Cuptimize is an image-processing software indicated to assist in the positioning of total hip replacement components, with a specific focus on the acetabular component. It is intended to assist in the precise positioning of the acetabular component intra-operatively by measuring its position relative to the bone structures of interest provided that the points of interest can be identified from radiology images.

The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software. The software is not for primary image interpretation. The software is not for use on mobile phones.

Device Description

Cuptimize is a software as a medical device (SaMD) system that provides acetabular component position data for hip replacement surgery. The software guides the user through a workflow that olves positioning a series of digital annotations on preoperative and intraoperative radiographic images. This enables the system to calculate inclination and anteversion data that describes the acetabular component position.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and details of the study for the Cuptimize device:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, JointPoint (K160284), rather than defining explicit acceptance criteria in a quantitative table. However, we can infer the primary acceptance criterion and the study used to demonstrate it.

Inferred Acceptance Criterion and Reported Device Performance

Acceptance Criterion (Inferred from Substantial Equivalence Claim)	Reported Device Performance (from "Cadaver Data - Cup Check")
Inclination and Anteversion measurements for acetabular component position	Inclination and Anteversion substantially equivalent to JointPoint (Predicate Device)

Study Details:

Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated, however, the text mentions "a cadaveric laboratory was performed to gather data." This implies a limited number of cadavers, likely a single cadaver given the singular phrasing ("a cadaver").
- Data Provenance: Prospective, as it was conducted in a "cadaveric laboratory." The country of origin is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The comparison is made against the output of the predicate device, JointPoint, not against an expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. The comparison relies on the output of the predicate device, JointPoint, as the reference for "substantial equivalence." There is no mention of independent human adjudication or consensus.
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 done. The study described is a comparison of the Cuptimize device's output against a predicate device's output, not a study involving human readers with and without AI assistance. The device is a "software as a medical device (SaMD) system that provides acetabular component position data," implying it directly outputs measurements, and its function is to "assist in the precise positioning" rather than directly improving human reader performance in interpretation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The "Cadaver Data - Cup Check" compared the outputs of the Cuptimize system directly against the outputs of the JointPoint predicate device. The device is described as "image-processing software indicated to assist in the positioning," implying it processes images and provides measurements without requiring real-time human intervention in the measurement process, although clinical judgment is still required for its use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the test set was the output data from the predicate device, JointPoint. This is a comparative ground truth against another device's measurements, rather than an independent expert consensus, pathology, or outcomes data ground truth.
The sample size for the training set:
- This information is not provided in the document. The summary focuses on verification and validation testing, not on the development or training of the software.
How the ground truth for the training set was established:
- This information is not provided as the training set details are omitted.

Summary

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February 26, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is a circular emblem with a stylized human figure. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.

Cuptimize, Inc. % Ms. Michelle McDonough Senior Director, Regulatory and Clinical Affairs MCRA, LLC 1050 K Street NW, Suite 1000 WASHINGTON DC 20001

Re: K203651

Trade/Device Name: Cuptimize Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 23, 2020 Received: December 23, 2020

Dear Ms. McDonough:

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.

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) K203651

Device Name Cuptimize

Indications for Use (Describe)

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

Manufacturer:	Cuptimize, Inc.2840 West Bay Drive, Unit #163Belleair Bluffs, FL 33770
Contact:	Michelle McDonough, MSMCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001202.552.5800 (phone)202.552.5798 (fax)
Date Prepared:	February 18, 2021
Device Trade Name:	Cuptimize
Common Name:	Picture archiving and communications system (PACS)
Classification:	21 CFR 892.2050
Class:	II
Product Code:	LLZ; HAW

Indications for Use:

The device allows for overlaying of digital annotations on radiological images and includes tools for performing measurements using the images and digital annotations. Clinical judgment and experience are required to properly use the software is not for primary image interpretation. The software is not for use on mobile phones.

