(177 days)
The INTESS Lumbar Cage 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. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade 1 spondylolisthesis at the involved level(s). INTESS Lumbar Cage implants are to be used with autogenous bone graft and implanted via a transforaminal approach, or an open posterior or lateral approach. The INTESS Lumbar Cage implants are to be used with supplemental fixation. Patients should have at least (6) months of non-operative treatment prior to treatment with an intervertebral cage. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.
The INTESS Lumbar Cage was developed as implants for the stabilization of the lumbar spinal column. The INTESS implants have ridges on both their inferior and superior surfaces to prevent migration, and graft windows which help facilitate bony integration. X-ray markers are integrated for visualization of the implants after surgery.
The provided text is a 510(k) summary for a medical device called the INTESS Lumbar Cage. It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to predicate devices.
However, the provided document explicitly states under "6. CLINICAL TEST SUMMARY": "No clinical studies were performed".
This means that the document does not contain any information about:
- Acceptance criteria for device performance based on clinical data.
- A study that proves the device meets specific performance criteria through clinical data.
- Sample sizes for test sets (as no test set from a clinical study was used).
- Number of experts, their qualifications, or adjudication methods for ground truth (as no clinical ground truth was established through expert review).
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (clinical).
- Training set size or how its ground truth was established (as no AI/algorithm training was performed or reported).
The 510(k) summary focuses entirely on non-clinical testing (static and dynamic compression, subsidence, and expulsion) to demonstrate substantial equivalence based on mechanical safety and performance and material properties to legally marketed predicate devices, rather than clinical performance (e.g., efficacy or safety in patient outcomes).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance in a clinical context, as the document explicitly states no clinical studies were performed. The acceptance criteria and "proof" presented are entirely based on the equivalence of mechanical properties to existing devices.
§ 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.