Panther Stereotactic is an optional software module that has been added to the existing Prowess Panther Treatment Planning System to support planning with multiple shots instead of beams/arcs. Each shot is defined as a full or partial arc of one or multiple radiation sources with different collimator sizes depending on the machine configuration depending on the delivery types. Stereotactic forward planning extends Prowess Panther's existing arc definition features to define shot parameters such as location, size and arc angles. Stereotactic inverse planning extends Prowess Panther's existing simulated annealing algorithm to find optimal shot parameters such as location, size and arc angles.

AI/ML Overview

This document is a 510(k) summary for the Panther Stereotactic device by Prowess, Inc. It describes a software module intended to support highly advanced precision-targeted radiation planning.

Based on the provided text, a comprehensive study proving the device meets specific acceptance criteria, with the details requested, is not explicitly detailed. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a dedicated clinical study with detailed metrics.

However, we can infer information about the non-clinical testing and general verification/validation activities that serve to establish the device's safety and effectiveness.

Here’s a breakdown based on the available information, noting where specific details are not provided:

Acceptance Criteria and Device Performance (Inferred from Non-Clinical Testing):

Since specific quantitative acceptance criteria for performance are not explicitly stated in a table format in the provided text, we must infer them based on the description of the verification and validation (V&V) activities. The primary acceptance criterion appears to be functional correctness, safety, and effectiveness equivalent to predicate devices within a radiation planning context.

Acceptance Criteria (Inferred)	Reported Device Performance (Summary from Non-Clinical Tests)
Functional Correctness: The software performs as intended for stereotactic planning, including shot parameter definition and optimization.	"Verification and validation of the software was performed in-house according to established test plans and protocol... Functional testing was conducted both in-house and by OUR New Medical Technologies Ltd. ... Verification and validation testing has demonstrated that Panther Stereotactic has met its predetermined specifications, demonstrated substantially equivalent performance to the predicate devices, functions as intended..."
Safety: Risk mitigation successfully addresses identified hazards, and the software does not introduce new safety concerns.	"A hazard analysis was conducted, and associated documentation has been included. Methods for preventing and/or mitigating defined hazards are detailed... 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." "Its use does not raise any new or different safety and effectiveness concerns when compared to the predicates."
Effectiveness: The device is effective for precision-targeted radiation planning, comparable to predicate devices.	"...demonstrated substantially equivalent performance to the predicate devices... functions as intended, and is safe and effective for its specified use." "This testing has confirmed that the software is safe and effective in a clinical environment." "The software has been found to perform as intended and the benefits to patient and user outweigh any inherent risks..."
No Unanticipated Negative Impact (Regression Testing): Changes to the software do not negatively affect other areas.	"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."
User Environment Performance: Software performs well in a clinical use setting.	"Although clinical testing is not required to demonstrate substantial equivalence... we elected to conduct beta testing by OUR New Medical Technologies Ltd. to perform stereotactic planning 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... the system was also tested by our beta-site using clinical cases."
Compliance with Standards: Adherence to relevant medical device and software standards.	"design and development of the medical device software complies with internationally recognized standards including ISO 14971:2007 Medical devices – Application of risk management to medical devices, IEC 62304 Medical device software life cycle processes, and IEC 62083 Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems."

1. Sample sizes used for the test set and the data provenance:

Test Set Sample Size: The document mentions "clinical cases" for beta testing and "established test plans" for in-house verification. However, specific numerical sample sizes for the test set (number of cases/patients) are not provided.
Data Provenance: The beta testing was conducted by "OUR New Medical Technologies Ltd.", which implies it was an external site, likely a clinical environment. No specific country of origin is mentioned for the data, nor is it explicitly stated whether the cases were retrospective or prospective, though "clinical environment" and "clinical cases" suggest they were real-world patient data. In-house testing uses unspecified "test plans."

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

The document states that "clinical physicists contracted by Prowess" verified the adequacy of risk mitigation methods. For the beta site testing, "OUR New Medical Technologies Ltd." performed the testing, implying that their clinical staff (likely medical physicists, radiation oncologists, or dosimetrists) were involved in generating and evaluating results.
Specific numbers or qualifications (e.g., years of experience) of these experts are not provided.

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

The document does not describe any formal adjudication method for establishing ground truth or evaluating test results, such as a consensus process among multiple readers. The emphasis is on testing by the beta site and verification by Prowess's internal teams and contracted physicists.

4. 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 MRMC study was conducted or reported. The device is a radiation therapy treatment planning system, not explicitly described as an AI-assisted diagnostic or decision support tool where human reader improvement would be typically measured. The focus is on the software's ability to plan treatment, not on improving human diagnostic accuracy.

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

The software's core function is planning. The "functional testing" and "verification and validation" would inherently involve evaluating the algorithm's output (e.g., dose calculations, shot parameter optimization) in a "standalone" sense, though it's always within the context of a treatment planning workflow.
The document states, "The software has been verified and validated based on established testing plans. The functionalities have been tested by in-house test engineers." This suggests standalone performance evaluation of the algorithms.

