3D-Cut is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, non-joint replacing ostector of bone tumors, for femur, tibia and pelvis including sacrum.

Device Description

3D-Cut is a patient-matched additively manufactured single use surgical instrument (PS). Based on a preoperative planning, the instruments are intended to assist physicians in guiding the marking of bone and guiding surgical instruments in bone tumor resection surgery, excluding joint replacement surgeries.

The 3D-Cut instruments are designed starting from patient medical images, computed tomography (CT) and magnetic resonance imaging (MRI) device. The clinician delineates the tumor on the MRI. MRI and the delineated tumor are merged onto the CT which is used to extract the 3D CAD model of the bone. A draft treatment plan is submitted for evaluation to the treating clinician. Upon surgeon's approval, a PSI is designed and again submitted to the clinician. After validation, the PSI is produced using additive manufacturing.

AI/ML Overview

The provided text describes the 3D-Cut device and its 510(k) submission, focusing on regulatory aspects, indications for use, and a high-level summary of performance data. However, this document does not contain the detailed information necessary to fully answer the specific questions regarding acceptance criteria, sample sizes, expert qualifications, ground truth establishment, or clinical study specifics like MRMC study results or effect sizes.

The text states: "Several tests have been conducted to demonstrate the output of the manufacturing process conforms to the device specifications. A combination of bench, cadaveric and clinical (OUS published case series) testing was executed to demonstrate the subject device is substantially equivalent to the predicate device and performs in accordance with its intended use." It also mentions "Software verification and validation were performed, and documentation was included in this submission in accordance with FDA Guidance 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'".

This indicates that internal performance specifications and software verification/validation were performed, but the document does not elaborate on the specific acceptance criteria for these tests, nor does it provide details of a clinical study that would assess algorithm performance in the way suggested by the questions (e.g., number of experts, adjudication methods, MRMC studies, standalone performance data).

Therefore, I can only provide an answer that reflects the absence of the requested detailed information in the provided document.

Here's an assessment based on the provided document, highlighting the missing information:

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

The document mentions that "Several tests have been conducted to demonstrate the output of the manufacturing process conforms to the device specifications." and "Software verification and validation were performed". However, the specific acceptance criteria and the quantitative reported device performance for these tests are NOT provided in this document.

2. Sample sizes used for the test set and the data provenance

The document refers to "bench, cadaveric and clinical (OUS published case series) testing."

Bench and Cadaveric Testing: No sample sizes are specified.
Clinical Testing ("OUS published case series"): No sample size for the "case series" is provided, nor are details about the data provenance (e.g., specific country of origin, retrospective or prospective nature of these case series).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that the "clinician delineates the tumor on the MRI" and a "draft treatment plan is submitted for evaluation to the treating clinician. Upon surgeon's approval, a PSI is designed and again submitted to the clinician. After validation, the PSI is produced." This implies clinical input for planning, but it does not specify the number of experts, their qualifications, or how a 'ground truth' for evaluating the device's performance (e.g., guiding surgery accuracy) was established for a test set. The clinical "validation" mentioned likely refers to the surgeon's approval of the design for a specific patient, not a generalized ground truth for a test set.

4. Adjudication method for the test set

No information on adjudication methods for a test set is provided.

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

There is no mention of an MRMC comparative effectiveness study, nor any data on how human readers (or surgeons in this context) improve with or without AI (device) assistance. The device is a physical surgical instrument resulting from preoperative planning, not explicitly an AI diagnostic tool for image interpretation.

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

The device is a "patient-matched additively manufactured single use surgical instrument (PSI)" based on "preoperative planning." The planning process involves a "clinician delineat[ing] the tumor on the MRI" and approving the treatment plan and PSI design. This indicates a human-in-the-loop process. No standalone algorithm performance data without human input is mentioned or applicable given the nature of the device.

7. The type of ground truth used

For the design and approval process, the "treating clinician's approval" and "validation" serves as the ground truth for shaping the PSI. For the performance of the manufactured device, "dimensional stability," "mechanical testing," and "simulated use testing on cadaveric specimen" would rely on physical measurements and surgical outcomes on cadavers. The "OUS published case series" would likely rely on clinical outcomes. However, a specific, generalized "ground truth" definition for a test set that would validate the device's accuracy in a structured study format (e.g., expert consensus on image interpretation, pathology, or long-term patient outcomes for a large cohort) is not described.

