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The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

The MectaLIF 3D Metal are a line extension to the MectaLIF Oblique and Posterior PEEK implants (K110927, K131671, K181970 and K212831) and MectaLIF Oblique and Posterior TiPEEK implants (K133192, K181970 and K212831). Specifically, the purpose of this submission is to obtain the clearance of MectaLIF 3D Metal Posterior, Oblique and Oblique Dome additively manufactured from Ti6Al4V according to ASTM F2924-14. MectaLIF implants are used to replace a degenerative disc in order to restore the height of the spinal column structure. The devices are not intended to be coupled with other implants but are intended to be used with supplemental fixation and autogenous bone graft. The subject implants are provided individually packed, sterile and single-use.

This document is an FDA 510(k) clearance letter for a medical device called "MectaLIF 3D Metal." This type of document is a regulatory submission demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not generally contain acceptance criteria or detailed study results for AI/software-as-a-medical-device (SaMD), as it pertains to a physical implant.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text because it is not relevant to this type of device or submission.

The document details the following for a physical medical device (intervertebral body fusion device):

• Device Name: MectaLIF 3D Metal
• Regulation Number: 21 CFR 888.3080
• Regulation Name: Intervertebral Body Fusion Device
• Regulatory Class: Class II
• Product Code: MAX
• Indications for Use: The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion.
• Predicate Devices: MectaLIF Extension (K212831), MectaLIF Posterior Extension (K181970), MectaLIF TiPEEK (K133192), MectaLIF Extension (K131671), MectaLIF (K110927).
• References Devices: Mpact 3D Metal Implants – DMLS Technology (K202568), GMK 3D Metal Tibial Tray (K221850).
• Performance Data (Non-Clinical Studies): Mechanical standard tests (static and dynamic axial/shear compression, axial compressive subsidence), expulsion test, wear analysis, stereological evaluation, abrasion test, static tensile test, static shear test, pyrogenicity testing, biocompatibility assessment, and shelf-life evaluation. These tests are conducted according to various ASTM and ISO standards for intervertebral body fusion devices and implant materials.
• Clinical Studies: No clinical studies were conducted for this submission, as is often the case for 510(k) clearances when substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.

In summary, the provided text does not contain information about acceptance criteria or performance studies related to AI/software, as it describes the 510(k) clearance for a physical orthopedic implant.

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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 implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

The subject MectaLIF Extension implants are a line extension to the MectaLIF Oblique and Posterior PEEK implants (K110927, K131671 and K181970) and MectaLIF Oblique and Posterior TiPEEK implants (K133192 and K181970). MectaLIF implants are used to replace a degenerative disc in order to restore the height of the spinal column structure. The devices are not intended to be coupled with other implants but are intended to be used with supplemental fixation and autogenous bone graft. The subject MectaLIF Extension includes various sizes of MectaLIF Oblique and MectaLIF Posterior implants with different widths, lengths, heights, and lordosis angles. The implants are made of implant grade Polyetherketone and have markers made of Tantalum. The devices are available both uncoated or coated with commercially pure titanium coating.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MectaLIF Extension device.

It's important to note that the document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed within this context of demonstrating equivalence through non-clinical performance data rather than a full-scale clinical trial.

Acceptance Criteria and Device Performance for MectaLIF Extension (Based on 510(k) Summary)

Based on the provided FDA 510(k) summary (K212831), the "acceptance criteria" for the MectaLIF Extension are implicitly tied to demonstrating performance comparable to its predicate devices, aligning with relevant ASTM and ISO standards for intervertebral body fusion devices. The study proving these criteria are met consists primarily of non-clinical (benchtop) performance testing. No clinical studies were conducted for this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

