Search Results

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: 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, K111127 and K112108) manufactured by SPINEART consist of:

• Addition of Romeo® 25D & 25T Screws made of Titanium alloy Ti6AI4V ELI . conforming to ISO 5832.3 and ASTM F136
• Addition of Romeo® Straight and Multiaxial Cross Connectors made of Titanium . alloy Ti6AI4V ELI conforming to ISO 5832-3 and ASTM F136
• Additional lengths of Percutaneous Pre-bent and Straight Rods made of Titanium . alloy (Ti6AI4V ELI conforming to ISO 5832-3 and ASTM F136).

These components are supplied either sterile or not sterile.

• Addition of a Cross connector caliper and a 3.5 mm tightener (not sterile). .

The medical device described in K130267 is a spinal osteosynthesis system, not an AI device. Therefore, the acceptance criteria and study information typically sought for AI/ML devices, such as performance metrics like accuracy, sensitivity, specificity, and related study designs (e.g., MRMC, standalone studies, ground truth establishment by experts, sample sizes for training and test sets), are not applicable in this context.

This 510(k) summary focuses on demonstrating substantial equivalence for an extension to an existing mechanical spinal implant system. The "performance data" section explicitly states: "Mechanical testing including static compression bending, static torsion, dynamic axial compression tests have been performed according to ASTM F1717-12. Results demonstrate that additional components perform as safely and effectively as their predicate devices. No clinical data has been presented."

Therefore, I cannot provide a table of acceptance criteria and device performance as requested in the format for an AI device. Instead, I can summarize the mechanical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance (for mechanical testing):

This information is not explicitly detailed in a pass/fail table format within the provided 510(k) summary. However, the summary states:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not applicable. For mechanical testing, this typically refers to the number of devices or components tested. The specific number of components and repetitions for each test (static compression bending, static torsion, dynamic axial compression) according to ASTM F1717-12 is not specified in the summary but would have been part of the full testing report.
• Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data originates from laboratory testing conducted by the manufacturer according to specified ASTM standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth as typically understood for AI/ML refers to clinical labels or expert annotations on patient data. For mechanical testing, the "ground truth" is compliance with engineering standards and performance relative to predicate devices, verified by engineering and regulatory experts within the testing facility and the FDA.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods are relevant for human expert review of clinical data. For mechanical testing, results are objectively measured and compared against predefined engineering specifications and predicate device performance.

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 is a mechanical device, not an AI/ML device that assists human readers.

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

• Not applicable. This is a mechanical device.

7. The type of ground truth used:

• For mechanical testing, the "ground truth" is adherence to validated engineering test standards (ASTM F1717-12) and comparison against the performance of legally marketed predicate devices. The objective is to demonstrate that the new components meet the same safety and effectiveness profiles as the existing, approved devices.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm involved to train.

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

• Not applicable. There is no training set for an AI/ML algorithm.

Ask a specific question about this device

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).

The modifications to ROMEO posterior osteosynthesis system (K081165, K093170, K101678) manufactured by SPINEART consist of addition of Extension of the length range of pre-bent Rod Ø5.4mm (35, 45 and 55 mm) Extension of the length range of straight Rod Ø5.4mm (55 mm) Extension of the length range of transverse Connectors (20, 30 and 40 mm) Addition of iliac Connectors (Length 15, 20, 30, 40, 50 and 60 mm) Addition of axial Rod Connector, Parallel Rod Connector, Addition of Percutaneous pre-bent and straight titanium Rod Ø5.4 (Length 30 to 200 mm) These components are supplied either sterile or not sterile

The provided document is a 510(k) summary for a medical device called the ROMEO posterior osteosynthesis system. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through mechanical testing of the additional components. It does not describe a study about the performance of an AI/ML powered device, nor does it contain acceptance criteria or reported performance metrics typically associated with such devices.

Therefore, I cannot extract the information required in your request regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI-powered device.

The "Performance data" section refers to:

• Acceptance Criteria/Standards: Conformity 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.
• Study: Mechanical testing including static axial compression, static torsion, and dynamic axial compression tests have been performed according to ASTM F1717-09.
• Reported Device Performance: "Results demonstrate that additional components perform as safely and effectively as their predicate devices."

This is, however, for the physical components of the spinal system, not for an AI/ML powered device.

Ask a specific question about this device