The intended use of Puma is to allow the radiation therapist to deliver treatment to the patient via linear accelerator (linac). This entails selection of the patient, selection of the day's correct treatment for the patient, set up, and delivery of the treatment fields and recording of the treatment. Puma supports auto-sequencing, a process of automatically downloading a group of fields or segments from the record and verify system to the control of the linear accelerator sequentially, without user intervention. In addition, Puma also supports IMRT (Intensity Modulated Radiation Therapy), a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

Device Description

Puma is a medical device, which allows the user to deliver radiation treatment on linear accelerator to a patient. The software has been developed to be a record and verify system that also manages oncology medical information in order to simplify the oncologist administrative tasks and to optimize the quality of patient treatment. It is a Windows® based system, which uses a single database that can be accessed by any Puma client station in the treatment facility. Additionally, Puma is capable of performing such functions as:

Importing treatment plans in DICOM or RTP format -
Downloading of beams contained in the treatment plans to the linear accelerator -
Verifying that the beams from the treatment plan are correctly set up on the linear accelerator -
Recording treatments delivered by the linear accelerator ・
Managing patient schedules -
Managing schedules for resources such as treatment machines and personnel -
Maintaining a central repository of treatment plans and records -

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Prowess Puma device:

The provided text (K100801 for the Puma device) is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through extensive clinical trials. As such, the information on specific acceptance criteria and detailed study results, particularly for standalone performance or comparative effectiveness with human readers, is limited.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria or performance metrics in a table format. Instead, it relies on general statements of meeting specifications and being "as safe and effective" as predicate devices.

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence	Perform all functions described in the device description and intended use, similar to predicate devices.	"Puma has met its predetermined specifications, is substantially equivalent in performance as compared to the predicate devices, functions as intended, and is safe and effective for its specified use."
Safety	Prevent hazards identified in hazard analysis; protect patient and user.	"Key safety features of Puma include Defined privileges... Patient identification... Data locking... Verifying that the beams... A comprehensive risk analysis has been conducted. Detailed methods of mitigating these potential risks have been identified... and determined to be adequate. The benefits to patient and user outweigh any inherent risks..."
Effectiveness	Deliver radiation treatment accurately, manage oncology information, support auto-sequencing and IMRT.	"The software has been found to perform as intended." "Functions as intended, and is safe and effective for its specified use."
Regulatory Compliance	Comply with relevant FDA regulations, ISO standards, and quality system requirements.	"Quality system meets the requirements of ISO 13485, Medical Device Directive 93/42/EEC Annex II and FDA's Quality System Regulation, 21 CFR 820." "Complies with internationally recognized standards including ISO 14971:2007, IEC 62304, and IEC 62274."
Data Integrity/Security	Protect patient health information, prevent data loss/alteration.	"Puma includes features specifically designed to protect confidential patient health information in accordance with the HIPAA regulations, including such security measures as password protection and access privilege set up and modification."

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

Sample Size for Test Set: The document mentions "real patient cases" were used during beta testing at Auburn University, but does not specify the sample size (number of cases or patients) for this test set.
Data Provenance: The beta testing was conducted at "Auburn University," which is in the USA. The data was from "real patient cases" and was likely retrospective as it refers to "clinical cases" used for testing a developed device.

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

Number of Experts: The document states "medical physicists/dosimetrists at Auburn University" conducted functional testing and "clinical physicists contracted by Prowess" verified risk mitigation. It does not provide an explicit number of experts.
Qualifications of Experts: "Medical physicists/dosimetrists" and "clinical physicists" are mentioned. No specific experience levels (e.g., "10 years of experience") are provided.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The testing involved "medical physicists/dosimetrists" and "clinical physicists" validating the system, implying their professional judgment served as the benchmark, but the process for resolving disagreements is not detailed.

5. 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

MRMC Study: No, an MRMC comparative effectiveness study involving human readers assisting with or without AI was not conducted or described.
Effect Size: Therefore, no effect size for human reader improvement with AI assistance is reported. The Puma device is a record and verify system, not primarily an AI-driven diagnostic or interpretative tool designed to "assist human readers" in the typical sense of AI-enabled image analysis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: The non-clinical tests involved "Verification and validation of the software... Functional testing was conducted both in-house and by medical physicists/dosimetrists." This implies extensive standalone (algorithm only) testing against predetermined specifications. The core function of Puma is as a "record and verify system" that automates certain processes (like auto-sequencing), meaning its performance inherently relies on the algorithm operating correctly without continuous human intervention during those automated steps. The clinical physicist/dosimetrist involvement was to validate these functions.

7. The Type of Ground Truth Used

The ground truth for the testing appears to be based on:

Predetermined Specifications: The software "has met its predetermined specifications."
Expert Consensus/Clinical Judgment: Functional testing by "medical physicists/dosimetrists" and verification by "clinical physicists" against "real patient cases" implies that the correct operation and output were judged against established clinical practice and expert knowledge in radiation therapy planning and delivery.
Comparison to Predicate Devices: The overall goal was to demonstrate substantial equivalence, meaning the device's performance aligned with that of legally marketed, safe, and effective predicate devices.

8. The Sample Size for the Training Set

The document does not specify any sample size for a training set. As a record and verify system, especially one cleared in 2010, it's highly unlikely that it relied on machine learning models requiring large "training sets" in the modern AI sense. Its development would have followed traditional software engineering and validation processes against designed specifications.

