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ROMEO® posterior osteosynthesis 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: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
When used as a posterior, non-cervical, non-pedicle screw fixation system, ROMEO® posterior osteosynthesis system is intended for the following indications: degenerative disc disease (DDD) (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 Romeo® posterior fixation system comprises polyaxial screws, monoaxial screws, spondylolisthesis screws, setscrew, straight and pre-bent Titanium or CoCrMo rods, and cross connectors. The Romeo® Polyaxial Screws come in various lengths (from 25 to 90 mm) and diameters (4.0, 4.5, 5.0, 5.5, 6.0, 7.0 and 8.0 mm) to accommodate different patient anatomies. The modification to Romeo® posterior osteosynthesis system consists of the addition of a polyaxial pedicle screw 5 mm in diameter and 25 mm in length.

The provided document is a 510(k) summary for the SPINEART Romeo® posterior osteosynthesis system. This type of regulatory submission in the medical device industry focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proof of meeting acceptance criteria through clinical studies. Therefore, the information requested regarding acceptance criteria and a study proving their fulfillment is largely not present in this document in the way it would be for a software-as-a-medical-device (SaMD) or a novel device requiring extensive performance testing against defined metrics.

However, I can extract the relevant information and explain why certain aspects of your request cannot be fully answered from this specific regulatory submission.

Explanation of Device and Regulatory Context:

The Romeo® posterior osteosynthesis system is a pedicle screw spinal system. The 510(k) submission (K140948) is for a modification to an existing, legally marketed device (Romeo® posterior osteosynthesis system, K101678, and Ellipse posterior osteosynthesis system, K081165). The modification specifically involves the addition of a polyaxial pedicle screw with a 5 mm diameter and 25 mm length.

For this type of modification, the focus of the regulatory review is on demonstrating that the new component (the added screw) does not introduce new questions of safety or effectiveness and remains substantially equivalent to the predicate devices. This is primarily done through material, design, and mechanical property comparisons, often supported by bench testing (mechanical and material characterization). Clinical studies are typically not required unless the modification significantly alters the fundamental scientific technology or poses new clinical risks.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) like one would see for a diagnostic device or an AI algorithm. Instead, the "acceptance criteria" for this type of device modification would relate to its physical and mechanical properties being comparable to, or exceeding, those of the predicate devices and relevant industry standards.

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

• Sample Size for Test Set: Not applicable in the context of this device and submission. There was no "test set" of patient data in the sense of clinical images or outcomes for an AI/diagnostic device. The testing mentioned refers to mechanical and material testing of the physical screw.
• Data Provenance: Not applicable. The "data" pertains to engineering and material specifications, and mechanical test results, not clinical data from patients.

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):

• Number of Experts & Qualifications: Not applicable. Ground truth, in the context of diagnostic performance (e.g., for AI), is not relevant here. The "ground truth" for a mechanical implant relates to engineering specifications and performance standards. Engineers, material scientists, and biomechanical experts would be involved in designing and testing such a device, but not in establishing "ground truth" in the diagnostic sense.

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

• Adjudication Method: Not applicable. There was no diagnostic "test set" requiring adjudication.

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:

• MRMC Study: No. This is a spinal implant, not an AI-assisted diagnostic device. Therefore, no MRMC study was performed, and there is no "effect size of human readers improving with AI."

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

• Standalone Performance: No. This is a physical implant, not a standalone algorithm.

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

• Type of Ground Truth: The "ground truth" for this device's performance is based on established mechanical testing standards (e.g., those referenced in the "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document") and material specifications (e.g., ASTM F136 for Titanium Ta6V Eli grade). The conclusion states that "Verification Activity and Validation Activity" demonstrate performance, indicating these engineering benchmarks were met.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that uses a training set.

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI algorithm, no ground truth was established for it.

Summary regarding the Study:

The "study" referenced in the document is the set of Verification Activity and Validation Activity which would typically encompass:

• Material Characterization: Ensuring the Titanium alloy meets ASTM F136.
• Mechanical Bench Testing: Such as static and fatigue testing of the screw, screw-rod assembly, and potentially the construct, compared against the predicate devices and relevant ASTM/ISO standards. This includes evaluating parameters like pull-out strength, bending stiffness, torsional strength, and fatigue life.
• Biocompatibility Assessment: Primarily by demonstrating the material's compliance with established standards for implantable materials.
• Sterilization Validation: If provided sterile, ensuring the gamma sterilization process is effective for the device.

The conclusion of the 510(k) states that these activities successfully demonstrated that the added polyaxial pedicle screw is "as safe, as effective, and performs at least as safely and effectively as its predicates polyaxial pedicle screws." This means the testing showed equivalence to the previously cleared devices, satisfying the regulatory requirement for this specific type of modification.

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