(116 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; 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:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformity to special controls for Pedicle screw spinal system | Conforms to special controls |
| Conformity to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" (May 3, 2004) | Conforms to guidance document |
| Performance as safely and effectively as predicate devices | Demonstrates performance as safely and effectively as predicate devices for additional components |
| Withstand mechanical testing according to ASTM F1717-12 | Mechanical testing (static compression bending, static torsion, dynamic axial compression) performed according to ASTM F1717-12. Results deemed adequate to demonstrate substantial equivalence. |
| Substantial equivalence in terms of intended use, material, design, mechanical properties, and function | Additional components are substantially equivalent to predicate devices |
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.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to 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 safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.