(240 days)
The VerteLP is indicated for use in skeletally mature patients with Degenerative Disc Discase (DDD) at one or two contiguous levels from L2-L5. 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 I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received 6 months of non-operative treatment with the devices. The device is intended to be used with supplemental fixation to the integrated fixation jaws, and must be used with autograft bone.
The Vertel.P implant is an Intervertebral Body Fusion Device (IBFD) intended to be used in the lumbar spine via a lateral surgical approach. It is intended to stabilize a spinal segment to promote fusion between adjacent vertebral bodies. It also provides indirect decompression to relieve constricted nerve roots. Center apertures have been designed into the VerteLP implant for placement of bone graft to promote fusion through the center of the implant. The device has integrated fixation in the form of laterally- locking jaws to facilitate additional stability. VerteLP is available in a variety of sizes and shapes in order to better accommodate each patient's unique anatomy. The implant is made from Ti6Al4V alloy per ASTM F-136, Zeniva PEEK ZA-500 per ASTM F2026, UHMWPE per ASTM F648 and tantalum per ASTM F560. The devices are available in two widths, heights from 7-17mm and in both parallel and lordotic shapes to accommodate varied patient's anatomy.
The provided document is a 510(k) premarket notification for the "VerteLP Interbody Fusion Device." This type of document is for a medical device that does not require extensive clinical trials to prove safety and effectiveness but rather demonstrates "substantial equivalence" to a predicate device already on the market.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/algorithm-based medical device. This document describes a physical interbody fusion device, not a software algorithm.
Here's why the requested information cannot be extracted from the provided text:
- Acceptance Criteria for AI/Software Performance: The document does not discuss performance metrics like sensitivity, specificity, accuracy, or any other statistical measures typically used for AI-powered diagnostic or predictive tools. Its "performance standards" section refers to mechanical testing for a physical implant.
- Study Design for AI/Software: There is no mention of a test set, training set, data provenance (e.g., country of origin for images), expert adjudication, multi-reader multi-case studies, or standalone algorithm performance. The study described is mechanical testing of the physical implant.
- Ground Truth: The concept of "ground truth" as it applies to AI/software (e.g., expert consensus, pathology, outcome data) is not relevant to this physical device's evaluation. The mechanical tests use specified physical standards.
Instead, the document focuses on:
- Substantial Equivalence: The primary goal of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device.
- Mechanical Testing: Performance is assessed through mechanical tests (static compression, shear, torsion, subsidence, dynamic compression, dynamic compression shear) against established ASTM standards (ASTM F2077-14 and F2267-04).
- Materials and Design: Comparison of material properties (Ti6Al4V alloy, Zeniva PEEK, UHMWPE, tantalum) and physical dimensions (sizes, shapes, heights) to predicate devices.
- Indications for Use: Defining the medical conditions for which the device is intended.
In summary, the provided text does not contain the specific information requested about acceptance criteria and a study proving device performance for an AI/algorithm-based medical device. It pertains to the regulatory submission for a physical interbody fusion 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.