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CAPSTONE™ SPINAL SYSTEM
The CAPSTONE™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

CLYDESDALE PTC™ SPINAL SYSTEM
The CLYDESDALE PTC™ Spinal System is designed to be used with autogenous bone graft to facilitate interbody fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The CLYDESDALE PTC™ Spinal System is used for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a minimally invasive lateral approach.

CRESCENT™ SPINAL SYSTEM
The CRESCENT® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature of nonoperative treatment. These implants are to be used autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

CRESCENT™ SPINAL SYSTEM TITANIUM
The CRESCENT Spinal System Titanium is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants are to be used with autogenous bone graft. These devices are intended to be used with Medronic supplemental fixation which has been cleared by the FDA for use in the lumbar spine.

DIVERGENCE-L™ ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM
The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature patients and is to be used with supplementation cleared for use in the lumbar spine. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the DIVERGENCE-L™ Anterior Oblique Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should have had six months of non- operative treatment. The DIVERGENCEL™ Anterior/ Oblique Lumbar Fusion System interbody device is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System interbody cage is also required to be used with autogenous bone graft. These implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

The Intervertebral Body Fusion Device Systems are intended for vertebral body fixation of the thoracic or lumbar spine during the development of a thoracic or lumbar spinal fusion. Lumbar interbody fusion devices are intended for stabilization use and to promote bone fusion during the normal healing process following surgical correction of disorders of the spine.

This document [K191788](https://510k.innolitics.com/search/K191788) is a 510(k) premarket notification for Medtronic Intervertebral Body Fusion Device Systems (specifically, the CAPSTONE™ Spinal System, CLYDESDALE PTC™ Spinal System, CRESCENT™ Spinal System, CRESCENT™ Spinal System Titanium, and DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System).

The submission is primarily focused on an MRI Update for these existing devices, meaning the purpose is to provide data demonstrating their safety and compatibility within the Magnetic Resonance (MR) environment. This is a common type of submission for established medical devices when new safety information or a change in labeling regarding MR compatibility needs to be supported.

Based on the provided text, there is no AI/ML component to this specific submission. The "device" in question refers to intervertebral body fusion implants, which are passive mechanical implants, not software algorithms or AI-driven systems. Therefore, most of the requested information regarding acceptance criteria and studies for an AI/ML device is not applicable to this document.

Here's a breakdown based on the information provided, highlighting the absence of AI/ML-specific details:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable (N/A) for an AI/ML test set.
• The performance data provided is for MR safety testing of physical implants, not an AI/ML algorithm. The "test set" would consist of the physical devices themselves and the materials they are made from, subjected to various MR field conditions in a lab environment.
• Data provenance is typically from controlled laboratory testing environments, not patient data in the context of AI/ML.

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

• Not Applicable (N/A). This is a question relevant to AI/ML model evaluation involving human expert interpretation. For physical device MR safety testing, ground truth is established by physical measurements and compliance with ASTM standards, not expert consensus on interpretations.

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

• Not Applicable (N/A). Adjudication methods are for human interpretation of data, often in AI/ML performance studies. MR safety testing involves physical measurements and engineering evaluations.

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 (N/A). There is no AI/ML component or human-in-the-loop scenario described in this submission. This is a K-number for physical intervertebral body fusion devices and their MR compatibility, not an AI/ML software.

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

• Not Applicable (N/A). This document concerns physical intervertebral body fusion implants, not a standalone AI/ML algorithm.

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

• Not Applicable (N/A) in the context of AI/ML.
• For the MR safety testing, the "ground truth" (or reference standard) is defined by the ASTM test methods and their specified thresholds/parameters. For example, a certain level of magnetically induced displacement is acceptable, and exceeding that is considered unsafe.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML algorithm in this submission, and therefore no training set.

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

• Not Applicable (N/A). There is no AI/ML algorithm or training set discussed in this document.