• Static and dynamic shear compression test (ASTM F2077-18)
• Axial compressive subsidence test (ASTM F2077-18)
• Measuring Load Induced subsidence (ASTM F2267-04)
• Expulsion Test rationale (Implied adherence to performance requirements) | Design validation and performance testing conducted to written protocols. Implied to meet or exceed relevant predicate device and standard requirements. |
  | Material Properties & Coating Performance | - TiPEEK coating validation (ASTM F1854-15 for stereological evaluation of porous coatings; ASTM F1147-05 for tension testing)
• Wear analysis of TiPEEK coated devices (ISO 17853:2011; ASTM F1877-16) | Adherence to relevant ASTM and ISO standards for material and coating validation. Implied acceptable performance. |
  | Biocompatibility & Sterility | - Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter )
• Pyrogen test according to USP chapter
• Biocompatibility assessment (General statement, implying tests like cytotoxicity, sensitization, irritation performed per ISO 10993)
• Sterility Validation | Tests were conducted. Devices are not labeled as non-pyrogenic. Implied to meet biocompatibility and sterility requirements. |
  | Shelf-Life & Packaging | - Shelf-life evaluation
• Packaging validation | Evaluation/validation done. Implied acceptable. |
  | Design Integrity (New Sizes/Lordosis/Volume) | - Design Validation Report for MectaLIF Oblique 10mm width instrument/implant interface (specific to one of the new configurations, implies assessment of fit, function, and instrument compatibility for new sizes/lordosis) | Conducted as part of design validation to written protocols. Implied suitable. |

Note: The document states that "Based on the risk analysis, design validation and performance testing were conducted to written protocols." and lists the specific tests. The detailed quantitative results (e.g., exact load values survived, specific wear rates) are not included in this public summary but would be part of the full 510(k) submission. The "reported device performance" in this context is the statement that these tests were conducted and support the claim of substantial equivalence.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify the exact sample sizes (number of devices tested) for each non-clinical performance test (e.g., how many cages underwent axial compression testing). These numbers are typically defined by the specific ASTM/ISO standards referenced.
• Data Provenance: The tests are explicitly non-clinical (benchtop mechanical, material, and biological tests).
  • Country of Origin: The submitter is "Medacta International SA, Strada Regina 6874 Castel San Pietro (CH) Switzerland." The testing would presumably have been performed in a lab accredited to conduct these tests, likely in Switzerland or a country with recognized testing facilities.
  • Retrospective or Prospective: Not applicable as these are benchtop tests, not clinical data from patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This concept is not applicable in this context. For a 510(k) submission primarily relying on non-clinical performance data, there is no "ground truth" derived from expert clinical opinion or patient outcomes in the same way there would be for an AI/CADe device submitting clinical study results. The "ground truth" for non-clinical tests is established by:

• The measurement equipment and its calibration.
• The test methods defined by recognized standards (e.g., ASTM, ISO), which dictate how a device's performance characteristic is measured.
• The acceptance criteria set by the manufacturer (and implicitly accepted by the FDA for substantial equivalence) based on predicate device performance and standard requirements.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication methods (e.g., 2+1, 3+1) are used in clinical studies, particularly for diagnostic accuracy or image review, to resolve discrepancies between readers or to establish a definitive diagnosis as ground truth. Since this submission relies on non-clinical benchtop testing, there are no human readers or clinical cases requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Studies: No clinical studies were conducted." This type of study would be relevant for a device intended to aid in clinical diagnosis or treatment decisions by human readers, typically for AI/CADe.

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

No, a standalone performance evaluation (as defined for AI algorithms) was not done. This device is an intervertebral body fusion implant, not software or an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for determining acceptance for this device is based on:

• Engineering Standards and Specifications: Adherence to defined physical and mechanical properties, material composition, and dimensions as tested against industry standards (ASTM F2077, F2267, F1854, F1147) and biocompatibility standards (ISO, USP, European Pharmacopoeia).
• Predicate Device Equivalence: The primary "ground truth" for a 510(k) clearance is demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device regarding safety and effectiveness. This means the performance characteristics of the new device are comparable to, or better than, the predicate devices based on the non-clinical tests.

8. The Sample Size for the Training Set

This concept is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical medical implant, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

This concept is not applicable. As stated above, this is a physical medical device, not an AI/ML algorithm requiring a training set and associated ground truth establishment.