Device Description:

K203651

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images. This enables the system to calculate inclination and anteversion data that describes the acetabular component position.

Predicate Devices:

Cuptimize is substantially equivalent to JointPoint (K160284).

Verification and Validation Testing Summary:

Verification activities included system and unit testing via automated regression testing and manual test procedure analyses. Validation testing was performed to analyze acetabular component position on a cadaver by comparing output data from the Cuptimize system to the output of a predicate device, JointPoint.

Substantial Equivalence:

Cuptimize and JointPoint are both image-processing software indicated to assist in the positioning of total hip replacement components. The Cuptimize software is focused on a sub-set of the capabilities of the JointPoint system, specifically the acetabular component. Both devices assist in positioning of the acetabular component by measuring the position relative to the bone structures of interest provided that the points of interest can be identified from radiology images.

Testing performed on this device demonstrates that Cuptimize is substantially equivalent to the predicate device. Performance testing of the Cuptimize system included reproducible verification and validation scripts using known measurements to establish data against a measured control. Additionally, anteversion and inclination data was compared against analysis from the JointPoint predicate device (510k clearance "K160284"). Finally, a cadaveric laboratory was performed to gather data to validate the system's intended use and to perform sensitivity testing.

	Subject Device	Predicate Device
Device Name	Cuptimize	JointPoint
Company	Cuptimize, Inc.	JointPoint, Inc.
K Number	Subject Device	K160284
Classification	21 CFR 892.2050	21 CFR 892.2050
Product Code	LLZ; HAW	LLZ; HAW
Indications forUse Statement	Cuptimize is an image-processing softwareindicated to assist in the positioning of totalhip replacement components, with a specificfocus on the acetabular component. It isintended to assist in the precise positioningof the acetabular component intra-operatively by measuring its position relativeto the bone structures of interest providedthat the points of interest can be identifiedfrom radiology images.The device allows for overlaying of digitalannotations on radiological images and	JointPoint is an image-processing softwareindicated to assist in the positioning of totalhip replacement components. It is intendedto assist in precisely positioning total hipreplacement components intra-operativelyby measuring their positions relative to thebone structures of interest provided that thepoints of interest can be identified fromradiology images.JointPoint is also indicated for assistinghealthcare professionals in preoperativeplanning and postoperative analysis of

Predicate Comparison Table

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	Subject Device	Predicate Device
Device Name	Cuptimizeincludes tools for performing measurementsusing the images and digital annotations.Clinical judgment and experience arerequired to properly use the software. Thesoftware is not for primary imageinterpretation. The software is not for use onmobile phones.	JointPointorthopedic surgery in Total HipReplacement, Total Knee Replacement, andIntertrochanteric Fracture Reduction. Thedevice allows for overlaying of prosthesistemplates on radiological images, andincludes tools for performing measurementson the image and for positioning thetemplate. Clinical judgment and experienceare required to properly use the software.The software is not for primary imageinterpretation. The software is not for use onmobile phones.
Components	Identical	Identical
Computer	Identical	Identical
OperatingSystems	Identical	Identical
AnatomicalLocations	Hip	Hip; Knee
Input Data	Identical	Identical
Output Data	Measurements and calculations for cupposition analysis.	Measurements and calculations for cupposition analysis, leg length and offsetanalysis, contralateral leg length analysis andintertrochanteric fracture reduction analysis.
Software Features	Preoperative and intraoperative cup positionanalysis.	Preoperative leg length and offset analysis,interoperative cup position analysis, leglength and offset analysis, contralateral leglength analysis and intertrochanteric fracturereduction analysis.
V&V Testing	All Unit and System Tests Passed	All Unit and System Tests Passed
Cadaver Data -Cup Check	Inclination and Anteversion substantially equivalent to JointPoint

Conclusion:

Cuptimize is shown to be substantially equivalent to previously cleared devices with respect to its intended use, indications for use, technological characteristics, and performance characteristics.

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).