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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.

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The Captiva Spine TirboLOX-C™ Cervical IBFD is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one-disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. The Captiva Spine TirboLOX-C™ Cervical IBFD is used to facilitate fusion in the cervical spine and is placed via an anterior approach at the C3 to C7 disc levels with autograft bone and/or allogenic bone graft composed of cancellous bone graft. Patients should have at least six weeks of non-operative to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

The Captiva Spine, Inc. TirboLOX-CTM Cervical IBFD is made from a titanium alloy and is created using 3D printing technologies. The implants are available in various footprints to accommodate a variety of patient anatomies and is provided sterile. The device has a window in the center of device to accept autogenous bone and/or allogenic bone graft. The implant is available in the following configurations: lordotic, anatomically correct and parallel

This is a 510(k) premarket notification for a medical device, not a study evaluating an AI algorithm. Therefore, the requested information about acceptance criteria, study data, ground truth, and AI performance metrics is not applicable here.

The document describes the Captiva Spine TirboLOX-C™ Cervical IBFD, an intervertebral body fusion device. It focuses on demonstrating the device's substantial equivalence to legally marketed predicate devices through a series of non-clinical mechanical tests.

Here's a breakdown of the relevant information present in the document:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with specific quantitative acceptance criteria alongside performance data. Instead, it states that "The results of this non-clinical testing show that the strength of the TirboLOX-C™ Cervical IBFD is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This implies that the device's performance in the listed tests met predetermined criteria acceptable for demonstrating equivalence to the predicate devices, but the exact numerical thresholds are not disclosed.

Device Performance (as reported):

• ASTM F2077-14: Static Axial Compression, Static Shear, Static Torsion, Dynamic Axial Compression, Dynamic Shear, Dynamic Torsion
• ASTM 2267-04: Static Subsidence
• ASTM F1978-12: Abrasion Resistance
• ASTM F1877-16: Wear Debris
• Additionally: Expulsion testing was performed.

The reported performance is qualitative: the device's strength is sufficient for its intended use and substantially equivalent to predicate devices. Specific quantitative results are not provided in this summary document.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided because it's a mechanical device testing, not a clinical study on human data. The "sample" would refer to the number of devices tested, which is not specified. Data provenance like country of origin or retrospective/prospective is not relevant for this type of non-clinical, in-vitro testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth as typically defined for AI/medical imaging studies (e.g., expert consensus on diagnoses) is not relevant for mechanical device testing. The "ground truth" for these tests are the established standards and specifications of the ASTM methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in clinical trials or expert reviews to resolve disagreements in interpretations, which is not part of mechanical testing.

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

Not applicable. This is a spinal implant, not an AI-powered diagnostic device. No human readers or AI assistance were involved in the testing described in this document.

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

Not applicable. This device is an implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the mechanical performance tests are the established ASTM (American Society for Testing and Materials) standards and test methodologies. These standards define the parameters, procedures, and conditions for evaluating the mechanical properties of medical implants to ensure their safety and effectiveness. The goal is to show the device performs within acceptable limits mandated by these standards and comparably to predicate devices.

8. The sample size for the training set

Not applicable. There is no AI algorithm being described, so there is no training set.

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

Not applicable, as there is no training set.

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The Captiva Spine, Inc. TirboLOX-L™ Lumbar IBFD is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DDD patients may also have up to a Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The Captiva Spine, Inc. TirboLOX-L™ Lumbar IBFD is made from a titanium alloy (Ti-6Al-4V ELI per ASTM F3001 and TI-6Al-4V ELI per ASTM F136) and is created using 3D printing technologies. The implants are available in various footprints to accommodate a variety of patient anatomies and is provided sterile. The device has a window in the center of device to accept autogenous bone and/or allogenic bone graft. The implant is available in the following configurations: PLIF (Lordotic; 3°, 6°, and 15°, Convex) and TLIF (Straight, Curved Lordotic and Curved Parallel)

This document describes the regulatory clearance for a medical device and, as such, does not contain information about acceptance criteria or a study proving a device meets them in the way described in your request.

The provided text is a 510(k) summary for the TirboLOX-L™ Lumbar IBFD, an intervertebral body fusion device. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to establish performance against acceptance criteria in the context of an AI/software as a medical device (SaMD) evaluation.

Therefore, I cannot extract the following information as it is not present in the provided document:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• The sample size for the training set.
• How the ground truth for the training set was established.

What the document does describe in terms of "performance data" is the results of non-clinical, mechanical testing to ensure the structural integrity and biocompatibility of the physical implant.

Here's the relevant section from the document concerning "Performance Data":

Performance Data:
The TirboLOX-L™ Lumbar IBFD has been tested in the following test modes:

• ASTM F2177-14 Static Axial Compression
• Static Shear
• Dynamic Axial Compression
• Dynamic Shear
• ASTM 3267-04 Static Subsidence
• AAMI ST72 Bacterial Endotoxin Testing

Additionally, expulsion testing was performed. The results of this non-clinical testing show that the strength of the TirboLOX-L™ Lumbar IBFD is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

This information relates to the physical characteristics and safety of the implant itself, not to the performance of a diagnostic or therapeutic algorithm.

