Search Results

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.

Ask a specific question about this device

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.

MectaLIF Transforaminal lumbar intervertebral body fusion device is characterized by different sizes of PEEK-OPTIMA LT1 (Polyetheretherketone) implants that can be applied with a TLIF procedure (Transforaminal Lumbar Intervertebral Fusion). Mectal IF Transforaminal is used to replace a degenerative disc in order to restore the height of the spinal column structure. They are made of PEEK-OPTIMA LT1 and contain Tantalum Markers as well as a titanium gear which enables the surgeon to alter the angle of the MectaLIF Transforaminal in situ in 15° increments and to reposition during surgery without switching instrumentation. MectaLIF Transforaminal is intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft. The dimensions of MectaLIF Transforaminal are within the following range: Length 30-34mm; Height 8-15mm; Width 12-14mm; Lordosis 5°. The materials of the components of MectaLIF Transforaminal are as follows: Implant: PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026), Gear: Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136), and Marker: Tantalum (ISO 13782 / ASTM F 560).

This document describes the premarket notification (510(k)) for the MectaLIF Transforaminal intervertebral body fusion device.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MectaLIF Transforaminal device are implicitly based on comparison to legally marketed predicate devices, demonstrating substantial equivalence in terms of performance characteristics. The document states that the device has "similar performance testing as the predicates." While specific quantitative acceptance criteria or pass/fail thresholds are not explicitly stated for each test, the successful completion of these tests and the determination of substantial equivalence indicates that the device met the necessary performance benchmarks.

2. Sample Size and Data Provenance:

The provided document describes the mechanical testing conducted for the MectaLIF Transforaminal device. For this type of device, "sample size" typically refers to the number of devices tested in the mechanical studies. However, the document does not specify the exact sample sizes used for each of the performance tests (Static Axial Compression, Dynamic Axial Compression, Static Compression/Shear, Dynamic Compression/Shear, Subsidence Resistance).

The data provenance for these mechanical tests would be from laboratory testing performed on the physical devices. The document does not specify the country of origin where the testing was physically conducted, but the applicant, Medacta International SA, is based in Switzerland, and Medacta USA (contact person) is in the USA. The testing is assumed to be prospective laboratory testing for regulatory submission rather than retrospective or prospective clinical data.

3. Number of Experts and Qualifications for Ground Truth:

This submission is for a medical device (intervertebral body fusion device) primarily supported by mechanical testing and substantial equivalence to predicate devices, not an AI/ML software device. Therefore, the concept of "ground truth" derived from expert consensus, typically used for assessing diagnostic or prognostic AI/ML algorithms, does not apply in this context. The "ground truth" for the performance of this device is established by its physical and mechanical properties as measured by the specified ASTM standards.

4. Adjudication Method:

Since no human "experts" were used to establish a diagnostic or prognostic ground truth for a test set (as this is not an AI/ML device), there was no adjudication method used in the sense of reconciling expert opinions. The performance is based on objective laboratory measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable to this type of medical device submission. MRMC studies are typically used to evaluate the impact of AI on human reader performance in diagnostic imaging. This submission focuses on the mechanical and material equivalence of an implantable device. The submission does not refer to human readers or AI assistance.

6. Standalone Performance (Algorithm Only):

This section is not applicable as the MectaLIF Transforaminal is a physical medical device, not an algorithm or software. Its performance is inherent to its physical properties and design, not an algorithm's output.

7. Type of Ground Truth Used:

The ground truth used for proving the device meets acceptance criteria is based on objective mechanical and material property testing performed according to recognized industry standards (ASTM F2077, ASTM F2267). This is a form of engineering or laboratory "ground truth" rather than clinical or expert consensus ground truth. The comparison to predicates also establishes substantial equivalence based on previously cleared devices meeting these same standards.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this type of device submission. Training sets are used in the development of AI/ML algorithms. This submission pertains to a physical medical implant.

9. How Ground Truth for the Training Set Was Established:

As there is no "training set" for this physical device, this question is not applicable.

Ask a specific question about this device