(267 days)
The Biolign® Tlif Interbody Fusion Devices are indicated for use with autograft bone graft in skeletally mature patients with degenerative disc disease (DDD) at one level or two contiguous levels of the lumbar spine (L2 - S1). DDD is defined as backpain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six (6) months of non-operative therapy. The Biolign® TLIF Intervertebral fusion devices are used to facilitate fusion in the lumbar spine and are implanted via a postero-lateral approach. The Biolign® intervertebral fusion devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine for example posterior pedicle screw and rod systems.
The Biolign® ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign® ACIF System is intended to be used with supplemental fixation systems that have been cleared for in the cervical spine, such as Anterior Cervical plating systems.
The Biolign® STACC ACIF System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease at one level from C3-C7. Cervical disc disease is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Patients should have six (6) weeks of non-operative treatment. The Biolign® STACC ACIF System is to be used with autograft bone graft and is implanted via an open anterior approach. The Biolign STACC ACIF system is intended to be used as a stand-alone system using the bone screws provided for fixation. It may also be used with supplemental fixation system that have been cleared for use in the cervical spine, such as cervical plating systems.
The Biolign TLIF device is a slightly curved cage manufactured from Invibio PEEK Optima LT1 with cavities which can be packed with autograft. The cage has tantalum markers which allow accurate and correct placement of the device. The cage is postero-laterally inserted. The cage incorporates a threaded introducer hole on each end and has serrated inferior and superior endplates. It is available in two footprints (30x13mm, and 36x13mm), two lordotic angles (5° and 10°), and a range of heights ranging from 6 - 12mm with 1mm intervals These sizing options allow selection for individual pathology and anatomical conditions. The device is used with supplemental fixation such as screw and rod systems. The Biolign® TLIF system is provided sterile.. The System is single use only.
The Biolign ACIF device is an anatomically correct cage manufactured from Invibio PEEK Optima LT1 with a central cavity which can be packed with autograft. The cage is available in two footprints (15 and 17mm) with a 10° lordotic angle. Cage heights range from 6mm-10mm with 1mm intervals. These sizing options allow selection for individual pathology and anatomical conditions. Tantalum radiographic markers enable clear x-ray control during placement and follow-up. The cage endplates are serrated. The Device is inserted below the anterior surface of the cervical vertebrae. It is used with supplemental cervical plating systems which have prominence from the spine (plate thickness). The Biolign® ACIF system is provided sterile The System is for single use only.
The Biolign® STACC ACIF Interbody Fusion Device is a stand-alone device and does not rely on additional fixation such as cervical plates. The device is an anatomically shaped ring, with a central cavity which can be packed with autograft. It is manufactured of Invibio Peek Optima LT1. Two Tantalum pins are placed in the device to enable radiographic visualization for placement and follow-up evaluations. The superior, and inferior endplates of the device are serrated. Two fixation screws per cage are used as supplemental fixation. These screws are placed into the cage and purchase into the vertebral endplates. The fixation screws are manufactured of Titanium 6Al4V ELI. The footprint of the cage is available in one size (17 x 14mm), and in heights ranging from 5.5 - 9.5mm with 1mm intervals. The cage is available in a domed (superior endplate is domed, and inferior endplate has 3° lordosis angle) and a tapered version (8° lordosis - 4° per endplate) The device is implanted using an anterior approach and after implantation does not stand prominent from the cervical spine. It lies below the anterior surface of the cervical spine. The Biolign® STACC ACIF system is supplied sterile. The System is for single use only.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Biolign® Intervertebral Body Fusion Systems:
It's important to note that this document is a 510(k) Summary, which demonstrates substantial equivalence to a predicate device, rather than a full pre-market approval (PMA) application that would typically require extensive clinical trials. Therefore, the information regarding "acceptance criteria" and "study" is framed within the context of demonstrating substantial equivalence through non-clinical (bench) testing, rather than clinical efficacy.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for these devices are implicitly defined by their substantial equivalence to predicate devices, specifically in terms of design, function, performance, material, sterilization, and intended use. The key performance criteria are primarily mechanical properties, demonstrated through bench testing.
