(69 days)
The Alphatec Solus Anterior Lumbar Interbody Fusion (ALIF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades.
The Alphatec Solus® Anterior Lumbar Interbody Fusion (ALIF) System is an intervertebral body fixation system consisting of implants with various heights and lordosis to accommodate individual patient pathology. System implants are manufactured from implant grade polyetheretherketone (PEEK), titanium anchoring blades and tantalum radiographic markers. System instruments are manufactured from stainless steel. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac® Spinal Fixation System, AspidaTM Anterior Lumbar Plating System, ILLICO® MIS Posterior Fixation System, ILLICO® FS Facet Fixation System, or the BridgePoint™ Spinous Process Fixation System.
This document describes the premarket notification for the Alphatec SOLUS® Anterior Lumbar Interbody Fusion (ALIF) System, focusing on non-clinical testing to establish substantial equivalence.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Axial Compression | Per ASTM F2077 Standards (Recognized Consensus) | "All testing passed established acceptance criteria." |
| Dynamic Axial Compression | Per ASTM F2077 Standards (Recognized Consensus) | "All testing passed established acceptance criteria." |
| Compression Shear Testing | Per ASTM F2077 Standards (Recognized Consensus) | "All testing passed established acceptance criteria." |
| Static Torsion | Per ASTM F2077 Standards (Recognized Consensus) | "All testing passed established acceptance criteria." |
| Dynamic Torsion | Per ASTM F2077 Standards (Recognized Consensus) | "All testing passed established acceptance criteria." |
| Subsidence Testing | Per ASTM F2267 Standards (Recognized Consensus) | "All testing passed established acceptance criteria." |
| Static Expulsion Testing | Per ASTM Draft Standard F-04.25.02.02 Standards | "All testing passed established acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify the sample sizes (number of devices tested) for each of the non-clinical tests. It also does not discuss data provenance as these are non-clinical (mechanical) tests, not human studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this document. The device's performance was evaluated against engineering standards, not expert clinical ground truth from a test set of data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are relevant for clinical studies with expert reviewers, not for mechanical testing against predefined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. This document pertains to the mechanical and material equivalence of a medical implant, not an AI or imaging device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established by recognized consensus standards (ASTM F2077, ASTM F2267) and an ASTM Draft Standard (F-04.25.02.02) for mechanical and material properties. These standards define the acceptable range of performance for intervertebral body fusion devices.
8. The Sample Size for the Training Set
This information is not applicable. There is no concept of a "training set" in the context of mechanical endurance and safety testing for a medical implant like the Alphatec SOLUS® system, which does not involve machine learning algorithms.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device and testing.
§ 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.