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The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

MectaLIF Transforaminal TiPEEK lumbar intervertebral body fusion device is characterized by different sizes of implants that can be applied with a TLIF procedure (Transforaminal Lumbar Intervertebral Fusion). They are provided sterile and used to replace a degenerative disc in order to restore the height of the spinal column structure. MectaLIF Transforaminal TiPEEK is intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft. MectaLIF Transforaminal TiPEEK consists of a PEEK (ASTM F2026) body, tantalum (ISO 13782 / ASTM F560) markers and a titanium (Ti6A14V ISO 5832-3 / ASTM F136) gear that acts as an instrument interface. The implant surface is coated with commercially pure titanium (CPT) ASTM F1580).

This document describes a 510(k) premarket notification for the "MectaLIF Transforaminal TiPEEK" intervertebral body fusion device. The focus of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies for new device types. As such, the information provided primarily addresses non-clinical performance and material characterization, and explicitly states that no clinical studies were conducted. Therefore, the request for details related to acceptance criteria, AI performance, expert adjudication, and MRMC studies are not applicable to this specific submission.

Here's a breakdown of the available information regarding testing and "acceptance" in the context of this 510(k):

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

Since this is a 510(k) for a device with a new material composition (TiPEEK coating) but otherwise similar design to a predicate, the "acceptance criteria" are primarily related to material properties, biocompatibility, and mechanical performance to demonstrate equivalence. The document doesn't provide a direct table of acceptance criteria and results in the typical sense of a clinical trial. Instead, it lists the types of non-clinical tests performed:

• Pyrogen test according to USP chapter for pyrogenicity determination.
• Note: The subject devices are not labeled as non-pyrogenic or pyrogen free. |
  | Biocompatibility (implicit) | - PEEK (ASTM F2026), tantalum (ISO 13782 / ASTM F560), titanium (Ti6A14V ISO 5832-3 / ASTM F136), commercially pure titanium (CPT) ASTM F1580 coatings are listed, indicating adherence to established material standards. The submission states the TiPEEK coating is the same as cleared in K133192. |
  | Technological Characteristics Comparison | - Claimed equivalence in shape, sizes, biocompatibility, device usage, sterility, shelf life, and packaging to the predicate device (K131671). The only difference is the material (TiPEEK coating). |

The acceptance criteria for these tests would typically be compliance with the specified standards (e.g., ASTM, ISO, USP) and demonstrating that the new material/device performs equivalently to, or within acceptable safety parameters of, the predicate device. The document states:
"The comparison of technological characteristics and performance data provided within this submission, shows that there are no new risks associated with the subject devices design, and supports the substantial equivalence of the MectaLIF Transforaminal TiPEEK implants to the identified predicate devices."

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 for Test Set: Not explicitly stated in terms of the number of devices tested for wear or pyrogenicity, but testing was conducted on samples of the device. This is typical for engineering and material characterization studies rather than clinical trials on human subjects.
• Data Provenance: The test methods refer to international and US standards (IL, European Pharmacopoeia, USP, ASTM, ISO). The company, Medacta International SA, is located in Switzerland, and Medacta USA in Memphis, Tennessee. The specific location where the non-clinical tests were conducted is not detailed, but it would have been laboratories certified to perform these types of material and mechanical tests. This data is non-clinical/bench testing.

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)

Not applicable. This is a non-clinical submission for a medical device's physical and material properties. There is no "ground truth" derived from expert clinical assessment for this type of submission. The "ground truth" is established by adherence to validated test methods and material specifications.

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

Not applicable. As this is not a clinical study involving human assessment of images or outcomes, adjudication methods are not relevant.

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

Not applicable. This device is an implantable intervertebral body fusion device, not an AI-powered diagnostic or assistive tool. No MRMC studies were performed.

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

Not applicable. This is not an algorithm or AI device.

