The Mbrace Cable is designed as a cerclage system for long bones and to reattach the greater trochanter in case of fractures or osteotomies. The device is intended for long-term implantation inside the human body for single use only. The Mbrace Cable is not intended for use as a suture cable in soft tissue approximation and/or ligation.

Device Description

The Mbrace cable is an implantable flexible braided cable made of UHMWPE and designed as a cerclage bone system. The Mbrace cable is provided individually packed, sterile and single-use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, categorized as requested. It's important to note that the document primarily describes the non-clinical performance testing conducted to demonstrate substantial equivalence, rather than a clinical effectiveness study with human subjects.

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

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes performance tests conducted and the general outcomes. The acceptance criteria can be inferred from the stated goals of the tests.

Acceptance Criteria (Inferred from Test Goal)	Reported Device Performance
Quasi-Static Load to Failure: Demonstrate suitable ultimate strengths and related maximum displacements compared to the predicate device.	Tested; results showed the subject device's performance was sufficient to not raise new safety/effectiveness issues compared to the predicate.
Dynamic Resistance: Demonstrate ability to pass 1 million load cycles without signs of failure to ensure safe and effective clinical use.	Tested; the subject Mbrace Cable was able to pass 1 million load cycles without any signs of failure.
Pyrogenicity (Bacterial Endotoxin Test): Meet the standards of European Pharmacopoeia §2.6.14 (equivalent to USP <85>).	Tested according to European Pharmacopoeia §2.6.14. (Result is implied to be acceptable as no issues were raised).
Pyrogenicity (Pyrogen Test): Meet the standards of USP <151> for pyrogenicity determination.	Tested according to USP <151>. (Result is implied to be acceptable as no issues were raised).
Biocompatibility: Demonstrate biocompatibility of materials.	Assessed; considered the same as the additional predicate device (HS Fiber, K100006) due to identical materials, processing, and sterilization.
Design Validation (Sawbone Workshop): Evaluate device's suitability.	Conducted; results showed device's suitability (implied acceptable as no issues were raised).
Sterilization: Demonstrate effective sterilization (ETO).	Fully validated (The different sterilization method of the subject device is due to different materials but has no impact on safety/effectiveness).
Shelf-life: Evaluate shelf-life.	Evaluated (Implied acceptable performance as no issues were raised).

2. Sample size 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: The document does not specify the exact number of devices or test samples used for the quasi-static load, dynamic resistance, pyrogenicity, or biocompatibility tests. It only mentions that the tests were conducted. For the Design Validation, it states "sawbone workshop," implying physical models were used, but the quantity of models or devices tested within the workshop is not detailed.
Data Provenance: Not explicitly stated. The manufacturer, Medacta International SA, is located in Switzerland, but the location where the tests were performed or the origin of any raw data used in validation is not mentioned. Given these are non-clinical hardware tests, "retrospective or prospective" doesn't directly apply in the same way it would to clinical patient data. The tests are prospective in the sense that they were planned and executed to support the submission.

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 device is a bone fixation cable, and the performance data presented is from non-clinical mechanical, material, and sterilization tests. The "ground truth" for these types of tests is established by industry standards, engineering principles, and validated test methods, rather than expert consensus on medical images or patient outcomes. The "sawbone workshop" likely involved surgical or biomechanical experts, but their number and specific qualifications are not detailed.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where multiple human readers interpret data to establish a ground truth or resolve discrepancies. These methods are not relevant for the non-clinical hardware validation tests 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

No. This is a medical device (bone fixation cable), not an AI/CAD system. Therefore, an MRMC study or AI assistance evaluation is not relevant or applicable.

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

Not applicable. This is a medical device, not a software algorithm.

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

For the non-clinical tests described:

Mechanical Performance: Ground truth derived from established engineering and biomechanical principles, material science, and relevant ISO/ASTM standards (implied, though not explicitly cited beyond "written protocols"). The predicate device's performance often serves as a benchmark for comparison.
Biocompatibility: Ground truth from established biocompatibility standards (e.g., ISO 10993 series, though not explicitly cited).
Pyrogenicity/Sterilization: Ground truth from pharmacopoeial standards (European Pharmacopoeia §2.6.14, USP <85>, USP <151>).

