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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 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. 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.

MectaLIF Anterior Stand Alone Fusion Device System, consisting of cages, plates and screws, does not require additional fixation. The MectaLIF Anterior cage can be coupled with four different profiles of stand-alone plates: flush, long, L5-S1 and hybrid. The purpose of this submission is to gain the clearance for a design change performed on the MectaLIF Anterior lag plates flush and their related cover plate already cleared within K221545. The lag plate flush is secured to the disc spacer via an interlocking mechanism and an additional antiback-out cover plate, used to reduce the risk of screw migration after the implantation. No materials' changes have been performed, thus both the plates and the screws are made of Ti6Al4V ELI (ISO 5832-3/ASTM F136).

The provided text describes a 510(k) premarket notification for a medical device called "MectaLIF Anterior Lag Extension" and compares it to a predicate device. It explicitly states that no clinical studies were conducted for this submission. The performance data relied on non-clinical studies.

Therefore, many of the requested details regarding acceptance criteria, sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone performance data, and ground truth for test and training sets cannot be extracted from this document, as they pertain to clinical studies.

However, based on the provided text, here's what can be gathered regarding the device's performance claims, focusing on the non-clinical studies:

Acceptance Criteria and Reported Device Performance (Non-Clinical Studies)

Since no clinical studies were performed, the acceptance criteria and performance are related to the mechanical and biological aspects of the device, primarily through simulated-use and resistance testing.

Study Details (Limited to Non-Clinical Data from this Document)

1. Sample sized used for the test set and the data provenance:

   • The document does not specify the sample sizes for the simulated-use testing, resistance testing, or other non-clinical tests (bacterial endotoxin, pyrogen, biocompatibility, shelf-life).
   • Data Provenance: Not explicitly stated, but these would typically be conducted by the manufacturer (Medacta International SA or Medacta USA) in a laboratory setting.
   • Retrospective or Prospective: These non-clinical tests are prospective in nature, designed and executed to evaluate the device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as this information is relevant for clinical studies, which were not conducted. Ground truth for non-clinical testing is typically defined by engineering specifications and standards.

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

   • Not applicable as this information is relevant for clinical studies.

4. 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 applicable. No clinical studies were conducted, and this is not an AI-assisted device.

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

   • Not applicable. This is a physical intervertebral fusion device, not an algorithm.

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

   • For the non-clinical studies, the "ground truth" or reference points would be the established engineering specifications, mechanical properties standards (e.g., for resistance testing), and biological safety standards (e.g., for pyrogenicity and biocompatibility testing).

7. The sample size for the training set:

   • Not applicable. This concept pertains to machine learning models, which are not relevant for this device's submission.

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

   • Not applicable.

Summary from the provided document:

The 510(k) clearance for the MectaLIF Anterior Lag Extension device was based on a comparison to a predicate device (MectaLIF Anterior Extension, K221545) and a series of non-clinical performance tests. The document explicitly states: "No clinical studies were conducted." The acceptance criteria are therefore derived from the successful completion of these non-clinical tests, demonstrating that the device's design change (on sub-components of lag plates flush and cover plate) does not raise new questions of safety and effectiveness compared to the predicate.

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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 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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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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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 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 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. MectaLIF Anterior Stand-Alone is intended to be used with bone screws provided and requires no additional supplementary fixation.

MectaLIF Anterior Stand-Alone consists of disc spacers made of PEEK Implant Grade Polyetheretherketone (ASTM F 2026) body. The spacer is available without any coatings and with a commercially pure titanium (CPTi, ASTM F 1580) coating. Both coated and uncoated spacers contain tantalum markers (ISO 13782 / ASTM F 560), and include 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 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 purpose of this submission is to alter the indications for use, and introduce new plate and screw designs.

The provided text describes the MectaLIF Anterior Stand-Alone device and its performance testing as part of a 510(k) submission to the FDA. However, this document does not include specific acceptance criteria for performance metrics (such as a minimum load for static axial compression) or reported device performance in the format of a table with specific numerical results.

Instead, it lists the types of performance tests conducted and concludes that the device is substantially equivalent to predicate devices based on these tests and other characteristics.

Therefore, I cannot populate a table of acceptance criteria and reported device performance from the provided text. I also cannot provide information on sample size for the test set, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance details, training set information, or how ground truth was established for the training set, as these details are not present in the document.

What the document does provide regarding device performance:

The document states that the following tests were conducted on the MectaLIF Anterior Stand-Alone in accordance with ASTM F2077, ASTM F2267, ASTM F1877, and ISO 17853:

• Static Axial Compression
• Dynamic Axial Compression
• Static Compression-Shear
• Dynamic Compression-Shear
• Static Torsion
• Dynamic Torsion
• Subsidence
• Expulsion

The conclusion is that based on the information presented, the MectaLIF Anterior Stand Alone is substantially equivalent to the predicate devices. This implies that the device met the performance requirements demonstrated by the predicate devices through these tests, but the specific numerical acceptance criteria and reported results are not detailed in this public summary.

In summary, the provided document largely focuses on regulatory and descriptive aspects of the device, rather than a detailed report of performance study results against specific criteria.

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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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