The Mecta-C Stand Alone is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The interior of the Mecta-C Stand Alone should be packed with autogenous bone graft and implanted via an anterior approach.

Device Description

The Mecta-C Stand Alone implants are a line extension to Medacta's anterior cervical discectomy and fusion devices' portfolio. The Mecta-C Stand Alone implants are composed of Mecta-C Stand Alone PEEK and Mecta-C Stand Alone TiPEEK implants. The Mecta-C Stand Alone implants are intended to be used during cervical interbody fusion surgeries. The implants are characterized by different sizes of the PEEK body, in combination with different plate designs and screws. The PEEK body is available uncoated as well as with a Titanium coating. The Mecta-C Stand Alone implants are composed of cages, plates, locking screws, lag screws, and antibackout screws. The cages are available in various widths, heights, and lengths, with a fixed 7° of lordosis. The cages are to be inserted between two (2) cervical vertebral bodies to provide support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows the cages to be packed with bone graft. The plates are designed with different shapes to promote a specific approach or to simplify the procedure in a specific area. The plates are assembled in front of the cage and allow for mounting of a certain number of screws. The screws are placed through the plate and cage in order to fix the device to the vertebral bodies. The Mecta-C Stand Alone implants are designed for long-term implantation inside the human body. The implants are provided sterile in single-use packages.

AI/ML Overview

This document is a 510(k) summary for the Medacta International SA Mecta-C Stand Alone intervertebral body fusion device. It details the device's characteristics, indications for use, and comparison to predicate devices, focusing on demonstrating substantial equivalence. The document primarily focuses on non-clinical testing.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is missing:

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

The document lists the types of performance tests conducted and the standards followed, but it does not provide a specific table of acceptance criteria and the reported device performance results. It states: "Testing was conducted according to written protocols with acceptance criteria that were based on standards." This implies that such a table or detailed results exist in the full submission to the FDA, but they are not included in this public summary.

The non-clinical performance tests mentioned are:

Performance Tests per ASTM F2077-18:
- Static compression
- Static compression-shear
- Static torsion
- Dynamic compression
- Dynamic compression-shear
- Dynamic torsion
- Plate removal
Performance Tests per ASTM F2267-2004 (Reapproved 2018):
- Subsidence
Performance Tests per ASTM F543-17:
- Pull-out
- Insertion and removal torque
Other performance tests:
- Expulsion
- Torsion (listed separately from ASTM F2077-18 torsion)
- Wear testing
- MRI evaluation
- Implant imaging properties
Pyrogenicity:
- Bacterial Endotoxin Test (LAL test) per European Pharmacopoeia §2.6.14 (equivalent to USP chapter <85>)
- Pyrogen test per USP chapter <151>

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: Not specified for any of the non-clinical tests. The phrase "worst-case implants" is used, suggesting a selection of samples, but not the quantity.
Data Provenance: Not explicitly stated. The submitting company is Medacta International SA in Switzerland, and Medacta USA is also mentioned. However, the location where the testing was performed (country of origin of the data) is not given. The nature of these mechanical and biological tests (non-clinical) means "retrospective or prospective" doesn't strictly apply in the same way it would to clinical studies.

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)

This information is not applicable as the document explicitly states: "No clinical studies were conducted." The testing described is non-clinical (mechanical, material, and biocompatibility testing), which does not involve human subjects or expert clinical review for ground truth establishment.

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

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies involving human interpretation or consensus.

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

This information is not applicable. The device is an intervertebral body fusion device, not an AI-powered diagnostic or assistive tool. No MRMC studies were conducted as there were no clinical studies at all.

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

This information is not applicable. The device is a physical implant, not an algorithm.

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

For the non-clinical tests, the "ground truth" is established by adherence to pre-defined engineering standards and their associated acceptance criteria. For example, the "ground truth" for static compression is that the device must withstand a certain load as defined by ASTM F2077-18 without failing, or for pyrogenicity, that the bacterial endotoxin levels must be below a specified threshold. There are no clinical "ground truth" types (like pathology or outcomes data) mentioned because no clinical studies were performed.

8. The sample size for the training set

This information is not applicable. As a physical implant, this device does not have a "training set" in the context of machine learning or AI.

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

This information is not applicable for the same reason as point 8.

Summary of what is missing/not applicable for this device submission:

Since this 510(k) submission primarily relies on non-clinical performance testing and comparison to predicate devices, and explicitly states no clinical studies were conducted, many of your questions related to clinical trials, expert review, AI performance, and human reader studies are not relevant to this particular submission.

