The Panther StereoSeed module is intended to create a plan that is optimized for seed locations and needle directions, allowing needles to be inserted in any angle in order to avoid critical structures.

Device Description

Panther StereoSeed is an optional software module that has been added to the existing Prowess Panther Brachy system to produce a seed implant plan that is optimized for seed locations and needle directions. The key distinction between Panther StereoSeed and traditional brachytherapy systems is that StereoSeed allows plans to be created such that bones and critical structures can be avoided.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study that definitively "proves" the device meets specific performance criteria in a quantitative sense with specific metrics and thresholds. Instead, it describes a substantial equivalence submission to the FDA for the Panther StereoSeed device.

Based on the information provided, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific quantitative performance acceptance criteria in the typical "accuracy/sensitivity/specificity" sense. The "acceptance criteria" are broad and relate to safety and effectiveness, as demonstrated by verification and validation testing, and comparison to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance (Summary from Document)
Safety and Effectiveness	- Hazard analysis conducted with mitigation methods detailed.- Verification and validation testing performed in-house and at a beta-site, demonstrating the device "met its predetermined specifications, demonstrated substantially equivalent performance to the predicate device, functions as intended, and is safe and effective for its specified use."- Relevant regression testing conducted to ensure no unanticipated negative impact from changes.
Intended Use Fulfillment	Device "is intended to create a plan that is optimized for seed locations and needle directions, allowing needles to be inserted in any angle in order to avoid bones and critical structures," and V&V testing confirms it "performs as intended."
Substantial Equivalence	"Panther StereoSeed is substantially equivalent to predicate devices... for the purposes of premarket clearance... rationalization for substantial equivalence is further evidenced through discussion of similar technological characteristics... as well as test results."
Compliance with Regulations	Designed and implemented according to established Prowess Inc. design and development and quality management procedures, and complies with international standards (ISO 14971:2007, IEC 62304, IEC 62083) and FDA's QSR, 21 CFR 820.
No New Safety/Effectiveness	"Its use does not raise any new safety or effectiveness concerns when compared to the predicates."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: The document mentions "real patient cases" were used for beta testing at the user site. However, the exact number of cases or the sample size of the test set is not specified.
Data Provenance: The beta testing was conducted at the Department of Minimal Invasive Cancer Center of Inner Mongolia Cancer Hospital (IMCH) in Hohhot City, China, using "real patient cases." This suggests the data was retrospective (using existing patient data) or, less likely but possible, prospective (patients treated during the beta test), but the document does not explicitly state which. Given "real patient cases" and a beta test, it's more likely retrospective in nature, or a mix, to evaluate the planning system.

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

The document mentions "beta testing at the Department of Minimal Invasive Cancer Center of Inner Magnolia Cancer Hospital (IMCH) in Hohhot City, China using real patient cases." It also states, "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."

The number of experts involved in establishing ground truth for the test set is not specified.
The qualifications of the experts involved in verifying risks are mentioned as "clinical physicists contracted by Prowess." No specific experience level is given. It is implied that these physicists, or other clinical personnel at IMCH, would be the experts using and evaluating the device and its output in real patient cases, thereby implicitly contributing to the "ground truth" assessment of plan quality and safety, but this is not explicitly detailed as a ground truth establishment process.

4. Adjudication Method for the Test Set:

None is mentioned. The beta testing was conducted to "obtain feedback and to verify the results of in-house testing in a user environment." This suggests an evaluation rather than a formal adjudication process for establishing a definitive ground truth by consensus.

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

No. The document describes a substantial equivalence submission, which typically does not involve MRMC comparative effectiveness studies with human readers. The comparison is primarily between the device's features and its predicate devices, validated through technical testing and user-site feedback.

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

Yes, in-house verification and validation (V&V) testing was performed. "Functional testing was conducted both in-house... Verification and validation testing has demonstrated that Panther StereoSeed has met its predetermined specifications, demonstrated substantially equivalent performance to the predicate device, functions as intended, and is safe and effective for its specified use." This implies testing of the algorithm's performance against specifications without direct human intervention as part of the primary performance metric.

