(100 days)
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.
| Acceptance Criteria (Implicit for 510(k) with expanded indication) | Reported Device Performance (Summary of evidence) |
|---|---|
| No new risks to patients with the expanded indication (allogenic bone graft) | Published retrospective clinical data for similar lumbar interbody fusion devices demonstrate that the use of allogenic bone graft in interbody fusion procedures for the specified patient population poses no new risks. |
| Maintenance of substantial equivalence to predicate devices with the expanded indication | The devices are identical in design to their respective predicates (K133577 for CLYDESDALE®, K133650 for CAPSTONE®). No changes were made to the existing devices or new components added. The only change is the inclusion of allogenic bone graft as an option. |
| Design and material consistency with predicates | Both systems are manufactured from the same materials as their respective predicates. |
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.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.