The Calypso® 4D Localization System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The Calypso System provides accurate, precise, and continuous localization of a treatment isocenter by using two or more Beacon® transponders.

Beacon transponders are indicated for permanent implantation in the prostate only.

Device Description

The Calypso 4D Localization System (Calypso System) is designed to provide accurate, objective, and continuous localization of a treatment target for patient alignment and target position monitoring during radiation therapy. Use of the Calypso System for target localization is based on the system's detection of electromagnetic signals from passive implanted markers, called Beacon transponders. The Beacon transponders are implanted in or near the treatment target. When used with the Calypso System, the Beacon transponder signals enable objective measurement of the location of the treatment target in 3 dimensions. The system operator uses this information to align the patient's treatment target to the isocenter of the linear accelerator prior to radiation therapy and to monitor the position of the treatment target during treatment.

AI/ML Overview

The provided text does not contain explicit acceptance criteria or a detailed study description with specific metrics and results that would allow for the completion of the requested table.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices and outlining the device's indications for use. It mentions "performance testing" and "clinical and nonclinical testing" but does not provide the specific details needed to answer most of your questions.

Here's an analysis of what is and isn't available:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated in the provided text. There are no numerical targets or thresholds mentioned for accuracy, precision, or other performance metrics.
Reported Device Performance: The text generally states that the system is "accurate and reliable" and "can accurately and reliably provide localization and tracking information." However, it does not provide quantitative results like mean error, standard deviation, sensitivity, specificity, or AUC.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Test Set Sample Size: Not mentioned. The text refers to "a subset of the patients" for tracking prostate motion but provides no number.
Data Provenance: Not mentioned. It's unclear if the data was retrospective or prospective, or from what country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

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

Not mentioned. There is no information on how ground truth was established by experts.

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: Not mentioned. The device is for patient localization and tracking, not for analysis by human readers in the traditional sense of an imaging diagnostic AI. The "human-in-the-loop" would be the operator using the system for alignment and monitoring, but no comparative effectiveness study on their improvement is described.
Effect Size: Not applicable based on the available information.

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

The device inherently involves a human operator to physically align the patient based on the system's output. Therefore, a purely "standalone" (algorithm only, no human action) performance test as typically understood for an AI diagnosing images, is not directly applicable. The performance described relates to the system's ability to provide localization data, which then enables human action.

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

Not explicitly stated. Given the nature of the device (localization of an implanted transponder), the ground truth for localization would likely be derived from a highly accurate, independent measurement system or fiducial reference, but this is not detailed.

8. The sample size for the training set:

Not mentioned.

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

Not mentioned.

In summary, the provided document focuses on regulatory compliance (510(k) summary) and broad statements of safety and effectiveness, rather than a detailed scientific study report with specific performance metrics and methodologies. To obtain the requested information, a full clinical study report or a more detailed technical document would be required.

Summary

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5.0 510(K) SUMMARY OF SAFETY & EFFECTIVENESS

This 510(k) Summary of Safety and Effectiveness is provided in accordance with 21 CFR 807.92.

Date of preparation: March 31, 2006

Submitter information:

Calypso® Medical Technologies, Inc. 2101 Fourth Avenue, Suite 1550 Seattle, WA 98121

Phone: 206-254-0600 Fax: 206-254-0606

Contact: Sue Ridge Regulatory Affairs/Quality Systems Manager

Device trade name: Calypso® 4D Localization System
Common name: Patient localization system

Classification name: Accelerator, Linear, Medical

Classification:

CFR 892.5050 Class II Product code - IYE

Predicate devices: BrainLAB ExacTrac Patient Positioning System (K983660, K003285, K040585)

GE Medical Systems Instatrak System (K960330, K983529, and K994270)

Northwest Medical Physics Equipment (NMPE) Acculoc implanted fiducials (K012575)

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Indications for use:

Beacon transponders are indicated for permanent implantation in the prostate only.

Device description:

Performance testing:

The Calypso System and Beacon transponders have been the subject of performance testing, including design verification and validation, packaging, sterility, electromagnetic compatibility as well as other assessments to demonstrate that the system meets its intended use, is safe and effective, and performs comparably to legally marketed devices. Other types of testing, such as biocompatibility and software verification and validation, also were performed.

Summary of Clinical and Nonclinical Testing:

Clinical and nonclinical testing demonstrates that the Calypso System is safe and effective, and performs comparably to legally marketed devices. The system was used successfully to localize patients during set-up and alignment and to track prostate motion during therapy delivery in a subset of the patients. Results show that the Calypso System can accurately and reliably provide localization and tracking information throughout all treatment fractions.

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Image /page/2/Picture/1 description: The image shows a logo with a circular border containing the words "HUMAN SERVICES USA" in a sans-serif font. Inside the circle is a stylized symbol consisting of three curved lines that resemble a person or figure in motion. The logo is black and white and appears to be a seal or emblem.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 2 8 2006

Mr. Eric Meier President and Chief Executive Officer Calvpso Medical Technologies, Inc. 2101 Fourth Avenue, Suite 1550 SEATTLE WA 98121

Re: K060906

Trade/Device Name: Calypso 4D Localization System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 22, 2006 Received: June 26, 2006

Dear Mr. Meier:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image is a black and white circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "PA" are in the center of the circle in a bold font. The word "Centennial" is below the letters "PA". There are three stars below the word "Centennial".

Protecting and Promoting Public Health

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Page 2 -

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); 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.

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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4.0 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _____________ Calypso 4D Localization System

Indication for Use:

Beacon transponders are indicated for permanent implantation in the prostate only.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Janeye broglon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number Ka60906

Page 4.1

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.