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

As no training set is described (due to the nature of the device and the development era), the method for establishing its ground truth is not applicable/not provided.

Summary

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K100801

Image /page/0/Picture/1 description: The image shows the word "PROWESS" in all capital letters. The font is a serif font, and the letters are black. The word is centered in the image and takes up most of the space. The letter "O" has some damage to it.

510(k) SUMMARY

As required by 21 CFR Part 807.92

JUN 1 8 2010

May 7, 2010

Submitter: Prowess, Inc. 1. 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
	E-mail: rachel.scarano@prowess.com

Device Manufacturer:	Prowess, Inc.
	1844 Clayton Road
	Concord, CA. 94520

1. Device Trade Name: Puma
  Medical charged-particle radiation therapy system Classification Name: (21 CFR § 892.5050), Product Code MUJ, Class II

Establishment Reg. No.: 2939248

Common Name:	Radiation Therapy Record and Verify SystemOncology Information System
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3. Predicate Devices:

a) Siemens Medical System's Lantis Treatstation K972275
b) Varian Medical System's 4D Integrated Treatment Console (4DITC) K091132

Device Description 4.

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Importing treatment plans in DICOM or RTP format -
Downloading of beams contained in the treatment plans to the linear accelerator -
Verifying that the beams from the treatment plan are correctly set up on the linear accelerator -
Recording treatments delivered by the linear accelerator ・
Managing patient schedules -
Managing schedules for resources such as treatment machines and personnel -
Maintaining a central repository of treatment plans and records -

Intended Use 5.

The intended use of Puma is to allow the radiation therapist to deliver treatment to the patient via linear accelerator (linac). This entails selection of the patient, selection of the day's correct treatment for that patient, set up, and delivery of the treatment fields and recording of the treatment. Puma supports auto-sequencing, a process of automatically downloading a group of fields or segments from the record and verify system to the control of the linear accelerator sequentially, without user intervention. In addition, Puma also supports IMRT (Intensity Modulated Radiation Therapy), a process of shaping, modifying, and moving a beam around a target to maximize dose at the target and minimize the dose to normal structures.

Summary of Comparisons to Predicate Devices 6.

Puma is substantially equivalent to the predicate devices, Siemens' Lantis Treatstation and Varian's 4DITC, for purposes of FDA clearance for commercial distribution, as demonstrated and documented in this premarket notification submission. It has the same intended use and indications for use. In addition, the rationalization for substantial equivalence is further evidenced through discussion of similar technological characteristics between Puma and the predicates, as well as test results, which prove that Puma is as safe and effective as the predicate devices.

Summary of Technological Considerations 7.

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

Summary of Non-clinical Tests 8.

A hazard analysis was completed for Puma. Methods for preventing such hazards were detailed (Section VIII). Verification and validation of the software was conducted in house according to the Verification and Validation (V&V) Protocol, Puma Testing Protocol, and test results are included in Section IX of this submission. Functional testing was conducted both in-house and by medical physicists/dosimetrists at Auburn University. These tests have demonstrated that Puma has met its predetermined specifications, is substantially equivalent in performance as compared to the predicate devices, functions as intended, and is safe and effective for its specified use.

Summary of Clinical Tests 9.

Although clinical testing is not required to demonstrate substantial equivalence in safety and effectiveness, we elected to conduct testing at Auburn University using real patient cases. We feel that

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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 and beta testing at a user site during device development.

10. Labeling

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

Commercial and marketing materials are also included in Section VI.

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 11.

Prowess, Inc. is a registered medical device establishment, whose quality system meets the a. requirements of ISO 13485, the Medical Device Directive 93/42/EEC Annex II and FDA's Quality System Regulation, 21 CFR 820.
Puma was designed and implemented according to the established design and development ﻀ 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 14971:2007Medical devices - Application of risk management to medical devices, IEC 62304 Medical device software – Software life cycle processes, and IEC 62274 Medical electrical equipment - Safety of radiotherapy record and verify 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 IX of the submission.
に Key safety features of Puma include
- Defined privileges to access specified areas of the functionality for different roles and users
- Patient identification by an ID photo associated to the patient during registration -
- Data locking and messaging to prevent simultaneous access to patient treatment data -
- Verifying that the beams contained in the treatment plan are correctly set up on the linear accelerator
Puma includes features specifically designed to protect confidential patient health g. information in accordance with the HIPAA regulations, including such security measures as

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password protection and access privilege set up and modification. By restricting access and other rights, patient health information can be safeguarded against deletion and/or alteration.

h. Steps and precautions for the safe and effective use are included in the Instructions for Use and User Manual. Training by a Prowess specialist may also be provided as at the time of product distribution, when requested by the customer.

12. Level of Concern

As medical device software, the submission for Puma 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.

13. Conclusions

Puma 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 our field tests. Its use does not raise any new or different safety and effectiveness concerns when compared to the predicate

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUN 1 8 2010

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

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

Re: K100801

Trade/Device Name: Puma Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 27, 2010 Received: June 1, 2010

Dear Mr. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 or uny I oderal statutes and requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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Enclosure

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donald J. Trump

Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K100801

Device Name: Puma

Indications for Use:

メ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

D. N. R.

(Division Sign-O on of Radiologics

510K K100801

Page 1 of 1

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.