(309 days)
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.
§ 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.