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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 Spinal System is a posterior. non-cervical pedicle fixation system intended to provide immobilization and stabilization of spinal seements 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 Spinal 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 Pedicle Screw System is a permanent implant device made from a titanium alloy TI 6AL4V-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 30-55mm. Rods are available in 5.5mm diameter, as either straight rods available in lengths from 30-500mm or precurved rods available in lengths from 30-120mm. The system includes a set screw, tulip heads, a cap and cross connectors to complete the assembly.

1. Acceptance Criteria and Device Performance

The provided document, K120292 for the CapLOX II Pedicle Screw System, describes a Special 510(k) submission for minor changes to an already cleared device. As such, the performance testing focuses on demonstrating that the mechanical characteristics of the modified device are not altered compared to the predicate device.

2. Sample Size for Test Set and Data Provenance

The document states: "New performance testing per ASTM F1798 was completed at an independent laboratory." However, the specific sample size used for this mechanical testing is not explicitly stated within the provided text.

The data provenance is from mechanical testing performed at an independent laboratory, rather than from patient data. Therefore, the concepts of "country of origin of the data" and "retrospective or prospective" do not directly apply in the context of this mechanical performance study.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to this submission. The ground truth for this device's performance is established through mechanical testing per a recognized standard (ASTM F1798), not through expert review of clinical cases or data.

4. Adjudication Method for the Test Set

This information is not applicable. Mechanical testing results are objective measurements against a standard, not subject to adjudication by multiple parties in the way clinical data might be.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device and submission. This device is a pedicle screw system, and the submission addresses mechanical characteristics, not diagnostic or interpretive tasks where human readers' performance with/without AI assistance would be relevant.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device's mechanical performance was evaluated independently against the ASTM F1798 standard. This was an "algorithm only" (or rather, "device only") performance evaluation, without human interpretation in the loop.

7. Type of Ground Truth Used

The ground truth used was compliance with the mechanical testing standard ASTM F1798. This standard sets specific methodologies and acceptance criteria for evaluating the mechanical properties of pedicle screw systems.

8. Sample Size for the Training Set

This information is not applicable. This submission is for a physical medical device (pedicle screw system), not a machine learning or AI algorithm that requires a training set of data.

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

This information is not applicable, as there is no training set for a physical medical device.

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The CapLOX II Spinal 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 Spinal 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 Captiva Spine CapLOX II Spinal System is a top-loading spinal fixation system consisting of polyaxial pedicle screws, cannulated polyaxial pedicle screws set screws, rods, and cross connectors assembled to create a rigid spinal construct. It is intended to provide stabilization during the development of fusion utilizing a bone graft as well as aid in the surgical correction of various spinal deformities and pathologies in the thoracolumbo-sacral iliac portion of the spine. The titanium alloy, single-use components are provided clean and non-sterile. Various sizes of the implants (screws and rods) are available to accommodate individual patient anatomy. The purpose of this submission is to add additional screws to the pedicle screw system.

The provided 510(k) summary for the Captiva Spine CapLOX II Spinal System focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than clinical performance studies with acceptance criteria based on metrics like sensitivity or specificity. Therefore, many of the requested data points related to clinical or AI/algorithm performance are not applicable to this submission.

Here's a breakdown of the information that is applicable and a note on what is not:

Acceptance Criteria and Device Performance:

Study Information:

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

   • Not applicable. This submission relies on engineering analysis (FEA) and comparison to predicate devices, not clinical performance data from a test set of patients or cases.

2. 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. No ground truth establishment by experts for a test set of clinical images/data is mentioned. The evaluation is based on engineering principles and comparison to existing devices.

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

   • Not applicable. No test set requiring adjudication is mentioned.

4. 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 not an AI/software device, and no MRMC study or assessment of human reader performance with or without AI assistance was conducted.

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

   • Not applicable. This is a spinal implant system, not an algorithm or AI device.

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

   • Not applicable. For this type of orthopedic implant, "ground truth" would typically relate to mechanical testing standards and successful clinical history of the predicate devices. The submission points to "Verification activities including FEA and engineering analysis" and "Documentation provided demonstrates that the Captiva Spine CapLOX II Conclusion: Spinal System is substantially equivalent to predicate devices." This implies that the 'truth' for evaluation is adherence to engineering principles and established performance characteristics of predicate devices, rather than clinical outcomes or diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable. No training set is mentioned as this is not a machine learning or AI device.

8. How the ground truth for the training set was established:

   • Not applicable. No training set or associated ground truth establishment is mentioned.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the Captiva Spine CapLOX II Spinal System meets acceptance criteria is a technical and engineering analysis comparing the subject device to legally marketed predicate devices. This is characteristic of a 510(k) submission for mechanical devices, where the primary goal is not to prove new clinical efficacy or diagnostic accuracy but to demonstrate "substantial equivalence" to a device already on the market.

