ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

Device Description

ONE Planner™ Hip (OPH) is an interactive software application intended to be used as a preoperative tool for Total Hip Arthroplasty. It enables 2D sizing and positioning of implants in the patient's anatomy, calculates biomechanical measurements and performs functional analysis based on the patient's pelvic kinematics. The biomechanical measurements include measurements related to leg length and femoral offset. The functional analysis includes determination of pelvic parameters (e.g. pelvic tilt), and cup orientation calculations.

The software application consists of an automated templating system and a web-based templating user interface.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the ONE Planner™ Hip, a software device for preoperative surgical planning in total hip arthroplasty. It details the device's intended use, technological characteristics, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

However, the document does not provide information on:

Specific acceptance criteria and reported device performance in a table format.
Details of the test set: sample size, data provenance, number/qualifications of experts, or adjudication methods.
MRMC comparative effectiveness study.
Standalone algorithm performance.
Type of ground truth used for performance evaluation.
Details about the training set: sample size, or how its ground truth was established.

The document explicitly states:

"Software verification and validation testing was conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process)."
"The software is considered a 'moderate' level of concern, a malfunction in the device could lead to a minor injury."
"Non-clinical testing was performed to assess the usability and performance of the ONE Planner™ Hip to demonstrate that the device functions as intended."
"Clinical testing was not necessary for the determination of substantial equivalence."

This indicates that the clearance was based on non-clinical software verification and validation, and usability/performance testing, demonstrating that the device functions as intended and does not introduce new questions of safety and effectiveness compared to the predicate device. It does not describe a study involving an AI component with specific performance metrics against a ground truth, expert readers, or a test/training set in the context of an AI-driven medical device. The "Acceptance Criteria" and "Study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, or reader improvement) are not present in this document.

Therefore, many of the requested details cannot be extracted from the provided text.

Based on the available information, here's what can be addressed:

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

Not provided in the document. The document mentions "Software verification and validation testing" and "Non-clinical testing to assess the usability and performance...to demonstrate that the device functions as intended." It does not specify quantitative performance metrics or acceptance criteria for those metrics.

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

Not provided in the document. The document refers to "non-clinical testing" but does not detail the size or provenance of any "test set" in the context of evaluating an AI model's performance; instead, it refers to software V&V and usability.

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

Not provided in the document. Since "clinical testing was not necessary" and no AI performance study with a test set evaluated by experts is described, this information is absent.

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

Not provided in the document.

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

Not provided in the document. The document does not describe any MRMC study or AI assistance to human readers.

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

Not provided in the document. The device is described as "interact[ing]" with the user, suggesting a human-in-the-loop, but no standalone performance data is presented.

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

Not provided in the document.

8. The sample size for the training set

Not provided in the document. There is no mention of a training set as would be relevant for an AI model.

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

Not provided in the document.

Summary of what's described in the document regarding testing:

Type of Testing: Software Verification & Validation Testing and Non-Clinical Testing (Usability and Performance).
Purpose of Testing: To satisfy FDA guidance (IEC 62304) and demonstrate that the device functions as intended and does not introduce new safety and effectiveness questions compared to the predicate device.
Level of Concern: Moderate (malfunction could lead to minor injury).
Clinical Testing: Not deemed necessary for substantial equivalence determination.

Summary

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July 7, 2021

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Orthosoft d/b/a Zimmer CAS % Mr. Paul Hardy Regulatory Affairs Associate Director 75 Queen Street, Suite 3300 Montreal, Quebec H3C 2N6 CANADA

Re: K210653

Trade/Device Name: ONE Planner™ Hip Regulation Number: 21 CFR 892.2050 Regulation Name: Medical imaging management and processing system Regulatory Class: Class II Product Code: LLZ, LZO, PBI, LPH Dated: May 25, 2021 Received: June 1, 2021

Dear Mr. Hardy:

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K210653

Device Name ONE Planner™ Hip

Indications for Use (Describe)

ONE Planner™ Hip is intended for use as preoperative surgical planning software to aid orthopedic surgeons in component selection, sizing and placement for primary total hip arthroplasty.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart C)

X 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 and the Safe Medical Devices Act of 1990, the following information is provided for the ONE Planner TM Hip 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.

