The SITTER 3.5mm Versatile System is indicated for fixation of fractures, osteotomies and nonunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula in adult patients with normal or osteopenic bone.

Device Description

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the devices are MR Conditional.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "SITTER 3.5mm Versatile System," which is part of the Bonebridge Osteosynthesis Plating System. The purpose of this notification is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

The provided text focuses on the non-clinical tests performed to demonstrate this substantial equivalence. It explicitly states that clinical investigations were not required and that usability tests were performed, but not to establish clinical effectiveness or diagnostic performance in the way an AI/ML medical device would. Therefore, the information needed to answer many of your specific questions related to AI/ML device performance and clinical studies (e.g., MRMC studies, standalone algorithm performance, ground truth for training sets) is not present in the provided document.

However, I can extract and present the acceptance criteria and study information for the non-clinical tests detailed in the document.

Here's the breakdown of the information that is available:

Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)

Since this is a mechanical fixation device, the "performance" described relates to material and mechanical properties, not diagnostic accuracy.

Acceptance Criteria Category	Specific Test/Evaluation	Acceptance Criteria (Implicit from "Pass" result)	Reported Device Performance
Sterilization Validation	Gamma irradiation	Achieve a Sterility Assurance Level (SAL) of 10⁻⁶ using VDmax25 method and per ISO 11137-2.	Pass (Minimal dose of 25kGy validated, SAL of 10⁻⁶ confirmed).
	Steam sterilization	Cleaning and sterilization procedures validated in accordance with ISO 17664 and ISO 17665-1 at 132°C (270°F) for 4 minutes and 20 min drying time.	Pass (Procedures successfully validated).
Packaging Validation	Validation tests (e.g., Dye-Penetration, Visual inspection, Seal strength, Microbial barrier testing, Transport simulation)	Meet standards of ISO 11607 1/2, ASTM F1980, ISTA 2A, ASTM F1929, ASTM F1886/1886M, ASTM F88/F88M, DIN 58953-6.	Pass (Validation of sterile packaging successfully performed, transport simulation conducted followed by specified tests).
Biocompatibility	Biological Evaluation and toxicological risk assessment (Chemical Characterization, Cytotoxicity, LAL Testing)	Device's biological safety for intended use evaluated in accordance with ISO 10993-series and FDA guidance.	Pass (Evaluation performed, device considered biocompatible, corrosion-resistant, non-toxic).
Mechanical Testing	Plates (Static and dynamic comparative testing)	Non-inferiority to the predicate device with regard to maximum force (static test) and maximum force for a given number of cycles (dynamic test), meeting predefined acceptance criteria.	Pass (Comparative testing performed, non-inferiority successfully met predefined acceptance criteria).
	Design verification	Compatibility of implants and instruments, assessment of anatomical shape and appearance successfully completed.	Pass (Design verification successfully completed).
MRI Safety	Assessment of displacement force and torque effects (ASTM F2052-21, ASTM F2213-17)	No unsafe displacement or torque in static magnetic fields (e.g., 3.0 Tesla, extrapolated for 30T/m gradient).	Pass (Assessment performed at 3.0 Tesla, extrapolation for 30T/m gradient completed).
	Assessment of heating effects (ASTM F2182-19e1)	No unsafe heating due to RF-field during MR scans at 1.5Tesla and 3Tesla.	Pass (Assessment performed at 1.5 Tesla and 3 Tesla).
	Assessment of image artifacts (ASTM F2119-07 (2013))	Acceptable image artifacts at 3Tesla.	Pass (Assessment performed at 3 Tesla).

Information Not Available / Not Applicable for this Device Type:

The remainder of your questions pertain to clinical performance studies, particularly those relevant to AI/ML devices for diagnostic purposes. The provided document explicitly states that clinical investigations were not required for this device, and the focus is on mechanical and material equivalence. Therefore, the following information is not present in the document:

Sample sizes used for the test set and the data provenance: Not applicable for non-clinical mechanical testing, and no clinical test set was used.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no diagnostic ground truth was established.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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, as this is a passive medical device (bone plate) and not an AI/ML diagnostic aid.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable (no AI/ML training set).
How the ground truth for the training set was established: Not applicable.

Summary

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August 23, 2024

Bonebridge AG Michelle Gumpelmayer Head of OM&RA Bahnhofstrasse 11 Zug, Zug 6300 Switzerland

Re: K240318

Trade/Device Name: SITTER 3.5mm Versatile System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: July 29, 2024 Received: July 30, 2024

Dear Michelle Gumpelmayer:

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.

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).

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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 (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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/trainingeducation/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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Christopher Ferreira -S

Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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

Submission Number (if known)

K240318

Device Name

SITTER 3.5mm Versatile System

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

In accordance with 21 CFR 807.92 the following information is provided for the Bonebridge Osteosynthesis Plating System.