8. The sample size for the training set

Not applicable. This is a medical device for which non-clinical performance data is provided, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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May 3, 2024

Medacta International S.A. % Christopher Lussier Senior Director, Quality, Regulatory and Clinical Research Medacta International SA 6386 Global Drive, Suite 101 Memphis, Tennessee 38141

Re: K232733

Trade/Device Name: Mbrace Cable Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ Dated: April 4, 2024 Received: April 4, 2024

Dear Christopher 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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Shumaya Ali -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K232733

Device Name

Mbrace Cable

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 Baj, Regulatory and Compliance Director, Medacta International SA Applicant Correspondent: Chris Lussier, Sr. Director, Quality, Regulatory, and Clinical Research, Medacta USA Date Prepared: September 7, 2023 Date Revised: April 26, 2024

II. Device

Device Proprietary Name:	Mbrace Cable
Common or Usual Name:	Cerclage, Fixation
Classification Name:	Bone fixation cerclage
Primary Product Code	JDQ
Regulation Number:	21 CFR 888.3010
Device Classification	II

III. Predicate Device

Substantial equivalence is claimed to the following predicate devices.

Primary Predicate device:

Titanium alloy Songer cable system, K920201, SOFAMOR DANEK MFG., Inc. ●

Additional Predicate device:

HS Fiber, K10006, Riverpoint Medical ●

IV. Device Description

The Mbrace cable is an implantable flexible braided cable made of UHMWPE and designed as a cerclage bone system.

The Mbrace cable is provided individually packed, sterile and single-use.

Indications for Use V.

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VI. Comparison of Technological Characteristics

The subject Mbrace cable and the predicate Titanium alloy Songer cable system (K920201) are substantially equivalent with respect to the following characteristics:

General design;
Biocompatibility;
Device usage; and
Packaging. ●

The subject Mbrace cable is technologically different from the predicate Titanium alloy Songer cable system (K920201) as follows:

Diameter and fixation:
Material: and
Sterilization. ●

Discussion

The different diameter and fixation method of the subject Mbrace cable with respect to the predicate Titanium alloy Songer cable system (K920201), as well as the different material, do not raise any new issue related to safety and effectiveness as demonstrated by the results of the mechanical test. The different sterilization method between the subject and the predicate devices is due to the different materials, but it has not any impact on device's safety and effectiveness since the ETO sterilization method of the subject device is fully validated. The subject Mbrace cable, in its final form, is identical to the additional predicate (HS Fiber, K100006) with regards to materials of construction, processing, geometry, sterilization method and shelf-life, thus the biocompatibility of the subject and additional predicate device can be considered the same even if the subject device is intended to be used in long bones and greater trochanter, while the additional predicate is intended for use in soft tissues.

The comparison of technological characteristics and performance data provided within the submission supports the substantial equivalence of the subject device respect to the predicate devices.

VII. Performance Data

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

Non-Clinical Studies

DESIGN VALIDATION
- o Mbrace cable design validation sawbone workshop to evaluate device's suitability.
PERFORMANCE TESTING ●
- Quasi-static load to failure properties of Mbrace cable comparing subject and predicate O devices ultimate strengths and evaluating the related maximum displacement.
- Dynamic resistance properties of Mbrace cable to assess the endurance properties of the o subject Mbrace Cable and demonstrate that the subject device is able to pass 1 million load cycles without any signs of failure, thus ensuring its safe and effective clinical use.

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. PYROGENICITY
- 0 Bacterial endotoxin test (LAL test) according to European Pharmacopoeia §2.6.14 (which is equivalent to USP chapter <85>)
- o Pyrogen test according to USP chapter <151> for pyrogenicity determination
- o The subject devices are not labeled as non-pyrogenic or pyrogen free.
BIOCOMPATIBILITY assessment. .
SHELF-LIFE evaluation. .

Clinical Studies:

. No clinical studies were conducted.

VIII. Conclusion

The information provided above supports that the subject device is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.