(60 days)
The CapLOX II/TowerLOX Pedicle Screw System is a posterior, non-cervical pedicle fixation system 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 including degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, pseudloarthrosis and failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CapLOX II/TowerLOX Pedicle Screw System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral, L5-S1 vertebra, who are receiving fusion by autogenous bone graft only, who are having the device attached to the lumbar and sacral spine (levels may be from L3 to the sacrum/ilium), who are having the device removed after the attainment of a solid fusion.
The CapLOX II/TowerLOX Pedicle Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI. It is to be implanted from the posterior approach. The screws are available in diameters from 4.9-8.0mm and in lengths from 30-100mm. Rods are available in 5.5mm diameter in lengths from 30-600mm and in an array of configurations including, straight and prelordosed configurations. The system includes set screws, and rods alone with the associated instrumentation to complete the procedure and implant construct.
The provided text is a 510(k) summary for the CapLOX II/TowerLOX Pedicle Screw System. This document is a premarket notification to the FDA for a medical device and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific performance acceptance criteria.
Therefore, the document does not contain the requested information regarding acceptance criteria or a study that proves the device meets those criteria, as typically defined for performance studies of AI/software devices.
Here's why and what information can be extracted/inferred:
- Type of Device: The CapLOX II/TowerLOX Pedicle Screw System is a physical medical implant (pedicle screw spinal system), not a software-as-a-medical-device (SaMD) or an AI-powered diagnostic/analysis tool. The questions you've asked (e.g., sample size for test/training sets, ground truth establishment, MRMC studies, standalone performance, expert consensus) are primarily relevant for AI/software-based medical devices.
- Regulatory Pathway (510(k)): For a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device. This often involves comparing technological characteristics, materials, and intended uses, typically supported by bench testing (e.g., mechanical strength, fatigue testing) and sometimes animal or limited clinical studies, but not necessarily the extensive performance metrics and study designs described in your prompt for AI.
- Focus of the Document: The document explicitly states: "The subject modified is CapLOX II/TowerLOX Pedicle Screw System very similar to previously cleared CapLOX II/TowerLOX Pedicle Screw System. The subject CapLOX II/TowerLOX Pedicle Screw System has similar intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions." This confirms the focus on equivalence rather than independent performance validation against novel criteria.
Based on the provided text, I cannot fill in the table or answer the specific questions about acceptance criteria and a study proving the device meets them in the context of an AI/software device.
However, I can extract the following relevant information about the device and its submission:
- Device Name: CapLOX II/TowerLOX Pedicle Screw System
- Regulation Number: 21 CFR 888.3070 (Pedicle screw spinal system)
- Regulatory Class: Class II
- Product Code: MNH, MNI
- Material: Titanium alloy Ti-6Al-4V ELI (conforms to ASTM F136)
- Indications for Use: Posterior, non-cervical pedicle fixation system for immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in treatment of various acute and chronic instabilities/deformities of the thoracic, lumbar, and sacral spine (e.g., degenerative spondylolisthesis, fracture, scoliosis, kyphosis, spinal tumor, pseudloarthrosis, failed previous fusion). Also for severe spondylolisthesis (Grades 3 and 4) of L5-S1.
- Predicate Device: K131538 CapLOX II/TowerLOX Pedicle Screw System by Captiva Spine.
- Key Argument for Equivalence: Similar intended uses, indications, technological characteristics, principles of operation, and materials of manufacture, with minor differences (modular extended tab pedicle screw head assembly, instrumentation and rotating rods) that raise no new safety/effectiveness questions.
To get the type of information you are asking for, you would typically need a performance study report for an AI/software medical device, which would detail clinical performance metrics (sensitivity, specificity, accuracy, AUC, FROC, etc.), ground truth methods, reader studies, and statistical analyses. This document relates to a physical implant and its regulatory clearance via substantial equivalence for new iterations.
§ 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.