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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 nonoperative treatment prior to treatment with an intervertebral cage.

The VENUS Lumbar Intervertebral body Fusion Cage System is intended 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-6Al-4V ELI). The purpose of this submission is to add the size of the devices.

Here's an analysis of the provided text regarding the VENUS Lumbar Intervertebral body Fusion Cage System, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance Study for VENUS Lumbar Intervertebral body Fusion Cage System (K121096)

Based on the provided 510(k) summary, this submission is a Special 510(K) for a line extension, specifically to add additional device sizes to an already cleared intervertebral body fusion cage system. This type of submission relies heavily on substantial equivalence to previously cleared devices rather than new, extensive clinical or non-clinical performance studies to establish acceptance criteria for a novel device.

Therefore, the "acceptance criteria" here are primarily met through demonstrating that the proposed size additions do not introduce new safety or effectiveness concerns, and that the device, with its new sizes, remains substantially equivalent to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. This submission is for a line extension based on substantial equivalence to predicate devices, not a new device requiring a separate "test set" in the context of clinical or performance data generation. The "test" here is the comparison of the design characteristics of the newly sized devices against the previously cleared predicate devices.
• Data Provenance: Not applicable in the context of generating new clinical or performance data. The "data" used is the existing regulatory clearances and technical specifications of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. Ground truth, in the sense of clinical outcome or diagnostic accuracy, is not being established for a new device here. The regulatory review process involves FDA experts to assess substantial equivalence.

4. Adjudication Method for the Test Set

• Not applicable. There is no "test set" in the sense of evaluating diagnostic performance or clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

• No, a MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the diagnostic performance of AI or imaging devices with human readers, which is not relevant to a spinal implant line extension applying for 510(k) clearance based on substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

• No, a standalone performance study was not done. This is not an AI or algorithm-based device.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is the established safety and effectiveness of the identified predicate devices through their prior FDA clearances (K110783, K120063, K100516, K083661, K090816, K093704, K092162, K043405, K052210, K071795, K081611, K081888, K101720, K100175, K112405, K113528). The submission's "truth" is that the new sizes do not alter this established safety and effectiveness.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not an AI/ML device or a study involving data modeling.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. There is no "training set" for this device.

Summary Rationale for K121096 (Line Extension):

This 510(k) submission for the VENUS Lumbar Intervertebral body Fusion Cage System is a "Special 510(k)" specifically for a line extension to add more device sizes. In this context, the primary "study" is the non-clinical comparison to predicate devices to demonstrate substantial equivalence.

The core argument is that the expanded sizes do not introduce new questions of safety or effectiveness because:

• The fundamental design remains the same.
• The materials are identical.
• The intended use and indications for use are unchanged.
• The added sizes are within the expected physiological range and manufacturing capabilities already established for the predicate devices, thus not constituting a "new worst case."

Therefore, the "acceptance criteria" are met by successfully demonstrating this robust substantial equivalence to already cleared devices through non-clinical reasoning and comparison, rather than through new human clinical trials or extensive novel performance testing.

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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.

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