The "study" involved:

• Verification activities: These included Finite Element Analysis (FEA) and general engineering analysis. These analyses would assess the mechanical properties, stress distribution, and overall design integrity of the new components (additional screws) to ensure they perform equivalently to the existing components and predicate devices.
• Comparison to predicate devices: The submission explicitly states the subject device is "substantially equivalent to the above listed predicate devices in terms of materials, design, indications for use and operational principles." This comparison forms the core of the "proof" for a 510(k) submission.

In essence, the "acceptance criteria" were met by demonstrating through engineering data and direct comparison that the CapLOX II Spinal System performs as safely and effectively as the predicate devices for its stated indications.

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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. Captiva Spine FuseLox 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 System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided non-sterile.

This is a 510(k) premarket notification for a medical device called the "Captiva Spine FuseLox Cervical IBF System." It is a premarket notification for a traditional medical device, not an AI/ML-powered device. Therefore, the questions related to AI/ML device performance, such as sample size, ground truth, expert adjudication, MRMC studies, and training set information, are not applicable.

The document states that the performance data indicates the subject device is substantially equivalent to predicate devices. This means that instead of conducting new clinical trials to evaluate specific performance criteria against a predefined acceptance threshold, the manufacturer demonstrated that their device performs similarly to devices that have already been cleared by the FDA.

Here's what can be extracted from the provided text based on the nature of this submission:

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

Since this is a 510(k) for a traditional medical device (an intervertebral body fusion system), the "acceptance criteria" are primarily related to demonstrating equivalence to predicate devices, rather than specific performance metrics against a pre-defined numerical threshold for an AI/ML algorithm.

2. Sample size used for the test set and the data provenance: Not applicable. Performance was demonstrated through substantial equivalence to predicate devices rather than a new clinical study with a test set of data for an AI/ML algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 traditional medical device, not an AI/ML-powered device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in the context of AI/ML performance evaluation is not relevant here. The "truth" for this submission is established by the accepted performance and safety profile of the predicate devices.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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The Pivotec LIFD implant 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 Pivotec LIFD Implant 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 Pivotec LIFD 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 of PEEK-Optima with Tantalum markers and is provided in various configurations and heights, containing a hollow core to receive bone autograft. Placement is achieved with an insertion instrument that allows for manipulation of the implant within the intra-vertebral disc space.

The provided text describes a 510(k) summary for the Pivotec Lumbar Interbody Fusion Device (LIFD). This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing, rather than a clinical study evaluating diagnostic or prognostic performance in the way an AI/ML medical device might undergo.

Therefore, many of the requested sections related to AI/ML device studies (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission. The study described is a mechanical performance study.

Here's a breakdown of the available information:

Acceptance Criteria and Device Performance

The acceptance criteria for this device are based on its mechanical performance, demonstrating functionality and safety comparable to legally marketed predicate devices. The "reported device performance" refers to the results of these mechanical tests.

Key Finding on Performance: "The device performed as designed and met, or exceeded, all product specifications."

Study Details (Mechanical Testing)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for mechanical testing, but typically involves a number of device samples (e.g., n=5 or n=10 per test condition) to perform the specified ASTM tests. The focus here is on device physical properties, not patient data.
   • Data Provenance: Not applicable in the sense of patient data. The "data" comes from engineering laboratory testing of the manufactured devices.

2. 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. Mechanical testing does not involve human experts establishing ground truth in the context of diagnostic or prognostic accuracy. The "ground truth" is defined by the objective physical properties and performance benchmarks established by the ASTM standards.

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

   • Not Applicable. Adjudication methods are used to resolve disagreements among human reviewers on clinical data. Mechanical testing involves objective measurements of physical properties.

4. 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 mechanical device, not an AI/ML diagnostic or prognostic tool.

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

   • Not Applicable. This is a mechanical device.

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

   • Mechanical Standards: The "ground truth" (or benchmark for performance) is established by the relevant ASTM (American Society for Testing and Materials) standards:
     • ASTM F2077-03 (Standard Test Methods for Intervertebral Body Fusion Devices)
     • ASTM F2267-04 (Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression)
   • The device's performance is compared against the requirements and typical performance characteristics of predicate devices that have successfully met these standards.

7. The sample size for the training set:

   • Not Applicable. This device uses mechanical testing, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not Applicable. (See point 7).

Conclusion of the Study:
"The documentation provided demonstrates that the Pivotec LIFD is substantially equivalent to the predicate devices listed above. This conclusion is based on the devices' similarities in materials, design, indications for use, function and mechanical function."

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