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.

Device Description

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).

AI/ML Overview

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:

Test Type	Reported Performance/Method
CHARACTERIZATION TESTING	- Wear Test according to IL 07.09.237 rev.7 and Test Reports 970.1970715.30.1385 and 970.190829.70.1272.
PYROGENICITY	- Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter <85>). - Pyrogen test according to USP chapter <151> 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.

Summary

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February 12, 2021

Medacta International SA % Chris Lussier Director, Quality and Regulatory Medacta USA 3973 Delp Street Memphis, Tennessee 38118

Re: K200551

Trade/Device Name: MectaLIF Transforaminal TiPEEK Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: January 13, 2021 Received: January 14, 2021

Dear Chris Lussier:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200551

Device Name MectaLIF Transforaminal TiPEEK

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. Submitter

Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Stefano Bai, Regulatory and Compliance Director. Medacta International SA Applicant Correspondent: Chris Lussier, Senior Director of Quality and Regulatory, Medacta USA Date Prepared: March 2, 2020 Date Revised: January 13, 2021

II. Device

Device Proprietary Name:	MectaLIF Transforaminal TiPEEK
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Primary Product Code:	MAX
Regulation Number:	21 CFR 888.3080
Device Classification:	II

III. Predicate Device

Substantial equivalence is claimed to the following device:

A MectaLIF Extension, K131671, Medacta Interational SA
In addition, the following reference devices are cited within the submission:
A MectaLIF TiPEEK, K133192, Medacta International SA
MectaLIF Posterior Extension, K181970, Medacta International SA A

Device Description IV.

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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).

V. 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. 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.

VI. Comparison of Technological Characteristics

The MectaLIF Transforaminal TiPEEK and the predicate MectaLIF Extension (K131671) share the following characteristics:

shape:
sizes: ●
biocompatibility;
device usage:
sterility: ●
shelf life: and ●
packaging.

The MectaLIF Transforaminal TiPEEK differs from the predicate device, MectaLIF Extension (K131671), with regards to the material only.

Discussion

Medacta International SA has not made any change to the intended use, shape, sizes, device usage, biocompatibility, sterility, shelf life, and packaging of the subject devices respect to the predicate devices.

The different material of the MectaLIF Transforaminal TiPEEK with respect to the predicate devices, does not compromise device safety and performance since the only material difference is the presence of TiPEEK coating on the subject devices respect to the predicate. Subject device TiPEEK coating is exactly the same coating used in the reference devices, MectaLIF TiPEEK, cleared within K133192.

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.

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VII. Performance Data

Based on the risk analysis, testing activities were conducted to written protocols. The following validation and tests are being provided in support of the substantial equivalence determination:

Non-Clinical Studies

CHARACTERIZATION TESTING
- o Wear Test according to IL 07.09.237 rev.7 and Test Reports 970.1970715.30.1385 and 970.190829.70.1272.
. PYROGENICITY:
- o Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>)
- 0 Pyrogen test according to USP chapter <151> for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.

Clinical Studies:

No clinical studies were conducted.

Conclusion VIII.

The information provided above supports that the MectaLIF Transforaminal TiPEEK are as safe and effective as the predicate devices. Therefore, it is concluded that the MectaLIF Transforaminal TiPEEK are substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.