The Newclip Patient-matched instrumentation non sterile PSI is indicated to be used as a surgical instrument to assist in pre-operative planning and/or in guiding surgical instruments in High Tibial Medial Opening or Closing Wedge Osteotomy, Distal Femoral Medial or Lateral Closing Wedge Osteotomy, High Tibial Lateral Closing Osteotomy, High Tibial Anterior Closing Osteotomy, Distal Femoral Lateral Opening Wedge Osteotomy and Distal Femoral Medial or Lateral Derotational Osteotomy, when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., computed tomography (CT)). Each PSI is designed to be compatible with implants from the Newclip High Tibial Osteotomy System or the Newclip Activmotion Range.

Device Description

The Newclip Patient-matched instrumentation non sterile PSI are patient-matched devices (PSI Guides). The PSI Guides are surgical drilling/cutting guides that are additively manufactured (3D printed) and are designed to match the patient's anatomy. They are intended to assist in pre-operative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies around the knee. They are single-use devices provided non sterilization by health care professionals before use. The Newclip Patient-matched instrumentation non sterile PSI can be used to facilitate implantation of the Newclip Activmotion Range devices. The purpose of this 510(k) notification is to add PSI Guides for High Tibial Lateral and Anterior Closing osteotomies. Material: Polyamide (PA2200).

AI/ML Overview

The provided document is a 510(k) Summary for the Newclip Patient-matched instrumentation non sterile PSI. It includes information on the device, its intended use, and a comparison to a predicate device (K240415). The document also outlines the performance data used for verification and validation but lacks specific quantitative acceptance criteria or detailed study results for objective efficacy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics. Instead, it describes acceptance in qualitative terms, primarily relying on comparison to the predicate device and satisfactory outcomes in simulated use.

Acceptance Criteria (Conceptual from text)	Reported Device Performance
Manufacturing Precision and Accuracy: Design, correction, and placement of PSI guides should be similar to the predicate device (K240415).	The results of the manufacturing validation activity demonstrated similar precision and accuracy of design, correction, and manufacture as the predicate PSI guide cleared in K240415.
Usability in Simulated Surgery: PSI guides can be positioned without issue, planned correction achieved, and hinge preserved.	During simulated use, the subject PSI guides were positioned without issue via lateral and anterior approaches, the planned correction to be achieved, and preservation of the hinge throughout the simulated surgery. The acceptance criteria used were the same as reported in K240415. (No quantitative performance metrics are provided in the document for the subject device or the predicate for these aspects).

Acceptance Criteria (Conceptual from text)

Reported Device Performance

Manufacturing Precision and Accuracy: Design, correction, and placement of PSI guides should be similar to the predicate device (K240415).

The results of the manufacturing validation activity demonstrated similar precision and accuracy of design, correction, and manufacture as the predicate PSI guide cleared in K240415.

Usability in Simulated Surgery: PSI guides can be positioned without issue, planned correction achieved, and hinge preserved.

During simulated use, the subject PSI guides were positioned without issue via lateral and anterior approaches, the planned correction to be achieved, and preservation of the hinge throughout the simulated surgery. The acceptance criteria used were the same as reported in K240415. (No quantitative performance metrics are provided in the document for the subject device or the predicate for these aspects).

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not specify a numerical sample size for the "worst-case guide design and manufacture" or the "simulated use" scenarios. It mentions "worst-case guide design" and "worst-case and subject PSI guides." This implies a limited, representative set rather than a large statistical sample.
Data Provenance: The studies were conducted by Newclip Technics, a French company (Sponsor Address: F-44115 Haute-Goulaine, FRANCE). The studies were internal verification and validation activities. The country of origin of the data subjects (if any beyond the guides themselves) is not specified, nor whether it was retrospective or prospective. Given the nature of a 510(k) submission for mechanical surgical guides, it's likely a laboratory/simulated environment and not involving human patient data directly for performance validation at this stage.

3. Number of Experts and Qualifications for Ground Truth

Manufacturing Validation: "Three NewClip operators with low, medium, and high levels of experience (novice, intermediate, expert)" were involved in the manufacturing validation. Their specific qualifications (e.g., years of experience, specific certifications) beyond their experience level are not detailed.
Simulated Surgery: "The same three novice surgeons" performed the simulated use. Their specific qualifications (e.g., years of surgical experience, board certification) are not detailed other than being designated "novice."

4. Adjudication Method

The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating performance. For the manufacturing validation, it involved comparison of dimensions, design, correction, and placement, presumably against predefined design specifications or an established 'true' state. For the simulated surgery, it seems the observation of the three novice surgeons' ability to achieve the desired outcomes (positioning, correction, hinge preservation) against unnamed criteria formed the basis of acceptability.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The performance data section describes internal verification and validation activities rather than a comparative study of human readers with and without AI assistance. The device is a surgical guide, not an AI diagnostic tool that assists human readers in interpreting images.

6. Standalone Performance Study

The performance data described focuses on the device itself (manufacturing precision and simulated usability) and its comparison to a predicate device. It is a standalone assessment of the algorithmic design and physical manufacturing of the guides, though its use is demonstrated in a simulated human-in-the-loop context (by surgeons). The "algorithm" here refers to the design software that creates the patient-matched guides.
- Manufacturing Test: The assessment of "precision and accuracy of design, correction, and manufacture" of the PSI guides can be considered a standalone algorithm/device performance evaluation as it assesses the output of the CAD/CAM process.
- Simulated Use: This evaluates the physical guides in use by surgeons, which is a human-in-the-loop scenario, but the performance of the guide itself (its fit, its ability to guide instruments correctly) is the primary focus.

