(161 days)
The C-PS is indicated for intervertebral body fusion of the cervical 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 C-PS is intended for use at one level 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 in patients who have had six weeks of non-operative treatment. The C-PS is intended to be used with a supplemental internal fixation system.
The L-PS is indicated for intervertebral body fusion of the lumbar 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 L-PS System 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 in patients who have had six months of non-operative treatment. The L-PS is intended to be used with a supplemental internal fixation system.
The C-PS comprises a closed annular ring, a hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces for resisting migration and expulsion.
The L-PS comprises a closed annular ring with integral anteroposterior cross-piece, a hollow center for placement of bone graft and sawtooth "teeth" on the inferior and superior surfaces for resisting migration and expulsion.
The provided text is a 510(k) Summary for the InterPlate™ C-PS and L-PS Interbody Spacers, which are medical devices. It details the device's description, materials, and intended use, along with a statement of substantial equivalence to previously cleared predicate devices.
However, the document DOES NOT contain information regarding acceptance criteria or a study that proves the device meets those criteria, as typically found in performance testing sections for AI/ML-driven devices or diagnostic tools.
This document pertains to an implantable medical device (interbody spacers), not a diagnostic or AI-enabled software device. Therefore, the questions about acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to the content provided here.
The "study" mentioned in this type of 510(k) is usually focused on substantial equivalence testing, which primarily involves comparing the new device's design, materials, intended use, and performance characteristics to legally marketed predicate devices to ensure it's as safe and effective. This often includes bench testing for mechanical properties (e.g., strength, fatigue) and biocompatibility, rather than clinical efficacy studies on human subjects for performance metrics.
In summary, based on the provided text, I cannot answer the specific questions related to acceptance criteria and a study proving performance, as this document is for an implantable hardware device and does not contain the type of data requested for diagnostic or AI-driven systems.
§ 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.