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| Mechanical Performance (TLIF) | Static/Dynamic axial compression strength, Static shear compression strength, Torsion testing, Subsidence resistance comparable to predicate. | "Results drawn from the testing performed, as well as from an engineering rationale, demonstrate that the Biolign TLIF spacer is substantially equivalent in performance to the predicate device." |
| Mechanical Performance (ACIF) | Static axial compression strength, Static shear compression strength, Static torsion testing comparable to predicate. | "Results drawn from the testing performed, as well as from an engineering rationale, demonstrate that the Biolign ACIF spacer is substantially equivalent in performance to the predicate device." |
| Mechanical Performance (STACC ACIF) | Static/Dynamic axial compression strength, Static shear compression strength, Static/Dynamic torsion testing, Screw push-out testing, Tension offset testing, Impact testing comparable to predicate. | "Results drawn from the testing performed, as well as from an engineering rationale, demonstrate that the Biolign STACC spacer is substantially equivalent in performance to the predicate device." |
| Material Biocompatibility | Use of Invibio PEEK Optima LT1 and Tantalum markers, and Titanium 6Al4V ELI (for STACC screws) known to be biocompatible and used in predicate devices. | Stated material composition is identical or similar to predicate devices, implying equivalent biocompatibility. |
| Sterilization | Provision as a sterile product with an established sterilization method. | "The System is provided sterile." |
| Intended Use | Matching indications for use and surgical approaches of predicate devices. | Indications for Use sections confirm alignment with predicate device applications. |
| Design/Function | Anatomical shape, central cavity for autograft, radiographic markers, serrated endplates, sizing options, threaded introducer hole (TLIF), fixation screws (STACC). Design features aim to replicate or be comparable to predicate devices. | Device Descriptions detail features that are presented as substantially equivalent to predicates. |
Study Details
Given this is a 510(k) submission, the "study" primarily refers to non-clinical (bench) testing to demonstrate substantial equivalence, rather than clinical trials.
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact sample sizes (e.g., number of cages tested) for the bench tests. It refers to "testing performed" as per ASTM standards.
- Data Provenance: The testing was conducted by Elite Surgical Supplies, which is based in South Africa. The document doesn't specify if the testing was done in South Africa, but it's implied the company managed the tests. The data is retrospective in the sense that it supports an existing product design against established standards.
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Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. For non-clinical bench testing, "ground truth" is established by adherence to recognized international standards (e.g., ASTM F2077, ASTM F2267) and engineering principles, rather than expert human consensus on image interpretation or pathology results. The "truth" is the measured mechanical property compared against acceptable limits derived from predicate device performance or standard requirements.
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Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical data review, especially in cases of conflicting expert opinions on diagnoses or outcomes. For bench testing, the results are quantitative measurements interpreted against pre-defined engineering criteria.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. MRMC studies are clinical studies involving multiple human readers evaluating medical images, often to compare diagnostic accuracy with and without AI assistance. This document explicitly states: "Clinical data and conclusions were not needed for this device."
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical intervertebral cage, not an algorithm or AI software. Therefore, the concept of "standalone performance" in the context of AI does not apply.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical (bench) testing, the "ground truth" refers to engineering specifications and established biomechanical standards (e.g., ASTM standards). The performance of the predicate device also serves as a comparative "ground truth" for substantial equivalence.
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The sample size for the training set:
- Not Applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.
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How the ground truth for the training set was established:
- Not Applicable. As there is no training set, there is no ground truth to establish for it.
In summary, the provided document focuses on demonstrating the substantial equivalence of the Biolign® Intervertebral Body Fusion Systems to existing predicate devices through comprehensive non-clinical bench testing. The "acceptance criteria" are intrinsically tied to meeting the mechanical performance characteristics and design specifications comparable to these legally marketed predicate devices, as guided by FDA recommendations and ASTM standards. No clinical studies, expert consensus reviews for ground truth, or AI-specific performance metrics are relevant or discussed in this 510(k) summary.
§ 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.