7. Type of Ground Truth Used

Manufacturing Validation: The ground truth for manufacturing precision and accuracy would be the original digital design specifications of the patient-matched instrumentation. The manufactured guides were compared against these known dimensions and design elements.
Simulated Surgery: The ground truth for the simulated surgery was the planned surgical correction and the expected function of the guide (e.g., correct positioning, preservation of the hinge). This is established based on the pre-operative planning and surgical goals.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI/machine learning model. The device (Patient-matched instrumentation) leverages CT images to create customized physical guides, which are then 3D printed. There is no indication of an AI algorithm being "trained" on a dataset in the typical sense. The "training" here would be for the CAD/CAM software to accurately generate the patient-specific geometry based on the CT scan data, which is typically a deterministic process rather than a machine learning one.

9. How the Ground Truth for the Training Set Was Established

As no training set for an AI/ML model is indicated, this question is not applicable based on the provided text. The "ground truth" for the device's function relies on accurate anatomical segmentation from CT scans and precise mechanical design parameters encoded in the CAD/CAM software.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder blue font, and the word "ADMINISTRATION" in a smaller blue font below.

February 13, 2024

NewClip Technics % Robert Poggie, PhD President BioVera. Inc. 65 Promenade Saint Louis Notre-Dame-de-L'Ile-Perrot, QC J7W3J6 Canada

Re: K243912

Trade/Device Name: Newclip Patient-matched instrumentation non sterile PSI Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: PBF Dated: December 19, 2024 Received: December 19, 2024

Dear Dr. Poggie:

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"

{1}------------------------------------------------

(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 OS 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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

{2}------------------------------------------------

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

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K243912

Device Name

Newclip Patient-matched instrumentation non sterile PSI

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

K243912 Page 1 of 3

510(k) Summary for K243912 Newclip Patient-matched instrumentation non sterile PSI

In accordance with 21 CFR 807.92, the following information is a 510(k) Summary for the Newclip Patient-matched instrumentation non sterile PSI.

A. SUBMITTER INFORMATION

Sponsor Name:	NEWCLIP TECHNICS
Sponsor Address:	P.A. de la Lande Saint Martin, 45 rue des Garottières,
	F-44115 Haute-Goulaine, FRANCE
Submitter Name:	BioVera, Inc.
Submitter Address:	65 Promenade Saint-Louis,
	Notre-Dame-De-L'Ile-Perrot, QC, J7W 3J6, CANADA
Contact Person:	Robert A. Poggie, PhD
Phone & Email:	(514) 349-7226 & orthobob@biovera.ca
Date of Preparation:	February 12th, 2025

B. DEVICE IDENTIFICATION

Device Trade Name:	Newclip Patient-matched instrumentation non sterile PSI
Device Common Name:	Orthopaedic Surgical Planning and Instrument Guides
Classification Code:	PBF
Classification Name :	Single/multiple component metallic bone fixation appliances andaccessories
Classification Panel:	Orthopedic
Regulation:	21 CFR 888.3030

C. PREDICATE DEVICE

{5}------------------------------------------------

D. DEVICE DESCRIPTION

E. INDICATIONS FOR USE

F. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The Newclip Patient-matched instrumentation non sterile PSI has the same or similar technological characteristics and indicated uses as the predicate device.

Target population: The Newclip Patient-matched instrumentation non sterile PSI are intended for the same subset of the target population (adults) of the predicate device.

Material: The Newclip Patient-matched instrumentation non sterile PSI uses the same additively manufactured (AM) Polyamide material as the predicate devices.

Manufacturing method: The Newclip Patient-matched instrumentation non sterile PSI are manufactured using the same AM method as the predicate devices.

Imagery technique: The Newclip Patient-matched instrumentation non sterile PSI uses the same image technique (CT) as the predicate device (K240415).

{6}------------------------------------------------

Surgeon training and documentation: The training of US surgeons on the new subject guides is performed with the presentation materials and training-form cleared in K240415, with the tibial closing wedge quides for anterior and lateral approaches.

The subject and predicate devices are indicated to be used as surgical instruments to assist in pre-operative planning and/or in guiding surgical instruments when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e. computed tomography (CT)). The primary predicate device are PSI guides for opening femoral and tibial, closing-femoral, and derotation wedge osteotomies about the knee whereas the subject device includes PSI guides for closing-tibial lateral and anterior approach osteotomies. The subject device is designed to be compatible with implants from the Newclip Activmotion Range. The intended purpose of the subject and predicate devices is the same, namely patient matched instruments for osteotomies about the knee.

Comparison of the technological characteristics and indicated use of the subject and predicate devices demonstrate that the subject device is substantially equivalent to the predicate device.

G. PERFORMANCE DATA

The two steps in verification & validation (V&V) activities for the subject device were: (1) a worst-case analysis for design and manufacturing of the PSI guides, and (2) a worst-case analysis of the usability of the subject PSI guides in simulated surgery.

(1) The validation and verification activity for manufacturing PSI quides was performed by three NewClip operators with low, medium, and high levels of experience (novice, intermediate, expert) applied to worst-case guide design and manufacture followed by comparison of dimensions, design, correction, and placement of the PSI guide. The results of this work demonstrated similar precision and accuracy of design, correction, and manufacture as the predicate PSI guide cleared in K240415.

(2) The simulated use of the worst-case and subject PSI guides was performed by the same three novice surgeons using the same performance measures and acceptance criteria as reported in K240415. The results showed the subject PSI guides to be positioned without issue via lateral and anterior approaches, the planned correction to be achieved, and preservation of the hinge throughout the simulated surgery.

The results of V&V activities demonstrate that the subject device is as safe and effective as the predicate device described in K240415.

H. CONCLUSION

The information in this 510(k) shows the Newclip Patient-matched instrumentation non sterile PSI to be substantially equivalent to the legally marketed predicate device.

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.