M-ARS ACL: Anatomic Ribbon Surgery System - M-ARS ACL Tibial Pull Suture Plate (PSP): Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.

M-ARS ACL: Anatomic Ribbon Surgery System: M-ARS ACL Extracortical Femoral Button: Reconstructive therapy of ruptures to the anterior cruciate ligament by means of autologous grafts.

Device Description

The M-ARS ACL: Anatomic Ribbon Surgery System components are implantable devices used for the reconstructive treatment of ligament ruptures as well as the fixation of an implanted Anterior Cruciate Ligament graft by means of suspensory extracortical fixation.

The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button component is an implantable extracortical suspension device used to secure the graft fixation on the femoral side during ACL reconstruction surgery. The M-ARS ACL: Anatomic Ribbon Surgery System Tibial Pull Suture Plate (PSP) component is an implantable extracortical suspension device used to secure the graft fixation on the tibial side during ACL reconstruction surgery.

The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button and Tibial Pull Suture Plate are manufactured with Titanium-6 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI).

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "M-ARS ACL: Anatomic Ribbon Surgery System," which is a medical device for reconstructive treatment of ruptured anterior and posterior cruciate ligaments. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with acceptance criteria.

Therefore, many of the requested categories (e.g., acceptance criteria table, sample sizes, expert ground truth, MRMC study, standalone performance, training set data) are not applicable as this submission is for a medical device that relies on the established safety and effectiveness of predicate devices, and the studies conducted are primarily non-clinical and comparative in nature, not performance studies with specific statistical acceptance criteria for a new AI or diagnostic device.

Here's an analysis based on the available information:

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

This information is not provided in the document as it is a 510(k) submission for a surgical implant device, not a diagnostic or AI device that typically presents performance metrics against acceptance criteria. The focus is on demonstrating substantial equivalence to predicate devices through material, design, and functional comparisons, along with non-clinical testing for safety.

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 (Test Set): Not applicable for the type of studies performed. The document mentions "design comparison" and "cadaver workshop." These are not statistical studies with defined test set sample sizes in the context of device performance metrics.
Data Provenance: Not applicable. The studies are non-clinical (design comparison, cadaver workshop).

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):

Experts and Qualifications: For the "cadaver workshop," the text mentions "surgeon evaluations to verify the design features and surgical technique." The specific number or qualifications of these surgeons are not detailed. This workshop serves to evaluate usability and design, not to establish a "ground truth" in the way it would be for a diagnostic AI system.

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

Adjudication Method: Not applicable. There is no mention of a formal adjudication process for the non-clinical studies described.

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:

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI tools, which is not the nature of the M-ARS ACL system.
Effect Size: Not applicable.

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

Standalone Performance Study: No, a standalone performance study was not done. This device is a surgical implant, not an algorithm.

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

Type of Ground Truth: Not applicable in the traditional sense of a diagnostic or AI device. For the non-clinical studies, "ground truth" would be related to engineering specifications, material properties, and surgical technique verification by surgeons. There's no pathological or outcomes data used to establish "ground truth" for the device's technical performance in this context.

8. The sample size for the training set:

Training Set Sample Size: Not applicable. This device is not an AI or machine learning algorithm requiring a training set.

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

Training Set Ground Truth Establishment: Not applicable.

Summary of Device Performance and Acceptance Criteria (as described in the context of a 510(k) submission for this device):

The document does not explicitly state "acceptance criteria" for performance metrics in the way one would for a diagnostic test (e.g., sensitivity, specificity thresholds). Instead, the "performance" is demonstrated through:

Design Comparison: Geometrical and comparative analysis between the M-ARS ACL System and predicate devices to show mechanical equivalence. The acceptance criterion here is implied as being "substantially equivalent" in design and mechanical properties to legally marketed predicate devices.
Cadaver Workshop: Surgeon evaluations to verify design features and surgical technique. The implied acceptance criterion would be that surgeons can successfully use the device and technique, and that the design is appropriate for its intended use.
Substantial Equivalence Evaluation: A comparative analysis, especially for the Tibial Pull Suture Plate, against the predicate device. This ensures that any differences in design do not raise new questions of safety or effectiveness.
Biocompatibility and Sterilization: The device materials (Titanium Alloy ELI) have an extensive history of use in medical devices and have been previously reviewed by the FDA, implying they meet established biocompatibility standards. The device is sterile and single-use, meeting standard regulatory requirements for such implants.
Pyrogenicity: Medacta uses Bacterial Endotoxin Test (LAL test) and Pyrogen Test (USP chapter <151>), indicating compliance with standards for sterility and pyrogenicity, though they do not label the devices as non-pyrogenic or pyrogen-free.

