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The Mecta-C Stand Alone is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the Mecta-C Stand Alone should be packed with autogenous bone graft and implanted via an anterior approach.

The Mecta-C Stand Alone implants are a line extension to Medacta's anterior cervical discectomy and fusion devices' portfolio. The Mecta-C Stand Alone implants are composed of Mecta-C Stand Alone PEEK and Mecta-C Stand Alone TiPEEK implants. The Mecta-C Stand Alone implants are intended to be used during cervical interbody fusion surgeries. The implants are characterized by different sizes of the PEEK body, in combination with different plate designs and screws. The PEEK body is available uncoated as well as with a Titanium coating. The Mecta-C Stand Alone implants are composed of cages, plates, locking screws, lag screws, and antibackout screws. The cages are available in various widths, heights, and lengths, with a fixed 7° of lordosis. The cages are to be inserted between two (2) cervical vertebral bodies to provide support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows the cages to be packed with bone graft. The plates are designed with different shapes to promote a specific approach or to simplify the procedure in a specific area. The plates are assembled in front of the cage and allow for mounting of a certain number of screws. The screws are placed through the plate and cage in order to fix the device to the vertebral bodies. The Mecta-C Stand Alone implants are designed for long-term implantation inside the human body. The implants are provided sterile in single-use packages.

This document is a 510(k) summary for the Medacta International SA Mecta-C Stand Alone intervertebral body fusion device. It details the device's characteristics, indications for use, and comparison to predicate devices, focusing on demonstrating substantial equivalence. The document primarily focuses on non-clinical testing.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

The document lists the types of performance tests conducted and the standards followed, but it does not provide a specific table of acceptance criteria and the reported device performance results. It states: "Testing was conducted according to written protocols with acceptance criteria that were based on standards." This implies that such a table or detailed results exist in the full submission to the FDA, but they are not included in this public summary.

The non-clinical performance tests mentioned are:

• Performance Tests per ASTM F2077-18:
  • Static compression
  • Static compression-shear
  • Static torsion
  • Dynamic compression
  • Dynamic compression-shear
  • Dynamic torsion
  • Plate removal
• Performance Tests per ASTM F2267-2004 (Reapproved 2018):
  • Subsidence
• Performance Tests per ASTM F543-17:
  • Pull-out
  • Insertion and removal torque
• Other performance tests:
  • Expulsion
  • Torsion (listed separately from ASTM F2077-18 torsion)
  • Wear testing
  • MRI evaluation
  • Implant imaging properties
• Pyrogenicity:
  • Bacterial Endotoxin Test (LAL test) per European Pharmacopoeia §2.6.14 (equivalent to USP chapter )
  • Pyrogen test per USP chapter

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for any of the non-clinical tests. The phrase "worst-case implants" is used, suggesting a selection of samples, but not the quantity.
• Data Provenance: Not explicitly stated. The submitting company is Medacta International SA in Switzerland, and Medacta USA is also mentioned. However, the location where the testing was performed (country of origin of the data) is not given. The nature of these mechanical and biological tests (non-clinical) means "retrospective or prospective" doesn't strictly apply in the same way it would to clinical studies.

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 document explicitly states: "No clinical studies were conducted." The testing described is non-clinical (mechanical, material, and biocompatibility testing), which does not involve human subjects or expert clinical review for ground truth establishment.

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

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies involving human interpretation or consensus.

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 device is an intervertebral body fusion device, not an AI-powered diagnostic or assistive tool. No MRMC studies were conducted as there were no clinical studies at all.

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

This information is not applicable. The device is a physical implant, not an algorithm.

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

For the non-clinical tests, the "ground truth" is established by adherence to pre-defined engineering standards and their associated acceptance criteria. For example, the "ground truth" for static compression is that the device must withstand a certain load as defined by ASTM F2077-18 without failing, or for pyrogenicity, that the bacterial endotoxin levels must be below a specified threshold. There are no clinical "ground truth" types (like pathology or outcomes data) mentioned because no clinical studies were performed.

8. The sample size for the training set

This information is not applicable. As a physical implant, this device does not have a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as point 8.

Summary of what is missing/not applicable for this device submission:

Since this 510(k) submission primarily relies on non-clinical performance testing and comparison to predicate devices, and explicitly states no clinical studies were conducted, many of your questions related to clinical trials, expert review, AI performance, and human reader studies are not relevant to this particular submission.

The critical missing information from the public summary, in relation to your questions about acceptance criteria and device performance, is the quantitative results of the non-clinical tests and the specific numerical acceptance criteria for each test. The document states these exist ("written protocols with acceptance criteria") but does not disclose them.

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