(30 days)
The Hexanium® TLIF (Transforaminal Lumbar Interbody Fusion) system is an intervertebral body fusion device indicated for use with autogenous bone graft in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two continuous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Patients should have received at least 6 months of non-operative treatment prior to treatment with Hexanium® TLIF system. This device has to be filled with autogenous bone graft material. This device is implanted via transforaminal approach. Hexanium® TLIF system must be used in combination with supplemental internal spinal fixation which has been cleared by the FDA for use in the lumbar spine.
The Hexanium® TLIF is a titanium alloy (Ti6Al4V ELI) interbody cage manufactured via an Additive Manufacturing method. The honeycomb structure allows for bone through-growth through the structure of the device as well as providing lateral and vertical bone graft windows in the body of the cage.
Hexanium® TLIF is available in a straight and curved shape in heights of 7mm to 16mm in 1mm increments in a Small footprint (28mm x 10mm) and a Medium footprint (32mm x 10mm) for the straight cage and a Small footprint (28mm x 9mm) and a Medium footprint (32mm x 10.5mm) for the curved cage. Hexanium® TLIF has a 5° Lordosis angle.
Hexanium® TLIF devices are provided sterile.
This document describes the regulatory clearance for the Hexanium® TLIF intervertebral body fusion device and focuses on its substantial equivalence to a predicate device rather than its performance against specific acceptance criteria for an AI/ML algorithm. Therefore, many of the requested categories regarding AI/ML study design, such as MRMC studies, expert ground truth establishment, and training/test set details, are not applicable or cannot be extracted from this document.
The acceptance criteria described here pertain to the device's mechanical properties, materials, and overall safety and efficacy as an implant, demonstrated through testing and comparison to a legally marketed predicate device.
Here's an attempt to populate the table and answer the questions based on the provided text, indicating "Not Applicable" (NA) or "Not Provided" (NP) where the information isn't present in the context of an AI/ML study.
Acceptance Criteria and Device Performance (for a Medical Device, not AI/ML)
| Acceptance Criteria Category | Specific Criterion (if stated) | Reported Device Performance |
|---|---|---|
| Mechanical Testing (Fatigue, Compression, etc.) | Compliance with ASTM 2267-04 and ASTM F2077-14 standards, specifically demonstrating equivalent or superior mechanical properties to the predicate for: |
- Axial compression
- Compression shear
- Torsion
- Expulsion
- Bone fusion (in terms of surface area and volume for grafting) | The mechanical testing performed for the predicate device (Hexanium TLIF system, K180437) was submitted and found to support the subject Hexanium TLIF cages.
The study showed that the predicate Hexanium TLIF cage remains the worst-case construct compared to the subject device for: - Highest von Mises stress: in axial compression, compression shear, torsion, and expulsion. This implies the subject device experiences less stress under similar loads.
- Smallest surface area between bone graft and endplates: This means the predicate is the worst-case for bone fusion, implying the subject device offers better or equivalent bone fusion potential.
- Lowest bone graft volume: Reinforcing the predicate as worst-case for bone fusion. |
| Material Biocompatibility | Use of biocompatible materials. | Manufactured from titanium alloy (Ti6Al4V ELI). (Implicitly accepted as a common, biocompatible material for implants). |
| Sterilization & Cleaning | Demonstrates ease of cleaning and effective sterilization. | The predicate Hexanium TLIF (K180437) is the worst-case for cleaning and sterilization as it is the most difficult-to-clean, has the largest surface area and volume, and has the heaviest weight. This implies the subject device is easier to clean and sterilize. |
| Pyrogenicity | Meets pyrogen limit specifications. | Bacterial Endotoxins Test was performed in accordance with USP to demonstrate that the device meets pyrogen limit specifications. |
| Design Consistency | Equivalent in design, mechanical properties, and function to predicate. | Hexanium® TLIF is substantially equivalent to the primary predicate device in terms of intended use, design, mechanical properties, and function. The specific design difference noted is the honeycomb structure, which is an additive manufacturing feature, but the overall form, lordosis angle (5°), and size ranges are similar to the predicate, and critically, the new design is shown not to be mechanically inferior. |
| Regulatory Compliance | Conforms to Class II Special Controls Guidance Document. | The Hexanium® TLIF device conforms to the Class II Special Controls Guidance Document: Intervertebral Body Fusion Device Document issued on June 12, 2007. |
Study Details (Relevant to Device Clearance, Not AI/ML Performance)
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of an AI/ML test set. For mechanical testing, devices were tested according to ASTM standards, which would imply specific sample sizes for destructive and non-destructive testing, but these exact numbers are not provided in the summary. The study relies on demonstrating that predefined worst-case predicate constructs were mechanically and cleaning/sterilization-wise more challenging than the proposed device.
- Data Provenance: Not specified for a "test set" in the AI/ML sense. The "data" comes from mechanical testing of the Hexanium TLIF system (K180437) and the subject devices, which would have been conducted in a lab setting. Geographical origin of this specific testing data is not provided. The study is retrospective in the sense that it leverages prior testing data from the predicate device and compares it to the new device via analysis (e.g., FEA) rather than new large-scale clinical trials.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable (NA). This document does not pertain to an AI/ML system requiring expert-established ground truth from images or clinical data. Device performance is established via engineering principles, material science, and mechanical testing against recognized standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- NA. No human adjudication of clinical or image data for an AI/ML test set was performed.
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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:
- NA. This is a hardware medical device (an implant), not an AI/ML diagnostic or assistive software. No human reader studies were conducted or are relevant for this type of clearance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- NA. This is not an AI/ML algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" here is based on established engineering standards (ASTM), material properties, and physical performance under controlled mechanical testing conditions. In some cases, it's a comparison to a "worst-case" scenario of an existing cleared device.
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The sample size for the training set:
- NA. No AI/ML training set was involved.
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How the ground truth for the training set was established:
- NA. No AI/ML training set was involved.
Summary of Device Acceptance:
The Hexanium® TLIF device was accepted through a 510(k) pathway, demonstrating substantial equivalence to a previously cleared predicate device (Hexanium® TLIF, K180437). This was primarily achieved by:
- Mechanical Testing and Analysis: Leveraging existing mechanical testing data from the predicate and performing further analysis (e.g., Finite Element Analysis - FEA) to show that the new device meets or exceeds the performance of the predicate. Crucially, the predicate device was shown to represent the "worst-case" scenario in terms of mechanical stress response (axial compression, shear, torsion, expulsion) and properties affecting bone fusion (surface area, volume) and cleaning/sterilization. This means if the predicate passed, the subject device, being "less worst-case" or "better," would also pass.
- Material Equivalence: Using the same established biocompatible material (Ti6Al4V ELI).
- Sterilization and Pyrogenicity: Demonstrating compliance with specific standards (USP) for bacterial endotoxins and showing the predicate was the worst-case for cleaning/sterilization.
- Compliance with Special Controls: Adhering to the specific guidance for intervertebral body fusion devices.
No clinical data was presented or required for this 510(k) clearance, as functional and safety equivalence was demonstrated through non-clinical testing and comparison to the predicate.
§ 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.