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The CLYDESDALE® 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® Spinal System is used 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 I 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 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. These implants may be implanted via a minimally invasive lateral approach.

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 autogenous bone graft. When used to supplement pedicle screw fixation systems in adult degenerative scoliosis cases, the CLYDESDALE® device is used as a construct anchor and to help restore sagittal and coronal balance.

The provided text is a 510(k) summary for the CLYDESDALE® Spinal System, focusing on expanding its indications for use. This document describes a medical device (spinal interbody fusion device) and its regulatory clearance process, not a clinical study or an AI/software device. Therefore, the information requested about acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or extractable from this type of regulatory submission.

The document primarily states that:

• The CLYDESDALE® Spinal System is used with autogenous bone graft for interbody fusion.
• It's intended for patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1, potentially with Grade I Spondylolisthesis or retrolisthesis.
• The new indication is to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation.
• The device components are identical to those previously cleared, and no new implants are included.
• No additional testing was required or performed for this specific 510(k) submission to expand the indication. Instead, the submission relies on existing clearances and published retrospective clinical data for the CLYDESDALE® Spinal System and similar predicate devices (like CAPSTONE® Spinal System).

The summary discusses the comparability of patient outcomes (pain scores, deformity correction) to those reported in the literature for similar procedures using predicate devices. However, this is not presented as a controlled study with specific acceptance criteria or a direct measurement of "device performance" in the way a diagnostic AI algorithm might be evaluated.

Therefore, I cannot populate the requested table and answer the specific questions because the provided document does not contain the type of study data (e.g., performance metrics against acceptance criteria, ground truth establishment, sample sizes for specific performance tests) that would be relevant to evaluating a novel medical device's performance or an AI algorithm. The document focuses on regulatory equivalence based on existing data and prior clearances.

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The CAPSTONE® L 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 CAPSTONE® L 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 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 a minimally invasive lateral approach.

The CAPSTONE® L Spinal System consists of spacers of various widths and heights made of PEEK with tantalum markers. The spacers can be inserted between two lumbar or lumbo-sacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The implant has non-lordotic and 6° lordotic options. The superior and inferior surfaces of the implant are designed with teeth that interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them to be packed with autogenous bone graft. The implants are provided sterile by gamma irradiation, and are to be used with supplemental fixation. CAPSTONE® L Spinal System is used with new reusable instrumentation that enables the surgeon to implant the devices via a lateral approach.

The CAPSTONE® L Spinal System is a medical device designed for lumbar interbody fusion surgeries. The submission document focuses on demonstrating substantial equivalence to predicate devices through non-clinical mechanical testing.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size (number of implants tested) for each mechanical test. It only mentions that "All mechanical testing met the predetermined acceptance criteria." The data provenance is from non-clinical tests performed by Medtronic Sofamor Danek. This is retrospective in the sense that the device was manufactured, and then tested, rather than a prospective study design with human subjects.

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

Not applicable. This study involves mechanical testing of a physical device, not subjective interpretation of data (e.g., images) by experts. The "ground truth" for these tests is the physical behavior of the device under defined loads, measured by standard testing equipment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this study involves mechanical testing, which does not require an adjudication method by experts. The results are quantitative measurements against predefined 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

Not applicable. This is not an AI/software device and therefore no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not applicable. This is a physical intervertebral body fusion device, not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established engineering principles, FDA guidance documents, and standardized test methods (ASTM F2077, ASTM F2267). The "ground truth" essentially refers to the expected mechanical performance parameters derived from these standards and comparison to the predicate device's known performance.

8. The Sample Size for the Training Set

Not applicable. This is a physical device undergoing mechanical testing, not a machine learning model requiring a training set.

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

Not applicable. As this is not a machine learning study, there is no training set or ground truth in that context.

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