Panther OIS is an information management system used to manage medical data and clinical workflow in a hospital or clinic. To support radiation oncology users, it allows the user to:

· Enter or import, modify, store and archive treatment plans and images from treatment planning systems.
· Import, view, manipulate, enhance, annotate, store, and archive radiological images.
· Select and provide radiation treatment plans to a radiation treatment delivery system for atment.
· Store and view treatment records provided by the radiation treatment delivery system.

Device Description

Panther OIS is an information management system used to organize medical data and facilitate the clinic workflow in a hospital or clinic. It is built on the Windows system as standard thin client-server system with a centralized database.

Panther OlS has incorporated and enhanced the previously cleared Prowess Panther OIS|R&V (K122616) into its framework so the user is able to:

Record patient related information, especially radiation treatment planning and records. ●
Schedule patients, medical resources and any type of activity.
Capture procedure codes that will be used for billing.
Generate reports for statistics purpose.
Complete their tasks easily using the new ribbon Ul that supports their workflow.
Import treatment plans
Record patient treatment histories
. Deliver treatment plans on radiation treatment delivery systems that have a DICOM interface for both external and stereotactic plans.
Import, access, store and archive radiological images and review images to verify delivered treatment.
The client is updated to a thin client so that it can be installed on more supported devices.
Support for stereotactic treatment workflow which is similar to the external beam workflow but using a shot concept instead of a beam/arc concept.

Changes within the scope of this 510(k):

Addition of support for stereotactic planning ●
Addition of thin-client support, running resources stored on a central server instead of its localized hard drive
R&V-related functionalities have been removed

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Panther OIS device, based on the provided FDA 510(k) summary:

The Panther OIS is an information management system for radiation oncology. It is not an AI-powered diagnostic device, and therefore, many of the typical AI-related study components (like expert ground truth, MRMC studies, or specific performance metrics like sensitivity/specificity) are not directly applicable or reported in this type of submission.

The acceptance criteria primarily revolve around the system's functionality, safety, and adherence to established software development and quality standards, demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an Oncology Information System (OIS) focusing on data management and workflow, the "acceptance criteria" are primarily related to its ability to perform its defined functions reliably and safely, matching or exceeding the predicate devices. Performance is demonstrated through successful verification and validation (V&V) testing.

Acceptance Criteria (Implied from Summary)	Reported Device Performance (Summary of V&V Results)
Functional Equivalence to Predicate Devices:
- Patient Chart/Record Management	Yes (performs as intended)
- DICOM Import/Export (including plans with beams/arcs/shots)	Yes (performs as intended)
- Treatment Plans (Import, Store, Access, Modify, Archive)	Yes (performs as intended)
- Images (Import, Store, Access, Modify, Archive)	Yes (performs as intended - an enhancement over the primary predicate which did not have this feature for images)
- Image Review	Yes (performs as intended - an enhancement over the primary predicate)
- Treatment Machine Characterization	Yes (performs as intended)
- Scheduling	Yes (performs as intended)
- Activity Capture	Yes (performs as intended - an enhancement over the primary predicate)
- Support for Stereotactic Planning	Yes (performs as intended - new addition in the subject device)
Software Quality and Safety:
- Adherence to Predetermined Specifications	Demonstrated by verification and validation (V&V) testing.
- Substantially Equivalent Performance to Predicate Devices	Demonstrated by V&V testing and comparison of features.
- Operation as Intended	Demonstrated by V&V testing.
- Safety and Effectiveness for Specified Use	Demonstrated by hazard analysis, V&V testing (in-house and external), and user site testing, confirming that the benefits outweigh risks.
- Compliance with Software Development Standards (ISO 14971, IEC 62304)	Stated compliance.
- No Unanticipated Negative Impact from Changes (Thin-Client, Stereotactic)	Relevant regression testing was conducted.
User Experience and Clinical Integration:
- Performance in Clinical Environment (safety & feedback)	Verified through external testing by "OUR United" and user site (beta-site) testing using clinical cases. This testing confirmed the software is safe and effective in a clinical environment.

