EmbedMed is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the system, and the result is an output data file. This file may then be provided as digital models or used an input to an additive manufacturing portion of the system. The additive manufacturing portion of the system produces physical outputs including anatomical models and surgical guides for use in maxillofacial surgeries. EmbedMed is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

Device Description

EmbedMed utilizes Commercial Off-The-Shelf (COTS) software to manipulate 3D medical images to create digital and additive manufactured, patient-specific physical anatomical models and surgical guides for use in surgical procedures. Imaging data files are obtained from the surgeons for treatment planning and various patient-specific products that are manufactured with biocompatible photopolymer resins using additive manufacturing (stereolithography).

AI/ML Overview

The provided text describes the 3D LifePrints UK Ltd. EmbedMed device (K220366), an image segmentation software and additive manufacturing system for creating patient-specific anatomical models and surgical guides for maxillofacial surgeries.

Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics for the EmbedMed device in terms of clinical accuracy (e.g., sensitivity, specificity, or deviation). Instead, the performance data presented is focused on demonstrating the physical and functional aspects of the manufactured outputs and their compliance with general medical device standards.

However, based on the provided text, we can infer some "acceptance criteria" through the verification and validation testing performed. These are more general compliance points rather than precise numerical performance targets for the AI component's diagnostic accuracy.

Acceptance Criteria Category	Stated Verification/Validation/Performance
Biocompatibility	EmbedMed meets the requirements of ISO 10993-1:2018, ISO 14971:2019, and FDA Guidance Document Use of International Standard ISO 10993-1:2016 for short term (≤ 24 hours) contact with tissue and bone. Tested endpoints: cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity.
Sterilization Validation (End User)	Sterilization process validated to a sterility assurance level (SAL) of 10-6 using the over-kill method according to ISO 17665-1:2006. Drying time validation also conducted.
Functional/System Performance (Software & Manufacturing)	Installation, Operational, and Performance Qualification (IO/PQ) confirmed.
Dimensional Accuracy (Physical Outputs)	Verified that physical outputs (anatomical models, surgical guides) meet dimensional accuracy requirements across the range of possible patient-specific devices.
Feature Accuracy (Physical Outputs)	Verified that physical outputs meet feature accuracy requirements across the range of possible patient-specific devices.
Simulated Use Testing	Performed to confirm EmbedMed physical outputs meet requirements.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a specific "test set" for evaluating the performance of the image segmentation system in terms of diagnostic accuracy or clinical utility. The testing described focuses on the physical outputs and system performance rather than the AI's ability to accurately segment anatomical structures on a test dataset.

Sample Size for Test Set: Not explicitly stated for the image segmentation component. The "Verification and Validation Testing" indicates testing was performed "across the range of possible patient-specific devices," implying a variety of cases were used for dimensional and feature accuracy, but not a specific count or dataset description.
Data Provenance: Not specified. The input imaging information is stated to come from "a medical scanner such as a CT based system." There is no mention of country of origin or whether data was retrospective or prospective for any internal testing of the image segmentation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The study described does not involve establishing ground truth for image segmentation using expert consensus for a test set, nor does it quantify the performance of the image segmentation algorithm in terms of accuracy against such a ground truth. The "ground truth" for the physical outputs (dimensional and feature accuracy) would likely be based on the digital models generated by the system and engineering specifications, not expert clinical interpretation.

4. Adjudication Method for the Test Set

This information is not provided. As no specific test set for image segmentation performance against expert ground truth is described, an adjudication method is not mentioned.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states under "5.8.4. Clinical Studies": "Clinical testing was not necessary for the demonstration of substantial equivalence." The focus was on the substantial equivalence of the system and the physical outputs, not on comparing reader performance with and without AI assistance.

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

A standalone performance evaluation of the image segmentation algorithm in terms of its accuracy (e.g., Dice score, Hausdorff distance, etc.) against a clinical ground truth is not explicitly described or provided. The system is described as a "software system and image segmentation system," but its performance metrics as an algorithm by itself are not detailed. The digital output is "reviewed and approved by the prescribing clinician prior to delivery of the final outputs," indicating a human-in-the-loop workflow.

