(24 days)
The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. 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 Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.
The Incite Anchored Cervical Interbody (ACI) Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Device is manufactured from PEEK and Ti 6A1 4V titanium alloy with tantalum radiopaque markers.
Purpose of this 510(k) submission: The purpose of this submission is to add the updated ACI II Inserter to the ACI System. The ACI II Inserter is used with the Incite Innovation Anchored Cervical Interbody Device. The inserter places the implant in the surgical site, deploys the anchor and detaches from the implant. The patient contacting material of the inserter is stainless steel (SS 17-4). The ACI II Inserter has been modified to be smaller, lighter in weight and easier to use.
The provided text describes a 510(k) premarket notification for the Incite Anchored Cervical Interbody Device, specifically focusing on an updated inserter (ACI II Inserter). It does not contain information about acceptance criteria or a dedicated study proving the device meets distinct performance criteria and does not describe AI/ML aspects of a medical device.
Key points from the document regarding "performance data":
- Device Under Review: The primary focus of this 510(k) submission (K150913) is to add an "updated ACI II Inserter to the ACI System." The Incite Anchored Cervical Interbody Device itself (the implant) has not changed since previous submissions (K130306 and K122008).
- Performance Data Provided: The section "VII. PERFORMANCE DATA" specifically addresses the ACI II Inserter.
- Design Verification: Involved "verification of the ACI II Inserter component dimensions performed through Device Interface Analysis (DIA)." This analysis aimed to ensure "that the interfacing components fit and function as specified for the components of the instrument as well as, the instrument with the implant."
- Design Validation: "Based on products requirements for the ACI II Inserter and on the previous inserter user validation methodology (ACI Inserter, K122008 & K130306)." This validation used a "human cadaver demonstrated that the instrument met the user's needs in terms of overall use by attaching, placing, deploying and detaching from the implant."
- Conclusion: "Verification and validation data demonstrate that the performance and functionality of the ACI II Inserter is substantially equivalent to the ACI Inserter."
Therefore, based on the provided text, I cannot answer the specific questions about acceptance criteria, detailed study results, sample sizes for test/training sets, expert qualifications, or AI/ML-related performance metrics because this information is not present. The document focuses on demonstrating substantial equivalence of a modified surgical instrument, not a new implant or an AI/ML-driven device.
§ 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.