(116 days)
The Velofix™ TLIF Cage is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. The Velofix™ TLIF Cage is to be used with supplemental internal spinal fixation. Additionally, the Velofix™ TLIF Cage is to be used with autogenous bone graft material.
The Velofix™ TLIF Cage consists of implants available in various heights, width, length and angle with an open architecture to accept packing of auto bone graft material. The device is consisted of cage body, articulating component and radiographic markers. The articulating component is for attachment to the inserter instrument to allow the cage to pivot to the final positioning. The Velofix™ TLIF Cage may be implanted a single device via a transforaminal approach and adopted to the anterior anatomy of the vertebral endplates. The Velofix™ TLIF Cage is constructed of medical grade Polyetheretherketone (PEEK for ASTM F2026) with a titanium alloy for articulating component (Ti6Al4V ELI for ASTM F136), and tantalum radiographic markers for spinal applications(Tantalum for ASTM F560). The Velofix™ TLIF Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
The provided text describes a 510(k) premarket notification for the Velofix™ TLIF Cage. This is a medical device for intervertebral body fusion. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance testing (bench testing).
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Acceptance Criteria and Study Details
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on Predicate Devices, e.g., Velofix™ Interbody Fusion System (K132926, K140864)) | Reported Velofix™ TLIF Cage Performance |
|---|---|
| Static compression test (according to ASTM F2077) | Met acceptance criteria |
| Dynamic compression test (according to ASTM F2077) | Met acceptance criteria |
| Static compression-shear test (according to ASTM F2077) | Met acceptance criteria |
| Dynamic compression-shear test (according to ASTM F2077) | Met acceptance criteria |
| Subsidence test (according to ASTM F2267) | Met acceptance criteria |
Note: The document states "All tests met all acceptance criteria" and "The acceptance criteria for performance testing were developed using the data of the primary predicate, Velofix™ Interbody Fusion System (K132926, K140864)." However, the specific numerical thresholds for these acceptance criteria are not provided in this document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The tests are "bench testing" which typically involves a set number of implants for mechanical evaluation. The document mentions "selection of the worst case implants" through finite element analysis, implying that a specific subset of the device's configurations was tested.
- Data Provenance: The tests were "non-clinical setting (bench testing)," meaning conducted in a laboratory, not involving human or animal subjects. The location where the testing was performed is not specified, but the manufacturer is based in Korea. This is not patient data, so country of origin of data or retrospective/prospective does not apply in the typical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. This study is non-clinical bench testing evaluating mechanical performance, not a clinical study requiring expert assessment of patient-derived data to establish ground truth.
4. Adjudication Method for the Test Set
- Not applicable. This relates to clinical data assessment, not mechanical bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This document describes non-clinical bench testing of a physical implant (cage), not an AI/software device that would involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/software device. The testing described is for the mechanical performance of a physical implant.
7. The Type of Ground Truth Used
- The "ground truth" for the mechanical performance tests are the established biomechanical standards (ASTM F2077, ASTM F2267) and the performance data of the predicate devices. The device is considered to meet the acceptance criteria if its mechanical properties fall within acceptable ranges defined by these standards and predicate device performance.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/software device that requires a "training set" in the context of machine learning. The term "training set" is not relevant here.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
Summary of the Study:
The study described is a series of non-clinical bench tests designed to assess the mechanical performance of the Velofix™ TLIF Cage (an intervertebral body fusion device). The tests were conducted according to established ASTM standards (F2077 for compression and shear, F2267 for subsidence). The acceptance criteria for these tests were derived from the performance data of the predicate devices, primarily the Velofix™ Interbody Fusion System (K132926, K140864). The document states that all tests met their respective acceptance criteria, supporting the conclusion of substantial equivalence to predicate devices in mechanical performance. Finite element analysis was also used to identify "worst-case implants" for testing, although the specific number of implants tested is not detailed.
§ 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.