(73 days)
The Hexanium® TLIF (Transformational 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 device 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 heights of 7mm to 16mm in 1mm increments in a Small footprint (28mm X 9mm) or a Medium footprint (32mm X 10.5mm). Hexanium® TLIF has a 5° Lordosis angle. Hexanium® TLIF devices are provided sterile.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hexanium® TLIF device:
This document is a 510(k) Premarket Notification from the FDA for the Hexanium® TLIF device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study report in the way a clinical trial or algorithm validation study would.
Based on the provided text, the "acceptance criteria" and "study" are described in terms of mechanical and biological performance, aiming for equivalence to a predicate device, as typically required for a 510(k) submission for an intervertebral body fusion device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category/Test | Acceptance Criteria (Implicit from Device Guidance & Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Static Compression | Conforms to ASTM F2077-14; Comparable to predicate device. | Performed according to ASTM F2077-14; Results demonstrate comparable mechanical properties to the predicate device. |
| Dynamic Compression | Conforms to ASTM F2077-14; Comparable to predicate device. | Performed according to ASTM F2077-14; Results demonstrate comparable mechanical properties to the predicate device. |
| Static Compression Shear | Conforms to ASTM F2077-14; Comparable to predicate device. | Performed according to ASTM F2077-14; Results demonstrate comparable mechanical properties to the predicate device. |
| Dynamic Compression Shear | Conforms to ASTM F2077-14; Comparable to predicate device. | Performed according to ASTM F2077-14; Results demonstrate comparable mechanical properties to the predicate device. |
| Subsidence | Conforms to ASTM F2267-04; Comparable to predicate device. | Performed according to ASTM F2267-04; Results demonstrate comparable mechanical properties to the predicate device. |
| Expulsion Testing | Comparable to predicate device. | Performed; Results demonstrate comparable mechanical properties to the predicate device. |
| Biological Performance | ||
| Bacterial Endotoxins Test | Meets pyrogen limit specifications (in accordance with USP). | Performed in accordance with USP; Device meets pyrogen limit specifications. |
| General Conformance | Conforms to "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device Document issued on June 12, 2007." | Device conforms to the specified guidance document. |
Explanation of the "Study":
The "study" described here is a series of benchtop mechanical and biological tests designed to demonstrate that the Hexanium® TLIF device performs equivalently to its predicate device (SpaceVision® Interbody Fusion Cages, K153783) and meets relevant industry standards and FDA guidance for intervertebral body fusion devices.
Missing Information (based on the provided text):
The provided text is a 510(k) summary, which is a regulatory document and not a detailed study report. Therefore, several of the requested points are not applicable (N/A) or not explicitly stated in this type of document, especially those related to AI algorithm validation, human-reader studies, or clinical trials.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in terms of number of devices/units tested for each mechanical test. Typically, these benchtop tests involve a small, statistically valid number of samples (e.g., 5-10 per test condition), but the exact number is not provided.
- Data Provenance: The tests are described as being performed to ASTM standards and USP. This implies laboratory testing. The manufacturing entity, SpineVision SAS, is based in France, so the testing could have been conducted in France or at a qualified testing facility elsewhere. The document doesn't specify a "country of origin for data" in the context of patient data, as this is a benchtop study. The testing is prospective in the sense that it was conducted specifically to support this 510(k) submission, not retrospectively analyzing existing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- N/A. This is a mechanical/biological benchtop study, not a study involving interpretation of medical images or clinical outcomes by human experts to establish ground truth. The "ground truth" for these tests is defined by the ASTM standards and USP specifications.
4. Adjudication Method for the Test Set:
- N/A. As it's a benchtop physical and biological test comparing to standards and a predicate, there's no "adjudication method" in the sense of expert consensus for interpretations. The results are quantitative measurements against defined criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC comparative effectiveness study is typically performed for diagnostic devices, especially those involving image interpretation or AI algorithms, to assess inter-reader variability and the impact of the device on human performance. This is a spinal implant for fusion, and no such study is mentioned or required for this type of device in a 510(k) context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical implant, not an AI algorithm. Therefore, "standalone algorithm performance" is not applicable.
7. The Type of Ground Truth Used:
- For mechanical testing: Industry Standards (ASTM F2077-14, ASTM F2267-04) and Predicate Device Performance (side-by-side comparison).
- For biological testing: Pharmacopoeial Standards (USP for Bacterial Endotoxins Test).
8. The Sample Size for the Training Set:
- N/A. This study does not involve a "training set" as it is not an AI/machine learning model.
9. How the Ground Truth for the Training Set was Established:
- N/A. This study does not involve a "training set" or "ground truth for a training set."
In summary, the provided document details the regulatory pathway for a conventional medical device (spinal implant) through a 510(k) submission. The "acceptance criteria" and "study" revolve around demonstrating mechanical and biological equivalence to a previously cleared predicate device and compliance with established industry standards through benchtop testing, rather than complex clinical or AI-based performance studies.
§ 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.