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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, scoliosis, kyphosis, spinal tumor, pseudarthrosis 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/ilum), who are having the device removed after the attainment of a solid fusion.

The CapLOX II® / TowerLOX® MIS Pedicle Screw System is an implant device made from a titanium alloy Ti-6Al-4V ELI per ASTM F136. It is to be implanted from the posterior approach. The screws are currently available in diameters from 4.9-9.0mm and in lengths from 30-100mm. The line extension will include the addition of 4.9-9.0mm extended tab screws to be marketed as TowerLOX® EXT MIS Extended Tab Pedicle Screws in lengths of 30-100mm. All screws with a 5.5mm, 6.5mm and 7.5mm screw diameters will have an updated tip angle. The set screws currently have a 5mm hex, will also be available with a T25 Torx interface. Additional instrumentation will also be added to the system. Overall, the system includes set screws, pedicle screws, and rods with the associated instrumentation in order to complete the procedure and implant construct when performed using minimally invasive surgical techniques.

This FDA 510(k) premarket notification describes the CapLOX II® / TowerLOX® MIS Pedicle Screw System, a pedicle screw system, as a line extension. This means it is based on a previously cleared predicate device (CapLOX II® / TowerLOX® Pedicle Screw System, K131538). The submission focuses on demonstrating substantial equivalence to this predicate device by highlighting that the new components do not introduce new safety or effectiveness concerns.

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a table with numerical goals and reported performance values. Instead, it relies on demonstrating substantial equivalence to a predicate device. The primary "performance" reported is that the modifications (extended tab pedicle screws, updated screw tip angle, additional set screw interface) do not create a new worst case when compared against the predicate devices and were concluded as not raising any new issues for safety and effectiveness. This implies that the device performs at least as well as the predicate device in terms of safety and effectiveness.

The document highlights the following similarities and an implied performance level:

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a "test set" in the context of clinical data for evaluating the device's performance. This submission is for a line extension of a medical device, and the evaluation relies on demonstrating that the new components are substantially equivalent to the previously cleared predicate device. This typically involves non-clinical performance testing (e.g., mechanical, material characterization) rather than a clinical study with a patient "test set". Therefore, information regarding sample size, country of origin, or retrospective/prospective nature for a clinical test set is not applicable here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since there is no "test set" in a clinical context as described above, this information is not applicable. The "ground truth" for this type of submission largely rests on compliance with established material and mechanical standards, and engineering analysis comparing the new components to the predicate. Internal engineering experts and regulatory affairs personnel within Captiva Spine, Inc. would have been involved in this assessment.

4. Adjudication Method for the Test Set

As there is no clinical "test set" described, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic or AI-assisted devices where human readers interpret medical images or data. The CapLOX II® / TowerLOX® MIS Pedicle Screw System is an implantable surgical device, and its evaluation does not involve human readers interpreting data in this manner.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone (algorithm only) performance study was not done. This concept is relevant for AI/ML-driven devices. This submission concerns a physical implantable device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Material properties data: Conformance to ASTM F136 for titanium alloy Ti-6Al-4V ELI.
• Mechanical testing data: Implied by the statement "These modifications have been assessed using risk management techniques and were concluded as not creating a new worst case when compared against the predicate devices." This typically involves bench testing (e.g., fatigue, static strength) to ensure the new components meet or exceed the performance characteristics of the predicate.
• Engineering analysis: Comparing the design and function of the new extended tab screws, updated tip angle, and set screw interfaces to the predicate device to determine that no new safety or effectiveness concerns are introduced.

8. The Sample Size for the Training Set

There is no "training set" in the context of this device submission. This refers to data used to train AI models, which is not applicable here.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set," this question is not applicable.

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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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