(65 days)
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-S V vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; 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 cross connectors. The Romeo® Polyaxial 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. The modification to Romeo® posterior osteosynthesis system consists of the addition of a prebent cross connectors and prebent CoCr rods.
This document is a 510(k) premarket notification for the ROMEO® Posterior Osteosynthesis System, seeking to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain information about the acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical study for an AI/ML device would.
Instead, this document focuses on mechanical and material equivalence for a traditional medical device (spinal system components). Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This document doesn't define pass/fail criteria for a study in terms of accuracy, sensitivity, specificity, etc., as it's not a diagnostic or AI/ML device. The "performance" described relates to the physical characteristics and intended use of the spinal components.
- Sample size and data provenance for a test set: No test set in the context of an AI/ML or diagnostic study is described.
- Number of experts and qualifications for ground truth: Not applicable, as there's no diagnostic ground truth being established.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How ground truth for the training set was established: Not applicable.
What the document does convey regarding "acceptance criteria" and "study" is related to engineering principles and regulatory compliance for a spinal implant system:
- Acceptance Criteria (Implicitly): The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate devices. This involves showing that the new components (prebent cross connectors and prebent CoCr rods) have equivalent intended use, material, design, mechanical properties, and function to existing cleared devices. The "special controls established for Pedicle screw spinal system" and the "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" (May 3, 2004) serve as the regulatory framework and implicitly contain design and performance expectations.
- "Study" (Demonstration of Equivalence): The "study" isn't a traditional clinical trial or performance study with human subjects, but rather a technical assessment and comparison. The document states:
- "No additional testing has been performed for the added prebent cross connectors and prebent CoCr rods." This is a crucial statement and indicates that the manufacturer is relying on the established equivalence of the materials and design to existing cleared components.
- "Verification Activity and Validation Activity demonstrate that the added prebent cross connectors and prebent CoCr rods are substantially equivalent to previously cleared devices." This suggests that internal engineering verification and validation activities (e.g., material testing, mechanical load testing, fatigue testing, dimensional analysis) were conducted to ensure the new components meet the same functional and safety profiles as the predicate components, even if no new testing was deemed necessary beyond that for existing components.
In summary, this document is a regulatory filing for a physical medical device (spinal implant components), not for an AI/ML diagnostic or prognostic tool. Therefore, the questions related to clinical performance metrics, ground truth, and reader studies are not applicable to the information provided.
§ 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.