(97 days)
The Spinal USA Interbody Fusion Device 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.
The Spinal USA Interbody Fusion Device ACIF System is intended for use in the cervical spine, from C3 to T1, for the treatment of cervical disc disease defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are 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 autogenuos bone graft. Patients should have at least six months of nonoperative treatment prior to treatment with a lumbar intervertebral fusion device.
The Spinal USA Interbody Fusion Device RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The RPIF device is not meant for stand alone use.
The Spinal USA Interbody Fusion Device consists of implants with various widths, heights, lengths and bone screws to accommodate individual patient anatomy and graft material size. All components are manufactured from Ti-6Al-4V titanium alloy (ASTM F136). The products are supplied clean and "NON-STERILE".
This document primarily focuses on a 510(k) summary for the Spinal USA Intervertebral Body Fusion Device, establishing its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the context of diagnostic accuracy, which is what your questions are geared towards.
The provided text is a regulatory submission for a physical medical implant (intervertebral fusion device), not an AI/software as a medical device (SaMD) that would typically have acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, AUC).
Therefore, I cannot answer questions 1-9 based on the provided text. The document is about:
- Intended Use/Indications for Use: What the device is for and how it's used.
- Device Description: The materials and forms of the device.
- Equivalent Device: Claiming substantial equivalence to predicate devices based on intended use, indications, anatomic sites, performance, and material.
- Regulatory Information: Classification, product codes, and the FDA's formal clearance letter.
There is no mention of "acceptance criteria" for a study in the sense of diagnostic performance, nor any study conducted to assess such performance.
§ 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.