The Calypso System is intended for use as an adjunct in treatment planning and radiation the our poor ijo align and/or the patient's position relative to the isocenter of a radiation therapy system. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.

The optional Dynamic Edge™ Gating component may signal a radiation therapy system to impose a beam-hold when the treatment target position has moved outside the defined tracking limits and to signal the radiation therapy system to remove the beam-hold upon the target's return to a position inside the defined tracking limits. The Dynamic Edge Gating feature has been shown to be compatible with Varian and Siemens radiation therapy treatment systems with external gating interfaces.

Implanted Beacon® transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.

Permanent Beacon transponders are indicated for implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed) to align and monitor the treatment isocenter in real time during radiation therapy.

Surface Beacon® transponders are indicated for temporary external placement on the skin, to monitor respiratory motion and other patient motion in real time during radiation therapy.

Device Description

The Calypso System utilizes non-ionizing electromagnetic and optical technology 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 non-ionizing electromagnetic signals from passive markers, called Beacon® transponders which are implanted in or near the treatment target or placed externally on the surface of a patient.

Implanted Beacon transponders when used with the Calypso System enable objective measurement of the location of the target in 3 dimensions. The system operator uses this information to align the patient's treatment target to the isocenter of the therapy system prior to treatment. This information can also be used to monitor (track) the position of the treatment target during radiation therapy treatment.

When using Surface Beacon transponders this information can be used to monitor respiratory motion and other patient motion in real time during radiotherapy. When correlated to the patient's treatment target motion the system provides objective measurement of the location of the target in 3 dimensions.

The Dynamic Edge™ Gating feature enables the Calypso System to interface with radiation therapy systems configured with gating capabilities via an interface to external systems. With this optional feature added to the Calypso System, a beam hold is signaled to the radiation therapy system when the treatment target position has moved outside the defined tracking limits. The radiation therapy system is signaled to remove the beam-hold upon the target's return to a position inside the defined tracking limits.

AI/ML Overview

The provided text is a 510(K) summary for the Calypso® System Surface Beacon® transponders. It describes the device, its indications for use, and a summary of performance testing. However, it does not contain specific acceptance criteria, detailed study results, sample sizes for test/training sets, or details about expert ground truth establishment for the performance testing.

The summary states: "Results of verification and validation testing demonstrate that the Surface Beacon transponder satisfies the intended use as described above." This is a general statement that implies the device met its performance goals, but the specific metrics, criteria, and detailed study information are not included in this document.

Therefore, I cannot populate the requested table or provide the detailed information about the study design using only the provided text.

Here's a breakdown of what could be extracted if the information were present, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Specific Metric & Threshold)	Reported Device Performance (Value/Outcome)
Not provided in the document	Not provided in the document

Missing Information for 2-9:

Sample size used for the test set and the data provenance: The document mentions "verification and validation testing" but does not specify the sample size (number of cases/patients) or the data source (e.g., country of origin, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: The document describes a "patient localization system" and "monitoring respiratory motion," which suggests it's a device for real-time tracking, not an AI for image interpretation that would typically involve human readers needing improvement with AI assistance. Therefore, an MRMC study in this context is unlikely, and no such study is described or referenced.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The "Summary of Performance Testing" notes that "Results of verification and validation testing demonstrate that the Surface Beacon transponder satisfies the intended use." While this implies standalone performance was evaluated, the details of that evaluation are missing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not specified. For a tracking system, ground truth would likely involve highly precise physical measurements or a gold-standard tracking system, but this is not detailed.
The sample size for the training set: The document doesn't mention any training sets, which is typical for a hardware-based tracking system rather than an AI/machine learning model.
How the ground truth for the training set was established: Not applicable, as no training set is mentioned for this type of device.

In summary, the provided 510(k) summary only states that performance testing was conducted and the device met its intended use. It does not provide the specific details of the acceptance criteria or the study methodology requested.

Summary

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(1128-

510(K) SUMMARY

FEB 1 6 2012

This 510(k) Summary is provided in accordance with 21 CFR 807.92.

Date of preparation: 28 September 2011

Submitter information:

Calypso Medical Technologies, Inc. 2101 Fourth Avenue, Suite 500 Seattle, WA 98121

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

Contact:	Marcia A Page Vice President Quality Assurance and Regulatory Affairs
Device trade name:	Calypso® System Surface Beacon® transponders
Common name:	Patient localization system
Classification name:	Medical charged-particle radiation therapy system
Classification:	CFR 892.5050 Class II Product code – LHN, IYE
Predicate devices:	Calypso System (K060906, K080726, K102373) RPM Respiratory Gating System (K102024) Respisens (K092845)

Device Description:

Use of the Calypso System for target localization is based on the system's detection of non-ionizing electromagnetic signals from passive markers, called Beacon® transponders

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which are implanted in or near the treatment target or placed externally on the surface of a patient.

Indications for Use:

The Calypso 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 radiation therapy system. The Calypso System provides accurate, precise and continuous localization of a treatment isocenter by using two or more Beacon transponders.

Implanted Beacon transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.

Permanent Beacon transponders are indicated for implantation in the prostate and the peri-prostatic tissue (i.e., prostatic bed).

Surface Beacon transponders are indicated for temporary external placement on the skin, to monitor respiratory motion and other patient motion in real time during radiation therapy.

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Technological Characteristics - See device comparison table below

Feature and/or Specificationof new/modified device	Calypso System with implantedBeacon Transponders	Calypso System with SurfaceBeacon Transponders
Sensing Technology	Cameras and infrared targets onarray and Beacon Transponders	Cameras and infrared targets onarray and Surface BeaconTransponders
Monitoring	Real Time Monitor patientmotion	No change
Tracking	Real Time Tracking Patientmotion	Real Time Tracking Patient andRespiratory motion
Gating	Interface to external systems	No change
Records	Display and Record motion	No change
Computer hardware andsoftware	Computer systems (console andtracking station) to controldevice functions and provide foruser interface	No change
Electromagnetic technology(array)	Used to track motion duringtherapeutic procedures	No change
Compatibility with theenvironment and otherdevices	Operates in a radiation therapysystem environment	No change
Electrical safety mechanicalsafety	IEC 60601-1; IEC 60601-1-1	No change
EMC Safety	IEC 60601-1-2	No change

Summary of Performance Testing:

Results of verification and validation testing demonstrate that the Surface Beacon transponder satisfies the intended use as described above.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract shapes resembling human figures or waves, stacked on top of each other.

Public Health Service

FEB 1 6 2012

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

Ms. Marcia Page Vice President Quality Assurance and Regulatory Affairs Calypso Medical Technologies, Inc. 2101 Fourth Ave South, Suite 500 SEATTLE WA 98121

Re: K112841

Trade/Device Name: Calypso® System Surface Beacon transponders Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: January 3, 2012 Received: January 4, 2012

Dear Ms. Page:

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 comply with all the Act's 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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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,

Mary S. Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): K112841 ----------

Device Name: Calypso@ System Surface Beacon transponders

Implanted Beacon® transponders are indicated for use to radiographically and electromagnetically mark soft tissue for future therapeutic procedures.

Surface Beacon® transponders are indicated for temporary external placement on the skin, to monitor respiratory motion and other patient motion in real time during radiation therapy.

x Prescription Use (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 IF NEEDED)

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

Mary S. Pastel

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k)

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.