(131 days)
HEDRON C™ Spacers and HEDRON IC™ Spacers are interbody fusion devices indicated at one or more levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.
HEDRON C™ Spacers and HEDRON IC™ Spacers are intended to be used with supplemental fixation, such an anterior cervical plate or posterior cervical fixation. These devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone.
When the HEDRON IC™ Spacer is used with the COALITION AGX® Plate, the plate-spacer assembly (HEDRON IC™ Plate-Spacer) is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. These devices are to be used with two titanium alloy screws which accompany the implants (≥20°) must be used with supplemental fixation in addition to the two screws.
HEDRON™ Cervical Spacers (HEDRON CTM and HEDRON ICT™) are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. HEDRON ICT™ Spacer may be assembled to the COALITION AGX® Plate to create the HEDRON ICT™ Plate-Spacer, a stand-alone cervical interbody fusion device. HEDRON™ Spacers are additively manufactured from titanium alloy, as specified in ASTM F3001.
The provided document is a 510(k) summary for a medical device (HEDRON™ Cervical Spacers), which focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data. It does not describe an AI medical device or a clinical study that establishes acceptance criteria and proves the device meets those criteria from an AI performance perspective.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance for an AI model, as this document is not about an AI medical device.
The document discusses:
- Device Name: HEDRON™ Cervical Spacers
- Intended Use: Interbody fusion devices for cervical spine
- Mechanical Testing: Static and dynamic compression, torsion, compression-shear, subsidence, and expulsion in accordance with specific ASTM standards and FDA guidance.
- Basis of Substantial Equivalence: Similar technological characteristics (design, intended use, material composition, sizes) to predicate devices.
However, none of this relates to AI performance metrics, ground truth establishment, expert adjudication, or MRMC studies for AI 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.