(231 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 non-operative 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 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 device has two types: the one is consisted of cage body (PEEK), articulating component (Ti Alloy) and radiographic markers (Tantalum); the other is consisted of cage body and articulating component made of Ti Alloy. The articulating component is for attachment to the inserter instrument to allow the cage to pivot to the final positioning.
The Velofix™ TLIF Cage has 3 types as follows:
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- TLIF Cage, which is made of Polyether-ether-ketone (PEEK);
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- TLIF Ti Cage, which is made of Titanium alloy (Ti6Al4V ELI);
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- TLIF Ti LW Cage, which is made of Titanium alloy (Ti6Al4V ELI) with the expanded graft window of the side part.
The Velofix™ TLIF Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
The provided text is a 510(k) summary for the Velofix™ TLIF Cage, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as would be typical for an AI-powered diagnostic device.
Therefore, many of the requested points regarding acceptance criteria, study design, ground truth, and human expert involvement are not applicable to this type of submission.
However, I can extract the relevant information concerning performance testing.
Here's a breakdown of the information that is available in the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria in a table format. Instead, it refers to performance testing and implies that mechanical performance should be equivalent to or satisfy standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No new safety and effectiveness issues compared to predicate. | "No new safety and effectiveness issues were not raised by the proposed device." |
| Mechanical performance equivalent to predicate device (K140864). | "axial compression and compression shear testing per ASTM F2077 was conducted to compare data of proposed device of the Velofix™ Interbody Fuson System (K140864)" |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of a clinical study or a dataset of patients/images. The testing described is mechanical (material and device performance).
Therefore, information on sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study described is mechanical testing of a medical implant, not a study involving interpretation of data by human experts.
4. Adjudication method for the test set
This information is not applicable as the study described is mechanical testing of a medical implant, not a study involving interpretation of data.
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
This information is not applicable. The device is an intervertebral body fusion cage, not an AI-powered diagnostic tool assisted by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used
For the mechanical performance testing, the "ground truth" would be the established material properties (e.g., ASTM F136 for titanium alloy) and mechanical testing standards (ASTM F2077). These standards define how the material and device should perform under specified loads.
8. The sample size for the training set
This information is not applicable. There is no concept of a "training set" for the mechanical testing of this medical implant.
9. How the ground truth for the training set was established
This information is 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.