Summary of Document K191788:

This 510(k) premarket notification is for intervertebral body fusion device systems (implants used in spinal surgery). The core of this particular submission is an MRI Update, which means the manufacturer is providing data to demonstrate the safety and compatibility of these existing physical implants when subjected to Magnetic Resonance (MR) imaging environments. The document details the various predicate devices and the indications for use of the Medtronic systems. The "performance data" section explicitly lists MR safety testing conducted according to recognized ASTM standards. The conclusion states that based on this data, the devices are "as safe and effective as the following predicates" and have been appropriately labeled for MR safety. The document does not involve any artificial intelligence, machine learning, or software algorithm performance evaluation.

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The CAPSTONE® Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CAPSTONE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CAPSTONE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CAPSTONE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach.

The CLYDESDALE® Spinal System is intended to be used in interbody fusion procedures for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. When used for these indications, the CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine. Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. These patients should be skeletally mature and have had six months of nonoperative treatment. The CLYDESDALE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach.

CLYDESDALE® Spinal System: The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The purpose of this 510(k) submission is to expand the indications of the CLYDESDALE® Spinal System to allow the device to be used with the aforementioned allogenic bone graft.

CAPSTONE® Spinal System: The CAPSTONE® Spinal System consists of PEEK cages, titanium alloy cages and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. The CAPSTONE® Spinal System includes various instruments, including trials used to assist in placement of the implants. The purpose of this 510(k) submission is to expand the indications of the CAPSTONE® Spinal System to allow the device to be used with the aforementioned allogenic bone graft.

This document describes a 510(k) premarket notification for the Medtronic Sofamor Danek USA CLYDESDALE® Spinal System and CAPSTONE® Spinal System. The purpose of this submission is to expand the indications for these intervertebral body fusion devices to allow the use of allogenic bone graft.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing specific performance acceptance criteria for a novel device. The "acceptance criteria" here relate to demonstrating that the expanded indication (use with allogenic bone graft) does not introduce new safety or effectiveness concerns.

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

• Sample Size: Not explicitly stated as a separate "test set" for a new study. The submission refers to "Published retrospective clinical data." The sample size of these published studies is not provided in this document.
• Data Provenance: The data is "retrospective clinical data" from published sources. The country of origin is not specified but implicitly refers to data relevant to demonstrating the use of allogenic bone graft in lumbar interbody fusion.

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

This type of information is generally not applicable to a 510(k) submission that relies on demonstrating substantial equivalence to predicate devices and referencing published clinical literature. The "ground truth" here is derived from the established surgical outcomes and safety profiles reported in professional medical literature concerning the use of allogenic bone graft in spinal fusion. There isn't a specific "test set" with ground truth established by a panel of experts for this particular submission.

4. Adjudication Method for the Test Set

Not applicable. As noted above, there isn't a specific test set requiring adjudication in the context of this 510(k) submission.

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 submission concerns spinal fusion devices and bone graft materials, not AI-assisted reading or diagnostic imaging.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This submission does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth used is based on:

• Clinical Outcomes/Safety Data: As reported in "published retrospective clinical data" regarding the use of allogenic bone graft in interbody fusion procedures. This data serves as evidence for the safety and effectiveness of the expanded indication.
• Established Predicate Device Performance: The primary ground truth for a 510(k) is the demonstrated safety and effectiveness of the legally marketed predicate devices. The submission asserts that the subject devices are identical in design and materials to the predicates, and the expanded indication does not alter this fundamental equivalence.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that would involve a training set.

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

Not applicable, as there is no training set for this type of device submission.

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The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Additionally, the CAPSTONE® Spinal System is indicated in the setting of spinal deformity as a supplement to pedicle screw fixation in patients diagnosed with degenerative scoliosis.

These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The purpose of this 510(k) submission is to add additional CAPSTONE® Spinal System implants with 3°. 6° and 9° options for angles of lordosis. The subject devices are being included to this system in order to provide the surgeon with additional options to accommodate varving patient anatomies. Additionally, subject trial instruments corresponding to the angles of lordosis of the subject implants are included in this submission.

