(89 days)
Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.
The Odyssey radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). The system includes functions for imaging, target and non-target delineation, beam planning, verification and quality assurance. An earlier version of the software was known as "OptiRad" (K993895). In addition to forward planning, users who have the Intensity Modulated Radiation Treatment (IMRT) module can perform inverse planning.
The provided text does not contain specific acceptance criteria or an analytical study proving the device meets them. Instead, it is a 510(k) summary for a medical device (Odyssey radiation treatment planning system) and related FDA correspondence.
Based on the document, here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative metrics. The summary focuses on equivalence to predicate devices.
- Reported Device Performance: Not presented as quantitative performance metrics. The document states a general conclusion: "Odyssey is as safe, as effective, and is substantially equivalent to the legally marketed predicate devices."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No quantitative performance metrics reported for comparison. The document states that the device is "safe and effective" and "substantially equivalent" to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable. No clinical testing was required or performed for this 510(k) submission.
- Data Provenance: Not applicable. No test set was used for clinical evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No test set requiring expert ground truth was used for clinical evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. No test set requiring adjudication was used.
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. The document explicitly states: "Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of Odyssey." This implies no human reader studies were conducted.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No standalone clinical performance study was conducted. The "Summary of Non-Clinical Testing" mentions "Verification and Validation" and "Hazard Analysis and Failure Modes and Effects Analysis" were completed, demonstrating the device to be safe and effective, but these are typically internal engineering and software validation activities, not a standalone clinical performance study.
7. The type of ground truth used:
- Type of Ground Truth: Not applicable for clinical performance. For the described non-clinical verification and validation, ground truth would be based on engineering specifications, known algorithmic outputs, and safety standards.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable. The device is a "Radiation Treatment Planning System" which uses algorithms to compute estimated radiation doses. It's not described as an AI/ML device that requires a training set in the contemporary sense. Its functionality is based on established physics algorithms, not learned patterns from data.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set. The algorithms would be based on well-established mathematical and physical models.
In summary, the document states that:
- Clinical testing was not required for the Odyssey device to demonstrate substantial equivalence.
- The device contains no technological characteristics not already present in its predicate devices (ADAC P3MRT and OptiRad).
- Non-clinical Verification and Validation, along with Hazard Analysis and FMEA, were performed to demonstrate safety and effectiveness.
This submission relies on substantial equivalence to predicate devices and internal verification, rather than clinical performance studies with specific acceptance criteria and ground truth.
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JAN 1 2 2005
102
Image /page/0/Picture/2 description: The image shows the logo for PerMEdics Inc. The logo features a stylized compass rose to the left of the company name. The text "PERMEDICS" is in a serif font, with "inc." in a smaller, sans-serif font to the right.
510(k) Summary
Submitter:
PerMedics, Inc. 1475 S. Victoria Ct. San Bernardino, CA. 92408 Phone: (909) 478-5000 Fax: (909) 478-5016
Contact Person:
Jessica Connor Quality Assurance Manager
Date Prepared:
October 12, 2004
Device Name:
Odyssey
Common Name:
Radiation Treatment Planning System
Classification Name:
System, Planning, Radiation Treatment
Predicate Devices:
ADAC P3MRT™ - K002237 OptiRad - K993895
Device Description:
The Odyssey radiation treatment planning system is a collection of software modules that execute algorithms to produce radiation dose computations (estimations). The system includes functions for imaging, target and non-target delineation, beam planning, verification and quality assurance. An earlier version of the software was known as "OptiRad" (K993895). In addition to forward planning, users who have the Intensity Modulated Radiation Treatment (IMRT) module can perform inverse planning.
Intended Use:
Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.
PerMedics, Inc. ♦ 1475 S. Victoria Ct., San Bernardino, CA 92408 909.478.5000 ♦ Fax 909.478.5016 ♦ Email: information@permedics.com
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Kov-281 2if
Summary of Technological Characteristics Compared to Predicate Devices:
Odyssey contains no technological characteristics not currently contained in the predicate devices, ADAC P3 MRT inverse planning option (K002237) and OptiRad (K993895).
Summary of Non-Clinical Testing:
The performance and results of Verification and Validation demonstrate Odyssey to be safe and effective. A Hazard Analysis and Failure Modes and Effects Analysis were completed, with all hazards and failure modes mitigated to acceptable levels.
Summary of Clinical Testing:
Clinical testing is not required to demonstrate substantial equivalence or safety and effectiveness of Odyssey.
Conclusion:
Odyssey is as safe, as effective, and is substantially equivalent to the legally marketed predicate devices.
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Image /page/2/Picture/1 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 image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 2 2005
Ms. Jessica Connor Quality Assurance Manager PerMedics, Inc. 1475 S. Victoria Ct. SAN BERNARDINO CA 92408
Re: K042861
Trade/Device Name: Odyssey Regulation Number: 21 CFR §892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: December 9, 2004 Received: December 10, 2004
Dear Ms. Connor:
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 (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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms iction will and in your of substantial equivalence of your device to a legally prematication: "The PDF maning on 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 If you done spoorne at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, process not regulation eeneral information on your responsibilities under the Act from the 801:57). " Ou may oount ourers, International and Consumer Assistance at its toll-free number (800) DIVISION of of othern handracters, its Internet address http://www.fda.gov/cdrh/dsmadsmamain.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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Indications for Use
Page 1 of 1
510(k) Number (if known): Ko42861
Device Name: Odyssey
Indications for Use:
Odyssey is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
(Posted July 1, 1998)
\
(Division Signature)
Division of Banks
Prescription Use
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
§ 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.