2. Sample Size for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify a numerical "sample size" in terms of cases or patients for the software testing. Instead, it refers to:
- "Established test plans and protocol" for in-house V&V.
- External testing by "OUR United" to verify safety and performance under conditions equivalent to an actual clinical environment.
- "Our beta-site using clinical cases" for additional in-field testing.
Data Provenance:
- External testing by "OUR United": The specific country of origin is not mentioned.
- Beta-site testing: Not specified.
- Retrospective or Prospective: Not explicitly stated, but the use of "clinical cases" during beta-site testing implies retrospective data or data collected prospectively during the test period. The functionality of an OIS would typically be tested with existing clinical data or simulated patient data.

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

Ground Truth for OIS Functionality: The concept of "ground truth" for an OIS is different from that for an AI diagnostic algorithm. For an OIS, ground truth relates to the accuracy of data handling, workflow execution, and proper interfacing. This is typically established through:
- Defined specifications: The software correctly implements its intended functions.
- Comparison to predicate devices: The functionality matches or improves upon what is already cleared.
- Clinical expert review: In this case, "clinical physicists contracted by Prowess" were involved in verifying the adequacy of risk mitigation. This implies their expertise was used to validate the safety and functional integrity of the system in a clinical context.
Number of Experts & Qualifications:
- The document mentions "clinical physicists contracted by Prowess" were involved in verifying the adequacy of risk mitigation. The specific number of these physicists is not provided.
- Their qualification is stated as "clinical physicists," implying expertise in the practical application and safety aspects of radiation oncology systems.

4. Adjudication Method for the Test Set

The document does not describe a traditional adjudication method (like 2+1 or 3+1) because the study is not focused on evaluating human-level diagnostic performance or AI algorithm output agreement. Instead, verification and validation involved:

In-house testing: By "in-house test engineers."
External testing: By "OUR United" for performance in equivalent clinical conditions.
Beta-site testing: By "our beta-site using clinical cases" to confirm safety and effectiveness in a clinical environment.

The "adjudication" is implicitly done by confirming that the software meets its predetermined specifications and functions as intended without errors, as evaluated by these different testing groups.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done.
- This type of study is typically conducted for AI-powered diagnostic devices to assess how the AI assists human readers (e.g., radiologists) in their diagnostic tasks.
- The Panther OIS is an information management system, not an AI diagnostic algorithm, so an MRMC study is not relevant to its clearance.

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

Yes, in essence, standalone performance testing was done for the software's functional adherence to specifications.
- The "verification and validation of the software was performed in-house according to established test plans and protocol." This represents the core "standalone" performance testing of the software's functionalities (e.g., can it import a DICOM plan correctly, can it store a patient record, can it generate a report?).
- The "functional testing was conducted both in-house and by OUR United."
- It's important to distinguish that "standalone performance" for an OIS means proving the software itself works as intended according to its functional and safety requirements, not demonstrating a diagnostic accuracy metric.

7. The Type of Ground Truth Used

For an OIS, the "ground truth" is primarily based on:

Predetermined Specifications: The software is designed to perform specific functions according to a set of requirements. The "ground truth" is that the software correctly executes these requirements.
Predicate Device Functionality: The Panther OIS demonstrated "substantial equivalence" to predicate devices, meaning its functional behavior aligns with or improves upon established, legally marketed systems.
Clinical Expert Verification: "Clinical physicists contracted by Prowess" validated risk mitigation, indirectly confirming the system's safe and effective operation within clinical workflows.

There isn't a "pathology" or "outcomes data" type of ground truth in the diagnostic sense, as this device doesn't make diagnostic calls.

8. The Sample Size for the Training Set

Not applicable / not provided: The Panther OIS is an information management system, not an AI algorithm that undergoes a "training" phase with a dataset. Therefore, there is no "training set sample size" as would be seen for a machine learning model. Its development follows traditional software engineering principles.

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

Not applicable: As explained above, this device does not utilize a "training set" in the context of machine learning. The "ground truth" for its development is its functional specifications, compliance with regulatory standards, and established best practices in oncology information systems and software engineering.