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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, 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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The Captiva Spine SmartLOX Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion. WARNING: The Captiva Spine SmartLOX Cervical Plate System is not intended for screw attachment or the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

The Captiva Spine SmartLOX Cervical Plate system is intended for anterior screw fixation of the cervical spine. This system has been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudoarthrosis or failed previous fusion.

The Captiva Spine SmartLOX Cervical Plate System includes plates, screws, and a screwretaining rail lock. The plates are available in a variety of lengths ranging from 20 to 110mm. Screws are offered in two diameters, a primary screw diameter and a rescue diameter. Primary screws are available in self-drilling, and both screw diameters are available in fixed and variable versions. Screw lengths range from 12 to 18mm in 2mm increments. The rails are assembled with the plate during the manufacturing process and their configuration varies with the plate length.

The Captiva Spine SmartLOX Cervical Plate System is supplied with the instrumentation necessary for implantation of the system. The Captiva Spine SmartLOX Cervical Plate System is for single use only.

This document is a 510(k) summary for the Captiva Spine SmartLOX Cervical Plate System. It details the device, its intended use, and its substantial equivalence to predicate devices, but it does not describe a study that uses acceptance criteria for device performance based on human reader evaluations or AI performance metrics.

Instead, the "acceptance criteria" and "study" described in the document refer to mechanical and material testing performed to demonstrate the device's safety and effectiveness compared to existing, legally marketed predicate devices.

Here's an breakdown based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table with acceptance criteria and device performance in the way one might expect for an AI diagnostic device. Instead, it states that the device was evaluated against existing ASTM standards and engineering analyses.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the "test set" in this context refers to mechanical test samples, not a dataset of patient images or clinical data. The document mentions "worst-case implants" were tested, but not a specific sample size. No country of origin or retrospective/prospective data provenance is relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The ground truth for mechanical testing is established by engineering standards (e.g., ASTM F1717) and physical measurements, not by experts reviewing clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are relevant for subjective interpretations of data, typically in clinical studies or AI evaluations. For mechanical testing, results are objectively measured against predefined standards.

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

No, a multi-reader, multi-case comparative effectiveness study was not done. This device is a medical implant (cervical plate system), not a diagnostic AI software. Therefore, there is no concept of human readers or AI assistance in this context.

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

No, a standalone performance evaluation of an algorithm was not done. This is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is based on adherence to recognized mechanical and material testing standards (e.g., ASTM F1717, F2129-08, F3044-14) and engineering analyses (FMEA, comparative analysis). These standards define acceptable performance for spinal implant devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" for this type of medical device. The design and manufacturing processes are informed by engineering principles, material science, and prior device designs, not by machine learning training data.

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

This information is not applicable as there is no training set.

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The Captiva Spine FuseLOX Cervical IBF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. FuseLOX Cervical IBF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.

The Captiva Spine FuseLOX Cervical IBF is intended to provide mechanical support of the cervical spine while biologic fusion occurs. It is intended to be used with supplemental fixation.

The Captiva Spine FuseLOX Cervical IBF System includes various size implants manufactured from implant grade PEEK-OPTIMA'™ LT1 conforming to ASTM F2026-12. The devices also have radiopaque markers made from either titanium alloy (Ti6Al4V) per ASTM F136 or tantalum per ASTM F560-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.

The provided text describes the Captiva Spine FuseLOX Cervical IBF System, a medical device for intervertebral body fusion. However, it does not include information about AI algorithms, acceptance criteria for AI performance, or any studies involving AI assistance or standalone AI performance.

Therefore, I cannot answer your specific questions related to AI device performance, sample sizes for AI training/test sets, expert adjudication methods, MRMC studies, or how AI ground truth was established, as this information is not present in the provided document.

The document discusses the regulatory submission for a physical medical device and its substantial equivalence to a predicate device based on mechanical testing. It does not pertain to the evaluation of an AI-powered diagnostic or assistive tool.

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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.

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

This submission is for a Special 510(k) for the CapLOX II/TowerLOX Pedicle Screw System. The changes involve adding new rod lengths, new instrumentation, and new cross connector sizes.

Based on the provided information, no new performance testing was required because the changes were considered to be within the scope of the previously cleared predicate devices and did not raise new questions of safety or effectiveness. Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document states:

• "Based on the risk analysis for the proposed changes, no new performance testing is required."
• "Captiva Spine concludes that these changes to the CapLOX II/TowerLOX Pedicle Screw System is substantially equivalent to the predicate with the same name and raises no new questions of safety or effectiveness."

