(226 days)
The Chesapeake Spinal System is intended to be used with the bone screws provided and requires no additional supplementary fixation. The Chesapeake implants are intended for spinal fusion procedures in skeletally mature patients who have had six months of non-operative treatment.
When used as intervertebral body fusion devices, the implants are indicated for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. This device is intended to be used with autogenous bone graft.
When used as vertebral body replacement devices the Chesapeake implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Chesapeake implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The interior of the spacer may be packed with allograft or autograft.
The Chesapeake Spinal System consists of PEEK spacers and titanium bone screws for intervertebral body fusion, without the need for supplementary fixation. The spacers are hollow tube structures that can be packed with bone graft and allow for passage of screws for fixation to the vertebral body. Multiple sizes of implants are available to accommodate anatomical variations.
Materials: The spacers are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTMA LT1 (Invibio) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads are Grade UNS R05200, UNS R05400 according to ASTM F560. The screws are fabricated from Ti6Al4V per ASTM 1472.
Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the lumbar segments of the spine.
The provided document is a 510(k) summary for the Chesapeake Spinal System, an intervertebral body fusion device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the document does not contain information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets, data provenance, number of experts for ground truth, or adjudication methods for a study.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
- Standalone (algorithm only) performance studies.
- The type of ground truth used in such studies.
- Sample size for training sets or how ground truth for training sets was established.
Instead, the document states:
"Documentation was provided which demonstrated that the subject Chesapeake Spinal System components are substantially equivalent to the K2M Aleutian Interbody Spacer Systems (K051454, K082698), Surgicraft Stalif System (K073109), Synthes Synfix (K062083, K072253), Spinal Elements (K083475), and Biomet Solitaire (K081501)."
And further, it claims:
"There are no significant differences between the Chesapeake Spinal System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use."
This indicates that the "study" proving the device met its acceptance criteria was a substantial equivalence comparison to predicate devices, rather than a new performance study against pre-defined acceptance criteria. The acceptance criteria for a 510(k) submission are typically that the device is as safe and effective as a legally marketed predicate device, based on comparison of technological characteristics, materials, and intended use. Performance data, if present in a 510(k), is usually bench testing or non-clinical data demonstrating equivalence to the predicate, not clinical performance against specific acceptance metrics.
§ 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.