FX SPS is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

Device Description

FX SPS is a preoperative standalone web-based medical software used for the planning of primary shoulder replacement from CT-images. It comprises a secure database which enables the patient's cases management and the access to the planning interface. Preliminary to the planning, a manual segmentation needs to be performed from the patient's CT-images. The segmentation process consists in building 3D bone models of the patient's shoulder and positioning anatomic landmarks on it. Once these data are generated, their compliance is checked. They are then imported into the FX SPS's database making the planning available for the surgeon. The planning step involves virtually positioning of the shoulder prosthesis on the 3D reconstruction of the patient's shoulder. On that purpose, the surgeon chooses implants from a library of implants. Afterwards, he selects the size of the implant more suitable to the joint and he can move prosthesis components in all directions. Once the positioning of the implant is satisfying, he validates the planning to generate a planning report. During surgery, he will have at its disposal the planning report comprising preoperative and planned parameters.

AI/ML Overview

The provided text describes the 510(k) summary for the Pixee Medical FX SPS device, focusing on its substantial equivalence to a predicate device (e-ortho Shoulder Software). While it details the device's function, intended use, and comparison to the predicate, it does not contain information about acceptance criteria or a specific study proving the device meets those criteria with detailed performance metrics.

The "Non-Clinical Performance Data" section generically states that:

"Software verification and validation testing were conducted as required by IEC 62304..."
"All performance testing demonstrated that FX SPS performs according to its specifications and functions as intended."
"Concerning the angle or gap measurements, software verification and validation testing were conducted. All performance testing demonstrated that FX SPS performs according to its specifications and functions as intended to ensure the required angle accuracy of 1 degree and gap measurement accuracy of 1 mm."
"User needs validation The software was validated with intended users through a human factor test series to ensure the user needs and intended use requirements were met, in accordance with IEC 62366-1. All requirements were met and no new issues of safety or effectiveness were raised."

This summary indicates that testing was performed and the device met its specifications, but it does not provide the specific "acceptance criteria" table and "reported device performance" as requested in the prompt, nor does it detail a specific study with sample sizes, data provenance, ground truth establishment, or expert involvement.

Therefore, for aspects related to a specific performance study (sample size, experts, ground truth, MRMC, effect size, standalone performance, training set details), the provided document does not contain this information.

Based on the information available in the document, here's what can be inferred or stated about the device's validation:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (inferred/stated specifications):
  - Angle accuracy: 1 degree
  - Gap measurement accuracy: 1 mm
  - Software performs according to its specifications.
  - Software functions as intended.
  - User needs and intended use requirements are met (human factors).
- Reported Device Performance:
  - "All performance testing demonstrated that FX SPS performs according to its specifications and functions as intended."
  - "All performance testing demonstrated that FX SPS performs according to its specifications and functions as intended to ensure the required angle accuracy of 1 degree and gap measurement accuracy of 1 mm."
  - "All requirements were met and no new issues of safety or effectiveness were raised."
Sample sizes used for the test set and the data provenance: Not specified in the provided text. The document refers to "software verification and validation testing" and "human factor test series" but does not detail the number of cases or the origin of the data (country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text. The "human factor test series" implies involvement of "intended users" (surgeons), but details on the number or their qualifications are not provided.
Adjudication method for the test set: Not specified in the provided text.
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 specified in the provided text. The device is described as an "information tool to assist in the preoperative surgical planning," but no MRMC study comparing human performance with and without the tool is detailed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states "software verification and validation testing were conducted," which would typically include standalone performance against internal specifications (like the angle and gap accuracy). However, detailed results of such a standalone study beyond a general statement of compliance are not provided. The device itself is described as a "standalone web-based medical software."
The type of ground truth used: For the stated accuracy metrics (angle and gap), the ground truth would likely be derived from precisely measured simulated data or a highly accurate reference standard established during software development and testing. For human factors, the "ground truth" would be the fulfillment of user needs and intended use requirements assessed by users. Specific details are not provided.
The sample size for the training set: Not applicable/Not specified. The device performs 3D reconstruction and planning based on CT images and a library of implants. It's not explicitly described as an AI/machine learning device that requires a large "training set" in the conventional sense for model building. The software development likely involved well-defined algorithms, rather than data-driven learning. If there was a machine learning component for, e.g., segmentation (though it states manual segmentation), training set details are not provided.
How the ground truth for the training set was established: Not applicable/Not specified, for the same reasons as point 8.

Summary

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Pixee Medical % Agathe Joet Quality & Regulatory Affairs Engineer 18 rue Alain Savary Besancon, 25000 FRANCE

Re: K213922

July 22, 2022

Trade/Device Name: FX SPS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 15, 2022 Received: June 21, 2022

Dear Agathe Joet:

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 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,

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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510(k) Number (if known)

K213922

Device Name

FX SPS

Indications for Use (Describe)

FX SPS is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

Type of Use (Select one or both, as applicable)

図 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Pixee Medical's FX SPS

510(k) Submitter:

Name: Pixee Medical Address: 18 rue Alain Savary 25000 Besançon FRANCE

Phone: (+33) 4 58 10 13 65 Fax: (+33) 4 58 10 14 51

Contact Person: Agathe JOËT

Date Prepared: July 20, 2022

Device:

Trade name: FX SPS Common name: Planning software for Total Shoulder Arthroplasty Classification name: System, Image Processing, Radiological (21 CFR §892.2050) Product code: LLZ Regulatory class: II Classification Panel: Radiology

Predicate Device:

FX SPS is substantially equivalent to the legally marketed e-ortho Shoulder Software.

