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510(k) Data Aggregation
(28 days)
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).
ROMEO posterior osteosynthesis system includes pedicular screws, spondylolisthesis screws longitudinal rods and transverse connector rods, connector and nut. All components of ROMEO posterior osteosynthesis system are made of TA6V4ELI conforming to ISO 5832.3 and ASTM F 136. ROMEO components are supplied either sterile or not sterile and with a complete set of surgical instruments
The provided text describes a medical device, the "ROMEO posterior osteosynthesis system," and its regulatory clearance (510(k)). However, it does not contain information about acceptance criteria, device performance metrics, or any associated study data (sample sizes, ground truth establishment, expert qualifications, etc.).
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing de novo performance data against specific acceptance criteria.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study that proves the device meets them based on the provided text. The output will reflect this lack of information for each requested point.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states "ROMEO posterior osteosynthesis system conforms to special control established for Pedicle screw spinal system and to « Spinal System 510(k)s - Guidance for Industry and FDA Staff Document » issued on: May 3, 2004." This refers to general regulatory controls and guidance, not specific quantified performance acceptance criteria for this particular device. | Not provided in the document. The document asserts "ROMEO posterior osteosynthesis system is substantially equivalent to its predicate device in terms of intended use, material, design, mechanical properties and function," implying performance similar to the predicate, but no specific performance metrics are reported. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a clinical or performance study with a test set that would involve sample sizes or data provenance. 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 the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a study involving ground truth establishment by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study involving adjudication for a test set.
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. The document is for a physical medical device (osteosynthesis system) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The document is for a physical medical device and does not describe an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe a study that utilized ground truth.
8. The sample size for the training set
Not applicable. The document does not describe a training set for an algorithm or a study with a training phase.
9. How the ground truth for the training set was established
Not applicable. The document does not describe a training set or its ground truth establishment.
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