Search Results

The CAPSTONE CONTROL™ 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 nonoperative 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 CONTROL™ 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. The CAPSTONE CONTROL™ Spinal System implants will be available in heights of 8mm to 18mm, lengths of 22mm, 27, mm, and 32mm, and widths of 9mm or 10mm. In addition, the implants will be available with 0°, 6°, 12°, and 18° of lordosis.

The CAPSTONE CONTROL™ Spinal System is an intervertebral body fusion device.

Here's an analysis of the provided text in relation to acceptance criteria and device performance:

1. Table of Acceptance Criteria and Reported Device Performance

• Static compression testing
• Dynamic compression fatigue testing
• Static compression shear testing
• Dynamic compression shear fatigue testing
• Subsidence
• Rotational testing (due to "insert and rotate" feature) | Demonstrated that the subject device was as safe and effective as the predicate devices. |
  | Material Equivalence | Use of the same fundamental technology and material (Zeniva ZA-500 PEEK with tantalum markers) as predicate devices. | The CAPSTONE CONTROL™ Spinal System implants use Zeniva ZA-500 PEEK material with tantalum markers, identical to the predicate CAPSTONE® Spinal System. |
  | Design Equivalence | Similar convex, bullet-nosed interbody design to contain graft material and facilitate fusion. | Both the predicate and subject devices are convex, bullet-nosed interbody devices designed to contain graft material and facilitate a fusion. |
  | Indications for Use Equivalence | Same indications for use as the predicate CAPSTONE® Spinal System: interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1 (with or without Grade 1 Spondylolisthesis/retrolisthesis), skeletally mature, 6 months non-operative treatment, used with supplemental fixation. | The CAPSTONE CONTROL™ Spinal System has the same indications for use as the predicate CAPSTONE® Spinal System. |
  | Overall Equivalence | Demonstrating substantial equivalence to predicate devices (CAPSTONE® Spinal System (K073291, K103731), BoneBac™ T-PLIF, HOURGLASS®, CoRoent™, PERIMETER®, CRESCENT™) based on risk analysis and test results. | The subject CAPSTONE CONTROL™ Spinal System is determined to be as safe and effective as the predicates. |

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

The document does not explicitly state the sample size for the test set. However, it indicates mechanical testing was conducted. For such devices, samples typically refer to individual devices or components tested according to the standards. The provenance of this mechanical performance data would be laboratory testing performed by Medtronic Sofamor Danek, USA Inc.

The document does not provide details on the geographical origin of the data or whether it was retrospective or prospective, as it pertains to engineering-focused mechanical tests rather than patient studies.

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

This information is not applicable as the studies described are mechanical engineering tests rather than clinical or observational studies requiring expert consensus for ground truth. The "ground truth" here is defined by established engineering standards (ASTM F2077-11 and ASTM F2267-04) and FDA guidance.

4. Adjudication Method for the Test Set

This information is also not applicable for the same reasons as above. Adjudication methods like "2+1" or "3+1" are typical for clinical trials or image interpretation studies to resolve discrepancies in expert opinions. For mechanical testing, the results are objectively measured against predefined pass/fail criteria based on the standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an intervertebral body fusion device (an implantable medical device), not an Artificial Intelligence (AI) or diagnostic imaging system. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

No, a standalone algorithm-only performance study was not done. As mentioned, this is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for demonstrating device performance was engineering standards and regulatory guidance. Specifically:

• ASTM F2077-11: Test Methods for Intervertebral Body Fusion Devices
• ASTM F2267-04: Standard Test Method for Measuring Load Induced Subsidence of the Intervertebral Body Fusion Device under Static Axial Compression
• FDA's Guidance document: Class II Special Controls Guidance Document: Intervertebral Body Fusion Device issued June 12, 2007.

The "ground truth" for this submission is performance that meets the established mechanical requirements outlined in these standards and guidance documents.

8. The Sample Size for the Training Set

This information is not applicable. This submission describes the testing of a finished medical device against established standards, not the training of a machine learning algorithm.

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

This information is not applicable for the same reason as above. There is no training set mentioned in the context of this device submission for machine learning.

Ask a specific question about this device