The PSPS bone model is indicated, based on patient-specific radiological images (CT scans), to assist in pre-operative orthopedic planning for patients able to undergo orthopedic procedures and able to be radiologically scanned.

The PSPS bone model is a diagnostic tool to visually aid in orthopedic pre-operative surgical planning for skeletally mature individuals.

Be advised, the quality of medical images determines the accuracy of the 3D bone models. Zimmer Biomet recommends using CT Protocol PMI® Patient-Matched Implants CT Protocol. Only images obtained less than six (6) months prior should be used for simulating and/or evaluating orthopedic treatment options.

Device Description

The Patient Specific Planning Solution™ 3D Bone Model is a 3-dimensional representation of the requested anatomical bone site. The Bone Models are diagnostic tools to allow the Surgeon to physically and visually aid in pre-operative orthopedic planning to facilitate the implantation of medical devices.

The Patient Specific Planning Solutions™ are designed of polyamide (nylon) using additive manufacturing (selective laser sintering), based on the approved/finalized orthopedic pre-surgical plan and shipped prior to surgery. The Bone Models are provided non-sterile and are used pre-operatively for education, planning to aid in component selection, sizing, and placement based on patient specific radiological images (CT scan). Physical bone models' critical bony areas are printed at <1mm mean deviation.

The full-scale 3D printed Patient Specific Bone Model is shipped to the patient's surgery to facilitate pre-operative planning.

AI/ML Overview

This document does not contain the detailed information necessary to fully answer all aspects of your request, specifically regarding a multi-reader multi-case (MRMC) comparative effectiveness study, the number of experts for human-in-the-loop studies, the adjudication method, or specific effect sizes. The submission focuses on substantial equivalence to a predicate device, Mimics Medical (K183105), rather than a detailed performance study against specific acceptance criteria for a new AI algorithm.

However, based on the provided text, here's what can be extracted and inferred regarding the device's acceptance criteria and proven performance:

Device: Patient Specific Planning Solution™ Bone Models

Device Function Summary: These are 3D printed physical bone models derived from patient-specific CT scans. They are intended as diagnostic tools to visually aid in orthopedic pre-operative surgical planning and to facilitate the implantation of medical devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are primarily related to the geometric accuracy of the 3D-printed bone models compared to the digital input. The performance summary refers to the device utilizing the same geometric accuracy testing as its predicate.

Acceptance Criteria Category	Specific Criteria / Requirement	Reported Device Performance
Geometric Accuracy	Physical bone models' critical bony areas are printed at <1mm mean deviation.	"The subject and predicate device utilize the same geometric accuracy of models testing." "Physical bone models' critical bony areas are printed at <1mm mean deviation." (This statement is listed as a description of the device's design, implying it's an inherent performance characteristic that the device is designed to meet and has been validated.) "Additional design and test method validation were performed on the subject device to further ensure geometric and design accuracy..." "Test method validation testing included assessment of the workflow from input digital replica."
Material Properties	N/A (implied by "design and test method validation" for "material")	"Additional design and test method validation were performed on the subject device to further ensure geometric and design accuracy, including material..."
Physical Characteristics	Absence of burrs and sharp edges (implied by "design and test method validation" for "burrs and sharp edges")	"Additional design and test method validation were performed on the subject device to further ensure geometric and design accuracy, including... burrs and sharp edges..."
CT Scan Requirements	Use of "CT Protocol PMI® Patient-Matched Implants CT Protocol" for optimal accuracy. Images obtained less than six (6) months prior.	This is a recommendation for use to ensure accuracy; it's not a direct performance metric of the device itself but a prerequisite for optimal performance. The device is designed to work with images meeting these criteria.
Workflow Validation	Assessment of the workflow from digital input to physical replica.	"Test method validation testing included assessment of the workflow from input digital replica."

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

Sample Size: Not explicitly stated. The document mentions "Summary of Performance Data" and speaks generally about "geometric accuracy of models testing" and "Additional design and test method validation" but does not provide specific numbers of models or datasets used for these tests.
Data Provenance: Not explicitly stated. The bone models are based on "patient-specific radiological images (CT scans)." No information on the country of origin or whether the data was retrospective or prospective is provided. Given the nature of a 510(k) submission for manufacturing medical devices, the data would typically be derived from existing clinical CT scans.

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

Not applicable/Not stated. The "ground truth" for geometric accuracy testing would typically be the digital 3D model from which the physical model is printed (the "input digital replica"), not expert consensus on medical images for diagnostic purposes. The document doesn't describe any studies involving expert readers for image interpretation or diagnosis. The device's role is to provide a physical model for pre-surgical planning.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not stated. No adjudication method is mentioned as this is not a study assessing diagnostic accuracy of an AI algorithm on images, but rather the manufacturing accuracy of a physical model.

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. An MRMC comparative effectiveness study was not performed or mentioned. The submission is for a physical bone model, not an AI software intended to assist human readers in image interpretation or diagnosis. The predicate device, Mimics Medical, is software for creating 3D models from medical images.