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

For non-clinical testing of a medical implant, the "ground truth" is defined by established engineering and material science standards, performance specifications, and predicate device performance. For example, for a wear test, the ground truth is that the wear rate must be below a certain validated threshold, or comparable to the predicate device, as determined by the specific wear test protocol. For pyrogenicity, the ground truth is an absence of pyrogens per the specified USP/EP methods.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

In summary: This 510(k) submission for the MectaLIF Transforaminal TiPEEK device relies on non-clinical performance data and a comparison of technological characteristics to demonstrate substantial equivalence to a predicate device. It explicitly states that "No clinical studies were conducted," and therefore, none of the questions related to clinical performance, AI, expert assessment, or human-in-the-loop studies are relevant to this specific FDA submission document. The "proving the device meets acceptance criteria" here revolves around documented compliance with engineering standards and demonstration of equivalent physical and material properties to a previously cleared 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 implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 - S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radios. These patients may have had a previous non-fusion spiral surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of nonoperative treatment prior to treatment with the devices.

The subject MectaLIF Posterior Extension implants are line extension to the MectaLIF Posterior PEEK implants (K110927 and K131671) and MectaLIF Posterior TiPEEK implants (K133192). The MectaLIF Posterior Interbody Fusion implants are used to to treat degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. The devices are not intended to be coupled with other implants but are intended to be used with a supplementary fixation as posterior fixation or with autogenous bone graft. The subject devices provide an enlarged MectaLIF Posterior implants product range through the introduction of implants with width 9mm, length 22 and 25mm, height from 7 to 15mm, lordosis 0°, 5°, and 10°. This range extension is carried out in order to better cover the patient population. The MectaLIF Posterior Extension implants have been designed with the same or similar shape, dimensions and materials as the previously cleared MectaLIF (K110927). Medacta MectaLIF Extension (K131671), Medacta MectaLIF TiPEEK (K133192), and Aesculap ProSpace88 Interbody System (K071983). The subject MectaLIF Posterior Extension implants are manufactured by the following materials: MectaLIF Posterior PEEK implants: PEEK Implant Grade Polyetheretherketone body (ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) + Tantalum radiographic markers (ISO 13782:1996 Implants for surgery -Metallic materials - Unalloyed tantalum for surgical implant applications and ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications); and MectaLIF Posterior TiPEEK implants: PEEK Implant Grade Polyetheretherketone body (ASTM F2026-17 Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications) + Tantalum radiographic markers (ISO 13782:1996 Implants for surgery -Metallic materials - Unalloyed tantalum for surgical implant applications and ASTM F560-17 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications) + Titanium surface coating (CPTi (ASTM F1580-12 Standard Specification for Titanium and Titanium-6 Aluminum-4 Vanadium Alloy Powders for Coatings of Surgical Implants), Spondycoat-T 371A).

This document describes the MectaLIF Posterior Extension, an intervertebral body fusion device. While it mentions the performance data in the context of non-clinical studies and a comparison to predicate devices, it does not detail acceptance criteria or a study that rigorously "proves" the device meets specific performance thresholds in a clinical or AI-centric sense. The provided text is a 510(k) summary for a medical device, focusing on substantial equivalence to predicate devices rather than the kind of performance study you're asking about for a diagnostic or AI-driven tool.

Therefore, many of the requested fields cannot be directly extracted from the provided text as they pertain to a type of study not conducted or described here.

Here's an attempt to answer your questions based on the available information, with many points indicating that the information is "Not Applicable" or "Not Provided" in this specific document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not Applicable. The document describes non-clinical mechanical testing of the device itself (materials, design) rather than a test set of patient data for evaluating diagnostic performance.
• Data Provenance: Not Applicable. No patient data or clinical test set is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. No clinical ground truth or experts for establishing ground truth are mentioned as this is not a diagnostic/AI device.

4. Adjudication Method for the Test Set

• Not Applicable. No clinical test set or adjudication method is mentioned.

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

• Not Applicable. This is a physical intervertebral body fusion device, not an AI or diagnostic tool that would involve human readers or AI assistance. No clinical studies were conducted, as explicitly stated: "No clinical studies were conducted."

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

• Not Applicable. This is a physical medical device, not an algorithm.

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

• Not Applicable for clinical ground truth. The "ground truth" or reference for the mechanical testing would be the performance standards themselves (e.g., ASTM, ISO standards) and the material specifications.

8. The sample size for the training set

• Not Applicable. No training set is mentioned as this is not an AI/ML device.

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

• Not Applicable. No training set or ground truth for one is mentioned.

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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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