(217 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 spondylolistesis 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 devices intended for use as an aid in spinal 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-6Al-4V ELI).
The provided 510(k) summary (K110783) for the VENUS Lumbar Intervertebral Body Fusion Cage System details the device's substantial equivalence to previously marketed devices based on performance data derived from established ASTM standards. However, it does not describe a study involving human subjects or AI algorithms with human-in-the-loop performance.
Here's an analysis based on the information provided, highlighting the mechanical testing rather than clinical or AI-related studies:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (based on ASTM Standards) | Reported Device Performance |
|---|---|
| Static Axial Compression | Tested per ASTM F 2077 |
| Dynamic Axial Compression | Tested per ASTM F 2077 |
| Static Compression-Shear Testing | Tested per ASTM F 2077 |
| Dynamic Compression-Shear Testing | Tested per ASTM F 2077 |
| Static Torsion Testing | Tested per ASTM F 2077 |
| Dynamic Torsion Testing | Tested per ASTM F 2077 |
| Expulsion Testing | Tested per ASTM F 2077 |
| Static Subsidence Testing under Axial Compression | Tested per ASTM F 2267 |
Note: The document states that the device was "tested according to the ASTM F 2077" and "per ASTM F 2267." This implies that the device met the requirements of these standards, which are the acceptance criteria for mechanical performance of intervertebral body fusion devices. Specific quantitative results (e.g., actual load values, fatigue cycles) are not provided in this summary. Instead, the summary asserts that these tests demonstrate the device's functional equivalence to predicates.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The performance data refers to mechanical testing of the device itself, not a clinical test set with patient 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)
This information is not applicable as the study described is a mechanical performance study, not a study evaluating human interpretation or diagnosistic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the study described is a mechanical performance study.
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
There is no mention of an MRMC comparative effectiveness study in this 510(k) summary. The device is a physical intervertebral body fusion cage, not an AI software or diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
There is no mention of a standalone algorithm performance study as the device is a physical medical implant.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the mechanical performance testing, the "ground truth" (or standard against which performance is measured) is the established requirements and methodologies outlined in the ASTM F 2077 and ASTM F 2267 standards. These standards define how an intervertebral body fusion device should perform under various mechanical loads to be considered safe and effective for its intended use.
8. The sample size for the training set
This information is not applicable as there is no "training set" for physical implant device testing.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for physical implant device testing.
In summary:
The 510(k) summary describes a mechanical performance study demonstrating that the VENUS Lumbar Intervertebral Body Fusion Cage System meets the acceptance criteria set forth in ASTM F 2077 and ASTM F 2267 standards. It is a traditional 510(k) submission for a physical medical device and therefore does not involve clinical studies with human readers, AI algorithms, or the associated concepts of test sets, training sets, expert ground truth, or adjudication methods typically seen in AI/diagnostic device submissions. The "study" proving the device meets acceptance criteria is the successful completion of these defined mechanical tests, thereby supporting its substantial equivalence claim.
§ 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.