(79 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.
This document is a 510(k) summary for the SPINEART ROMEO posterior osteosynthesis system. It details the device's characteristics, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain the specific information required to complete the table and answer all questions related to acceptance criteria and a study proving those criteria.
The 510(k) process for devices like this typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical performance studies to meet specific acceptance criteria in the same way an AI/ML software device would. The "Performance data" section refers to conformity with "special control established for Pedicle screw spinal system" and "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document," which primarily relate to mechanical properties, material biocompatibility, and sterilization, rather than performance metrics like sensitivity or specificity.
Therefore, many of the requested fields are not applicable or the information is not present in this document.
Here's an attempt to answer based only on the provided text, with clear indications where information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformity to special control established for Pedicle screw spinal system | ROMEO posterior osteosynthesis system conforms to special control. |
| Conformity to "Spinal System 510(k)s - Guidance for Industry and FDA Staff Document" issued on May 3, 2004 | ROMEO posterior osteosynthesis system conforms to the guidance document. |
| Substantial equivalence in terms of intended use, material, design, mechanical properties, and function to predicate devices (ELLIPSE posterior osteosynthesis system K081165 and ROMEO posterior osteosynthesis system K093170) | ROMEO posterior osteosynthesis system is substantially equivalent to its predicate device in terms of intended use, material, design, mechanical properties and function. |
Study Information:
The provided document describes a 510(k) submission, which is a regulatory pathway to demonstrate substantial equivalence to a predicate device, not necessarily a study to prove novel acceptance criteria for device performance in the clinical sense (like AI/ML performance metrics). The "Performance data" section mentions conformity to established special controls and guidance documents for pedicle screw spinal systems. This implies that testing was conducted to meet the mechanical, material, and labeling requirements outlined in those documents, which are the "acceptance criteria" for this type of device within the 510(k) framework. However, the document does not detail specific study methodologies or results beyond the statement of conformity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable and not provided. The 510(k) does not describe a clinical performance study with a "test set" in the context of diagnostic or AI/ML performance. The "performance data" refers to compliance with regulatory standards, likely involving mechanical testing of device components, not patient data sets.
- Data provenance: Not applicable.
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. Ground truth as typically defined for AI/ML performance evaluation is not relevant to this 510(k) submission for a spinal implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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
- No. This is a spinal implant, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a spinal implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For a spinal implant, "ground truth" would relate to material properties, mechanical strength, biocompatibility, and clinical outcomes, evaluated through engineering tests and clinical follow-up (though no clinical study data is presented in this summary, as per the nature of the 510(k) process for this device type).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 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.