Search Results

The MectaLIF Anterior is an interbody fusion device indicated for use 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 I spondylolisthesis or retrolisthesis at the involved level(s). The interior of the spacer component of the MectaLIF Anterior can be packed with autograft or autologous bone graft. 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 at least six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The MectaLIF Anterior Stand-Alone system is intended to be used with bone screws provided and requires no additional supplementary fixation. The MectaLIF Anterior Simple requires additional supplementary fixation such as pedicle screws and rods or lumbar anterior plate system.

MectaLIF Anterior Stand Alone Fusion Device System, consisting of cages, plates and screws, does not require additional fixation. The MectaLIF Anterior cage can be coupled with four different profiles of stand-alone plates: flush, long, L5-S1 and hybrid. The purpose of this submission is to gain the clearance for a design change performed on the MectaLIF Anterior lag plates flush and their related cover plate already cleared within K221545. The lag plate flush is secured to the disc spacer via an interlocking mechanism and an additional antiback-out cover plate, used to reduce the risk of screw migration after the implantation. No materials' changes have been performed, thus both the plates and the screws are made of Ti6Al4V ELI (ISO 5832-3/ASTM F136).

The provided text describes a 510(k) premarket notification for a medical device called "MectaLIF Anterior Lag Extension" and compares it to a predicate device. It explicitly states that no clinical studies were conducted for this submission. The performance data relied on non-clinical studies.

Therefore, many of the requested details regarding acceptance criteria, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance data, and ground truth for test and training sets cannot be extracted from this document, as they pertain to clinical studies.

However, based on the provided text, here's what can be gathered regarding the device's performance claims, focusing on the non-clinical studies:

Acceptance Criteria and Reported Device Performance (Non-Clinical Studies)

Since no clinical studies were performed, the acceptance criteria and performance are related to the mechanical and biological aspects of the device, primarily through simulated-use and resistance testing.

Study Details (Limited to Non-Clinical Data from this Document)

1. Sample sized used for the test set and the data provenance:

   • The document does not specify the sample sizes for the simulated-use testing, resistance testing, or other non-clinical tests (bacterial endotoxin, pyrogen, biocompatibility, shelf-life).
   • Data Provenance: Not explicitly stated, but these would typically be conducted by the manufacturer (Medacta International SA or Medacta USA) in a laboratory setting.
   • Retrospective or Prospective: These non-clinical tests are prospective in nature, designed and executed to evaluate the device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this information is relevant for clinical studies, which were not conducted. Ground truth for non-clinical testing is typically defined by engineering specifications and standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable as this information is relevant for clinical studies.

4. 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. No clinical studies were conducted, and this is not an AI-assisted device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical intervertebral fusion device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical studies, the "ground truth" or reference points would be the established engineering specifications, mechanical properties standards (e.g., for resistance testing), and biological safety standards (e.g., for pyrogenicity and biocompatibility testing).

7. The sample size for the training set:

   • Not applicable. This concept pertains to machine learning models, which are not relevant for this device's submission.

8. How the ground truth for the training set was established:

   • Not applicable.

Summary from the provided document:

The 510(k) clearance for the MectaLIF Anterior Lag Extension device was based on a comparison to a predicate device (MectaLIF Anterior Extension, K221545) and a series of non-clinical performance tests. The document explicitly states: "No clinical studies were conducted." The acceptance criteria are therefore derived from the successful completion of these non-clinical tests, demonstrating that the device's design change (on sub-components of lag plates flush and cover plate) does not raise new questions of safety and effectiveness compared to the predicate.

Ask a specific question about this device