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The MectaLIF Anterior is an anterior interbody fusion device 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 System 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 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 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.

The MectaLIF Anterior Simple devices are interbody fusion devices which require supplementary fixation such as pedicle screws and rods or a lumbar anterior plate system. The design incorporates the benefits of a modular anterior plate and a radiolucent interbody spacer; the plate is secured to the disc spacer via an interlocking mechanism. The plates, manufactured from Ti6A14V ELI (ISO 5832-3 and ASTM F136), are provided sterile and are offered in five (5) heights (10 - 18 mm). The spacers, cleared under K124034, K160605, and K170455, are manufactured from PEEK and Ti-PEEK.

This FDA 510(k) summary for the MectaLIF Anterior Simple device does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of device performance related to diagnostic or clinical outcomes from a study. Instead, it outlines the regulatory basis for substantial equivalence for an intervertebral body fusion device.

The "Performance Data" section describes mechanical and material testing of the device components, not a clinical study to assess its diagnostic accuracy or clinical efficacy against predefined acceptance criteria for patient outcomes.

Therefore, many of the requested items cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Cannot be provided as requested.
The document describes mechanical tests performed on the device components (plates), not clinical performance metrics with defined acceptance criteria. The tests listed (static/dynamic axial compression, compression-shear, torsion, subsidence, expulsion) are engineering benchmarks to ensure structural integrity and safety, not measures of clinical outcomes or diagnostic accuracy.

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

Cannot be provided.
No clinical "test set" (i.e., a cohort of patients or samples used for a clinical performance study) is mentioned. The "worst-case device" for mechanical testing implies a limited number of physical samples for engineering evaluation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Cannot be provided.
No expert review or ground truth establishment relevant to clinical outcomes is described.

4. Adjudication Method for the Test Set

Cannot be provided.
No clinical test set or adjudication process is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Cannot be provided.
No such study is mentioned. The device is a physical intervertebral fusion device, not a diagnostic AI system that would typically be evaluated with MRMC studies comparing human readers with and without AI assistance.

6. Standalone Performance (Algorithm Only)

Cannot be provided.
Not applicable as this is a physical medical device, not an algorithm or AI system.

7. Type of Ground Truth Used

Cannot be provided.
No ground truth in the context of clinical outcomes, pathology, or expert consensus is discussed. The "performance data" refers to results from mechanical testing, where the "truth" is adherence to industry standards and the device's physical properties.

8. Sample Size for the Training Set

Cannot be provided.
Not applicable. No "training set" in the context of machine learning or clinical data is mentioned.

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

Cannot be provided.
Not applicable.

Summary of Available Information from the Provided Text:

The document focuses on demonstrating substantial equivalence for the MectaLIF Anterior Simple interbody fusion device to its predicate devices based on:

• Technological Characteristics Comparison: Similarities in size, materials, biocompatibility, usage, sterilization, shelf life, and packaging. The key difference is that the "Simple" version requires supplementary fixation and does not include bone screws, unlike the "Stand-Alone" predicates.
• Performance Data (Mechanical Testing):
  • The MectaLIF Anterior plates were tested according to ASTM F2077-11, ASTM F2267-04 (reapproved 2011), ASTM F1877-05 (reapproved 2010), and ISO 17853:2011.
  • Tests included: static axial compression, dynamic axial compression, static compression-shear, dynamic compression-shear, static torsion, dynamic torsion, subsidence, and expulsion.
  • Worst-case analysis determined that the MectaLIF Anterior Simple does not introduce a new worst-case plate compared to previously cleared plates (K124034), thus requiring no additional verification testing for these aspects.
  • Biocompatibility/Safety Testing: Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 (equivalent to USP ) and pyrogen test according to USP .

This FDA submission is for a physical implantable device, and the "performance data" section details engineering and safety tests rather than a clinical study evaluating diagnostic or treatment efficacy using human subjects. Therefore, many of the requested AI/diagnostic study related fields are not applicable.

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