Search Results

The CapLOX II® / TowerLOX® MIS 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® MIS 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 4.5mm 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 4.5mm screws for the CapLOX II® /TowerLOX® MIS Pedicle Screw System in lengths of 30-55mm. Additional instrumentation will also be added to the system. Overall, the system includes pedicle screws, and the instrumentation in order to complete the procedure and implant construct when performed using minimally invasive surgical techniques.

The provided document is a 510(k) premarket notification letter and summary for a medical device, specifically the CapLOX II® / TowerLOX® MIS Pedicle Screw System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical trial or a standalone study as might be seen for novel devices or AI/software products requiring such validation.

Therefore, the information requested in the prompt, such as detailed acceptance criteria, sample sizes for test/training sets, expert qualifications, and adjudication methods for AI performance, is not applicable to this document. This submission pertains to a mechanical implant (pedicle screw system) and its line extension (adding a 4.5mm screw and instrumentation). The "study" referenced in the document is primarily mechanical testing and engineering analysis to demonstrate that the new components perform equivalently to the predicate device and do not introduce new safety concerns.

Here's an attempt to address the prompt based only on the information available in the provided text, highlighting where the requested details are not present due to the nature of the device and submission:

Acceptance Criteria and Device Performance for Captiva Spine, Inc.'s CapLOX II® / TowerLOX® MIS Pedicle Screw System (K193270)

The device in question is a mechanical implant (pedicle screw system), and its 510(k) submission aims to demonstrate substantial equivalence to a predicate device, not necessarily to meet pre-defined acceptance criteria for a diagnostic or AI-driven system. The "acceptance criteria" here relate to demonstrating equivalence in mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify a "sample size" in the context of a clinical test set. The evaluation was primarily through mechanical testing (Dynamic Compression Bending testing per ASTM F1717). For such tests, the "sample size" would typically refer to the number of physical devices or components tested, which is not detailed in this summary.
• Data Provenance: Not applicable in the context of clinical data. The performance data is derived from benchtop mechanical testing. The origin would be the testing facility where the ASTM F1717 tests were performed. This is not retrospective or prospective clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts & Qualifications: Not applicable. Ground truth, in the sense of clinical diagnoses or interpretations, is not established for this type of mechanical device submission. The "ground truth" for mechanical testing is adherence to established engineering standards and material properties, evaluated by engineers.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There is no clinical test set requiring adjudication in this submission. Mechanical testing results are typically evaluated against pre-defined engineering specifications.

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

• MRMC Study: No. This device is a pedicle screw system, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Standalone Performance: No. This device is a physical implant, not an algorithm or software.

7. The type of ground truth used

• Type of Ground Truth: For the mechanical testing, the "ground truth" is defined by established engineering standards and material science properties (e.g., ASTM F1717 for mechanical performance, ASTM F136 for material composition). The objective is to demonstrate that the device meets these standards and performs comparably to the predicate.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not a machine learning or AI device that would utilize a training set.

9. How the ground truth for the training set was established

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for this device.

Ask a specific question about this device

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.

Ask a specific question about this device