7. The Type of Ground Truth Used:

For the in-house V&V, the "ground truth" would be established by the predetermined specifications for the software and potentially synthetic data or established clinical scenarios. For the beta testing with "real patient cases," the "ground truth" would likely be evaluated against clinical judgment and established treatment planning principles by the clinical users at IMCH, but this is not explicitly detailed as a formal "ground truth" labeling process in the document. No mention of pathology or outcomes data as ground truth is made.

8. The Sample Size for the Training Set:

This information is not provided in the document. The Panther StereoSeed is described as an "optional software module" that "produce[s] a seed implant plan that is optimized for seed locations and needle directions." The text implies an optimization algorithm rather than a machine learning model that requires a distinct "training set." Therefore, a traditional "training set sample size" may not be applicable in the sense of supervised learning.

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

This information is not provided. As noted above, the device's description suggests it might not rely on a traditional machine learning "training set" with established ground truth labels, but rather on optimization algorithms built upon predefined rules and clinical principles.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 11, 2015

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

Re: K143514 Trade/Device Name: Panther StereoSeed Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: November 20, 2015 Received: November 23, 2015

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143514

Device Name Panther StereoSeed

Indications for Use (Describe)

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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May 4, 2015

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 StereoSeed
	Classification Name:	Medical charged-particle radiation therapy system(21 CFR § 892.5050), Class II
	Establishment Reg. No.:	2939248
	Common Name:	Radiation Therapy Treatment Planning System, Brachytherapy
	Product Code:	MUJ
	Predicate Devices:	MIM Software Inc's MIM 5.2 (Brachy), K103576, Product code LLZVarian Medical System's VariSeed 7.0, K012017, product code MUJ

Device Description 3.

4. Intended Use

Panther StereoSeed is intended to create a plan that is optimized for seed locations and needle directions, allowing needles to be inserted in any angle in order to avoid bones and critical structures.

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5. Summary of Comparisons to Predicate Devices

Panther StereoSeed is substantially equivalent to predicate devices, MIM 5.2 (Brachy) by MIM Software Inc. and VariSeed 7.0 by Varian Medical Systems, Inc. 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 StereoSeed and the predicates, as well as test results, which prove that Panther StereoSeed is as safe and effective as the predicate devices.

6. Summary of Technological Considerations

Panther StereoSeed has many of the same technological characteristics as the predicate devices. There is a limited amount of distinguishing factors when comparing StereoSeed to the predicates, and those features that are different do not affect safety or effectiveness. This is described in detail in Section VIII: Substantial Equivalence Comparison.

Summary of Non-clinical Tests 7.

A hazard analysis was conducted, and associated documentation is included in Section XI. Methods for preventing and/or mitigating defined hazards are detailed in Section X: Software Verification & Validation. Verification and validation of the software was performed in-house according to established test plans and protocol, which have been included in Section IX as well. Functional testing was conducted both in-house and at the Department of Minimal Invasive Cancer Center of Inner Magnolia Cancer Hospital (IMCH) in Hohhot City, China. 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 StereoSeed has met its predetermined specifications, demonstrated substantially equivalent performance to the predicate device, functions as intended, and is safe and effective for its specified use.

Summary of User Site Testing 8.

Although clinical testing is not required to demonstrate substantial equivalence in safety and effectiveness, we elected to conduct beta testing at the Department of Minimal Invasive Cancer Center of Inner Magnolia Cancer Hospital (IMCH) in Hohhot City, China using real patient cases, 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

The CD media labeling, Instructions for Use, Panther Brachy User Manual, and marketing material are provided in Section IX of this submission. The User Manual, in digital format, is also included in the software media and can be viewed as part of the on-line help.

PROWESS

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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.

Summary of Safety and Effectiveness Information 10.

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 StereoSeed 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 – 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.
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 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. Documentation of these tests is included in Section X of the submission.
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.

Level of Concern 11.

As medical device software, the submission for Panther StereoSeed 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 results 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 StereoSeed 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 safety or effectiveness concerns when compared to the predicates.

PROWESS

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.