Search Results

The Ancora LLC Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The device must be used with supplemental fixation (i.e., lateral plating or pedicle screw systems), which is in addition to the integrated locking plates provided in the system. When used with the integrated locking plates, it is indicated to be used at one level from L2-L5. When used without the integrated locking plates, it is indicated to be used at one or two contiguous levels, from L2-S1. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). It is indicated to be used with autograft bone.

The Ancora system consists of different footprints and heights to provide options that correlate best to an individual's anatomy and pathology. The system offers optional integrated locking plates with corresponding locking pins. Implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F136 and PEEK Optima LT1 per ASTM F2026 with tantalum markers per ASTM F560. Supplemental anterior and/or posterior fixation is intended for use with the device to ensure stability of the spine.

The purpose of this submission is to add implant configurations to the Ancora LLC line of implants, and modify the indications for use so the locking plates are optional fixation devices. Surgical Instruments are also available for use with the system.

This document describes the Ancora LLC Interbody Fusion Device, a medical device designed to facilitate spinal fusion. The information provided outlines its intended use, technical specifications, and the testing conducted to demonstrate its substantial equivalence to previously approved devices.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria Description	Reported Device Performance (from Performance Data section)
   Static Axial Compression	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
   Dynamic Axial Compression	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
   Static Compression Shear	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
   Dynamic Compression Shear	Completed following ASTM F2077. Indicated substantial equivalence to predicate devices and adequacy for intended use.
   Expulsion Testing	Conducted following a recognized protocol to allow comparison evaluation of intervertebral body fusion device assemblies, and characterize their resistance to expulsion. Indicated substantial equivalence to predicate devices and adequacy for intended use.

   Note: The document states that the pre-clinical testing "indicated that the Ancora LLC Interbody Fusion Device is substantially equivalent to the predicate devices and is adequate for the intended use." Specific quantitative performance metrics (e.g., measured load capacities, displacement values) are not provided in this summary, only that the testing was performed according to relevant standards and the results met the criteria for substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:
   The provided document describes pre-clinical bench testing (static and dynamic axial compression, static and dynamic compression shear, and expulsion testing) of the device. This type of testing typically involves physical samples of the device itself rather than patient data. Therefore, the concepts of "sample size used for the test set" in terms of patients and "data provenance" (country of origin, retrospective/prospective) are not applicable to this pre-clinical performance data. The testing was conducted on device specimens in a laboratory setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
   Not applicable. As this is pre-clinical bench testing, there is no "ground truth" established by human experts in the way it would be for clinical data interpretation (e.g., radiologists assessing images). The acceptance criteria for mechanical performance tests are defined by ASTM standards and scientific principles, not expert consensus on individual cases.

4. Adjudication Method for the Test Set:
   Not applicable. Since expert human assessors are not involved in establishing ground truth for mechanical bench testing, an adjudication method is not relevant. The results are physical measurements compared against predefined engineering standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
   No. The document does not describe any MRMC comparative effectiveness study, as the filing pertains to pre-clinical bench testing of a spinal fusion device, not an AI or imaging diagnostic tool.

6. Standalone Performance Study:
   Yes, implicitly. The "Performance Data" section describes pre-clinical bench testing of the Ancora LLC Interbody Fusion Device itself. This testing evaluates the device's mechanical properties and resistance to expulsion in isolation, without human interaction during its function. This is a standalone evaluation of the device's physical performance.

7. Type of Ground Truth Used:
   For the mechanical performance testing, the "ground truth" is defined by the acceptance criteria established by engineering standards (ASTM F2077) and a "recognized protocol" for expulsion testing. The device's performance measurements are compared against these established specifications to determine if they meet the requirements for substantial equivalence.

8. Sample Size for the Training Set:
   Not applicable. This document describes the pre-clinical bench testing of a physical medical device. It does not involve AI algorithms, machine learning models, or the use of training data sets in the computational sense.

9. How the Ground Truth for the Training Set Was Established:
   Not applicable. As there is no training set for the type of device and testing described, the method for establishing its ground truth is irrelevant.

Ask a specific question about this device