(89 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 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 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 Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by the mean of the bone screws provided and ALSO additional supplemental 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 subject product line extension consists of an extended range of titanium alloy spacers intended to be used with the three unicortical cancellous bone screws previously approved (K181818).
Scarlet® AL-T product line extension comprises a range of hyperlordotic 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 Scarlet® AL-T Hyperlordotic (≥ 20°) cages are to be used with BOTH the integrated fixation by the mean of the bone screws provided and ALSO additional supplemental fixation system that has been cleared by the FDA for use in the lumbosacral spine.
The provided text describes a medical device, the Scarlet® AL-T intervertebral body fusion device, and its substantial equivalence to predicate devices, supported by non-clinical testing. However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of AI performance, human reader improvement with AI assistance, or standalone algorithm performance.
The document is a 510(k) summary for a spinal implant, which means the "acceptance criteria" are related to mechanical and biological performance, and the "study" is non-clinical testing. It explicitly states, "Based on the static testing results and engineering analysis it has been determined that dynamic testing was not necessary." This further confirms the absence of clinical trials or AI-related performance studies.
Therefore, I cannot fulfill the request for information regarding AI performance, human reader improvement, standalone performance, or sample sizes related to such studies, as this information is not present in the provided text.
Here is a partial answer based only on the information available in the document, focusing on the mechanical acceptance criteria and the non-clinical study conducted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static Axial Compression (ASTM F2077-18) | Comparable to predicate device | Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818). |
| Mechanical Performance | Static Shear-compression (ASTM F2077-18) | Comparable to predicate device | Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818). |
| Mechanical Performance | Static Torsion (ASTM F2077-18) | Comparable to predicate device | Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818). |
| Mechanical Performance | Subsidence (ASTM F2267-04) | Comparable to predicate device | Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818). |
| Mechanical Performance | Expulsion (ASTM Draft F-04.25.02.02) | Comparable to predicate device | Results demonstrate comparable mechanical properties to the predicate device Scarlet® AL-T (K181818). |
| Biocompatibility | Bacterial Endotoxin Testing (USP standard) | Endotoxin limit of |
§ 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.