(115 days)
The RESPONSE™ Rib and Pelvic System is indicated for skeletally immature patients with severe, progressive spinal deformities such as congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis and/or three-dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS).
The RESPONSE™ Rib and Pelvic System consists of longitudinal members (rods), anchors (saddles, hooks, and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) in a variety of sizes to accommodate differing anatomic requirements. The implants in the system can be assembled in a number of different configurations to accommodate the wide variety of anatomical deformities encountered by the clinician. The RESPONSE™ Rib and Pelvic System also includes surgical instruments. All implants and instruments in the system are provided non-sterile. The RESPONSE™ Rib and Pelvic System mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow. The subject devices are attached perpendicularly to the child's rib, thoracic vertebra, sacrum, ilium and pelvis. This mechanically stabilizes the chest wall and spine and enlarges the thorax to improve respiration and lung growth. Once the subject devices are in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery. The components of the RESPONSE™ Rib and Pelvic System are manufactured from titanium alloy per ASTM F136, unalloyed titanium per ASTM F67, or cobalt chromium per ASTM F1537.
The provided text details the FDA clearance for the OrthoPediatrics Corp. RESPONSE™ Rib and Pelvic System. However, this document does not describe an AI/ML device or its associated studies.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical and biocompatibility testing performed for the physically implanted medical device, not a software-based AI/ML diagnostic or prognostic tool.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance related to a software AI/ML device.
- Sample size used for a test set (in the context of AI/ML).
- Data provenance for AI/ML.
- Number of experts or their qualifications for ground truth in AI/ML.
- Adjudication method for AI/ML.
- MRMC comparative effectiveness study for AI/ML.
- Stand-alone performance for an AI/ML algorithm.
- Type of ground truth (clinical outcomes, pathology, expert consensus) for AI/ML.
- Sample size for training set for AI/ML.
- How ground truth for training set was established for AI/ML.
The document states:
- Performance Data (Section VII):
- "The Biocompatibility assessment and testing for the RESPONSE™ Rib and Pelvic System were performed in conformance with ISO 10993-1."
- "The implants of RESPONSE™ Rib and Pelvic System were evaluated for use in an MR Environment using ASTM F2052, ASTM F2213, ASTM F2182, and ASTM F2119, and were determined to be MR Conditional and will be labeled as such."
- "Mechanical performance evaluations included construct static and dynamic compression testing based on ASTM F1717; axial and torsional grip testing per ASTM F1798; and screw torsional strength, insertion torque, and removal torque testing per ASTM F543; and engineering analysis."
- "Results of the mechanical testing/analysis demonstrate substantially equivalent mechanical performance of the subject device as compared to the predicate."
This indicates that the acceptance criteria were based on established ASTM and ISO standards for mechanical performance and biocompatibility of implantable devices, and the device met these engineering and material standards to demonstrate substantial equivalence to predicate devices. It is a physical product, not a software 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.