8. The sample size for the training set

The document describes a custom manufacturing process where the device is "designed starting from patient medical images." This implies a patient-specific design, not a general algorithm that is "trained" on a large dataset in the typical sense of machine learning. While there might be internal design rules or algorithms, the concept of a "training set" as understood in a machine learning context for diagnostic AI is not explicitly described or applicable in the provided information about this custom-manufactured surgical instrument.

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

As there is no described "training set" in the context of an AI algorithm, this question is not applicable based on the provided text. The "ground truth" for the device's design is the clinician's approval of the proposed plan and PSI.

Summary

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November 29, 2021

Image /page/0/Picture/1 description: The image contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

3D-Side SA % Niels Festiens Regulatory Affairs Consultant OrthoGrow NV Davincilaan 1 Zaventem. Vlaams-Brabant 1930 Belgium

Re: K212237

Trade/Device Name: 3D-Cut 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: August 30, 2021 Received: August 31, 2021

Dear Niels Festjens:

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.

For

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) K122237

Device Name 3D-Cut

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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K212237

510(K) SUMMARY (21CFR807.92)

SUBMITTER

Company Name: Establishment registration number: Address:

Phone number: Principal contact person: Principal contact e-mail address Additional contact person: Additional contact e-mail address Additional contact person: Additional contact e-mail address Summary date: November 24, 2021

DEVICE

Name & trade name: Classification name:

3D-Side 3013561205 Rue André Dumont 5 1435 Mont-Saint-Guibert, BE +32 (0) 10 81 35 48 Mieke Janssen mieke@ortho-grow.com Laurent Paul lp@3dside.eu Niels Festjens niels@ortho-grow.com

3D-Cut 888.3030 - Orthopaedic surgical planning and instrument guides PBF

Classification product code:

PREDICATE AND REFERENCE DEVICES

The predicate device to which substantial equivalence is claimed:

Trade or proprietary or model name	VSP® Orthopedics
510(k) number	K190044
Decision date	August 21, 2019
Classification product code	PBF
Manufacturer	3D Systems, Inc.

Reference device:

Trade or proprietary or model name	KLSPatientPlanning System	Martin IndividualSolutions (IPS)
510(k) number	K192979
Decision date	March 11, 2020
Classification product code	PBF
Manufacturer	KLS-Martin L.P.

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Trade or proprietary or model name	FINE Osteotomy Around
	The Knee
510(k) number	K193614
Decision date	March 25, 2020
Classification product code	HRS, HWC, PBF
Manufacturer	Bodycad Laboratories, Inc.

DESCRIPTION AND FUNCTIONING OF THE DEVICE

INDICATIONS FOR USE

3D-Cut is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or in guiding surgical instruments in non-acute, nonjoint replacing osteotomies, including the resection of bone tumors, for femur, tibia and pelvis including sacrum.

Comparison of Technological Characteristics with the predicate device

The subject device 3D-Cut has either identical or substantially equivalent intended use and technological features as the predicate device K190044. Both devices differ in covered anatomical regions and patient population with the subject device covering more anatomical regions and indicated to be used for adults and adolescents. A comparison with the reference devices, risk analysis, and verification and validation testing were used to evaluate the potential impact on substantial equivalence.

SUMMARY OF PERFORMANCE DATA

Several tests have been conducted to demonstrate the output of the manufacturing process conforms to the device specifications. A combination of bench, cadaveric and clinical (OUS published case series) testing was executed to demonstrate the subject device is substantially equivalent to the predicate device and performs in accordance with its intended use.

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Testing included biocompatibility testing in accordance with ISO 10993, testing for cleaning, sterility, dimensional stability and packaging, mechanical testing and simulated use testing on cadaveric specimen. In addition, results from clinical investigations using 3D-Cut have been reported.

Software verification and validation were performed, and documentation was included in this submission in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

CONCLUSION

The characteristics that determine the functionality and performance of 3D-Cut, the subject device, are substantially equivalent to the predicate device cleared under K190044. The testing indicates that the subject device is as safe, as effective, and performs as well as the predicate.

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.