(195 days)
The STALIF C FLX™ device is intended to be used as an intervertebral body fusion cage as a standalone system used with bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space at one or two contiguous levels from the C2/C3 disc space to the C7/T1 disc space for the treatment of cervical degenerative disc disease (defined as neck pain with degeneration of the disc confirmed by history and radiographic studies). Patients with previous non-fusion spinal surgery at the treated level may be treated. The device system is designed for use with autograft bone graft composed of cancellous and/or corticocancellous bone graft to facilitate fusion.
The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.
The STALIF C FLX™ with lordotic angles greater than or equal to 10 degrees are required to be used with FDA-cleared supplemental fixation for use in the cervical spine.
The STALIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach.
The STALIF M FLX™ is a stand-alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIF M FLX™ with lordotic angles greater than or equal to 20 degrees are required to be used with FDA-cleared supplemental fixation for use in the lumbar spine.
The STALIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open lateral approach. The STALIF L FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.
The STALIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to L5. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the treated. These implants may be implants may be implanted via a laparoscopic or an open lateral approach. The STALIF Lateral-Oblique FLX™ is required to be used with supplementary fixation systems (e.g., pedicle screws) that have been cleared for use in the lumbar spine.
The ACTILIF C FLX™ is intended for spinal fusion procedures at multiple contiguous levels from the C2-C3 disc to the C7-T1 disc in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. The ACTILIF C FLX™ is to be used in a patient who has had six weeks of non-operative treatment prior to implantation of the cage. Implants are intended to be packed with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). Patients with previous non- fusion spinal surgery at the treated. The ACTILIF C FLX™ is intended to be used with a supplemental fixation system.
The ACTILIF M FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. Patients with previous non-fusion spinal surgery at the treated level may be treated. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion and are intended to be used with supplementation that has been cleared by the FDA for use in the lumbar spine.
The ACTILIF L FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplementation that has been cleared by the FDA for use in the lumbar spine.
The ACTILIF Lateral-Oblique FLX™ is indicated for use with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft) in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These 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. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous nonfusion spinal surgery at the treated level may be treated. These devices are intended for intervertebral body fusion and are intended to be used with supplemental fixation instrumentation that has been cleared by the FDA for use in the lumbar spine.
The FLXTM Platform is composed of 8 different interbody fusion implant families:
- STALIF C FLXTM
- STALIF M FLXTM
- STALIF L FLXTM and STALIF Lateral-Oblique FLXTM
- ACTILIF C FLXTM
- ACTILIF M FLXTM
- ACTILIF L FLXTM and ACTILIF Lateral-Oblique FLXTM
The FLX™ Platform is a novel range of interbody fusion implants with a complex randomized lattice. The Implants retain all of the benefits of the STALIF® product family while taking advantage of the benefits of porous, laser sintered Ti6Al4V. With the recent advances in additive manufacturing, titanium implants are printed with a porous scaffold structure which reduces the stiffness of the device to potentially reduce subsidence and facilitate bone growth through and around the implant.
The FLX™ Platform is intended to be implanted between the vertebral bodies into the cleared disc space to help provide stabilization and height restoration and facilitate the interbody fusion process. The device is intended to be used with bone graft (autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft). The devices are available in a variety of heights, lengths, and widths as well as different lordotic angles to provide surgeons with a wide array of solutions for the highly variable patient population. Surgical instrumentation has been previously developed for the STALIF® Platform and is compatible with the new devices.
In addition, interbody-only versions of the FLX™ devices are available in similar size ranges as the STALIF® versions. These devices are not designed to be used with the current STALIF® ABO screw constructs and are instead to be used with supplemental fixation.
This document is a 510(k) premarket notification for a medical device submitted to the FDA, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets them in the context of an AI/human reader performance evaluation.
Instead, this document describes the Centinel Spine FLX™ Platform, a series of intervertebral body fusion devices, and seeks to demonstrate substantial equivalence to previously cleared predicate devices. The "study" mentioned is performance testing focused on mechanical aspects of the implant to ensure it is as safe and effective as existing legally marketed devices.
Here's an breakdown of the information that can be extracted or inferred based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with numerical performance metrics in the way one would see for an AI device's diagnostic performance (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implied by the mechanical testing standards referenced and the outcome of "substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Static Compression per ASTM F2077-14 | Met (demonstrated substantial equivalence) |
| Static Compression-Shear per ASTM F2077-14 | Met (demonstrated substantial equivalence) |
| Dynamic Compression per ASTM F2077-14 | Met (demonstrated substantial equivalence) |
| Dynamic Compression-Shear per ASTM F2077-14 | Met (demonstrated substantial equivalence) |
| Expulsion per ASTM F2077-14 and F2267-04 | Met (demonstrated substantial equivalence) |
| Subsidence per ASTM F2077-14 and F2267-04 | Met (demonstrated substantial equivalence) |
| Wear Debris particle analysis | Ensured results consistent with predicate devices |
The "reported device performance" is a general statement that the testing demonstrated substantial equivalence to predicate devices, meaning it performed comparably to devices already on the market.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document discusses physical device testing, not clinical data or algorithm testing with a test set of data. Therefore, there is no information about a "test set" in the context of patient data, data provenance, or retrospective/prospective studies. The "test set" refers to the physical devices subjected to mechanical testing. The specific number of physical devices (samples) used for each mechanical test is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the document describes mechanical testing of physical medical devices, not a study involving expert review of data/images to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes mechanical testing of physical medical devices, not a study involving expert review of data/images.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document is for a physical implantable medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a physical implantable medical device, not an AI diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" is established by the specified ASTM standards (e.g., F2077-14, F2267-04). These standards define the test methods and performance requirements for intervertebral body fusion devices.
8. The sample size for the training set
This is not applicable. This document is for a physical implantable medical device, not an AI diagnostic tool that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This document is for a physical implantable medical device, not an AI diagnostic tool that requires a training set.
§ 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.