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The Raphael Pedicle Screw System is a posterior pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S I vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Raphael Pedicle 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 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 (pseudarthrosis).

The Raphael Hook System is intended for use as a posterior, noncervical, nonpedicle system indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma(i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The Raphael Hook System can be used in conjunction with Raphael Pedicle Screw System.

The Raphael Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system that consists of pedicle screws, rods, hooks, set screws, connectors, and a transverse (cross) linking mechanism. The Raphael Pedicle Screw System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion.

This document is a 510(k) premarket notification for the Raphael Pedicle Screw System. It seeks to demonstrate substantial equivalence to a predicate device, the Dio Medical Rexious Spinal Fixation System.

Based on the provided text, there is no study described that proves the device meets specific acceptance criteria in terms of performance derived from non-clinical or clinical testing.

Instead, the submission relies entirely on a claim of substantial equivalence to a previously cleared predicate device.

Here's an analysis based on the information provided and what is explicitly missing in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

No specific acceptance criteria are defined in the document for the Raphael Pedicle Screw System related to its performance.

The document states:
"Non-clinical testing was not performed as part of this submission."
"The subject device is identical to the predicate device in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling..."

Therefore, a table of reported device performance for the Raphael Pedicle Screw System cannot be generated from this document, as no performance testing was conducted or reported for this specific submission. The acceptance criteria, by extension, are implicitly met if the device is indeed "identical" to the predicate, whose performance would have been established through prior clearance.

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

Not applicable. No test set was used for this submission because no new performance testing (non-clinical or clinical) was performed. The clearance is based on substantial equivalence to a predicate device.

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

Not applicable. No test set was used, and therefore no ground truth establishment by experts was required for this submission.

4. Adjudication Method for the Test Set

Not applicable. No test set was used.

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 pedicle screw system, not an AI-assisted diagnostic or therapeutic device. 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 pedicle screw system, not an algorithm or AI device. No standalone performance study was conducted.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)

Not applicable. No new performance data requiring ground truth was generated for this submission. The "ground truth" for clearance in this case is the previously established performance and substantial equivalence of the predicate device.

8. The Sample Size for the Training Set

Not applicable. No training set was used as this is not an AI/ML device.

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

Not applicable. No training set was used.

In summary: The clearance for the Raphael Pedicle Screw System is based on a "Special 510(k)" pathway, where the manufacturer asserts that the device is identical to a previously cleared predicate device (Dio Medical Rexious Spinal Fixation System K113324, K111362, K100765) in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process, and labeling. Therefore, no new performance testing or clinical studies were conducted or reported in this specific document.

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