(26 days)
Bolus Compensators are used by radiation therapy professionals for the treatment of cancer patients. They are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient.
.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators for intensity modulation of external beam radiation therapy. The Bolus Compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
This document is a 510(k) Premarket Notification summary for a device called "Bolus Compensator". The key information related to acceptance criteria and supporting studies is as follows:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics using an established format. Instead, it states that "Clinically oriented validation test cases were written and executed in house .decimal personnel including Board Certified Medical Physicists where Bolus Compensators was deemed fit for clinical use." This implies that the acceptance criteria were met by these in-house validation tests. The "intended use" section suggests the implicit performance criteria:
- Manufactures solid Bolus Compensators for intensity modulation of external beam radiation therapy.
- Designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue.
- Guides radiation to the targeted area.
- Must be validated and approved by the radiation therapy professional prior to use on a patient.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Clinically oriented validation test cases were written and executed in house." It does not specify the number of test cases (i.e., sample size).
- Data Provenance: The tests were "executed in house" by .decimal personnel. This indicates the data is retrospective and generated internally for validation purposes. The country of origin would be the United States, given the company's address is in Sanford, Florida, and the submission is to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: The document states "including Board Certified Medical Physicists." It does not specify the exact number of medical physicists involved.
- Qualifications of Experts: The experts were "Board Certified Medical Physicists." No further details on their experience (e.g., years of experience) are provided.
4. Adjudication Method for the Test Set
The document simply states that the Bolus Compensators "was deemed fit for clinical use" based on the in-house validation. It does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The "Board Certified Medical Physicists" were involved in deeming the product fit, implying their expertise formed the basis of the determination, but not a specific multi-reader adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk." This implies that no study comparing human readers with and without AI assistance was conducted.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
The device is a "Bolus Compensator manufacturing service" and the physical bolus compensator itself. It is a physical device, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only) performance" study does not apply here. The validation focused on the physical characteristics and functional performance of the manufactured compensators.
7. The Type of Ground Truth Used
The ground truth was established by "Board Certified Medical Physicists" deeming the manufactured Bolus Compensators "fit for clinical use." This suggests a form of expert judgment/consensus on the functional suitability and accuracy of the manufactured devices based on the "clinically oriented validation test cases." It is not based on pathology, outcomes data, or patient-level clinical results, as no clinical testing with human subjects was performed.
8. The Sample Size for the Training Set
This device is a physical product (.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators), not an AI algorithm trained on data. Therefore, the concept of a "training set" is not applicable in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
As stated above, this is not an AI/machine learning device, so there is no training set or ground truth for a training set in the conventional sense. The "ground truth" equivalent would be the engineering specifications and performance expectations for the manufactured bolus compensators, which were assessed by medical physicists during an in-house validation process.
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JUL 21 2009
Section 7 510(k) Summary or 510(k) Statement
Section 807.87 (h) A 510(k) Summary as described in Section 807.92 or a 510(k) statement as described in 807.93
Premarket Notification [510(k)] Summary as required by 21 CFR 807.92
Date summary was prepared:
June 2009
Submitter's Name:
.decimal, Inc. 121 Central Park Pl Sanford, Florida 32771
Contact Person:
Daniel L. Bennett Director of Quality and Regulatory Affairs Phone: 407-330-3300 407-322-7546 Fax: Email:dbennett(@dotdecimal.com
Device Name:
Bolus Compensator
Classification Name:
IXI 21 CFR892.5710 Class II
Predicate Device(s):
.decimal Range Compensator (K071078)
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Intended Use:
.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators for intensity modulation of external beam radiation therapy. The Bolus Compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Summary of Technological Characteristics:
The device features of Bolus Compensators are similar to the predicate device (.decimal Range Compensators K071078 cleared in 2007). They both are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Whereas the Bolus Compensator is made using machinable wax, the Range Compensator is made using acrylic, despite the difference in materials they both share very similar densities. Like Range Compensators Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient. The target population is identical and the use parameters are also very similar.
A detailed comparison can be found in section 11 of this submittal.
Summary of Clinical Testing:
Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk. Clinically oriented validation test cases were written and executed in house .decimal personnel including Board Certified Medical Physicists where Bolus Compensators was deemed fit for clinical use. A declaration of conformity to this requirement can be found in section 12 of this document.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 21 2009
Mr. Daniel L. Bennett Director of Quality and Regulatory Affairs .decimal, Inc. 121 Central Park Pl. SANFORD FL 32771
Re: K091911
Trade/Device Name: Bolus Compensator Regulation Number: 21 CFR 892.5710 · Regulation Name: Radiation therapy beam-shaping block Regulatory Class: II Product Code: IXI Dated: June 24, 2009 Received: June 25, 2009
Dear Mr. Bennett:
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 (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.
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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
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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he benchmark for custom radiation therapy
| Section 6 | Indications for Use Statement |
|---|---|
| 510(k) Number (if known) | K091911 |
Device Name: Bolus Compensator
Indication for Use: Bolus Compensators are used by radiation therapy professionals for the treatment of cancer patients. They are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | -------------------------------------------------------- |
OR
| Over-The-Counter Use | ________________ |
|---|---|
| ---------------------- | ------------------ |
(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
| 510(k) Number | K091911 |
|---|---|
| --------------- | --------- |
§ 892.5710 Radiation therapy beam-shaping block.
(a)
Identification. A radiation therapy beam-shaping block is a device made of a highly attenuating material (such as lead) intended for medical purposes to modify the shape of a beam from a radiation therapy source.(b)
Classification. Class II.