(265 days)
The SAGICO Spinal System - Lucas Expandable Lumbar by SAGICO are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO are to be filled with autogenous bone graft material. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO is intended to be used with supplemental fixation cleared by the FDA to properly utilize this device.
The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO is to be filled with autogenous bone graft material and implanted via an open anterior approach. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO must be used with the additional internal fixation (e.g. anterior plate or cervical pedicle screws) cleared by the FDA to properly utilize this device.
LUMBAR: The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO implants are provided in different shapes to accommodate various surgical approaches to the lumbar spine (posterior, transforaminal [posterolateral] or lateral and can expand to the desired height. The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implant by SAGICO implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO Spinal System – Lucas Expandable Lumbar Spinal Implant by SAGICO implants are to be filled with autogenous bone graft material. Protrusions are located on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
CERVICAL: The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO are interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The SAGICO Spinal System - Carney Expandable Cervical Spinal Implant by SAGICO implant is intended to be used between two contiguous levels from C2 to T1 and placed via an open anterior surgical approach. The implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implants are comprised of PEEK Optima LT1 and include large central hollow window to be filled with autogenous bone graft material. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implants features protrusions located on the top and bottom surfaces of PEEK spacers to engage with superior and inferior endplates of the adjacent vertebrae to resist rotational and expulsion. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO includes internal titanium spin blade offering internal fixation and expansion of 1mm in height allowing low profile insertion. The SAGICO Spinal System – Carney Expandable Cervical Spinal Implant by SAGICO implant is intended to be used with FDA cleared supplemental fixation to properly utilize the device.
MATERIALS: The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implants, and Carney Expandable Cervical Spinal Implants by SAGICO, are implants that are manufactured from medical Grade PEEK (Polyetheretherketone) OPTIMAT LT I (InvibioTM) per ISO 10993-1 USP Class VI, and ASTM F2026, Titanium Alloy per ASTM F136 and Tantalum beads /rods to be Grade IJNS R05200, IJNS R05400 according to ASTM F560.
FUNCTION: The SAGICO Spinal System - Lucas Expandable Lumbar Spinal Implants, and Carney Expandable Cervical Spinal Implants by SAGICO implants are intervertebral body fusion devices to help restore integrity to the spine in the cervical and lumbar regions.
The provided text describes a 510(k) premarket notification for the "SAGICO Spinal System" and focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance data. It does not contain information about a study that proves the device meets acceptance criteria related to an AI/ML-based medical device.
The document details:
- Device Type: Intervertebral Body Fusion Device (implants for spinal fusion).
- Purpose of filing: 510(k) premarket notification to demonstrate substantial equivalence to legally marketed predicate devices.
- Study described: Non-clinical (benchtop) testing to evaluate the mechanical performance of the spinal implants against established ASTM standards. This is done to show the physical device's safety and performance, not the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device's performance, as the document concerns a physical medical implant and its non-clinical testing for 510(k) clearance.
If you have a different document or context related to an AI/ML medical device, please provide it, and I will do my best to answer your questions.
§ 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.