(95 days)
The AbacusTM Spacer System is indicated for interverebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The AbacusTM Spacer System is to be used with autogenous bone grafi and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment with an intervertebral body fusion device.
The Abacus™ Spacer System is an intervertebral body fusion device manufactured from PEEK-OPTIMA (ASTM F2026) and includes tantalum markers (ASTM 560/ISO 13782). The Abacus™ Spacer System is available in a variety of shapes and sizes to accommodate variations in anatomy. The Abacus™M Spacer System is a rectangular-shaped device with a textured "tooth" pattern on both the superior and inferior surfaces designed to resist migration of the device once it is surgically positioned. The device also incorporates an internal cavity that allows for the placement of autograft material.
This document describes the Abacus™ Spacer System, an intervertebral body fusion device. The acceptance criteria and the study that proves the device meets the acceptance criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static Axial Compression (per ASTM F2077) | Must meet or exceed the static axial compression requirements for intervertebral body fusion devices as defined in ASTM F2077. | Performed and reported as demonstrating substantial equivalence to predicate. |
| Mechanical Performance | Dynamic Axial Compression (per ASTM F2077) | Must meet or exceed the dynamic axial compression requirements for intervertebral body fusion devices as defined in ASTM F2077. | Performed and reported as demonstrating substantial equivalence to predicate. |
| Mechanical Performance | Static Compression Shear (per ASTM F2077) | Must meet or exceed the static compression shear requirements for intervertebral body fusion devices as defined in ASTM F2077. | Performed and reported as demonstrating substantial equivalence to predicate. |
| Mechanical Performance | Dynamic Compression Shear (per ASTM F2077) | Must meet or exceed the dynamic compression shear requirements for intervertebral body fusion devices as defined in ASTM F2077. | Performed and reported as demonstrating substantial equivalence to predicate. |
| Mechanical Performance | Subsidence (per ASTM F2267) | Must meet or exceed the subsidence requirements for intervertebral body fusion devices as defined in ASTM F2267. | Performed and reported as demonstrating substantial equivalence to predicate. |
| Biocompatibility | Material (PEEK-OPTIMA, ASTM F2026; Tantalum markers, ASTM 560/ISO 13782) | Biocompatibility of materials must be demonstrated for implantable devices. | Manufactured from PEEK-OPTIMA (ASTM F2026) and includes tantalum markers (ASTM 560/ISO 13782), which are widely accepted biocompatible materials for such applications. No specific biocompatibility testing reported in this summary, but reliance on material standards. |
| Substantial Equivalence | Intended Use, Indications for Use, Materials, Performance | Must demonstrate substantial equivalence to legally marketed predicate devices. | The submission concludes "substantial equivalence...in intended use, indications for use, materials and performance" to the StaXx® IBL System and CoRoent® System. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify a "test set" in the context of clinical or image-based data. The performance data presented refers to mechanical testing of the device.
- Sample Size for Mechanical Testing: The document does not explicitly state the number of samples used for each mechanical test (Static and dynamic axial compression, Static and dynamic compression shear, Subsidence). Mechanical testing typically involves multiple samples to establish statistical validity, but the exact numbers are not present here.
- Data Provenance: The mechanical tests were performed by Spine Wave, Inc. in support of the 510(k) submission. These are laboratory tests, not clinical data from patients or countries.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission concerns a physical medical device (intervertebral spacer) and its mechanical performance, not a diagnostic algorithm that requires expert-established ground truth from a test set of images or clinical cases. The "ground truth" for the mechanical tests is derived from the established testing standards (ASTM F2077, ASTM F2267).
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of clinical or image-based data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for an intervertebral body fusion device, not an AI-powered diagnostic tool. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance data in this submission is based on established mechanical testing standards (ASTM F2077 and ASTM F2267). The device's performance is compared against the requirements and specifications outlined in these industry standards to demonstrate mechanical suitability and substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set."
§ 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.