7. The Type of Ground Truth Used

For the "Feature Accuracy" and "Dimensional Accuracy" validation, the ground truth would likely be the digital design files generated by the EmbedMed software itself, against which the physical 3D-printed outputs are compared. For the biocompatibility and sterilization validation, the ground truth is established by international standards (ISO) and FDA guidance documents.

There is no mention of ground truth derived from expert consensus, pathology, or outcomes data for the performance of the image segmentation component of the software.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size for the image segmentation software. Given that the software is described as utilizing "Commercial Off-The-Shelf (COTS) software to manipulate 3D medical images," it is possible that the underlying segmentation algorithms were developed and trained externally or are based on traditional image processing techniques rather than a large, custom-trained deep learning model.

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

Since information regarding a specific training set is not provided, how its ground truth was established is also not mentioned.

Summary

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September 30, 2022

3D LifePrints UK Ltd. % Sam Murray Principal Consultant Olympus Regulatory Solutions 5 Seaconnet Ave Portsmouth, Rhode Island 02871

Re: K220366

Trade/Device Name: EmbedMed Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: August 30, 2022 Received: September 1, 2022

Dear Sam Murray:

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 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.

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220366

Device Name EmbedMed

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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5. 510(K) SUMMARY K220366

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.

5.1. Submitter's Information

Name:	3D LifePrints UK Ltd.
Address:	The Innovation Hub, Alder Hey Children's NHS Foundation Trust,Eaton Road West Derby, Liverpool Merseyside, England, L12 2APUnited Kingdom
Phone:	+44 15152 86830
Contact Person:	Henry PinchbeckCEO
Preparation Date:	29 September 2022

5.2. Device Name

Trade Name:	EmbedMed™
Common Name:	System for the creation of patient specific anatomical models and surgical guides
Classification Name:	Bone Cutting Instruments and Accessories
Regulation	21 CFR § 872.4120
Regulatory Class:	Class II
Product Code	DZJ, LLZ

5.3. Legally Marketed Predicate Device

CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K201353)

5.4. Device Description

Imaging data files are obtained from the surgeons for treatment planning and various patient-specific products that are manufactured with biocompatible photopolymer resins using additive manufacturing (stereolithography).

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5.4.1. Brief Written Description of the Device

EmbedMed receives patient specific medical imaging files from the prescribing clinician which is then then further processed. The processing includes a software program to segment the image file from 3D medical scan images and creates a patient-specific digital output. The digital output is then reviewed and approved by the prescribing clinician prior to delivery of the final outputs (physical or digital). A trained 3D LifePrints employee utilizes additive manufacturing (3D printing, SLA) to manufacture physical outputs which include anatomical models and surgical guides for use in maxillofacial surgeries. All outputs are provided non-sterile. All surgical guides are provided with the steps for sterilization prior to use in surgery. Anatomical models may also be provided with the steps for sterilization. The outputs of the subject device include:

. Anatomical models are physical replicas used to aid in surgical planning. They are intended to be used in conjunction with other diagnostic tools and expert clinical judgement. Anatomical models are not intended to come into contact with the patient or Surgical Guide
. Surgical Guides are used in surgical procedures to aid in bone cutting, bone marking, or bone repositioning. Drill sleeves are recommended to be used with the drilling guides. Clinicians use these cutting guides as they aid in cutting, by marking the angle and plane

OutputDevice	Model/DesignType Examples	Mechanism of Action/Narrative Description
SurgicalGuide	Jaw Cutting Guide	Guides with positional indicators, cutting planes and/or drilling holes that are affixed topatients during surgery to determine the locations and angles of osteotomies on themandible and/or maxilla
	OrthognathicSplint	Guides that rest upon the patient's teeth during surgery to reposition the maxilla and/ormandible during orthognathic surgery
	OrthognathicGuide	Guides with positional indicators, cutting planes and drilling holes which are affixed topatients during surgery to indicate angle and location of osteotomy facilitatingrepositioning of the maxilla and mandible during orthognathic surgery
AnatomicalModel	Sterilizablephysical replicamodel	Physical representation of patients' facial anatomy and pathology used for the planningof maxillofacial surgeries (e.g. reconstructive, TMJ, resection, orbital, mid-face, dental,orthognathic, cosmetic). The models are used to better understand the anatomy, fordecision making, reference, implant sizing, simulation etc. and that are intended to besterilized so they can be used within an the operating theater
	Non-sterilizablephysical replicamodel	Physical representation of patients' facial anatomy and pathology used for the planningof maxillofacial surgeries (e.g. reconstructive, TMJ, resection, orbital, mid-face, dental,orthognathic, cosmetic). The models are used to better understand the anatomy, fordecision making, reference, implant sizing, simulation etc.

