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Romeo® posterior osteosynthesis system is intended to provide immobilization 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; 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, 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 CoCr rods, and various connectors. The Romeo 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. Romeo components are delivered sterile (gamma sterilization) in a dedicated packaging or not sterile upon request. The Romeo posterior fixation system is supplied with a set of surgical instruments.

The provided text is a 510(k) summary for a medical device called the Romeo® posterior osteosynthesis system. It describes the device, its indications for use, and a comparison to predicate devices, including performance testing. However, it does not contain the specific information required to complete all sections of your request regarding clinical study details, such as acceptance criteria based on clinical performance metrics, expert reader studies, or detailed ground truth establishment methods for large datasets.

The document primarily focuses on demonstrating substantial equivalence through non-clinical performance testing, comparing the new components (Setscrew with modified hexalobe imprint, Parallel Rod Connector, and T Rod Connector) to previously cleared predicate devices.

Here's the information that can be extracted and what is missing:

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

Missing: Specific quantitative acceptance criteria (e.g., minimum torque values, maximum displacement, etc.) and quantitative performance data for the device components are not provided in this summary. The summary only states that the results "demonstrate comparable mechanical properties to the predicate devices."

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 as this is a non-clinical, mechanical performance study. The "test set" here refers to the actual device components tested. The number of components tested is not specified, but typically these tests involve several samples to ensure reproducibility and statistical power.
• Data Provenance: Not applicable for non-clinical mechanical testing of physical device components.

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. This submission relies on non-clinical, mechanical testing, not clinical data or expert interpretation of medical images.

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

Not applicable. This was non-clinical mechanical testing, not a study requiring adjudication of expert opinions.

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 document does not mention any multi-reader, multi-case clinical studies, nor does it describe an AI-powered device.

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

No. This document is for a physical orthopedic implant system, not a software algorithm.

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

The "ground truth" for this submission is based on established engineering and biomechanical standards and measurements. The performance of the new components is compared against the known performance of predicate devices through standardized mechanical tests.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. There is no training set for this device.

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