(63 days)
Sun Nuclear's DoseCHECK is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose.
DoseCHECK provides the clinician with the opportunity to compute dose using a different algorithm from that used by their treatment planning system (TPS). DoseCHECK utilizes the DICOM RT Plan, RT Structure Set, and CT Image Set from the TPS as inputs for the calculation, along with a linear accelerator characterization and CT-to-ED curve. The resulting dose distribution can be compared to the TPS dose distribution as a means of independent check. This comparison allows for detection of errors or inaccuracies that may occur within the TPS such as with beam modeling, calculation algorithm, and inhomogeneities.
The provided text describes the regulatory clearance for the device "Model 1217028 DoseCHECK" which is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose. However, the document provided does not contain detailed information about specific acceptance criteria, a comprehensive study proving the device meets those criteria, or the methodology (sample size, ground truth establishment, expert qualifications, adjudication, training set details) typically found in a clinical performance study.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Mobius3D) through performance data from "appropriate bench testing methods."
Based on the provided text, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitely defined in terms of specific thresholds or metrics for dose calculation accuracy or agreement. The general statement is that "the device performs within its design specifications." | "Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate device." |
2. Sample sized used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not specified.
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. This device is a software for independent dose calculation, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to human reader improvement is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, the essence of the device's function is standalone dose calculation. The document states: "DoseCHECK provides the clinician with the opportunity to compute dose using a different algorithm from that used by their treatment planning system (TPS)." and "The resulting dose distribution can be compared to the TPS dose distribution as a means of independent check." This implies the algorithm performs its calculation independently. The "bench testing methods" would assess this standalone performance against typically accepted benchmarks or the predicate device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not explicitly stated. For a dose calculation software, the "ground truth" would likely be a highly accurate or gold-standard dose calculation result, possibly from a very sophisticated and validated calculation engine, or physical dosimetry measurements in phantoms. The comparison is stated as being to the "TPS dose distribution," implying the TPS result is the primary reference for the check, but the device aims to provide an independent check, suggesting it performs its own calculation to a certain expected accuracy. The document mentions "beam modeling, calculation algorithm, and inhomogeneities" as areas where errors might occur in the TPS, which DoseCHECK is designed to detect, implying DoseCHECK has its own accurate model.
8. The sample size for the training set
- Sample Size: Not specified. The document does not mention "training" in the context of machine learning, as this is a physics-based calculation software. It uses "linear accelerator characterization and CT-to-ED curve" as inputs, which are configuration data rather than a "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable, as there's no mention of a training set in the machine learning sense. The device utilizes pre-characterized parameters (e.g., linear accelerator characterization, CT-to-ED curve) for its calculations.
Summary of Missing Information:
The provided document, being a 510(k) summary, focuses on substantial equivalence. It lacks the granular detail about specific performance metrics, the number of cases/patients in test sets, the methodologies for establishing ground truth (other than implicitly comparing to TPS or a "predicate device"), and expert involvement that would be needed to fully answer the detailed questions about acceptance criteria and study particulars. The "bench testing methods" are mentioned but not elaborated upon.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2016
Sun Nuclear Corporation % Ms. Rene' Hardee Regulatory Affairs Specialist III 3275 Suntree Blvd. MELBOURNE FL 32940
Re: K161946
Trade/Device Name: Model 1217028 DoseCHECK Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 8, 2016 Received: July 15, 2016
Dear Ms. Hardee:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161946
Device Name
Model 1217028 DoseCHECK
Indications for Use (Describe)
Sun Nuclear's DoseCHECK is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Sun Nuclear Corporation. The logo features a blue square with a yellow sun-like design inside on the left. To the right of the square, the words "SUN NUCLEAR" are written in a bold, blue font, with the word "corporation" written in a smaller, blue font underneath.
Section 5 - 510(k) Summary
Provided in accordance with 21 CFR 807.92 (c)
1 General Provisions
Date Prepared:
June 10, 2016
Submitted by:
Sun Nuclear Corporation 3275 Suntree Blvd. Melbourne, FL 32940 Ph: 321-259-6862 Fax: 321-259-7979 Web: www.sunnuclear.com
Contact Person:
Rene' Hardee ReneHardee@sunnuclear.com
Ph: 321-259-6862 extension 2304
Classification Name:
Accelerator, Linear, Medical
Common Name:
Secondary check QA software
Proprietary Names:
Model 1217028 DoseCHECK
Establishment Registration Number:
1038814
Classification:
Regulation Number: 21 CFR 892.5050 Name: Accelerator, Linear, Medical Product code: IYE
Class II
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Predicate Device(s):
| Model Name: | Mobius3D |
|---|---|
| Common Name: | Secondary check QA software |
| 510(k) # | K140660 |
| Manufacturer: | Mobius Medical Systems, LP |
| Submitted: | May 05, 2014 |
To our knowledge, this predicate has not been subject to a designrelated recall.
2 Description and Use:
DoseCHECK provides the clinician with the opportunity to compute dose using a different algorithm from that used by their treatment planning system (TPS). DoseCHECK utilizes the DICOM RT Plan, RT Structure Set, and CT Image Set from the TPS as inputs for the calculation, along with a linear accelerator characterization and CT-to-ED curve. The resulting dose distribution can be compared to the TPS dose distribution as a means of independent check. This comparison allows for detection of errors or inaccuracies that may occur within the TPS such as with beam modeling, calculation algorithm, and inhomogeneities.
3 Intended Use Statement:
Sun Nuclear's DoseCHECK is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose.
ব Technological Characteristics
The primary technological characteristics of the Model 1217028 DoseCHECK are the usage of three dimensional volumetric imaging information and beam intensity values in DICOM-RT format to compute a dose volume (also in DICOM-RT format) and a comparison of this independent calculation to the TPS dose distribution. The technological characteristics are believed to be substantially equivalent to the predicate device.
5 Performance Data and Comparison with Predicate
Model 1217028 DoseCHECK has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate device.
6 Summarv
Model 1217028 DoseCHECK is believed to be substantially equivalent to the predicate Mobius3D device due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate that Model 1217028 DoseCHECK is as safe, as effective, and performs as well as the predicate device.
§ 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.