(74 days)
The OmniPro Incline is a QA beam measuring system intended to be used for the verification of dose distribution in radio therapy. The system is intended to measure proton, photon and electron beams.
The Omni-Pro-Incline software is a workspace tool managing both the measurements and the analysis of depth dose distributions of particles with a range up to 33 cm Water Equivalent Thickness (WET): The software is delivered with a dedicated system of multi layer of ionization chambers and with a decicated electrometer based on the Tera chip technology. Single Bragg peaks as well as modulated distributions can be measured and analyzed with high spatial and temporal resolution (in the order of 2mm WET) with typical sampling time down to 10ms. The data format will be directly compatible with the one of the IBA Dosimetry conventional formats and at least easily exchangeable. The system is suitable for both active and passive delivery
I am sorry, but the provided text content does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study proving adherence to them for the OmniPro Incline device. The document primarily consists of a 510(k) summary and an FDA clearance letter, which focus on regulatory approval and substantial equivalence to a predicate device, rather than a detailed study report with specific performance metrics and study design elements.
However, I can extract the following information:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state acceptance criteria or reported device performance in a quantified manner. It describes the device's capabilities:
- "managing both the measurements and the analysis of depth dose distributions of particles with a range up to 33 cm Water Equivalent Thickness (WET)"
- "high spatial and temporal resolution (in the order of 2mm WET)"
- "typical sampling time down to 10ms"
Without specific numerical targets for accuracy, precision, or other performance metrics, a table of acceptance criteria and reported performance cannot be generated from the given text.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document acts as a summary for regulatory submission, not a detailed scientific study report.
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)
This information is not available in the provided text. The device is a QA beam measuring system, implying its measurements would be compared against expected physical properties or reference standards, not necessarily human expert consensus on diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not available in the provided text.
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
Given the device's function as a "Radiation therapy dose calculation QA tool" and its purpose "for the verification of dose distribution in radio therapy," it is highly unlikely that an MRMC comparative effectiveness study involving human readers and AI assistance was conducted or would be relevant for this type of device. The OmniPro Incline is a measurement and analysis tool for physical dose distributions, not an AI diagnostic or decision-support system for human interpretation. Therefore, there is no information about such a study or effect size in the provided text.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device is described as a "software" that "manag[es] both the measurements and the analysis." It is bundled with "a dedicated system of multi layer of ionization chambers and with a dedicated electrometer." This suggests the software operates in conjunction with hardware to make measurements. The document does not specify a "standalone" algorithm-only performance study in the context of typical AI device evaluations. Its function is to perform measurements and analysis, implying its "standalone" operation is its primary mode without human intervention in the data acquisition and initial analysis phases, but the specific wording of a "standalone study" akin to AI evaluation is not present.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for a device like OmniPro Incline, which measures and analyzes radiation dose distributions, would typically involve established physics principles, reference dosimetry standards (e.g., traceable to national labs), or highly accurate alternative measurement techniques. The text does not explicitly state the type of ground truth used but implies comparison to expected physical properties of radiation beams.
8. The sample size for the training set
This information is not available in the provided text. The device is described as software for measurement and analysis, not as a machine learning or AI model that typically undergoes "training."
9. How the ground truth for the training set was established
As the device is not described as a machine learning or AI model requiring a "training set" in the conventional sense, this information is not applicable and therefore not available in the provided text.
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5 510(k) Summary
5.1 510(k) owner
IBA Dosimetry GmbH Bahnhofstrasse 5 90592 Schwarzenbruck Germany
Tel: +49 9128 607 0 Fax: +49 9128 607 10
5.2 Contact Person
Martin Arold
5.3 Preparation date
2009-06-09
5.4 Trade Name
OminPro Incline
5.5 Common name
Radiation therapy dose calculation QA tool.
5.6 Classification Name
Accelerator, linear, medical
5.7 Predicate Devices
Omni-Pro Accept: K011763
5.8 Device Description
The Omni-Pro-Incline software is a workspace tool managing both the measurements and the analysis of depth dose distributions of particles with a range up to 33 cm Water Equivalent Thickness (WET): The software is delivered with a dedicated system of multi layer of ionization chambers and with a decicated electrometer based on the Tera chip technology. Single Bragg peaks as well as modulated distributions can be measured and analyzed with high spatial and temporal resolution (in the order of 2mm WET) with typical sampling time down to 10ms. The data format will be directly compatible with the one of the IBA Dosimetry conventional formats and at least easily exchangeable. The system is suitable for both active and passive delivery
SEP 1 8 2009
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Image /page/1/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three lines representing the serpent and staff, above a wavy line.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
SEP & 8 2009
IBA Dosimetry GmbH % Mr. Chuck Lindley President IBA Dosimetry America 3150 Stage Post Dr., Suite 110 BARTLETT TN 38133
Re: K092018
Trade/Device Name: OmniPro Incline Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 6, 2009 Received: July 6, 2009
Dear Mr. Lindley:
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); medical device reporting (reporting of medical
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device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4 Indications for Use Statement
510(k) Number (if known): -
Device Name: OmniPro Incline
Indications for Use:
The OmniPro Incline is a QA beam measuring system intended to be used for the verification of dose distribution in radio therapy. The system is intended to measure proton, photon and electron beams.
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 Device Evaluation (ODE)
Herle Lume
(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.