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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 Mectal IF Anterior Stand Alone system 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 MectaLIF Anterior Stand Alone 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 sketally mature and have had six months of non-operative treatment. The MectaLIF Anterior Stand-Alone system is a system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The MectaLIF Anterior Stand Alone devices are stand-alone anterior interbody fusion devices indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. MectaLIF Anterior Stand Alone is intended to be used with the provided bone screws and requires no additional supplementary fixation.

MectaLIF Anterior Stand Alone consists of disc spacers made of PEEK Implant Grade Polyetheretherketone. The spacers are provided uncoated or coated with a commercially pure titanium (CPTi). Both uncoated and coated spacers contain tantalum markers, and include titanium bone screws and a titanium plate.

The interior of the disc spacer can be packed with autograft or autologous bone graft. The plate comes in four different designs (Flush, Long, L5-S1, and Hybrid) 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, Long, and Hybrid plates are used with four bone screws while the L5-S1 plate is used with three bone screws.

The subject MectaLIF Anterior Stand Alone Extension introduces Long Head Screw implants that are line extension to the previously cleared Medacta International MectaLIF Anterior Stand Alone -K160605.

The MectaLIF Anterior Long Head Screw implants have been designed with the same or similar shape, dimensions and materials as the previously cleared MectaLIF Anterior Stand Alone screws (K160605): they share the lengths, the diameters, the material and the body shape, the only difference is the longer screw head (compared to current Medacta MectaLIF Anterior screws already on the market) and the tighter coupling dimensions (Torx interface) developed to allow better stability between the screw and the screwdriver during screw implantation.

The MectaLIF Anterior Long Head Screw implants are manufactured with the same material as the Medacta predicate device MectaLIF Anterior Stand Alone screws [cleared through K160605]: Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy + ASTM F136 Standard Specification for Wrought Titanium-6Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)).

The provided text is a 510(k) summary for a medical device (MectaLIF Anterior Stand Alone Extension) and outlines the regulatory submission process, device description, and a comparison to a predicate device. It does not describe an AI/ML-driven medical device, nor does it contain information about clinical studies with human participants, expert ground truth establishment, or typical performance metrics like accuracy, sensitivity, or specificity.

Therefore, the requested details regarding acceptance criteria, study design for AI/ML devices, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance are not available in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material, design, and biomechanical testing of an intervertebral body fusion device.

Here's what can be extracted from the document, though it doesn't fit the typical AI/ML study structure you described:

Acceptance Criteria and Reported Device Performance (as per a medical device submission, not AI)

The acceptance criteria here refer to meeting established standards for intervertebral body fusion devices, rather than a statistical threshold for AI performance. The "performance" is demonstrated through adherence to these standards.

Since this is not an AI/ML device, the following points are not applicable and cannot be answered from the provided text:

2. Sample size used for the test set and the data provenance: Not an AI/ML device; no test set of patient data described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI/ML device; ground truth in this context refers to physical testing standards.
4. Adjudication method for the test set: Not an AI/ML device; no human review process for a 'test set' of data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance, often with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm to evaluate.
7. The type of ground truth used: In the context of a physical medical device, "ground truth" is established by adherence to biomechanical and material standards. For the purpose of this 510(k), testing against ASTM and ISO standards serves as the "ground truth" to demonstrate physical performance.
8. The sample size for the training set: Not applicable. No AI/ML model for training.
9. How the ground truth for the training set was established: Not applicable. No AI/ML model for training.

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The MectaLIF Anterior Stand Alone system 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 Stand Alone 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. The MectaLIF Anterior Stand-Alone system intended to be used with bone screws provided and requires no additional supplementary fixation. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

The MectaLIF Anterior Stand Alone devices are stand-alone anterior interbody fusion devices indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. MectaLIF Anterior Stand Alone is intended to be used with the provided bone screws and requires no additional supplementary fixation.

MectaLIF Anterior Stand Alone consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F2026). The spacers are provided uncoated or coated with a commercially pure titanium (CPTi, ASTM F1580) coating. Both uncoated and coated spacers contain tantalum markers (ISO 13782/ASTM F560), and include bone screws made of Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F136), and a plate made of Titanium: Ti6A14V ELI (ISO 5832-3/ASTM F136).

The interior of the disc spacer can be packed with autograft or autologous bone graft. The plate comes in four different designs (Flush, Long, L5-S1, and Hybrid) 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, Long, and Hybrid plates are used with four bone screws while the L5-S1 plate is used with three bone screws.

The MectaLIF Anterior plates and bone screws were cleared under K124034 and K160605.

The provided text is a 510(k) summary for a medical device called "MectaLIF Anterior Stand Alone." It details the device, its intended use, and its comparison to a predicate device to establish substantial equivalence for regulatory approval.

However, the document does not contain any information about a study involving AI or human readers, or any performance data related to diagnostic accuracy, sensitivity, specificity, or AUC, or any details about ground truth establishment by experts.

Therefore, I cannot fulfill your request for the following information based on the provided text:

• A table of acceptance criteria and the reported device performance: This document does not describe acceptance criteria or performance metrics in the context of an AI-driven or diagnostic study. The "Performance Data" section refers to mechanical testing (static axial compression, dynamic axial compression, etc.) and states that the "subject devices do not represent a new worst case" compared to previously cleared devices. It does not provide numerical results for these tests either, only lists the types of tests.
• Sample size used for the test set and the data provenance: Not present.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
• Adjudication method for the test set: Not present.
• 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 present.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present.
• The type of ground truth used: Not applicable in the context of this device's mechanical testing.
• The sample size for the training set: Not applicable as there is no AI training described.
• How the ground truth for the training set was established: Not applicable as there is no AI training described.

In summary, the provided document describes a spinal interbody fusion device that underwent mechanical and material testing for substantial equivalence to a predicate device, not a study involving AI, human readers, or diagnostic performance evaluation.

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