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510(k) Data Aggregation
(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.
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(30 days)
The VelofixTM PEEK Cervical Cage is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six weeks of non-operative treatment with an intervertebral cage.
The VelofixTM PEEK Lumbar Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease(DDD) at one or two levels for L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended to be used with supplemental fixation.
The Velofix™ Interbody Fusion System(K132926) consists of implants available in various heights, width and angle with an open architecture to accept packing of autogenous bone graft and consist of:
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- Cervical Interbody Fusion Device (Velofix™ PEEK Cervical Cage), which may be implanted as a single device via an anterior approach.
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- Lumbar Interbody Fusion Device (Velofix™ PEEK Lumbar Cage), which may be implanted.
- o Bilaterally via a posterior(PLIF) approach;
- o As a single device via a transforaminal(TLIF) approach;
The Velofix™ Interbody Fusion System contains additional surface and angle in PEEK Cervical cages of the Velofix™ Interbody Fusion System (Cleared: K132926, K140864).
The implants are made of radiolucent polymer polyether-ether-ketone(PEEK-OPTIMA LT 1, ASTM F2026) body with the x-ray markers made of tantalum markers (ASTM F560). The Velofix™ PEEK Cervical Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
The provided document is a 510(k) summary for the Velofix™ Interbody Fusion System, which is a medical device for spinal fusion. This specific submission (K171749) focuses on an "additional surface and angle" for the PEEK Cervical Cage within the existing Velofix™ Interbody Fusion System (which had prior clearances K132926 and K140864).
The document describes pre-market clearance for a spinal implant, which is a physical device, not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML study design (such as human reader improvement with AI assistance, training set details, and expert adjudication for ground truth) are not applicable to this submission.
However, I can extract information related to the performance testing of the device itself.
Acceptance Criteria and Device Performance Study for Velofix™ Interbody Fusion System (K171749)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Static compression evaluation according to ASTM F2077 | "Met the acceptance criteria which have been established from the predicate device." | "The evaluation met all acceptance criteria." |
| Mechanical Performance | Static torsion evaluation according to ASTM F2077 | "Met the acceptance criteria which have been established from the predicate device." | "The evaluation met all acceptance criteria." |
| Substantial Equivalence | Design, Material, Mechanical Performance, Function, Intended Use | "Substantially equivalent to Velofix™ Interbody Fusion System (Cleared:K132926) in design, material, mechanical performance, function and intended use." | "The K171749 device is substantially equivalent to predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the traditional sense of a clinical or imaging dataset. The "test set" here refers to the device configurations/variants subjected to Finite Element Analysis (FEA). The document doesn't specify the number of simulations run but implies that the new designs (additional surface and angle) were fully evaluated.
- Data Provenance: Not applicable for a software or AI/ML product. The "data" comes from the mechanical properties of the materials and the geometric design of the implant, used as input for the FEA.
3. Number of experts used to establish the ground truth for the test set and their qualifications
Not applicable. This is a mechanical device, not an AI/ML system requiring expert-labeled ground truth. The "ground truth" for mechanical testing is established by recognized standards (ASTM F2077) and engineering principles.
4. Adjudication method for the test set
Not applicable. Mechanical testing and FEA results are objective and compared against pre-defined engineering acceptance criteria, not subjective expert opinion.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a physical intervertebral fusion cage, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The "standalone performance" refers to the mechanical performance of the implant itself, which was evaluated via FEA.
7. The type of ground truth used
The "ground truth" for this device's performance is based on established mechanical testing standards (ASTM F2077) and engineering principles, specifically for static compression and static torsion. The performance of the predicate device (Velofix™ Interbody Fusion System - K132926) also serves as a benchmark for substantial equivalence.
8. The sample size for the training set
Not applicable. This device is a physical implant, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. (See #8)
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