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The MectaLIF Anterior is an anterior 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.

The MectaLIF Anterior is a system intended to be used with the integrated bone screws provided and requires additional supplementary fixation such as pedicle screws and rods.

These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

These patients should be skeletally mature and have had six months of non-operative treatment.

The MectaLIF Anterior is an anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. MectaLIF Anterior is intended to be used with bone screws provided and requires additional supplementary fixation. MectaLIF Anterior consists of a disc spacer made of PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026) which contains three Tantalum Markers (ISO 13782 / ASTM F 560), bone screws made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136), and a plate made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136). The interior of the disc spacer can be packed with autograft or autologous bone graft. The plate comes in three different designs (Flush, Long, and L5-S1) and is secured to the disc spacer via an interlocking mechanism. The disc spacer and attached plate are secured to the vertebral body with the bone screws. The Flush and Long plates are used with four bone screws while the L5-S1 plate is used with three bone screws.

The presented document describes the performance testing for the MectaLIF Anterior, an anterior interbody fusion device, in the context of a 510(k) premarket notification. The goal of the testing was to demonstrate substantial equivalence to predicate devices.

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size: The document does not specify the exact sample size. It states that testing was performed "using the worst-case device for each of the following tests." This suggests that potentially one "worst-case" device was selected and subjected to each test. However, standards like ASTM F2077 and F2267 typically require multiple samples for statistical validity. Without specific numbers, it's impossible to confirm the sample size.
• Data provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that this is a 510(k) submission for a device manufactured by Medacta International SA (Switzerland) and represented by Medacta USA, the testing would likely have been conducted in a laboratory setting, possibly in Switzerland or the US, to meet regulatory requirements. The nature of the performance tests (mechanical testing) indicates this is prospective laboratory test data, not patient data.

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 to the supplied document. The "tests" described are mechanical performance tests of a medical device, not clinical studies involving expert interpretation of patient data or images. The "ground truth" for these tests is the quantitative measurement obtained through standardized mechanical testing protocols (ASTM F2077 and F2267).

4. Adjudication method for the test set:

• This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical studies or image review where there are multiple human readers whose interpretations need to be reconciled. The performance testing outlined here is mechanical.

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:

• This information is not applicable. The document describes mechanical performance testing of an interbody fusion device, not an AI-powered diagnostic or assistive technology for human readers.

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

• This information is not applicable. The document describes mechanical performance testing of an interbody fusion device, not an algorithm or AI system.

7. The type of ground truth used:

• For the mechanical performance tests, the "ground truth" is defined by the measured mechanical properties (e.g., load-bearing capacity, resistance to shear, subsidence, expulsion force) as determined by the standardized test methods ASTM F2077 and ASTM F2267. These standards define the experimental setup, loading conditions, and measurement techniques. The acceptance criteria are then set relative to predicate device performance.

8. The sample size for the training set:

• This information is not applicable. The document describes mechanical performance testing of a physical medical device, not a machine learning model that requires a training set.

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

• This information is not applicable, as there is no training set mentioned or implied in this document for the device's performance evaluation.

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