(67 days)
The ShurFit 2C Interbody Fusion Devices (LLIF and TLIF) are indicated for intervertebral body fusion of the spine in skeletally mature patients. The device is designed to be used with autograft to facilitate fusion. One device is used per intervertebral space for the LLIF and TLIF.
The ShurFit 2C Interbody Fusion Devices (LLIF and TLIF) are intended for use at either one level or two contiguous levels in the lumbar spine, for 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 2C Interbody Fusion System (LLIF and TLIF) consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy and graft material size. It is to be packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured from medical grade polyetheretherketone (PEEK Optima, LT1), and coated with Commercially Pure Titanium in compliance with ASTM F1580, and Hydroxyapatite in compliance with ASTM F1185-03. The products are supplied clean and "STERILE". The cages are included without a coating (already cleared K092193) or with a Cp Ti-HA (Commercially Pure Titanium - Hydroxyapatite) coating (this submission).
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the ShurFit 2C Lumbar Interbody Fusion System. It does not contain information about an AI/ML-based device or a study proving its performance against acceptance criteria in the context of AI/ML.
The acceptance criteria and study described in this document relate to the mechanical and physical performance of a spinal implant, not a diagnostic AI/ML algorithm. Therefore, I cannot extract the information required to populate the fields related to AI/ML device performance, such as sample size for test sets, expert ground truth establishment, MRMC studies, or training sets.
The information provided in the document focuses on:
- Device Description: Lumbar interbody fusion system made of PEEK Optima LT1, with or without a CpTi-HA coating.
- Purpose of Submission: To add CpTi-HA coated cages to an already cleared system.
- Indications for Use: Intervertebral body fusion for degenerative disc disease.
- Technological Characteristics: Comparison to predicate devices, emphasizing the new coating.
- Non-Clinical Testing: Mechanical performance tests (e.g., static/dynamic axial compression, shear, expulsion, subsidence) and coating property tests (e.g., tensile bond strength, shear fatigue, solubility).
Therefore, I cannot fulfill the request as it pertains to an AI/ML device.
§ 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.