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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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