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

For a treatment planning system, "ground truth" would primarily relate to the accuracy of dose calculations against established physics models or benchmarks, and the clinical feasibility/quality of the generated treatment plans.
The ground truth seems to have been established through a combination of:
- "Predetermined specifications" for functional testing.
- Comparison to "substantially equivalent performance to the predicate devices."
- Verification by "clinical physicists contracted by Prowess."
- Feedback and verification based on "clinical cases" from the beta site, implying a reference to clinical standards of care and expected plan quality.
No pathology or patient outcomes data were used as ground truth for this clearance.

7. The sample size for the training set:

The document describes the device as a "software module that has been added to the existing Prowess Panther Treatment Planning System." It refers to extending existing algorithms ("Panther's existing arc definition features" and "existing simulated annealing algorithm").
There's no mention of a separate "training set" in the context of machine learning, nor any indication that this module is an AI/ML product developed using a training set. The descriptions point to deterministic algorithms for planning.

8. How the ground truth for the training set was established:

As the device is described as an extension of existing deterministic algorithms (not an AI/ML model with a 'training set'), this question is not applicable based on the provided information.

Summary

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April 27, 2020

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

Re: K193459

Trade/Device Name: Panther Stereotactic Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: December 11, 2019 Received: March 30, 2020

Dear Ms. 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,

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) K193459

Device Name Panther Stereotactic

Indications for Use (Describe)

Panther Stereotactic is intended to support highly advanced precision-targeted radiation planning.

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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March 11, 2020

K193459

510(k) SUMMARY

As required by 21 CFR Part 807.92

1.	Submitter:	Prowess Inc.1844 Clayton RoadConcord, CA. 94520
	Contact Person:	Rachel ScaranoRegulatory Affairs ManagerProwess, Inc.1844 Clayton RoadConcord, CA. 94520PHONE: (925) 356-0360FAX: (925) 356-0363Rachel.scarano@prowess.com
	Device Manufacturer:	Prowess Inc.1844 Clayton RoadConcord, CA. 94520
2.	Device Trade Name:	Panther Stereotactic
	Classification Name:	Medical charged-particle radiation therapy system(21 CFR § 892.5050), Class II
	Product Code:	MUJ
	Establishment Reg. No.:	2939248
	Common Name:	Radiation Therapy Treatment Planning System
	Predicate Devices:	Primary Predicate:Elekta's Leksell GammaPlan, K173791Additional Predicates:American Radiosurgery, Inc.'s Explorer 4D TreatmentPlanning System, K101220

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3. Device Description

4. Intended Use

Panther Stereotactic is intended to support highly advanced precision-targeted radiation planning.

5. Summary of Comparisons to Predicate Devices

Panther Stereotactic is substantially equivalent to primary predicate device, Elekta's Leksell GammaPlan (K173791), and additional predicate devices, American Radiosurgery, Inc.'s Explorer 4D Treatment Planning System (K101220) and Prowess Inc.'s Panther ProArc (K101076) 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 Stereotactic and the predicates, as well as test results, which prove that Panther Stereotactic is as safe and effective as the predicate devices.

Summary of Technological Considerations 6.

Panther Stereotactic has many of the same technological characteristics as the predicate device. There is a limited amount of distinguishing factors when comparing Panther Stereotactic to the predicate, and those features that are different do not affect safety or effectiveness. The dose calculation methods are slightly different, but have the same TMR based algorithm. In addition, Leksell GammaPlan runs on a Limun Operating System and Explorer 4D Treatment Planning System runs on Mac OS X, while Panther TPS runs on a Microsoft Windows OS. 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 New Medical Technologies Ltd. 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 Stereotactic 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 beta testing by OUR New Medical Technologies Ltd. to perform stereotactic planning 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

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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

The CD media labeling, Instructions for Use, Panther TPS 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

Prowess, Inc. is a registered medical device establishment, whose quality system meets the a. requirements of ISO 13485, Annex II of Medical Device Directive 93/42/EEC, and FDA's QSR, 21 CFR 820.
b. Panther Stereotactic 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 14971:2007 Medical devices – Application of risk management to medical devices, IEC 62304 Medical device software life cycle processes, and IEC 62083 Medical electrical equipment – Requirements for the safety of radiotherapy treatment planning systems.
The management of the company is committed to the highest standards of quality ﻥ management. The Quality Management System is subject to regular, planned and documented audits by external consultants and by the FDA.
A comprehensive risk analysis has been conducted. Detailed methods of mitigating these d. 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 established testing plans. 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 Stereotactic 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

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Panther Stereotactic is substantially equivalent to the predicate devices for the purposes of FDA clearance for commercial distribution. It has the same intended use and similar 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.