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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 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.

The subject MectaLIF Anterior Extension implants are a line extension designed to provide a larger product offering in Medacta MectaLIF Anterior portfolio. The MectaLIF Anterior is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. The family of MectaLIF Anterior system features two designs: MectaLIF Anterior Stand-Alone Fusion Device System, which is a system consisting of cages, plates and is intended to be used with bone screws provided and requires no additional supplementary fixation. MectaLIF Anterior Simple, which is a cage/plate system requiring additional supplementary fixation. The purpose of this submission is to introduce new cages footprints as well as new plates and screws designs. Identically to already cleared MectaLIF Anterior implants, the subject MectaLIF Anterior Extension implants consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F2026) body coated with commercially pure titanium (CPT), ASTM F1580). The spacers contain tantalum markers (ISO 13782 / ASTM F560) and include a flush plate secured to the vertebral body with 4 bone screws. Both the plates and the screws are made of Ti6A14V ELI (ISO 5832-3/ASTM F136). The flush plate is secured to the disc spacer via an interlocking mechanism and it is available in two designs lock and lag where an additional anti-back-out cover plate is used to reduce the risk of screw migration after the implantation. The interior of the disc spacer can be packed with autograft or autologous bone graft.

The provided text describes the MectaLIF Anterior Extension, an interbody fusion device. However, it does not include acceptance criteria or the specifics of a study proving the device meets said criteria as would be present for an AI/ML powered device. This document is a 510(k) summary for a medical device that appears to be a physical implant, not an AI or software-based medical device. Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, is not applicable or available in this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance data (e.g., mechanical testing, biocompatibility).

Key Points from the document:

• Device Type: The MectaLIF Anterior Extension is a physical interbody fusion device (implants, plates, and screws).
• Approval Basis: The approval is based on demonstrating substantial equivalence to legally marketed predicate devices, not on proving new clinical effectiveness or AI/ML performance.
• No Clinical Studies: The document explicitly states: "No clinical studies were conducted."
• No AI/ML Component: There is no mention of any AI or machine learning component in the device description or performance data.

Therefore, I cannot provide the requested table or information because it is not within the scope of the provided document. The questions about AI/ML performance metrics are not relevant to this specific device.

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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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The MectaLock PEEK Suture anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the shoulder and hip in the following procedures:

· Hip: acetabular labral repair; and

· Shoulder: glenoid labrum repair.

The MectaLock PEEK® Suture Anchor is an implantable device used for soft tissue re-fixation (i.e.: muscles, tendons, ligaments...) composed of an anchoring component (PEEK® anchor) and an Ultra High Molecular Weight PolyEthylene non-absorbable braided suture. The MectaLock PEEK® Suture Anchor is a knotless device provided mounted on the tip of a dedicated disposable driver which allows the surgeon to insert the anchor into a pilot hole, previously drilled in the desired position into the patient's bone. The surgeon must combine the MectaLock PEEK® Suture Anchor with the provided non-absorbable UHMWPE suture, packaged and included in the whole product's blister. The driver can be disposed immediately after the implant has been placed. The MectaLock PEEK® Suture Anchor portfolio is composed of three anchor sizes: ø2.4, ø2.9, and ø3.4mm combined with two driver lengths: short and long.

The provided text is a 510(k) summary for the MectaLock PEEK Suture Anchor. It is a regulatory submission for a medical device that does not involve an AI/ML algorithm.

Therefore, the requested information about acceptance criteria and study data for an AI/ML device (e.g., sample size for test/training sets, experts for ground truth, MRMC studies) is not present in this document. The document describes the device, its intended use, comparison to predicate devices, and non-clinical performance testing (e.g., design validation, characterization testing, pyrogenicity, sterilization) to establish substantial equivalence to a legally marketed predicate device. It explicitly states: "No clinical studies were conducted."

Because this document is not about an AI/ML device, I cannot fulfill the request for information specific to AI/ML device studies.

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