Summary

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September 28, 2021

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Prowess Inc. % Rachel Scarano Regulatory Affairs Manager 1844 Clayton Road CONCORD CA 94520

Re: K211760

Trade/Device Name: Panther OIS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: June 4, 2021 Received: June 8, 2021

Dear Rachel Scarano:

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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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,

Michael D. O'Hara

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) K211760

Device Name Panther OIS

Indications for Use (Describe)

Panther OIS is an information management system used to manage medical data and clinical workflow in a hospital or clinic. To support radiation oncology users, it allows the user to:

· Enter or import, modify, store and archive treatment plans and images from treatment planning systems.
· Import, view, manipulate, enhance, annotate, store, and archive radiological images.
· Select and provide radiation treatment plans to a radiation treatment delivery system for atment.
· Store and view treatment records provided by the radiation treatment delivery system.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the word "PROWESS" in a bold, serif font. The letters are black, except for a curved design in the middle of the word. The design is made up of two curved lines, one in teal and one in yellow, that start at the bottom of the "R" and end at the top of the "W".

August 30, 2021

510(k) SUMMARY

As required by 21 CFR Part 807.92

K211760

1.	Submitter:	Prowess Inc.
		1844 Clayton Road
		Concord, CA. 94520
	Contact Person:	Rachel Scarano
		Regulatory Affairs Manager
		Prowess, Inc.
		1844 Clayton Road
		Concord, CA. 94520
		PHONE: (925) 356-0360
		FAX: (925) 356-0363
		Rachel.scarano@prowess.com
	Device Manufacturer:	Prowess Inc.
		1844 Clayton Road
		Concord, CA. 94520
2.	Device Trade Name:	Panther OIS
	Classification Name:	Medical charged-particle radiation therapy system(21 CFR § 892.5050), Class II
	Product Code:	IYE
	Establishment Reg. No.:	2939248
	Common Name:	Oncology Information System
	Predicate Devices:	Primary Predicate:Panther OIS R&V, K122616Additional Predicates:Varian Medical Systems, Inc.'s ARIA, K173838Elekta Solutions AB's MOSAIQ, K203172

Device Description 3.

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Panther OlS has incorporated and enhanced the previously cleared Prowess Panther OIS|R&V (K122616) into its framework so the user is able to:

Record patient related information, especially radiation treatment planning and records. ●
Schedule patients, medical resources and any type of activity.
Capture procedure codes that will be used for billing.
Generate reports for statistics purpose.
Complete their tasks easily using the new ribbon Ul that supports their workflow.
Import treatment plans
Record patient treatment histories
. Deliver treatment plans on radiation treatment delivery systems that have a DICOM interface for both external and stereotactic plans.
Import, access, store and archive radiological images and review images to verify delivered treatment.
The client is updated to a thin client so that it can be installed on more supported devices.
Support for stereotactic treatment workflow which is similar to the external beam workflow but using a shot concept instead of a beam/arc concept.

Changes within the scope of this 510(k):

Addition of support for stereotactic planning ●
Addition of thin-client support, running resources stored on a central server instead of its localized hard drive
R&V-related functionalities have been removed

Intended Use 4.

Panther OIS is an information management system used to manage medical data and clinical workflow in a hospital or clinic. To support radiation oncology users, it allows the user to:

Enter or import, modify, store and archive treatment plans and images from treatment planning ● systems.
. Import, view, manipulate, enhance, annotate, store and archive radiological images
Select and provide radiation treatment plans to a radiation treatment delivery system for patient treatment.
Store and view treatment records provided by the radiation treatment delivery system.

5. Summary of Comparisons to Predicate Devices

Panther OlS is substantially equivalent to primary predicate device, Prowess Panther OIS|R&V (K122616), and additional predicate devices, additional predicate devices, Varian's ARIA (K173838) and Elekta's MOSAIQ (K203172) for the purposes of premarket clearance, as demonstrated and documented in this premarket notification submission. In addition, the rationalization for substantial equivalence is further evidenced through discussion of similar technological characteristics between Panther OlS and the predicates, as well as test results, which prove that Panther OIS is as safe and effective as the predicate devices.