Table 1: Output Device Descriptions

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OutputDevice	Model/DesignType Examples	Mechanism of Action/Narrative Description
DigitalModel	Digital replicaanatomical model	Digital representation of patients' facial anatomy and pathology used for the planning ofmaxillofacial surgeries (e.g., reconstructive, TMJ, resection, orbital, mid-face, dental,orthognathic, cosmetic). The models are used to better understand the anatomy, fordecision making, reference, implant sizing, simulation etc.

The Surgical Guides are compatible with legally marketed bone screws and compatible metal sleeves

5.4.2. Materials of Use

EmbedMed physical outputs are additively manufactured by SLA utilizing medical-grade, acrylate-based photopolymers.

5.5. Intended Use

EmbedMed is intended for use as a software system and image segmentation system, for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the system, and the result is an output data file that is then used as input to an additive manufacturing portion of the system. The additive manufacturing portion of the system produces physical outputs including anatomical models and surgical guides.

Anatomical models are intended to be physical replicas used for to aid in surgical planning. They are intended to be used in conjunction with other diagnostic tools and expert clinical judgment. Surgical Guides are intended to be used in surgical procedures where they aid in bone cutting, bone marking, or bone repositioning.

5.6. Indications for Use

5.7. Substantial Equivalence Discussion

A comparison of the similarities and differences between EmbedMed and predicate devices are provided in Table 2.

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Table 2: Predicate Comparison

Specification/Characteristic	Subject Device	Predicate Device	Comparison
	EmbedMed (K220366)	CenterMed Patient Matched Assisted SurgicalPlanning (ASP) System (K201353)
Classification	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	21 CFR 872.4120, Class II21 CFR 892.2050, Class II	Identical
Product Code	DZJ, LLZ	DZJ, LLZ	Identical
Indications for Use	EmbedMed is intended for use as a software system andimage segmentation system for the transfer of imaginginformation from a medical scanner such as a CT basedsystem. The input data file is processed by the system,and the result is an output data file. This file may then beprovided as digital models or used an input to an additivemanufacturing portion of the system. The additivemanufacturing portion of the system produces physicaloutputs including anatomical models and surgical guidesfor use in maxillofacial surgeries. EmbedMed is alsointended as a pre-operative software tool forsimulating/evaluating surgical treatment options.	CenterMed Patient Matched Assisted Surgical Planning(ASP) System is intended for use as a software systemand image segmentation system for the transfer ofimaging information from a medical scanner such as a CTbased system. The input data file is processed by the ASPsystem and the result is an output data file. This file maythen be provided as digital models or used as input to arapid prototyping portion of the system that producesphysical outputs including anatomical models, surgicalguides, surgical splints and surgical planning case reportsfor use in maxillofacial surgery. CenterMed PatientMatched ASP System is also intended as a pre-operativesoftware tool for simulating/evaluating surgical treatmentoptions.	Identical
Specification/Characteristic	Subject Device	Predicate Device
	EmbedMed (K220366)	CenterMed Patient Matched Assisted SurgicalPlanning (ASP) System (K201353)	Comparison
Contraindications	1. Significant changes to the patient's anatomy haveoccurred since the medical scan used for planningpurposes was obtained.2. Hypersensitivity to acrylate resins.	1. Active infections (obvious, or clinically apparent).2. Hypersensitivity to foreign bodies.3. Circulatory problems, systematic diseases, ormetabolic disorders.4. Insufficient or inadequate bone tissue.5. Secondary diseases such as degenerative processesthat may have negative influences.6. Interventions carried out in a non-sterileenvironment7. Regions exposed to inappropriate forces orexcessive weight loads8. Patients unwilling to follow instructions during thepostoperative phase due to their mental,neurological, or physical condition.9. Obvious drug or alcohol abuse10. Significant changes to the patient's anatomy haveoccurred since the medical scan used for planningpurposes was obtained.	SubstantiallyEquivalent
ClinicalApplication	Maxillofacial Surgeries	Maxillofacial Surgeries	Identical
Inputs	CT, CBCT, MRI, PET, DICOM images or CBCT ofmouth/teeth) if applicable, Patients' digital photos ifapplicable	CT, CBCT DICOM images, Teeth models (stone models,STL file or CBCT of mouth/teeth) if applicable, Patients'digital photos if applicable	Identical
SegmentationSoftware	Simpleware Scan IP	Materialise Mimics	SubstantiallyEquivalent
Outputs	Anatomical Models, Surgical Guides, Digital Models	Anatomical models, Surgical splints, Surgical guides,Surgical planning case reports	SubstantiallyEquivalent
Materials	Anatomical models: Medical Grade Resin, acrylateSurgical guides: Medical Grade Resin, acrylateSleeve: Medical Grade Stainless Steel or Titanium	Anatomical models: Medical Grade Polyamide (PA-12)Surgical guides: Medical Grade Polyamide (PA-12)Sleeve: Medical Grade Stainless Steel 316L	SubstantiallyEquivalent
ManufacturingMethod	3D printing (additive)	3D printing (additive)	Identical
Patient Specific	Yes	Yes	Identical
Provided Sterile	No	No	Identical
Specification/Characteristic	Subject Device	Predicate Device	Comparison
	EmbedMed (K220366)	CenterMed Patient Matched Assisted SurgicalPlanning (ASP) System (K201353)
SterilizationMethod	Steam Sterilization	Steam Sterilization	Identical
Provided SingleUse	Yes	Yes	Identical
RecommendedTemporary fixationstyle	Drill free	Drill-Free, Tapping-Free	SubstantiallyEquivalent

