(444 days)
Peridot-PT Anterior Cervical Intervertebral body fusion System
The Peridot-PT Anterior Cervical Intervertebral body fusion system is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and or pain at one or multiple contiguous levels from C2-T1. The Peridot-PT Antervertebral body fusion system is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
The Peridot-PT Anterior Cervical Intervertebral body fusion system is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Peridot-PT Intervertebral body fusion system
The Peridot-PT Intervertebral body fusion system is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. The Peridot-PT Intervertebral body fusion system is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral cage.
The Peridot-PT Cages are a comprehensive portfolio of 3D-pri interbody devices intended to stabilize the spinal segment, restore intervertebral height and to facilitate interbody fusion in the cervical (C2-T1) and lumbar spine (L2-S1).
Designed to treat cervical and lumbar degenerative disc disease, the platform consists of the Cervical, Transforaminal (TLIF), Direct Lateral (LLIF), Anterior (ALIF) and Transforaminal / Posterior Lumbar (T/PLIF) systems. Each system features a full breadth of sizes, footprints, heights and angles.
The devices are intended to be used with supplemental spinal fixation, either applied anterior or posterior (e.g. using posterior pedicle screws, anterior plate system or anterior screw and rod system).
The implant cages are supplied sterilized.
The Peridot-PT Cages are made from Ti-6Al-4V ELI conforming to ASTM F3001 with an additive manufacturing process (Selective Laser Melting). The design contains solid structures and porous structures. The hollow geometry of the implants allows them to be packed with autogenous bone graft, and two of the systems allow for the cages to be packed with allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft.
The hyperlordotic lumbar cages (>20 degree) the form of supplemental fixation should be an anterior plate system.
The provided FDA 510(k) clearance letter and summary for the Peridot-PT Anterior Cervical Intervertebral body fusion System and Peridot-PT Intervertebral body fusion system do not contain information about the device's acceptance criteria or a study proving its performance in a clinical or AI-assisted setting.
The document outlines a typical medical device clearance process for a Class II device, specifically focusing on substantial equivalence to existing predicate devices. This typically relies on:
- Mechanical and Biocompatibility Testing: Ensuring the device's physical properties are safe and effective. The document explicitly mentions "Performance Testing" with ASTM standards (F2077 for static/fatigue and F2267 for subsidence), which are engineering tests for intervertebral body fusion devices, not clinical performance or AI performance.
- Material Equivalence: The document states the devices are made from Ti-6Al-4V ELI conforming to ASTM F3001, which is a standard for titanium alloy implants.
- Indications for Use Equivalence: The indications for use are compared to predicate devices.
Therefore, based solely on the provided text, I cannot answer questions 1 through 9 as they pertain to clinical performance, AI-assisted performance, or the establishment of ground truth for such studies.
The document describes a medical device, an intervertebral body fusion system, which is a physical implant. It does not describe a device that performs any diagnostic or AI-assisted function requiring performance criteria like sensitivity, specificity, or human reader improvement with AI assistance.
In summary, the provided text details the regulatory clearance of a physical medical implant (intervertebral body fusion system) based on substantial equivalence to predicate devices, primarily through engineering performance testing and material compliance, not clinical or AI performance studies.
§ 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.