The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates and non-locking screws for fixation and corresponding instruments.
Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F899), 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Bonebridge Osteosynthesis Plating System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on comparative testing and engineering validation rather than clinical study results with acceptance criteria.

Based on the provided document, here's an analysis addressing your points:

The document does not describe a study that proves the device meets specific performance acceptance criteria for an AI/software device, an MRMC study, or a standalone algorithm performance study. This is a different type of device (metallic bone fixation appliance) undergoing a different regulatory pathway (510(k) for substantial equivalence). The "acceptance criteria" referred to in the document pertain to engineering and material testing, not diagnostic performance of an AI.

However, I can extract the information relevant to the testing that was performed:

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

The document mentions "predefined acceptance criteria were successfully met" for mechanical testing, but it does not explicitly define those criteria or report specific numerical performance metrics in the summary. It broadly states the following validation results:

Test/Validation Type	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Sterilization (Gamma)	Minimal dose of 25kGy, based on ISO 11137-2, with a Sterility Assurance Level (SAL) of 10^-6.	"The minimal dose of 25kGy is validated using VDmax25 method as described in ISO 11137-2 and confirmed a Sterility Assurance Level SAL of 10^-6."
Sterilization (Steam)	Cleaning and sterilization procedures validated in accordance with ISO 17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and 20 min drying time.	"Cleaning and sterilization procedures have been successfully validated in accordance with ISO 17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and 20 min drying time."
Packaging Validation	In accordance with ISO 11607 1/2 and ASTM F1980, including transport simulation (ISTA 2A) and verification tests (Dye-Penetration, Visual inspection, Seal strength, Microbial barrier testing according to specified ASTM/DIN standards).	"Validation of the sterile packaging has been successfully performed in accordance with ISO 11607 1/2 and ASTM F1980. Furthermore, a transport simulation was conducted according ISTA 2A followed by these packaging verification tests: Dye-Penetration, ASTM F1929 Visual inspection, ASTM F1886/1886M Seal strength, ASTM F88/F88M Microbial barrier testing, DIN 58953-6, Chapter 2.14" (All implied to have passed).
Biocompatibility	In accordance with ISO 10993-1.	"A biological assessment has been performed in accordance with ISO 10993-1." (Implied to be successful).
Mechanical Testing: Plates	"Predefined acceptance criteria were successfully met" (presumably related to static and dynamic testing and comparative performance to the predicate device).	"Static and dynamic testing has been performed and included statistical analysis and comparative testing to the predicate devices. The predefined acceptance criteria were successfully met." (No specific numbers provided).
Mechanical Testing: Screws	In accordance with ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws), including comparative testing to predicate devices.	"Tested successfully in accordance with ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws an includes comparative testing to predicate devices." (Implied to be successful).
Design Verification	Successful completion of compatibility of implants and instruments, and assessment of anatomical shape and appearance.	"Design verification was successfully completed and included compatibility of implants and instruments as well as assessment of anatomical shape and appearance." (Implied to be successful).
MRI Safety	Assessment of displacement force/torque (ASTM F2052-15 & F2213-17), heating effects (ASTM F2182-11a), and image artifacts (ASTM F2119-07 (2013)).	"The Bonebridge Osteosythesis Plating System is MR conditional considering local SAR based on the following tests: Assessment of displacement force and torque effects in the main static magnetic field at 3Tesla. Additionally, the expected magnetic force in a stronger magnetic field gradient of 30T/m was extrapolated. (According to ASTM F2052-15 and ASTM F2213-17) Assessment of heating effects due to the RF-field during MR scans at 1.5Tesla and 3Tesla according to ASTM F2182-11a Assessment of image artifacts at 3Tesla according to ASTM F2119-07 (2013)" (All implied to support MR conditional status).
Usability	Based on IEC 62366-1, with acceptance criteria for primary objectives (e.g., safe and effective use; no significant usability issues).	"Summative usability evaluation studies in accordance with IEC 62366-1 support that 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 Osteosythesis Plating System are considered as successful. The study participants were able to use the products safely and effectively."

2. Sample sizes used for the test set and the data provenance:
* Test Set Sample Size: Not specified for any of the tests. The document refers to "statistical analysis" for plates and "comparative testing" for screws, implying multiple samples were used, but the exact numbers are not provided in this summary.
* Data Provenance: Not specified within the summary. These are laboratory/engineering tests performed by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This question is largely not applicable to the type of testing described in the document. The "ground truth" for mechanical properties, sterility, biocompatibility, etc., is established by adherence to recognized international standards (ISO, ASTM) and validated laboratory methods, not by expert consensus on clinical images or interpretations.
* For usability, "study participants" were involved, but their qualifications and the number of "experts" (if any) establishing criteria beyond standard usability engineering principles are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable as detailed in the document. This is not a study involving human interpretation of data requiring adjudication.