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5.7.1. Statement on Substantial Equivalence

EmbedMed is substantially equivalent to the legally marketed predicate device CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K201353) with respect to intended use, design, materials, performance, and labeling.

5.8. Performance Data

Testing as described below has been performed to demonstrate the outputs of the EmbedMed manufacturing process conforms to the device specifications.

Testing performed and documented in this submission was also in accordance with FDA Guidance Document Technical Considerations for Additive Manufactured Medical Devices (December 5th, 2017).

5.8.1. Biocompatibility Testing

EmbedMed was evaluated for the overall biological safety giving consideration to the following: type of patient contact and intended clinical use, potential hazards associated with the material of construction, biocompatibility data available on the 3D-printed raw material, the history of clinical use of the material of construction, manufacturing process information, and other information available according to ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process, and FDA Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Endpoints assessed include: cytotoxicity, sensitization, acute systemic toxicity, and material-mediated pyrogenicity.

The results of the biological risk assessment and endpoint testing confirm biocompatibility. Embed is considered to meet the requirements of ISO 10993-1:2018, ISO 14971:2019, and FDA Guidance Document Use of International Standard ISO 10993-1:2016, for an implant device that has short term (≤ 24 hours) contact with tissue and bone.

5.8.2. Sterilization Validation

The physical outputs of the subject device including the surgical guides and anatomical models are intended to be sterilized by the end user prior to use. The sterilization process was validated using the over-kill method according to ISO 17665-1: Sterilization of health care products - Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. The sterilization cycle identified in the Instructions for Use were validated to a sterility assurance level (SAL) of 10-6. Drying time validation was also conducted.

5.8.3. Verification and Validation Testing

The performance testing performed on EmbedMed were conducted as part of formal design verification and validation. The testing confirmed EmbedMed physical outputs meet the requirements across the range of possible patient-specific devices. Testing included:

Installation, Operational, and Performance Oualification
Feature Accuracy

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Dimensional Accuracy ●
. Simulated Use Testing

5.8.4. Clinical Studies

Clinical testing was not necessary for the demonstration of substantial equivalence.

Conclusions 5.9.

EmbedMed has the same intended use and similar technological characteristics as the predicate device. Minor differences have been addressed by verification and validation testing. The testing demonstrates the subject device is substantially equivalent to the predicate device

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.