(100 days)
The Theken Spine Vu aPOD Intervertebral Body Fusion Device is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the spacer component may be packed with autogenous bone graft material. The Theken Spine Vu aPOD Intervertebral Body Fusion Device is intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System.
Degenerative disc disease (DDD) is defined as back pain of discogenic 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
The Vu aPOD Intervertebral Body Fusion Device is comprised of PEEK-OPTIMA® LT cages which can be used in combination with an optional titanium spin plate. The cages include toothed spikes on the top and bottom surfaces to engage with the superior and inferior end plates of neighboring vertebral bodies to resist rotation and migration. The cage shape and open center allow for bony in-growth in and around the implant. A single cage is sufficient to be used at each intervertebral level.
The provided text does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the format requested. The document is a 510(k) premarket notification for a medical device (Vu aPOD Intervertebral Body Fusion Device), which focuses on establishing substantial equivalence to predicate devices rather than reporting on specific performance metrics and a study to meet pre-defined acceptance criteria.
Therefore, most of the requested fields cannot be filled from the provided text.
Here's an attempt to answer based on the available information and highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Mechanical Strength) | Reported Device Performance |
|---|---|
| Not specified in the document. | Not specified in the document in terms of quantitative performance against criteria. The document mentions "mechanical testing" was performed to demonstrate substantial equivalence, but no specific criteria or results are detailed. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size (Test Set): Not applicable. This document describes a 510(k) submission based on substantial equivalence, not a clinical trial with a test set of patient data.
- Data Provenance: Not applicable. The submission relies on design concept, use of established materials, feature comparisons, and mechanical testing to demonstrate equivalence, rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth for a test set of patient data is not relevant to this type of 510(k) submission.
4. Adjudication Method for the Test Set:
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was an MRMC study done? No.
- Effect Size of human readers with vs. without AI assistance: Not applicable.
6. Standalone (Algorithm Only) Performance Study:
- Was a standalone study done? No. This device is a physical intervertebral body fusion device, not a software algorithm.
7. Type of Ground Truth Used:
- Not applicable in the context of clinical performance metrics. The "ground truth" for this submission is related to demonstrating substantial equivalence for manufacturing, materials, design, and mechanical properties compared to predicate devices. This is typically established through engineering analysis and validated testing against industry standards, rather than clinical outcome data.
8. 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.
Summary of available information related to performance/equivalence:
- The submission asserts "sufficient evidence exists to reasonably conclude that the Vu aPOD Intervertebral Body Fusion Device is substantially equivalent to the predicate device...This is based on the design concept, the use of established, known materials, feature comparisons, mechanical testing, indications for use, pre-production quality assurance planning and engineering analysis."
- The device similarities to predicate devices include: Indications for use, same basic design, same operating principle, same materials (PEEK-OPTIMA LT, Tantalum, Titanium 6Al-4V ELI as per ASTM standards), used with supplemental fixation, same manufacturing environment, same sterilization process, and same packaging configurations.
- The FDA's decision is that the device is "substantially equivalent" for its stated indications for use, implying that it meets the safety and effectiveness profile of its predicate devices without raising new questions of safety or effectiveness.
§ 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.