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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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