The critical missing information from the public summary, in relation to your questions about acceptance criteria and device performance, is the quantitative results of the non-clinical tests and the specific numerical acceptance criteria for each test. The document states these exist ("written protocols with acceptance criteria") but does not disclose them.

Summary

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March 4, 2020

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Next to the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K192906

Trade/Device Name: Mecta-C Stand Alone Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: February 3, 2020 Received: February 4, 2020

Dear Mr. 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.

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

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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 mediation-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.

for

Brent Showalter, Ph.D. Assistant Director (Acting) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K192906

Device Name Mecta-C Stand Alone

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K192906 - 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 Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Director of Quality and Regulatory, Medacta USA Date Prepared: October 16, 2019 Date Revised: February 27, 2020

II. Device

Device Proprietary Name:	Mecta-C Stand Alone
Common or Usual Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Body Fusion Device
Primary Product Code:	OVE
Regulation Number:	21 CFR 888.3080
Device Classification:	II

III. Predicate Device

Substantial equivalence is claimed to the following devices:

Primary predicate device:

. Synthes Zero-P. K112459. Synthes Spine
Additional predicate devices:
MectaLIF Anterior, K124034, Medacta International SA ●
MectaLIF Anterior Stand-Alone, K160605, Medacta International SA ●
STALIF C, K120819, Centinel Spine
STALIF C, K072415, Centinel Spine ●
Anchor C, K102606, Stryker Spine
Mosaic-C, K133218, Spinal Elements ●
Mosaic-C, K071833, Spinal Elements

Device Description IV.

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The Mecta-C Stand Alone implants are composed of cages, plates, locking screws, lag screws, and antibackout screws.

The cages are available in various widths, heights, and lengths, with a fixed 7° of lordosis. The cages are to be inserted between two (2) cervical vertebral bodies to provide support and correction during cervical interbody fusion surgeries. The hollow geometry of the implants allows the cages to be packed with bone graft.

The plates are designed with different shapes to promote a specific approach or to simplify the procedure in a specific area. The plates are assembled in front of the cage and allow for mounting of a certain number of screws. The screws are placed through the plate and cage in order to fix the device to the vertebral bodies.

The Mecta-C Stand Alone implants are designed for long-term implantation inside the human body. The implants are provided sterile in single-use packages.

V. Indications for Use

The Mecta-C Stand Alone is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at one level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The interior of the spacer component of the Mecta-C Stand Alone should be packed with autogenous bone graft and implanted via an anterior approach.

VI. Comparison of Technological Characteristics

The Mecta-C Stand Alone implants and the predicate devices share the following characteristics:

cage height; ●
screw diameter;
screw length;
plate height: ●
materials of construction;
biocompatibility;
device usage;
sterility; ●
shelf life; and ●
packaging

The Mecta-C Stand Alone implants and the predicate devices are technologically different with respect to:

cage width;
cage depth; ●
cage lordosis; and
plate screw holes. ●

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Discussion

Medacta International SA has not made any changes to the intended use, cage height, screw diameter, screw length, plate height, materials of construction, biocompatibility, device usage, sterility, shelf life, and packaging of the subject devices. Based on the comparison of technological characteristics and performance data provided within this submission, the Mecta-C Stand Alone implants are substantially equivalent to the identified predicate devices.

VII. Performance Data

Testing was conducted according to written protocols with acceptance criteria that were based on standards. The following mechanical studies were performed on worst-case implants in support of a substantial equivalence determination:

Non-Clinical Studies:

Performance Tests ●
- static compression per ASTM F2077-18; o
- static compression-shear per ASTM F2077-18; o
- static torsion per ASTM F2077-18: o
- subsidence per ASTM F2267-2004 (Reapproved 2018); O
- expulsion; O
- dynamic compression per ASTM F2077-18; O
- dynamic compression-shear per ASTM F2077-18; O
- dynamic torsion per ASTM F2077-18; O
- plate removal per ASTM F2077-18; O
- pull-out per ASTM F543-17; O
- insertion and removal torque per ASTM F543-17; O
- torsion; o
- wear testing; O
- MRI evaluation: and o
- o implant imaging properties.
Pyrogenicity ●
- o Bacterial Endotoxin Test (LAL test) was conducted according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and 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. ●

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VIII. Conclusion

The information provided above supports that the Mecta-C Stand Alone implants are substantially equivalent to the identified predicate devices.

Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations. The Mecta-C Stand Alone implants are as safe and effective as the identified predicate devices.

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.