OIS Feature	Panther OIS(Subject Device)	Panther OIS R&V(Primary Predicate, K122616)
Windows Operating System	Yes	Yes
Patient Chart/Record	Yes	Yes

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OIS Feature	Panther OIS(Subject Device)	Panther OIS R&V(Primary Predicate, K122616)
DICOM Import	Yes	Yes
Export DICOM plan to treatment machinesfor plans containing beams/arcs/shots	Yes	Yes
Treatment Plans (Import, Store, Access,Modify, Archive)	Yes	Yes
Images (Import, Store, Access, Modify,Archive)	Yes	No
Image Review	Yes	No
Treatment machine Characterization	Yes	Yes
Scheduling	Yes	Yes
Activity Capture	Yes	No
Record & Verify (R&V)	No	Yes
Radiation Oncology	Yes	Yes
Medical Oncology	No	No
Support for Stereotactic Planning	Yes	No

6. Summary of Technological Considerations

Panther OIS has many of the same technological characteristics as the predicate device. There are a limited number of distinguishing factors when comparing Panther OIS to the predicate, and those features that are different do not affect safety or effectiveness. The main difference is that record and verify functions have been removed from the previously cleared device, which actually reduces the overall risk. These are minor technical differences and do not affect substantial equivalence to the predicate devices.

7. Summary of Non-clinical Tests

A hazard analysis was conducted, and associated documentation has been included. Methods for preventing and/or mitigating defined hazards are detailed, and verification and validation of the software was performed in-house according to established test plans and protocol, which have been included as well. Functional testing was conducted both in-house and by OUR United. In addition, relevant regression testing was conducted by Prowess Quality Assurance to ensure that changes to the software did not result in any unanticipated, negative impact on other areas of the software. Verification and validation testing has demonstrated that Panther OIS has met its predetermined specifications, demonstrated substantially equivalent performance to the predicate devices, functions as intended, and is safe and effective for its specified use.

8. Summary of User Site Testing

Although clinical testing is not required to demonstrate substantial equivalence in safety and effectiveness, we elected to conduct external testing by OUR United to verify safety and performance under conditions equivalent to that of an actual clinical environment, in order to obtain feedback and to verify the results of in-house testing in a user environment. We feel that no matter how carefully a product is tested at the manufacturer's facility, such testing cannot replace actual use of the device in a clinical setting. As such, we consider both in-house testing at a user site during device development to verify safety and effectiveness, as well as to ensure that benefits to the patient from treatment with the device outweigh any inherent risks.

9. Labeling

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The DVD-ROM media labeling, Instructions for Use, Panther OIS User Manual, and marketing material all meet applicable regulations. The User Manual, in digital format, is also included in the software media and can be viewed as part of the on-line help.

Product labels comply with 21 CFR 1040.10 and 1040.11 as applicable. In addition, labeling complies with applicable requirements of 21 CFR 801, including the requirement that the device be provided with adequate directions for use.

10. Summary of Safety and Effectiveness Information

a. Prowess, Inc. is a registered medical device establishment, whose quality system meets the requirements of ISO 13485, Annex II of Medical Device Directive 93/42/EEC, and FDA's QSR, , 21 CFR 820.
b. Panther OIS was designed and implemented according to established Prowess Inc. established design and development, as well as quality management, procedures of Prowess Inc. In addition, design and development of the medical device software complies with internationally recognized standards including ISO 14971:2019 Medical devices – Application of risk management to medical devices and IEC 62304 Medical device software – Software life cycle processes.
c. The management of the company is committed to the highest standards of quality The Quality Management System is subject to regular, planned and management. documented audits by external consultants and by the FDA.
d. A comprehensive risk analysis has been conducted. Detailed methods of mitigating these potential risks have been identified by the development team, and verified by clinical physicists contracted by Prowess and determined to be adequate.
e. The software has been verified and validated based on an established testing plan. The functionalities have been tested by in-house test engineers. In addition to in-house testing, the system was also tested by our beta-site using clinical cases. This testing has confirmed that the software is safe and effective in a clinical environment.
f. Directions and precautions for safe and effective use are included in the Instructions for Use and User Manual. Training by a Prowess specialist is also provided as part of product distribution/installation.

11. Level of Concern

As medical device software, the submission for Panther OIS follows FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Since prior to mitigation of hazards, a failure of the software device could result in death or serious injury to a patient, it has been determined that the software correlates to a Major Level of Concern, and as such, the associated documentation is included in this submission.

12. Conclusions

Panther OIS is substantially equivalent to the predicate devices for the purposes of FDA clearance for commercial distribution. It has similar intended use and technical characteristics. The software has been found to perform as intended and the benefits to patient and user outweigh any inherent risks, which has been demonstrated via in-house testing as well as in field tests. Its use does not raise any new or different safety and effectiveness concerns when compared to the predicates.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.