(168 days)
The VelofixTM PEEK Cervical Cage is 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-T 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 to facilitate fusion. Patients should have at least six weeks of nonoperative treatment prior to treatment with an intervertebral cage.
The VelofixTM PEEK Lumbar Cage is indicated for use with autogenous with degenerative disc disease(DD) at one or two levels for L2 to S1. These DDD patients may also have up w Grade I Spondylolisthesis 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 six months of non-operative treasment. These devices are intended to be used with supplemental fixation.
The Velofix™ Interbody Fusion System consists of implants available in various heights, width and angle with an open architecture to accept packing of bone graft material.
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.
-
- 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 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 and Lumbar) Cage is implanted by using the instruments manufactured from stainless steel materials that conform to ASTM F899.
The provided text describes the "Velofix™ Interbody Fusion System," a spinal implant, and its mechanical performance testing. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting a study to prove a device meets those criteria in a medical context (e.g., diagnostic accuracy for an AI device).
Therefore, the information requested about AI/algorithm performance, ground truth, expert review, and sample sizes for training/test sets is not applicable to this 510(k) summary, as it pertains to a physical medical device (interbody fusion system) and not an algorithmic/AI device.
However, I can extract information related to the device's mechanical performance and its acceptance criteria as outlined in the document, which are analogous to "acceptance criteria" for a physical device.
Here's a breakdown of the available information based on your request, adapted for a physical medical device:
1. A table of acceptance criteria and the reported device performance
The document states that the mechanical performance of the Velofix™ Interbody Fusion System "met the acceptance criteria which have been established from the predicate devices." It also explicitly lists the tests performed and implies that the results of these tests met criteria derived from the predicate devices. However, the specific numerical acceptance criteria and the specific numerical performance results (e.g., "withstanding X N of force") are not provided in this summary.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Performance | Met acceptance criteria established from predicate devices. |
Tests Performed:
For Velofix™ PEEK Cervical Cage:
- Static compression test (according to ASTM F2077)
- Static torsion test (according to ASTM F2077)
- Dynamic compression test (according to ASTM F2077)
- Dynamic torsion test (according to ASTM F2077)
- Subsidence test (according to ASTM F2267)
For Velofix™ PEEK Lumbar Cage:
- Static compression test (according to ASTM F2077)
- Dynamic compression test (according to ASTM F2077)
- Subsidence test (according to ASTM F2267)
The conclusion states: "The testing met all acceptance criteria and verifies that performance of the Velofix Interbody Fusion System is substantially equivalent to the predicate devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the number of individual devices or prototypes tested for each mechanical test.
- Data Provenance: The tests were conducted in a "non clinical setting (bench testing)." The manufacturer is U & I Corporation, located in Uijeongbu-si, Gyeonggi-do, Korea. Therefore, the testing was likely performed in Korea.
- Retrospective or Prospective: Not applicable as this refers to bench testing, not clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The "ground truth" for this device's performance is established by standardized mechanical testing protocols (ASTM F2077, ASTM F2267) and comparison to predicate device performance, not by expert medical review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically associated with human expert review of medical images or clinical outcomes, which is not relevant to mechanical bench testing.
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
- Not applicable. This study is for a physical medical device (spinal implant), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This study is for a physical medical device (spinal implant), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground Truth Type: For mechanical performance, the "ground truth" is established by adherence to recognized international mechanical testing standards (ASTM F2077, ASTM F2267) and by demonstrating substantial equivalence to the established mechanical performance of predicate devices. These standards define the parameters and methods for evaluating the structural integrity and performance of the device under various loads.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of mechanical bench testing for a physical device.
9. How the ground truth for the training set was established
- Not applicable. No training set was used.
§ 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.