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

Yes, in a sense, the geometric accuracy testing of the physical models against the digital models can be considered a standalone performance evaluation of the manufacturing process and the resulting physical product. It asserts that the physical models meet the specified dimensional tolerances (<1mm mean deviation in critical bony areas).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for assessing the geometric accuracy of the physical bone models is the digital 3D model (the "input digital replica") generated from the patient's CT scans. The deviation of the physical model from this digital blueprint is measured.

8. The sample size for the training set

Not applicable/Not stated. This is a 510(k) submission for a physical device manufactured based on given digital data, not an AI algorithm that undergoes training. The "Mimics Medical" software mentioned is the predicate, which is used for segmentation and 3D model creation, but details about its training are not part of this submission.

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

Not applicable, as no training set for an AI algorithm is described in this document for the device itself.

Summary

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Biomet Manufacturing Corp. % Ms. Katherine Choi Senior Regulatory Affairs Specialist 56 East Bell Drive WARSAW IN 46581

June 25, 2023

Re: K230540 Trade/Device Name: Patient Specific Planning Solution™ Bone Models Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 13, 2023 Received: June 14, 2023

Dear Ms. Choi:

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.

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

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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.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K230540

Device Name

Patient Specific Planning Solution TM Bone Models

Indications for Use (Describe)

The PSPS bone model is a diagnostic tool to visually aid in orthopedic pre-operative surgical planning for skeletally mature individuals.

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:

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"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."

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510(k) #:	K230540	510(k) Summary	Prepared on: 2023-06-14
-----------	---------	----------------	-------------------------

Contact Details	21 CFR 807.92(a)(1)
-----------------	---------------------

Applicant Name	Biomet Manufacturing Corp.
Applicant Address	56 East Bell Drive Warsaw IN 46581 United States
Applicant Contact Telephone	260-602-2359
Applicant Contact	Ms. Katherine Choi
Applicant Contact Email	Katherine.Choi@ZimmerBiomet.com
Correspondent Name	Biomet Manufacturing Corp.
Correspondent Address	56 East Bell Drive Warsaw IN 46581 United States
Correspondent Contact Telephone	609-579-8095
Correspondent Contact	Mr. Caleb Barylski
Correspondent Contact Email	Caleb.Barylski1@zimmerbiomet.com

Device Name	21 CFR 807.92(a)(2)
-------------	---------------------

Device Trade Name	Patient Specific Planning Solution™ Bone Models
Common Name	Medical image management and processing system
Classification Name	System, Image Processing, Radiological
Regulation Number	892.2050
Product Code	LLZ

Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
------------------------------------	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K183105	Mimics Medical	LLZ

Device Description Summary	21 CFR 807.92(a)(4)
----------------------------	---------------------

The Patient Specific Planning Solution™ 3D Bone Model is a 3-dimensional representation of the requested anatomical bone site. The
Bone Models are diagnostic tools to allow the Surgeon to physically and visually aid in pre-operative orthopedic planning to facilitate

Bone Models are diagnostic tools to allow the Surgeon to physically aid in pre-operative orthopedic planning to facilitate the implantation of medical devices.

The full-scale 3D printed Patient Specific Bone Model is shipped to the patient's surgery to facilitate pre-operative

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planning.

Intended Use/Indications for Use

The PSPS bone model is a diagnostic tool to visually aid in orthopedic pre-operative surgical planning for skeletally mature individuals.

Be advised, the quality of medical mages determines the accuracy of the 3D bone models. Zimmer Biomet recommends using CT Protocol PM® Patient-Matched Implants CT Protocol. Only images obtained less than six (6) months prior should be used for simulating and/or evaluating orthopedic treatment options.

Indications for Use Comparison

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

Intended Use: Similar

Conclusion: The intended use of the subject device partially consists of the intended of use of the subject device uses the predicate device software in the creation of the physical bone model used for diagnostic purposes.

Indications for Use:Similar

Conclusion: The subject device utilizes the Mimical software interface and image segmentation system in the creation of images to develop a physical bone model replica for use as a diagnotic tool by the surgeon. The predicate device allows the production of 3D models in orthopedic, maxillofacial, and cardiovascular applications.

Technological Comparison

The technological characteristics for both the subject and predicate device are identical in terms of device functionality, imaging modality, imaging information transfer, and design features. The subject device utilizes the predicate device to import CT scans, visualize and segment medical images check and correct the segmentations, and create digital 3D models for measuring, treatment planning, and producing the output file for 3D bone model creation.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Summary of Performance Data:

The subject and predicate device utilize the same geometric accuracy of models testing. Additional design and test method validation were performed on the subject device to further ensure geometric and design accuracy, including material, burrs and sharp edges, CT scanning requirements, bone model geometric specification, design, and formative evaluation testing. Test method validation testing included assessment of the workfow from input digital replica. These verification and validation activities demonstrate that the subject device performs as intended for the desired indications.

Clinical Tests: N/A

Conclusion of Safety and Effectiveness:

The subject device, Patient Specific Planning Solution™ Bone Models, has identical technological characteristics to the predicate device, Mimics Medical (K183105). The subject device has similar Intended Use, Indications for Use, and performance requirements as its predicate device and the information provided demonstrates:

· any differences do not raise new questions of safety and effectiveness; and

· the proposed device is at least as safe and effective as the legally marketed predicate device.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).