(54 days)
The SCARLET® AL-T system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These spinal implants are to be used with autogenous and /or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
When used with the integrated fixation by the mean of the bone screws provided, the SCARLET® AL-T is a stand-alone system and requires no additional supplemental fixation system.
When used as a lumbar intervertebral fusion device (i.e. without the bone screws provided), the SCARLET® AL-T interbody device must be used with supplemental internal spinal fixation system that has been cleared by the FDA for use in the lumbosacral spine.
The SCARLET® AL-T spinal system is an anterior lumbar interbody fusion device with integrated fixation intended to provide mechanical support to the lumbar spine and maintain adequate disc space until fusion occurs. The SCARLET® AL-T system comprises a range of intervertebral spacers implanted via an anterior approach, and having various sizes, heights, footprints and lordosis so as to adapt individual pathology and different patient's anatomical conditions. The interbody device is a box-shaped spacer with a large central cavity that can receive bone graft intended to promote intervertebral fusion. The SCARLET® AL-T spacers are all made from medical grade titanium alloy conforming to ASTM F136 standard and are produced by additive manufacturing (SLM) according to ASTM F3001. Subsequently the spacer is machined (thread tapping) and polished. The Scarlet® AL-T interbody spacer has a monolithic design that incorporates solid, lattice and porous structures along with superior and inferior rough surfaces intended to increase implant stability into the intervertebral space and bony integration throughout the implant. When used with its integrated fixation, the spacer is crossed by three (3) bone screws protruding into the vertebral endplates. The bone screws are secured by the mean of two (2) cam locks that prevent backing out. The SCARLET® AL-T spinal implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile). Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.The purpose of this submission is to add a 5° range of lordotic intervertebral spacers in 3 footprints (small, medium, a 20mm height to the existing 10° and 15° footprints to the previously cleared SCARLET® AL-T range of devices (K1818) K192993). The solid, lattice and porous structures of the same. No modifications have been made to the intended use, indications for use, materials, manufacturing process, sterilization process.
This document is a 510(k) premarket notification decision letter from the FDA to Spineart SA regarding their Scarlet® AL-T intervertebral body fusion device. It primarily focuses on the substantial equivalence determination for additional lordotic intervertebral spacers to their previously cleared devices.
Based on the provided text, there is no information available regarding the acceptance criteria, the specific study that proves the device meets acceptance criteria, or any of the detailed aspects of a clinical or analytical study as requested in the prompt.
The document states:
- "The present submission introduces only additional references for the interbody spacer and trials." (Page 5)
- "The engineering analysis has demonstrated that SCARLET® AL-T line extension (present submission) does not introduce new worst cases regarding the mechanical testing, so the tests performed on SCARLET® AL-T predicatedevices (K181818 / K192993) are still valid and cover the added cage references." (Page 6)
- "There is no significant difference between the SCARLET® AL-T line extension) and the previously cleared SCARLET® AL-T predicate devices (K1818 / K192993) which would adversely affect the use and performances of the product or raise any issue of safety and effectiveness. Consequently, no new mechanical tests were carried out." (Page 6)
This implies that the current submission relies on the testing and acceptance criteria established for the predicate devices (K181818 and K192993). The document does not provide details about those previous tests or acceptance criteria. It only lists a summary of non-clinical tests conducted on the predicate devices, such as:
- Static and dynamic axial compression (per ASTM F2077)
- Static and dynamic shear compression (per ASTM F2077)
- Static and dynamic torsion (per ASTM F2077)
- Expulsion
- Subsidence (per ASTM F2267)
- Mass loss determination after dynamic testing that passed 5 million cycles.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, or training set details because this information is not contained within the provided FDA 510(k) summary. The document is for a "line extension" of an already cleared device, asserting substantial equivalence based on prior testing, rather than presenting new comprehensive study data for the current 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.