Because no new performance testing was conducted for this specific submission, the following information cannot be extracted from the provided text:

1. Table of acceptance criteria and reported device performance: Not applicable as no new performance testing was conducted.
2. Sample size used for the test set and data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm-only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The regulatory review for this special 510(k) focused on demonstrating substantial equivalence to pre-existing predicate devices (K122332, K120292, and K121020) rather than presenting new performance study data.

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The FuseLOX Lumbar Interbody Fusion Device is an intervertebral body fusion device indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The FuseLOX Lumbar Interbody Fusion Device is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

The FuseLOX Lumbar Interbody Fusion System is an intervertebral body fusion device for use with autogenous bone graft in the intervertebral disc space to stabilize spinal segments and promote fusion. The device is made from PEEK-Optima with tantalum or titanium markers. The devices are provided in lordotic and convex configurations with heights ranging from 7-14mm in 1mm increments. Each device has a hollow core to receive bone graft. Placement is achieved with a series of device specific instruments provided.

Here's an analysis of the provided 510(k) summary for the Captiva Spine FuseLOX Lumbar Interbody Fusion System, focusing on acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

This 510(k) pertains to a medical device (intervertebral body fusion device), not an AI/software as a medical device (SaMD). Therefore, the "acceptance criteria" and "reported device performance" are based on mechanical testing and substantial equivalence to a predicate device, rather than diagnostic accuracy metrics.

• Static Compression: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device.
• Dynamic Compression: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device.
• Static Compression Shear: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device.
• Static Torsion: Performed according to ASTM F2077. Results were acceptable and comparable to the predicate device.
• Subsidence: Performed according to ASTM F2267. Results were acceptable and comparable to the predicate device. |
  | Material Biocompatibility | Not explicitly detailed in this summary, but would refer to the PEEK-Optima material, which is a common and well-established biocompatible material for implantable devices. Assumed to be met by substantial equivalence to predicate devices using similar materials. |
  | Design and Features | The changes in design and features (non-pivoting inserter, lordotic/convex configurations) were found not to introduce any new risks.
• The design changes were assessed for their impact on mechanical function and safety and found to be substantially equivalent to the predicate. |
  | Indications for Use | Identical to predicate device.
• The device is indicated for intervertebral body fusion at one or two contiguous levels in the lumbar spine (L2-S1) for patients with DDD with up to Grade 1 spondylolisthesis, who are skeletally mature and have had six months of non-operative treatment. Designed for use with autograft and supplemental fixation systems. |
  | Clinical Application | Similar to predicate device. Functionally comparable to the predicate device in its intended clinical use. |

Study Proving Acceptance Criteria Met:

The primary study that proves this device meets its acceptance criteria is a mechanical performance testing study conducted according to recognized ASTM standards (ASTM F2077 and ASTM F2267).

This is a Special 510(k) submission, which means the changes introduced (new marketing name, new configurations, new inserter/trial instrument designs, new tray design) are minor and do not significantly alter the fundamental scientific technology of the device or its intended use. Therefore, extensive new clinical trials or highly complex comparative studies are generally not required. The key is to demonstrate that the modified device remains as safe and effective as the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in terms of patient numbers. For mechanical testing, the "test set" would refer to the number of device samples (implants) subjected to each specific mechanical test (e.g., N samples for static compression, N samples for dynamic compression). These numbers are typically defined by the ASTM standards themselves, but are not provided in this summary.
• Data Provenance: The data is generated from laboratory mechanical testing of the device components, not from human patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts: Not applicable. For mechanical testing of an intervertebral body fusion device, "ground truth" is established by adherence to standardized testing protocols (e.g., ASTM F2077) and objective measurement of physical properties (e.g., load to failure, displacement). There are no human "experts" establishing a subjective ground truth in this context like there would be for an image classification SaMD.
• Qualifications of Experts: Not applicable. The "experts" would be the engineers and technicians performing and supervising the mechanical tests, ensuring adherence to the standards and accurate data collection.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies or image interpretation studies where there is subjective interpretation or discrepancies in expert opinions. In mechanical testing, results are objective measurements against defined criteria.

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 is a physical medical device, not an AI/SaMD.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: The "ground truth" for this device's performance is established by objective mechanical properties (e.g., strength, stiffness, resistance to subsidence) as defined by internationally recognized ASTM standards (ASTM F2077 and ASTM F2267). The "ground truth" for safety and effectiveness is ultimately demonstrated by substantial equivalence to an already cleared predicate device, meaning it performs similarly and presents no new safety risks.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical medical device, not an AI algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable.

Summary Specific to this Device:

This 510(k) submission is for a modification to an existing, already-cleared interbody fusion system. The regulatory pathway of a Special 510(k) relies heavily on demonstrating that the changes do not introduce new questions of safety or effectiveness. The core of the "study" proving acceptance criteria here is robust mechanical testing against established ASTM standards and a direct comparison of the modified device's performance to its cleared predicate device(s). The FDA's determination of substantial equivalence (K122956) indicates that these demonstrations were sufficient.

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