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 was not done. This device is a physical medical implant (bone plate), not an AI/imaging device. The concept of human readers and AI assistance is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No, this was not done. Again, this is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* For the mechanical and material tests, the "ground truth" is adherence to established international standards (ISO, ASTM) and engineering principles for material strength, biocompatibility, sterility, etc.
* For usability, the "ground truth" is the ability of participants to use the product safely and effectively against predefined usability objectives.
* Not applicable in the sense of clinical "ground truth" (e.g., pathology, patient outcomes) for diagnostic accuracy. The clinical justification is based on equivalence to predicate devices and established surgical interventions.

8. The sample size for the training set:
* Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:
* Not applicable. See point 8.

Summary

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October 5, 2021

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

Bonebridge AG % Sandra Soniec Managing Director meditec Consulting GmbH Obermoosstrasse 23 Boll, Berne 3067 Switzerland

Re: K203002

Trade/Device Name: Bonebridge Osteosynthesis Plating 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: September 3, 2021 Received: September 7, 2021

Dear Sandra Soniec:

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.

Shumaya Ali, M.P.H. 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

510(k) Number (if known) K203002

Device Name Bonebridge Osteosynthesis Plating System

Indications for Use (Describe)

The TRIFT 3.5mm 1/3 Tubular Plate is indicated for:

• Treatment of smaller fractures of long bones such as humerus, fibula, and ulna

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	October 5, 2021
Submission type:	Traditional 510(k)
Purpose of 510(k):	Introduction of a new osteosynthesis plating system
Submitter	Bonebridge AGBahnhofstrasse 116300 ZugSwitzerland
Official Contact	Christof Gerber M.D.CEO, Bonebridge AG
Alternative Contact	Sandra SoniecSenior consultant, meditec Consulting GmbHPhone: +41 31 535 3193Email soniec@meditec-consulting.ch
US agent	Viky Verna, confinis corporationEmail: viky.verna@confinis.com

DEVICE NAME AND CLASSIFICATION

Trade name:	Bonebridge Osteosynthesis Plating System
Variants, types:	TRIFT 3.5mm 1/3 Tubular System
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

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PREDICATE DEVICE

Bonebridge Osteosythesis Plating System

Primary predicate device

TRIFT 3.5mm 1/3 Tubular System

SYNTHES one-third tubular plate 3.5mm K011335 SYNTHS ONE-THIRD TUBULAR DCL PLATE

INDICATIONS FOR USE

The TRIFT 3.5mm 1/3 Tubular Plate is indicated for:

. Treatment of smaller fractures of long bones such as humerus, fibula, and ulna

DEVICE DESCRITION

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates and non-locking screws for fixation and corresponding instruments.

Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F899), 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.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND COMPARISON TO PREDICATE DEVICE

The subject device and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate device are all fabricated from the same or similar materials and share similar design characteristics, including plate screw holes to accommodate non-locking screws. The subject and predicate devices encompass the same range of physical dimensions, and the subject device is compatible with screws from the predicate device. The subject and predicate device 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 PERFORMANCE DATA

Sterilization validation:	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 procedures havebeen successfully validated in accordance with ISO 17664 andISO 17665-1 at 132°C (270F) for 4 minutes and 20 min dryingtime.
Packaging validation:	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
Biocompatibility:	A biological assessment has been performed in accordancewith ISO 10993-1.
Mechanical testing:	Plates: Static and dynamic testing has been performed andincluded statistical analysis and comparative testing to thepredicate devices. The predefined acceptance criteria weresuccessfully met.
	Screws: Tested successfully in accordance with ASTM F543:Standard Specification and Test Methods for Metallic MedicalBone Screws an includes comparative testing to predicatedevices.
	Design verification was successfully completed and includedcompatibility of implants and instruments as well asassessment of anatomical shape and appearance.
MRI safety:	The Bonebridge Osteosythesis Plating System is MRconditional considering local SAR based on the following tests Assessment of displacement force and torque effects inthe main static magnetic field at 3Tesla. Additionally, theexpected magnetic force in a stronger magnetic fieldgradient of 30T/m was extrapolated. (According to ASTMF2052-15 and ASTM F2213-17) Assessment of heating effects due to the RF-field duringMR scans at 1.5Tesla and 3Tesla according to ASTMF2182-11a Assessment of image artifacts at 3Tesla according toASTM F2119-07 (2013)
Usability:	Summative usability evaluation studies in accordance with IEC62366-1 support that there are no significant usability issuesdue to the study acceptance criteria of the primary objectivesprior Application/ Usability Risk Assessment update.Therefore, the summative usability evaluation studies of theBonebridge Osteosythesis Plating System are considered assuccessful. The study participants were able to use theproducts safely and effectively.
Clinical evaluation:	Based on the results of the literature review and the results ofverification and validation activities it has been concluded thatclinical investigations are not required, since surgicaltechnique, device design and material match establishedinterventions for the relevant indications.

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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.