth" for these tests is defined by the ASTM standards and recognized protocols, which are engineering and materials science specifications.

4. Adjudication method for the test set:

• Not applicable to bench testing. Testing against engineering standards does not involve expert adjudication in the way clinical data might.

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 device is a physical implant, not an AI or imaging diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used:

• For bench testing, the "ground truth" is adherence to established international standards (ASTM F2077-03, ASTM F2267-04, ISO 11607) and recognized protocols for assessing mechanical performance, such as resistance to expulsion.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this device's mechanical performance assessment against standards.

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

• Not applicable.

In summary: The provided document describes the mechanical testing conducted on the Giza® Vertebral Body Replacement to demonstrate its substantial equivalence to previously approved predicate devices. This involves proving that the new device meets established engineering performance standards for spinal implants, rather than clinical trial data or AI performance metrics.

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