Sponsor : Orthosoft, Inc. (d/b/a Zimmer CAS) 75 Queen St., Suite 3300 Montreal, QC, CANADA H3C 2N6 Establishment Registration Number: 9617840 Contact Person(s): Paul Hardy Regulatory Affairs Associate Director Telephone: 574-453-6739 Paul.Hardy@zimmerbiomet.com Dave Bierhuizen Quality Assurance and Regulatory Affairs Manager Dave.Bierhuizen@zimmerbiomet.com Date: June 29, 2021 Trade Name: ONE Planner™ Hip Subject Device: Common Name: Image Processing System Product Code(s) / Classification Name (s): LLZ - Picture Archiving and Communications System to ● Medical imaging management and processing system (21 CFR 892.2050). . LZO - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353) . PBI - Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310) LPH- Hip joint metal/polymer/metal semi-constrained porous-. coated uncemented prosthesis (21 CFR 888.3358

Predicate Device(s):

Manufacturer	Device Name	510(k) Number
Corin	Corin Optimized Positioning System Insight	K192656

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Purpose and DeviceDescription:	ONE Planner™ Hip (OPH) is an interactive software applicationintended to be used as a preoperative tool for Total HipArthroplasty. It enables 2D sizing and positioning of implants inthe patient's anatomy, calculates biomechanical measurements andperforms functional analysis based on the patient's pelvickinematics. The biomechanical measurements includemeasurements related to leg length and femoral offset. Thefunctional analysis includes determination of pelvic parameters(e.g. pelvic tilt), and cup orientation calculations.The software application consists of an automated templatingsystem and a web-based templating user interface.
Indications for Use:	ONE Planner™ Hip is intended for use as preoperative surgicalplanning software to aid orthopedic surgeons in componentselection, sizing and placement for primary total hip arthroplasty
Summary ofTechnologicalCharacteristics:	The rationale for substantial equivalence is based on considerationof the following characteristics:• Indications for Use: ONE Planner™ Hip and the predicatedevice have the same Indications for Use.• Design Features: Both devices have the following features:Ο ONE Planner™ Hip and the predicate device use input filesconsisting of X-ray images.Ο ONE Planner™ Hip and the predicate device provide imageprocessing tools.Ο ONE Planner™ Hip and the predicate device providepreoperative sizing values.Ο ONE Planner™ Hip and the predicate device providefunctional analysis of pelvic parametersΟ ONE Planner™ Hip and the predicate device provideinteractive adjustment of the preoperative surgical planΟ ONE Planner™ Hip and the predicate device provide toolsfor visualization and to perform measurements, and tochoose size and position implants.Ο ONE Planner™ Hip and the predicate device export apreoperative surgical plan.
Compatible Devices:	ONE Planner™ Hip can be used with the following implantsystems:G7 Acetabular Systems (K121874, K142746, K142882, K140669,K150522, K190660, K190656)Taperloc Complete Stems (K101086, K103755, K110400,K120030, K200196)

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Echo Bi-Metric Stems (K070274, K143009, K150503) Avenir Complete (K182048, K192189) Avenir Muller and Cemented Hip Stems (K123392, K131884, K193030)

ONE Planner™ Hip has been evaluated through the following nonclinical testing:

· Software Verification & Validation Testing

Software verification and validation testing was conducted to satisfy the requirements of the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and IEC 62304 (Medical Device Software- Life Cycle Process). The software is considered a "moderate" level of concern, a malfunction in the device could lead to a minor iniurv. The testing demonstrates that the ONE Planner™ Hip does not introduce new questions of safety and effectiveness as compared to the predicate device.

• Non-Clinical Testing

Non-clinical testing was performed to assess the usability and performance of the ONE Planner™ Hip to demonstrate that the device functions as intended.

· Clinical Testing

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

Substantial Equivalence Conclusion:

The subject device has the same intended use, same indications for use, similar technological characteristics and principles of operation as the predicate device. The differences between the subject device and the predicate device does not introduce new types of safety and effectiveness questions. Therefore, the subject device is at least as safe and effective as the legally marketed predicate device.

Summary of Performance Data (Nonclinical and/or Clinical):

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).