(159 days)
The ShurFit Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system.
The ShurFit Lumbar Interbody System (ALIF, LLIF, TLIF, T-PLIF and PLIF Systems) is intended 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 I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenous autograft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
The ShurFit® Lumbar Interbody System consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy and graft material size. The ShurFit® Lumbar Interbody System implants are offered as PLIF (straight), T-PLIF (oblique), TLIF (curved). ALIF. and LLIF. The implants are to be packed with autogenous bone graft to facilitate fusion. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured either from additive Ti-6Al-4V ELI per ASTM F3001 or from medical grade polyetheretherketone (PEEK Optima, LT1) per ASTM F2026 with or without a coating of Commercially Pure Titanium per ASTM F1580 and Hydroxyapatite per ASTM F1185. PEEK implants contain tantalum markers per ASTM F560. The PEEK implants are provided non-sterile with sterilization instructions; the titanium alloy and the PEEK coated implants are provided sterile.
The provided text is a 510(k) summary for the ShurFit® Lumbar Interbody System, a medical device for spinal fusion. This type of regulatory document is typically focused on demonstrating substantial equivalence to already-marketed predicate devices, rather than an AI-powered device undergoing a new type of clinical study for performance in diagnostic or prognostic tasks.
Therefore, the text does not contain any information regarding:
- Acceptance criteria and reported device performance for an AI system.
- Sample size for a test set or its provenance.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone AI performance study.
- Type of ground truth used for AI studies.
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the performance data section describes non-clinical testing relevant to the mechanical properties of an implantable spinal device:
- Static and dynamic axial compression per ASTM F2077
- Static and dynamic compression shear per ASTM F2077
- Subsidence per ASTM F2267
The conclusion states that "The results of this non-clinical testing show that the strength of the ShurFit® Lumbar Interbody System Implants is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This refers to physical, mechanical performance of an orthopedic implant, not to the performance of a diagnostic or prognostic algorithm.
§ 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.