ADMINISTRATIVE INFORMATION

Date prepared	July 29, 2024
Submission type:	Traditional 510(k)
Purpose of 510(k):	Modification of currently cleared device K231292Introduction of an additional plating system SITTER 3.5mmVersatile SystemAnnouncement of minor modifications to the device since thelast clearance (K231292)
Submitter	Bonebridge AGBahnhofstrasse 116300 ZugSwitzerland
Official Contact	Michelle GumpelmayerHead of QM&RA, Bonebridge AGPhone: +41 76 731 07 32Email michelle.gumpelmayer@bonebridge.ch
Alternative Contact	Alexander HäuslerCOO, Bonebridge AGPhone: +41 79 660 81 42Email alexander.haeusler@bonebridge.ch
US agent	Richard Robel, confinis corporationEmail: usagent@confinis.com
DEVICE NAME AND CLASSIFICATION
Trade name:	SITTER 3.5mm Versatile System(Bonebridge Osteosynthesis Plating System)
Variants, types:	TRIFT 3.5mm 1/3 Tubular System SALGINA2.5mm Volar Distal Radius SystemCASCELLA 3.5mm Superior Clavicle SystemTAMINA 3.5mm Proximal Humerus SystemPOYA 3.5mm Lateral Proximal Tibia SystemPOYA 3.5mm Posteromedial Tibia SystemDALVAZZA 2.5mm Distal Ulna SystemLEPORELLO 3.5mm Olecranon SystemLORRAINE 3.5mm Distal Humerus SystemSITTER 3.5mm Versatile System

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Common name:	Plate, Fixation, Bone
Regulation number:	21 CFR 888.3030
Classification name:	Single/multiple component metallic bone fixationappliances and accessories
Regulatory class:	Class II
Product Code:	HRS
PREDICATE DEVICESPrimary predicate device:	Bonebridge Osteosynthesis Plating System (K231292)TAMINA 3.5mm Proximal Humerus System
Additional predicate devices:

SITTER 3.5mm Versatile System

K082807 Synthes (USA) 3.5 mm Locking Compression Plate (LCP) System with Expanded Indications

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INDICATIONS FOR USE

SITTER 3.5mm Versatile System:

DEVICE DESCRIPTION

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE

The subject device and the predicate devices have the same intended use, similar indications for use, and have the same technological characteristics. The subject and predicate devices are all fabricated from the same or similar materials and share similar design characteristics, including plate screw holes to accommodate locking and nonlocking screws. The subject and predicate devices encompass the same range of physical dimensions, and the subject device is compatible with screws from the predicate devices. The subject and predicate devices are sterilized by the standard methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy.

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SUMMARY OF NON-CLINICAL TESTS

Sterilizationvalidation:	Gamma irradiation: The minimal dose of 25kGy is validatedusing VDmax25 method as described in ISO 11137-2 andconfirmed a Sterility Assurance Level SAL of 10-6.Steam sterilization: Cleaning and sterilization procedureshave been successfully validated in accordance with ISO17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and20 min drying time.	Pass
Packagingvalidation:	Validation of the sterile packaging has been successfullyperformed in accordance with ISO 11607 1/2 and ASTMF1980. Furthermore, a transport simulation was conductedaccording ISTA 2A followed by these packaging verificationtests:Dye-Penetration, ASTM F1929 Visual inspection, ASTM F1886/1886M Seal strength, ASTM F88/F88M Microbial barrier testing, DIN 58953-6, Chapter 2.14	Pass
Biocompatibility:	Biological Evaluation and toxicological risk assessment toevaluate the device's biological safety for the intended use,in accordance with ISO 10993-series and FDA guidance.Tests performed:Chemical Characterization, Cytotoxicity and LAL Testing	Pass
Mechanicaltesting:	Plates: Static and dynamic comparative testing has beenperformed and included statistical analysis and comparativetesting to the predicate device. Non-inferiority of theBonebridge device compared to the predicate device withregard to maximum force (static test) and maximum force fora given number of cycles (dynamic test). The predefinedacceptance criteria were successfully met.Design verification was successfully completed and includedcompatibility of implants and instruments as well asassessment of anatomical shape and appearance.	Pass
MRI safety:	The Bonebridge Osteosynthesis Plating System is MRconditional considering local SAR based on the followingtests Assessment of displacement force and torqueeffects of the implant in the main static magneticfield at 3.0Tesla according to ASTM F2052-21 andASTM F2213-17. Additionally, the expectedmagnetic force in a stronger magnetic field gradientof 30T/m was extrapolated. Assessment of heating effects due to the RF-fieldduring MR scans at 1.5Tesla and 3Tesla accordingto ASTM F2182-19e1. Assessment of image artifacts at 3Tesla accordingto ASTM F2119-07 (2013) The tested implant and associated product family can be	Pass

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SUMMARY OF CLINICAL AND USABILITY TESTS

Based on a clinical evaluation including literature review and the results of verification and validation activities it has been concluded that clinical investigations were not required. The summative usability evaluation according to IEC 62366-1 shows that the Bonebridge Osteosynthesis Plating System there are no significant usability issues due to the study acceptance criteria of the primary objectives prior Application/ Usability Risk Assessment update. Therefore, the summative usability evaluation studies of the Bonebridge Osteosynthesis Plating System are considered successful. The study participants were able to use the products safely and effectively.

CONCLUSION

The subject Bonebridge Osteosynthesis Plating System has similar indications, intended use, target populations, technological characteristics, and materials as the predicate devices. Non-clinical testing demonstrated that the performance of the proposed devices is equivalent to the predicate devices.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.