(181 days)
The Blackhawk™ Ti Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Blackhawk™ Ti Cervical Spacer System is to be used with autogenous bone and/or allogenic bone graft composed of cancellous and /or corticocancellous bone graft, and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.
The Blackhawk™ Ti Cervical Spacer System is an anterior cervical interbody device consisting of a titanium alloy (Ti-4Al-6V ELI) implant cage per ASTM F3001, nitinol internal locking components per ASTM F2063, two internal titanium alloy (Ti-6Al- 4V ELI) anchors per ASTM F136, and a titanium alloy (Ti- 6Al-4V ELI) locking cam per ASTM F136. They are intended for use as interbody fusion devices and offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone and/or allogenic bone graft material. The Blackhawk™ Ti Cervical Spacer System is used with two internal anchors that lock on deployment and provide additional fixation.
The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML algorithm or software.
The document is a 510(k) premarket notification approval letter for the ChoiceSpine Blackhawk™ Ti Cervical Spacer System, which is a medical device for anterior cervical interbody fusion procedures. The content focuses on:
- Regulatory clearance: FDA clearance based on substantial equivalence to predicate devices.
- Device description: Materials (titanium alloy, nitinol), components (implant cage, internal locking components, anchors, locking cam), and sizes.
- Intended use/indications: Anterior cervical interbody fusion for degenerative disc disease at one disc level (C2-T1) with autogenous/allogenic bone graft and supplemental fixation.
- Predicate devices: Comparison to previously cleared ChoiceSpine and Exactech cervical spacer systems.
- Non-clinical testing: Mechanical tests (static subsidence, expulsion, dynamic axial compression, dynamic compression-shear, dynamic torsion) to demonstrate equivalence to predicates. These are engineering performance tests of the physical implant, not studies involving human readers or AI performance.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth types, as these are related to studies evaluating AI/ML-driven medical devices, which is not the subject of this document.
§ 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.