Applicant Name	Device Name	Product code	510(k) number
FH INDUSTRIE	e-Ortho Shoulder Software	LLZ	K201928

No reference devices were used in this submission.

Device Description:

Preliminary to the planning, a manual segmentation needs to be performed from the patient's CTimages. The segmentation process consists in building 3D bone models of the patient's shoulder and positioning anatomic landmarks on it. Once these data are generated, their compliance is checked. They are then imported into the FX SPS's database making the planning available for the surgeon.

The planning step involves virtually positioning of the shoulder prosthesis on the 3D reconstruction of the patient's shoulder. On that purpose, the surgeon chooses implants from a library of implants.

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Afterwards, he selects the size of the implant more suitable to the joint and he can move prosthesis components in all directions. Once the positioning of the implant is satisfying, he validates the planning to generate a planning report.

During surgery, he will have at its disposal the planning report comprising preoperative and planned parameters.

Intended use / Indications for Use:

FX SPS is intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary total shoulder replacement.

Substantial equivalence:

Comparison of Intended Use / Indications for Use: .

FX SPS and the e-Ortho Shoulder Software are both web-based software indicated for primary total shoulder arthroplasty. Both devices are intended to be used as an information tool to assist in the preoperative surgical planning and visualization of a primary Total Shoulder Replacement. Thus, there is no difference between the subject device and the predicate device with respect to indications and intended use.

. Comparison of Operating principle

They both use CT-images of patients to reconstruct 3D models of the shoulder joint and to position anatomical landmarks through a manual segmentation process. In addition, they both allow the surgeons to perform a preoperative planning by enabling reverse and anatomical implant visualization and positioning within the specific patient's bone models. Furthermore, both devices compute and display pre-operative parameters. Both devices generate a downloadable planning report. Thus, FX SPS and E-ortho have the same principle of operation.

Comparison of technological characteristics with the predicate device: .

At a high level, the subject and predicate devices are based on the following same technological elements:

. Both are web-based software used pre-operatively;
. Both use CT-scan images;
Both inteqrate anatomic and reverse shoulder implants; .
Both rely on manual segmentation for 3D models reconstruction; .
. Both function with user profiles determining the possible user's actions;
Both manage the cases from a list of patients; .
Both provide to the user a milling tool; .

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Both integrate 3D and 2D representation of the humerus and the scapula. .
The following technological difference exists between the subject and predicate devices:
E-ortho provides software prediction of optimal implant sizing while FX SPS does not. .
Discussion regarding the technological characteristics:

Technologicalcharacteristics	FX SPS (Devicesubject of thisapplication)	E-Ortho ShoulderSoftware K201928(Predicate device)	Discussion
Type of software	Web-based software	Web-based software	Identical
Use time	Pre-operatively	Pre-operatively	Identical
Imaging used	CT-scan images	CT-scan images	Identical
Type of implantsplanned	Anatomical andreverse shoulderimplants	Anatomical andreverse shoulderimplants	Identical
Manual/automaticsegmentation	Manualsegmentationperformed.	Manualsegmentationperformed	Identical
User profiles	User profiles definethe authorizedactions for the user.	User profiles definethe authorizedactions for the user.	Identical
Casemanagement	List of cases	List of cases	Identical
Tools	Milling tool	Milling tool	Identical
Anatomyrepresentation	3D and 2Drepresentation of thehumerus and thescapula.	3D and 2Drepresentation of thehumerus and thescapula.	Identical
Recommandations	Does not include anypredictions andrecommendations.	Include softwareprediction of optimalimplant sizing.	While the E-ortho softwareincludes prediction of optimalimplant sizing, FX SPS doesnot. Yes, it makes FX SPSless critical regarding to thesafety, as the surgeon'splanning is not influenced

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The minor difference in technological characteristics between the subject device and the predicate does not alter the intended use of the device and does not raise new questions of safety nor effectiveness.

Non-Clinical Performance Data:

The following testing was conducted to evaluate the device:

. Software verification and validation testing were conducted as required by IEC 62304 and documentation was provided as recommended by the FDA Guidance "Content of Premarket Submissions for Software Contained in Medical Devices". The FX SPS software was considered as a software with a "moderate" level of concern. All performance testing demonstrated that FX SPS performs according to its specifications and functions as intended.
Concerning the angle or gap measurements, software verification and validation testing . were conducted. All performance testing demonstrated that FX SPS performs according to its specifications and functions as intended to ensure the required angle accuracy of 1 degree and gap measurement accuracy of 1 mm.
User needs validation The software was validated with intended users through a human . factor test series to ensure the user needs and intended use requirements were met, in accordance with IEC 62366-1. All requirements were met and no new issues of safety or effectiveness were raised.

Therefore, the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Conclusion:

FX SPS has the same intended use, indications and principle of operation as its predicate device, as well as similar technological characteristics. The minor differences in technological characteristics do not alter the intended use of the device and do not raise new questions of safety and effectiveness, and performance data demonstrated that FX SPS is as safe and effective as the E-ortho shoulder software. Thus, the FX SPS software is substantially equivalent to 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).