(101 days)
VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The VENUS Lumbar Intervertebral body Fusion Cage System is intend to help provide support in the intervertebral body space during fusion of vertebral bodies in the lumbar spine. This system is intended to be used with supplemental fixation. The VENUS Lumbar Intervertebral body Fusion Cage System consists of implants available in various heights and lordotic configurations with an open architecture to accept packing of bone graft material. The Implants are made of PEEK-OPTIMA " LTI body with the titanium marker pins made of Titanium alloy (Ti-6AI-4V ELI). The purpose of this submission is to add a new Lumbar Interbody device: VENUS DLIF Cages and to expand the size of the devices.
This is a 510(k) summary for a medical device (VENUS Lumbar Intervertebral body Fusion Cage System), not a study report that details acceptance criteria and performance data. Therefore, the requested information about acceptance criteria, device performance, study design, and ground truth establishment is not available in the provided text.
The document primarily focuses on establishing "substantial equivalence" of the VENUS Lumbar Intervertebral body Fusion Cage System to existing legally marketed predicate devices. This type of regulatory submission usually relies on demonstrating that the new device has similar technological characteristics and the same intended use as the predicate devices, rather than presenting a standalone clinical study with defined acceptance criteria and performance metrics.
Here's what can be extracted, and why other information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable / Not Provided. This document does not describe acceptance criteria or present performance data from a specific study. Substantial equivalence claims are often based on non-clinical testing (e.g., mechanical, biocompatibility) and comparison to predicate devices, rather than performance against pre-defined numerical thresholds in a clinical setting.
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. No "test set" in the context of clinical performance evaluation is mentioned. The submission is based on the substantial equivalence principle, comparing the new device's design, materials, and intended use to existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. No "ground truth" establishment by experts for a test set is discussed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No adjudication method is mentioned, as there is no described test set or expert evaluation.
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 / Not Provided. This device is a physical implant (Lumbar Intervertebral body Fusion Cage System), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study or AI performance evaluation is irrelevant and not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. As noted above, this is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided. No ground truth in the context of clinical or diagnostic performance is discussed. The "truth" in this submission lies in demonstrating that the device's characteristics are similar to predicate devices.
8. The sample size for the training set
- Not Applicable / Not Provided. This concept is not relevant to this type of device submission. There is no training set for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As above, this concept is not relevant.
Summary of what the document does state regarding the study (non-clinical testing for substantial equivalence):
The document explicitly states under "5. Non-clinical Testing":
- "The proposed line extension for the VENUS Lumbar Intervertebral body Fusion Cage System does not constitute a new worst case for the intended use and is substantially equivalent to the predicate device (K110783)."
This indicates that the safety and effectiveness of the new devices (line extension, expanded sizes) are being demonstrated by their substantial equivalence to an already cleared predicate device (K110783), which presumably underwent its own testing (mechanical, biocompatibility, etc.) at the time of its 510(k) clearance. For the current submission (K120063), the "study" is effectively a comparison to predicates, affirming that no new "worst case" scenarios are introduced that would necessitate new or more rigorous testing beyond what was done for the predicate.
This 510(k) submission is a regulatory filing, not a clinical trial report. It aims to demonstrate that a device is "substantially equivalent" to an existing legally marketed device, meaning it's as safe and effective as the predicate. This process often relies on non-clinical testing (e.g., mechanical tests, biocompatibility tests) rather than human clinical trials with specific performance metrics and acceptance criteria as would be found for a novel device or a diagnostic algorithm.
§ 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.