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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 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 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 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 autogenous bone graft.

This document is a 510(k) summary for the CAPSTONE® Spinal System, which is a premarket notification for a medical device. This type of document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting new clinical study data with acceptance criteria and performance metrics in the way a PMA (Pre-Market Approval) or a clinical trial report would.

Therefore, the input document does not contain the information requested regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth methodologies typically found in clinical evaluation reports for novel devices or software.

The document states:

• "Documentation, including mechanical test result, was provided which demonstrated that the subject CAPSTONE® Spinal System devices are substantially equivalent to the predicate CAPSTONE® Spinal System devices (K073291 SE 04/24/08, K082342 SE 09/15/08) as well as the VERTE-STACK® Spinal System devices (K062073 SE .08/14/06)."

This clearly indicates a predicate comparison approach, not a de novo clinical study with specific acceptance criteria as requested. The "acceptance criteria" here is substantial equivalence to the predicate devices based on mechanical testing and material properties, not clinical performance metrics against a defined standard.

In summary, the provided document does not contain the information needed to fill out the requested table and answer the detailed questions about clinical study design and performance metrics.

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The CAPSTONE® Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative 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 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 CAPSTONE® Spinal System consists of PEEK cages and titanium alloy 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,

This document is a 510(k) summary for a medical device (CAPSTONE® Spinal System) and as such, it primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing detailed acceptance criteria and a comprehensive study report with quantitative performance metrics typical for novel AI/diagnostic device clearances.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or not provided within this type of regulatory submission. The "study" here refers to the documentation of substantial equivalence through mechanical testing and comparison of features and intended use.

Here's an attempt to answer as much as possible based on the provided text, while acknowledging the limitations of this document type:

Acceptance Criteria and Device Performance

Note: The provided 510(k) summary does not specify explicit "acceptance criteria" in terms of performance metrics (e.g., accuracy thresholds, sensitivity, specificity) as one would expect for a diagnostic or AI device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if it matches or is comparable to the predicate device.

Study Details for Substantial Equivalence

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

   • Sample Size: Not specified in terms a number of "cases" or "patients" for a clinical study, as this is primarily a mechanical and design comparison for substantial equivalence. For mechanical testing, the "sample size" would refer to the number of devices tested, which is not provided in this summary.
   • Data Provenance: Not applicable in the context of clinical data for a device demonstrating substantial equivalence based on mechanical testing and comparison to existing predicate devices. The "data" primarily refers to design specifications, material properties, and mechanical test results, not patient data in the typical sense.

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

   • Not applicable. This device is an implant, and the "ground truth" for its performance is established through engineering and biomechanical testing, rather than expert evaluation of diagnostic output.

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

   • Not applicable. There is no "test set" of images or patient data requiring expert adjudication in this 510(k) summary.

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 spinal implant, not an AI or diagnostic imaging device.

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

   • Not applicable. This is a spinal implant, not an algorithm.

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

   • The "ground truth" for this type of device is established through:
     • Mechanical Testing Standards: Compliance with industry standards for spinal implants (e.g., fatigue, compression, expulsion testing).
     • Biocompatibility Standards: Ensuring materials are safe for implantation.
     • Design Specifications: Verification that the device meets its intended design parameters.
     • Predicate Device Performance: The primary "ground truth" is that the new device performs equivalently to previously cleared predicate devices, which have a history of safe and effective use.

7. The sample size for the training set:

   • Not applicable. This is an implant, not a machine learning model requiring a "training set."

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

   • Not applicable.

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