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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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