Conclusion stated in the document: "Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics as well as performance evaluations. The M-ARS ACL: Anatomic Ribbon Surgery System is as safe and effective as the predicate devices, Karl Storz's Flipptack (K982571) and Karl Storz's Endotack (K022853)."

In essence, the "acceptance criteria" are the demonstration of substantial equivalence to predicate devices, supported by non-clinical studies verifying design, materials, and surgical technique.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left, and the U.S. Food & Drug Administration logo is on the right. The FDA logo is blue and white and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

Medacta International SA % Ms. Elizabeth Rose Manager, Regulatory Affairs Mapi USA, Inc. 2343 Alexandria Drive, Suite 100 Lexington, Kentucky 40504

October 23, 2017

Re: K171640

Trade/Device Name: M-ARS ACL: Anatomic Ribbon Surgery System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: September 11, 2017 Received: September 12, 2017

Dear Ms. Rose:

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171640

Device Name

M-ARS ACL: Anatomic Ribbon Surgery System

Indications for Use (Describe)

M-ARS ACL: Anatomic Ribbon Surgery System - M-ARS ACL Tibial Pull Suture Plate (PSP): Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.

M-ARS ACL: Anatomic Ribbon Surgery System: M-ARS ACL Extracortical Femoral Button: Reconstructive therapy of ruptures to the anterior cruciate ligament by means of autologous grafts.

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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3.0 510(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 Affairs Manager Date Prepared: June 01, 2017 Date Revised: October 17, 2017

II. Device

Device Proprietary Name:	M-ARS ACL: Anatomic Ribbon Surgery System
Common or Usual Name:	Suture Anchor
Classification Name:	Fastener, Fixation, Nondegradable, Soft Tissue
Primary Product Code:	MBI
Regulation Number:	21 CFR 888.3040
Device Classification	2

III. Predicate Device

Substantial equivalence is claimed to the following devices:

KSEA Flipptack, K982571, Karl Storz Endoscopy - America, Inc. (also referred to as Karl Storz's Flipptack)
. Endotack, K022853, Karl Storz Endoscopy - America, Inc.

The following reference devices are cited within the submission:

M.U.S.T. Extension, K132878, Medacta International SA ●
M.U.S.T. Pedicle Screw System, K141988, Medacta International SA
M.U.S.T. Pedicle Screw System, K153664, Medacta International SA
M.U.S.T. Pedicle Screw System, K162061, Medacta International SA

IV. Device Description

The purpose of this submission is to gain clearance for the M-ARS ACL: Anatomic Ribbon Surgery System. The M-ARS ACL: Anatomic Ribbon Surgery System components are implantable devices used for the reconstructive treatment of ligament ruptures as well as the fixation of an implanted Anterior Cruciate Ligament graft by means of suspensory extracortical fixation.

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The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button and Tibial Pull Suture Plate are manufactured with Titanium-6 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI).

V. Indications for Use

M-ARS ACL Extracortical Femoral Button

Reconstructive therapy of ruptures to the anterior and posterior cruciate ligament by means of autologous grafts.

M-ARS ACL Tibial Pull Suture Plate (PSP)

Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.

Comparison of Technological Characteristics VI.

The M-ARS ACL: Anatomic Ribbon Surgery System and the predicate devices share the following characteristics:

Material;
Sterile: ●
device usage; and ●
Extracortical Fixation Button; ●
- . length;
- . width:
- . thickness;
- number and purpose of holes; and .
- . critical section thickness.

The M-ARS ACL: Anatomic Ribbon Surgery System is technologically different from the predicate devices as follows:

Tibial Pull Suture Plate, and
- length;
- . width:
- thickness; ●
- number and purpose of holes; ●
- . geometry; and
- . critical section dimensions
Extracortical Fixation Button ●
- . critical section width.

