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The Mega 5.5 Spine System is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogeneous bone graft, having implants attached to the lumbar and sacral spine (1.3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Mega 5.5 Spine 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 or deformities of the thoracic; lumbar and sacral spine: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).

The MEGA5.5 Spine System is a top-loading multiple component, posterior spinal fixation systems which consists of pedicle screws (mono, long-arm, multi-axial long-arm screw), rods, locking bolt, and a transverse linking mechanism (cross-link). The M EGA5.5 Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA5.5 Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA 5.5 Spine System.

The provided text describes a 510(k) premarket notification for the "MEGA 5.5 Spine System," which is a pedicle screw spinal fixation system. The study described is mechanical testing to demonstrate the substantial equivalence of the device to legally marketed predicate devices.

Here's an analysis of the provided information relative to your requested categories:

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

The document does not explicitly state numerical acceptance criteria in a table format. Instead, it states that the mechanical testing "demonstrates equivalence to the above predicate devices." This implies that the performance of the MEGA 5.5 Spine System met or exceeded the performance of the predicate devices under the specified ASTM standard.

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 sample size (e.g., number of screws, rods tested) for the mechanical testing. It also does not provide details on data provenance like country of origin or whether the data was retrospective or prospective, as mechanical testing is typically performed in a lab setting rather than with patient data.

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 category is not applicable. For mechanical testing of a spinal implant, "ground truth" as it relates to clinical or imaging expert assessment is not established. The ground truth is determined by the physical properties and performance metrics measured according to the ASTM standard.

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

This category is not applicable to mechanical testing. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or assessment, not for direct physical testing of device components.

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 comparative effectiveness study was not done. This device is a physical spinal implant, not an AI software B medical device that assists human readers.

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 is a physical medical device, not an algorithm.

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

The "ground truth" for this study is defined by the objective measurements and engineering standards outlined in ASTM F 1717 for spinal implant mechanical testing. It relies on physical measurements and compliance with established engineering specifications rather than expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This category is not applicable. Mechanical testing of a physical implant does not involve a "training set" in the context of machine learning or AI models. There is no algorithm being trained.

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

This category is not applicable for the same reason as above; there is no training set for mechanical testing.

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