(48 days)
The Vu c POD Intervertebral Body Fusion Device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical degenerative disc disease (DDD) at one level from C2-C3 to C7-T1. Cervical degenerative disc disease is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history of radiographic studies. The Vu c POD implants are to be used with autogenous bone graft and implanted via an open, anterior approach. The cervical device is to be used in patients who have had six weeks of non-operative treatment. The Vu c.POD Intervertebral Body Fusion Device is intended for use with supplemental internal fixation systems, such as the Theken Spine Manta Ray or the Theken Spine Tether systems.
The Vu c POD Intervertebral Body Fusion Device consists of cervical spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Vu c POD Intervertebral Body Fusion Device is manufactured from PEEK OPTIMA LT1 polymer. The Vu c·POD Intervertebral Body Fusion Device is for single level anterior spinal use from the C2-C3 to C7-T1 disc levels.
The provided text describes the Integra Spine Vu c-POD Intervertebral Body Fusion Device. It outlines its indications for use and states that preclinical testing was performed to demonstrate substantial equivalence to a predicate device. However, this document does not contain the specific acceptance criteria and detailed study that proves the device meets those criteria, as typically found in a clinical trial report or a performance goal document.
The information provided is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a previously marketed device rather than proving performance against detailed acceptance criteria from a new study.
Therefore, I cannot fulfill your request for the comprehensive table and detailed study information as it is not present in the provided text.
Here's what I can extract based on the information given, noting where data is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device | Not explicitly stated as a quantifiable "acceptance criteria" but implied by the 510(k) process. |
| Mechanical Performance (ASTM F2077) | Device performed per ASTM F2077, "indicating that the Vu c POD Intervertebral Body Fusion Device is substantially equivalent to the predicate device." |
| Mechanical Performance (ASTM F2267) | Device performed per ASTM F2267, "indicating that the Vu c POD Intervertebral Body Fusion Device is substantially equivalent to the predicate device." |
| Biocompatibility | (Not explicitly mentioned as an acceptance criterion or reported performance in this document, though generally required for implants.) |
| Sterility | (Not explicitly mentioned as an acceptance criterion or reported performance in this document, though generally required for implants.) |
| Clinical Efficacy (e.g., fusion rates, pain reduction) | (No specific clinical acceptance criteria or reported clinical performance is provided in this document as it's a 510(k) for substantial equivalence based on preclinical data.) |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not specified. The testing mentioned is "preclinical testing" per ASTM standards, which typically involves a number of samples for mechanical tests, but the exact count is not provided.
- Data provenance (country of origin, retrospective/prospective): Not specified. Preclinical testing data is usually generated in laboratories, but the location is not mentioned.
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 and not provided. The "ground truth" concept is typically used in AI/diagnostic studies to assess human expert performance against a reference standard. Here, the "truth" is established by adherence to ASTM mechanical testing standards.
4. Adjudication method for the test set
- Not applicable and not provided. Adjudication methods are typically used in clinical studies or AI performance evaluations involving human readers.
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
- No MRMC study was done or mentioned. This device is an implant, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- For the preclinical testing, the "ground truth" would be the established methods and expected outcomes defined by the ASTM F2077 and ASTM F2267 standards for spinal intervertebral body fusion devices.
8. The sample size for the training set
- Not applicable/Not specified. This device did not involve machine learning or AI training datasets.
9. How the ground truth for the training set was established
- 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.