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The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button and Tibial Pull Suture Plate are manufactured with Titanium-4 Vanadium Extra Low Interstitial Alloy according to ISO 5832-3:1996 Implants For Surgery - Metallic Materials - Part 3: Wrought Titanium 6-Aluminum 4-Vanadium Alloy and ASTM F136-13 Standard Specification For Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy For Surgical Implant Applications.

This material, used with Karl Storz's Flipptack (K982571) and Karl Storz's Endotack (K022853), has an extensive biocompatibility history and has been previously reviewed by FDA.

Due to the extensive history of use in currently marketed medical devices, additional biocompatibility testing was deemed unnecessary for the M-ARS ACL: Anatomic Ribbon Surgery System components. In addition, manufacturing processes for the subject devices are identical or similar to the reference devices the M.U.S.T. Pedicle Screw Systems (K162061, K153664, K141988, and K132878).

The tables below compare key technological features between the subject and predicate devices.

Parameters	M-ARS ACL: Anatomic RibbonSurgery System ExtracorticalFixation Button(Subject Device)	Karl Storz's FlipptackK982571(Predicate Device)
Material	Titanium Alloy (ELI)	Titanium Alloy
Length	12.3 mm	12.3 mm
Width	4 mm	4 mm
Thickness	1.5 mm	1.5 mm
Holes	2 for suture loop for graft fixation1 lateral hole for suture used to flipimplant1 lateral hole for suture used topull construct	2 for suture loop for graft fixation1 lateral hole for suture used to flipimplant1 lateral hole for suture used to pullconstruct
Critical SectionDimensions	Thickness: 1.5 mmWidth: 1.7 mm	Thickness: 1.5 mmWidth: 1.3 mm
Device Usage	Single Use	Single Use
Biocompatibility	Implant with permanent > 30 day	Implant with permanent > 30 day
Sterilization	Sterile	Sterile

Technological comparison

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Parameters	M-ARS ACL: Anatomic RibbonSurgery System Tibial PullSuture Plate(Subject Device)	Karl Storz's EndotackK022853(Predicate Device)
Material	Titanium Alloy (ELI)	Titanium Alloy
Length	20 mm	16 mm
Width	13 mm	10 mm
Thickness	1.2 mm	2 mm
Holes	2 central holes for adjustable sutureloop2 lateral holes for additionalsutures, graft fixation and tension	2 holes used for graft fixation andtension
Geometry	C-Shape	Round Shape
Critical Section	Thickness: 2 mm	Thickness: 3 mm
Dimensions	Width: 2.84 mm	Width: 2 mm
Device Usage	Single Use	Single Use
Biocompatibility	Implant with permanent > 30 day	Implant with permanent > 30 day
Sterilization	Sterile	Sterile

Discussion

As seen above, the technological differences between the subject and predicate devices do not raise new questions of safety and effectiveness. The M-ARS ACL: Anatomic Ribbon Surgery System is the same or similar to the predicate devices in terms of materials of construction, device usage, and sterility. Although there are some differences in the design attributes of the Tibial Pull Suture Plate, the intended use and functionality of the component are the same. Based on the comparison of technological characteristics and performance data provided within this submission, the data supports the substantial equivalence of the M-ARS ACL: Anatomic Ribbon Surgery System to the identified predicate devices.

VII. Performance Data

Risks were identified based on the proposed design and testing was conducted to mitigate those risks. Based on the risk analysis, the following studies were performed in support of a substantial equivalence determination:

Non-Clinical Studies

. design comparison: geometrical and comparative analysis between the M-ARS ACL: Anatomic Ribbon Surgery System and the predicate devices to show mechanical equivalence:
. cadaver workshop: surgeon evaluations to verify the design features and surgical technique: and
substantial equivalence evaluation: a comparative analysis between the M-ARS ACL: Anatomic Ribbon Surgery System Tibial Pull Suture Plate and the predicate device.

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Pyrogenicity

Medacta uses both the Bacterial Endotoxin Test (LAL test) according to European . Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>) and the Pyrogen Test according to USP chapter <151> for pyrogenicity determination.
Medacta does not intend to label the subject devices as non-pyrogenic or pyrogen free. ●

Clinical Studies

No clinical studies were conducted ●

VIII. Conclusion

Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics as well as performance evaluations. The M-ARS ACL: Anatomic Ribbon Surgery System is as safe and effective as the predicate devices, Karl Storz's Flipptack (K982571) and Karl Storz's Endotack (K022853).

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.