(83 days)
The Abacus™ Spacer System is indicated for intervertebral 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 at the involved level(s). The Abacus™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.
The Abacus™ Spacer System is an intervertebral body fusion device manufactured from PEEK-OPTIMA (ASTM F2026) with tantalum markers (ASTM F560) and a plasmasprayed commercially pure titanium coating (ASTM F1580). The Abacus™ Spacer System is available in a variety of shapes and sizes to accommodate variations in anatomy. The Abacus™ Spacer System is a rectangular-shaped device with the titanium coating on both the superior and inferior surfaces. The device also incorporates an internal cavity that allows for the placement of autograft material.
Here's a breakdown of the requested information based on the provided document:
The provided document describes a 510(k) submission for the Abacus™ Spacer System, focusing on the addition of a commercially pure titanium coating. It's important to note that a 510(k) submission typically aims to demonstrate substantial equivalence to a predicate device, rather than proving a device meets specific "acceptance criteria" in the same way a diagnostic test might. The "acceptance criteria" in this context refer to the performance standards and tests required to show this substantial equivalence for the modified device.
1. Table of Acceptance Criteria and Reported Device Performance
For intervertebral body fusion devices, particularly when a coating is introduced, the "acceptance criteria" are generally based on relevant ASTM standards and demonstrate that the modified device performs comparably to or better than the predicate device under various mechanical and material tests. The reported device performance is indicated by the completion of these tests.
| Acceptance Criteria (Test Performed) | Reported Device Performance (Outcome) |
|---|---|
| Coating Characterization | |
| Coating Microstructure (ASTM F1854) | Performed as indicated |
| Shear Fatigue Testing (ASTM F1160) | Performed as indicated |
| Static Shear Testing (ASTM F1044) | Performed as indicated |
| Tensile Testing (ASTM F1147) | Performed as indicated |
| Abrasion Testing (ASTM F1978) | Performed as indicated |
| Device Performance | |
| Static Axial Compression (ASTM F2077) | Performed to demonstrate substantial equivalence to predicate |
| Static & Dynamic Compression Shear (ASTM F2077) | Performed to demonstrate substantial equivalence to predicate |
| Wear Debris Analysis (ASTM F1877) | Performed to demonstrate substantial equivalence to predicate |
Note: The document states that these tests were "performed" and led to the conclusion of "substantial equivalence," implying that the results met the expected performance characteristics for the chosen predicate devices and relevant standards. Specific numerical values for the performance are not included in this summary.
Regarding the sections that are not applicable to this type of device submission:
Since this is a 510(k) submission for an orthopedic implant and not an AI/diagnostic device, many of the requested categories (2-9, relating to AI, human readers, ground truth for image analysis, etc.) are not applicable or cannot be extracted from this document. The focus of this submission is on the material and mechanical performance of the physical device.
Specifically, the following are not applicable or cannot be determined from the provided text:
- 2. Sample size used for the test set and the data provenance: This refers to clinical data for diagnostic performance, which is not provided for this device. The "test set" pertains to the physical device samples used for the mechanical tests, but their number and provenance are not detailed.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert review for diagnostic ground truth.
- 4. Adjudication method for the test set: Not applicable.
- 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 for an AI/diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a physical implant's mechanical testing. The "ground truth" for mechanical properties is typically the measured physical performance against engineering standards.
- 8. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical device testing.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.