The CAPSTONE® Spinal System consists of PEEK cages, titanium allov cages and titanium cage of various widths and heights. which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The CAPSTONE® Spinal System includes various instruments, including trials, used to assist in placement of the implants.

The provided text is a 510(k) Summary for the CAPSTONE® Spinal System, a medical device. It describes the device, its indications for use, and its substantial equivalence to previously marketed predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Based on the provided 510(k) summary, the device is a spinal implant, and the submission is to add additional angles of lordosis options. For this type of device, the "acceptance criteria" and "study" are not based on diagnostic performance metrics (like sensitivity, specificity, AUC) or clinical trials directly comparing the device to a standard of care in human patients for effectiveness. Instead, the acceptance criteria are met by demonstrating substantial equivalence to predicate devices through non-clinical testing and risk analysis.

Here's a breakdown of the requested information:

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

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical or diagnostic imaging study. The "test set" here refers to the device modifications themselves.
• Data Provenance: The data provenance for demonstrating substantial equivalence comes from the manufacturer's internal risk analysis and engineering rationale. This is typically based on design specifications, material properties, and potentially bench testing data (which isn't detailed here but is implied by "additional supporting documentation"). 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

• This is not applicable for this type of device submission. The "ground truth" for a spinal implant is its mechanical integrity, biocompatibility, and ability to perform its intended function, which are assessed through engineering and material science principles, not expert consensus on image interpretation or clinical outcomes in a test set.

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

• Not applicable. Adjudication methods like "2+1" typically refer to reconciling disagreements between multiple human readers in a diagnostic study. This submission relies on engineering and regulatory assessment, not human reader adjudication.

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 (MRMC) comparative effectiveness study was not done. This device is a spinal implant, not an AI diagnostic tool.

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

• Not applicable. This is not an AI algorithm.

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

• The "ground truth" for this device's acceptance is based on engineering and material science principles, demonstrating that the device modifications (additional lordosis angles) maintain the same levels of safety and performance as the previously cleared predicate devices. This involves demonstrating that the mechanical strength, materials, and design features are equivalent or superior such that no new risks are introduced.

8. The sample size for the training set

• Not applicable. "Training set" refers to data used to train an AI algorithm. The CAPSTONE® Spinal System is a physical medical device.

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

• Not applicable, as there is no training set for an AI algorithm.

In summary, this 510(k) submission for the CAPSTONE® Spinal System is a demonstration of substantial equivalence to predicate devices for minor design modifications. The "acceptance criteria" and "study" are primarily based on non-clinical engineering assessments and risk analyses, rather than clinical trials or diagnostic performance studies involving human subjects or AI.

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The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These implants are to be used with autogenous bone graft. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The purpose of this 510(k) submission is to include additional sizes of PEEK cages, an inserter and to make minor clarifications to the CAPSTONE® Spinal System IFU.

The CAPSTONE® Spinal System consists of Polyetheretherketone (PEEK) cages, titanium alloy and titanium cages of various widths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to provide support and correction of the lumbar spine during lumbar interbody fusion surgeries. The hollow geometry of the CAPSTONE® implants allows them to hold autogenous bone graft material.

Here's an analysis of the provided text regarding the CAPSTONE® Spinal System 510(k) summary, specifically addressing the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not mention a clinical test set or human data. All testing described is non-clinical bench testing. Therefore, there is no information on sample size for a test set, nor data provenance (country of origin, retrospective/prospective) for clinical data.

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

Not applicable. No clinical test set or ground truth established by experts is mentioned, as all testing was non-clinical bench testing.

4. Adjudication Method for the Test Set

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

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

No. The document explicitly states: "No clinical testing was performed." Therefore, no MRMC study was conducted, and no effect size on human readers' improvement with AI vs. without AI assistance can be reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device described is a spinal implant system, not a software algorithm or AI device.

7. Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was established by standardized mechanical testing methodologies (ASTM F2077-03 and ASTM F2267-04) where the predicate device served as the benchmark for performance and safety equivalence.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or algorithm-based system that requires a "training set" in the computational sense. The "training data" for the device's design and manufacturing would implicitly be the specifications and performance data of the predicate devices.

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

Not applicable in the context of an AI training set. For the design and development of the new PEEK cage sizes and inserter, the "ground truth" for the predicate devices' performance and safety was established through their prior FDA clearance (e.g., K073291, K103731, K120368, K110543, K094025), which would have involved their own comprehensive testing and review processes. The current submission relies on the established safety and effectiveness of these predicates.

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The CAPSTONE® Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an anterior and/or transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The CAPSTONE® PEEK Spinal System consists of a variety of hollow vertebral body spacers featuring a convex, bullet nose design and an axial void designed to hold bone graft material. The subject device is made of various lengths. The subject devices are designed with angular teeth to allow the implant to grip the superior and inferior end plates, thus allowing expulsion resistance. The devices range from 6mm to 16mm in height and from 22mm to 36mm in length.

This document describes a 510(k) submission for the CAPSTONE® Spinal System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical trial with specific acceptance criteria and performance studies in the way an AI algorithm might be evaluated. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

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

This is Not Applicable in the context of a 510(k) for a spinal implant. The evaluation is primarily based on demonstrating substantial equivalence to existing, legally marketed predicate devices through design comparison, material analysis, and in vitro mechanical testing. It does not involve a "test set" of patient data or clinical images like an AI device would.

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

This is Not Applicable. Ground truth, expert review, and clinical outcomes for a "test set" are not part of a 510(k) substantial equivalence determination for this type of device. The "ground truth" here is established by the existing regulatory clearance and safety/effectiveness history of the predicate devices.

4. Adjudication Method for the Test Set

This is Not Applicable. There is no "test set" in the context of an adjudication method for this type of 510(k) submission.

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

This is Not Applicable. MRMC studies are used for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This device is a surgical implant and does not involve AI assistance for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is Not Applicable. This device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for the device's acceptable safety and effectiveness is implicitly derived from the long-standing clinical use and regulatory clearance of the identified predicate devices. The submission demonstrates that the CAPSTONE® Spinal System shares fundamental technological characteristics (design, materials, indications for use) and performs similarly to these legally marketed predicates.

8. The Sample Size for the Training Set

This is Not Applicable. There is no "training set" for an AI algorithm in this context.

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

This is Not Applicable. There is no "training set" for an AI algorithm in this context.

Summary of the Study that Proves the Device Meets Acceptance Criteria for this 510(k) Submission:

The provided text indicates that the CAPSTONE® Spinal System demonstrated substantial equivalence through:

• Documentation and Mechanical Test Results: The submission included data from mechanical tests to show that the device's physical and functional properties (e.g., strength, stability, expulsion resistance, as implied by the "angular teeth") are comparable to the predicate devices. While specific test details or quantitative results are not in this summary, they would have been part of the full 510(k) submission.
• Published Literature: Relevant scientific and clinical literature was likely used to support the safety and effectiveness of the design principles and materials used, especially concerning intervertebral body fusion devices.
• Comparison to Predicate Devices: The core of the evidence relies on a detailed comparison to five specific, previously cleared interbody cages:
  • LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek)
  • BAK® Cage (P950002, Zimmer Spine)
  • RAY® Threaded Fusion Cage (P950019, Stryker)
  • Lumbar I/F Cage (P960025, DePuy)
  • PARAMOUNT INTERVERTEBRAL BODY FUSION Device (K072120, Innovative Spinal Technologies)

The study essentially demonstrated that the CAPSTONE® Spinal System is "as safe and effective as, and performs as well as" these predicate devices by showing equivalent design, materials (e.g., PEEK), indications for use, and mechanical performance.

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