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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; 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 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 modifications to ROMEO posterior osteosynthesis system (K081165, K093170, K101678) manufactured by SPINEART consist of addition of addition of R093170, 11010707 manufacturers - Public Public and pedicle hooks and pedicle hooks (angled, Ma These components are supplied either sterile or not sterile.

The provided text describes a 510(k) summary for a medical device called the "ROMEO posterior osteosynthesis system." It discusses modifications to an existing device, its intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain the level of detail requested regarding acceptance criteria and a specific study proving the device meets those criteria, particularly in the context of device performance metrics like sensitivity, specificity, AUC, or F1 score derived from a clinical or imaging study.

The performance data mentioned is focused on mechanical testing rather than clinical or imaging performance.

Here's a breakdown based on the information provided and what is missing:

The document states:
"Mechanical testing including static compression bending, static torsion, dynamic Mcchanical testing moraing performed according to ASTM F1717-10. Results compression that additional components perform as safely and effectively as their predicate devices."

And:
"ass, matther, performance testing according to special control demonstrate that Non- ellined. Ponents are as safe, as effective, and performs as safely and effectively as their predicate devices."

This indicates that the acceptance criteria are based on mechanical performance standards and equivalence to predicate devices in those mechanical aspects.

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)

• Not provided. The document describes mechanical testing, not a clinical or imaging study with a "test set" of 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)

• Not applicable. This information is relevant for clinical or imaging studies involving human interpretation or assessment, which is not described here.

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

• Not applicable. This information is relevant for clinical or imaging studies involving human interpretation or assessment, which is not described here.

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 document pertains to a mechanical spinal implant system, not an AI or imaging diagnostic device.

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

• Not applicable. This document pertains to a mechanical spinal implant system, not an AI or imaging diagnostic device.

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

• For mechanical testing, the "ground truth" would be the standards themselves (e.g., ASTM F1717-10 specifications) and the performance of the predicate devices as a benchmark for equivalence. There isn't a "ground truth" in the sense of clinical disease diagnosis or pathology.

8. The sample size for the training set

• Not applicable. This document describes mechanical testing for a spinal implant, not a machine learning model that requires a training set. If "sample size" refers to the number of devices or components tested, that specific number is not provided, only that "Mechanical testing including static compression bending, static torsion, dynamic Mcchanical testing moraing performed..."

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

• Not applicable. As above, this is not a machine learning context.

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