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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, pseudoarthrosis and failed previous fusion.

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), or 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 pre- lordosed configurations. The system includes set screws, pedicle screws, and rods along with the associated instrumentation to complete the procedure and implant construct.

I am sorry, but the provided text is a 510(k) premarket notification for a medical device (CapLOX II/TowerLOX Pedicle Screw System) and does not contain any information about acceptance criteria or a study proving that a device meets such criteria related to AI or software performance.

The document states:

• "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..." This is a regulatory clearance based on equivalence to existing devices, not performance against specific acceptance criteria for a new type of study (like those you've inquired about).
• "Performance testing was not conducted as part of this submission." This explicitly indicates that the type of performance study you're asking for was not done for this particular submission. The changes being submitted are additions of new pedicle screw sizes and associated instruments, which do not represent a new worst-case for mechanical integrity and are within clinically accepted size ranges, thus not requiring new performance testing for substantial equivalence.

Therefore, I cannot provide the requested information from this document.

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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.

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