(54 days)
.decimal's Photon Block manufacturing service manufactures Photon Blocks for external beam photon radiation therapy. The Photon Block is designed by the customer's treatment planning system or physician specifications to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Photon Blocks are intended for use by healthcare professionals.
In IMRT therapy for cancer, a photon beam is aimed at the cancerous tissue using a linear accelerator. The linear accelerator is rotated around the patient while the patient lies on a treatment table; the linear accelerator consists of the gantry, which rotates around the patient. The gantry contains a collimator, which points at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires custom-made, beam modifying, patient specific devices called: Photon Block.
The Photon Block is inserted into the gantry's collimator to shape and focus the beam as it exits the gantry en route to the targeted area. The photon block is also called a cerrobend block, which defines the area that is to be treated with the photon beam. Photon Blocks are generated out of the treatment planning system or physician's specifications and are unique to each patient and each gantry angle.
The .decimal Photon Block is a Cerrobend block (or material with similar attenuating properties) with a 2D pattern/hole made from it, which defines the area that is to be treated with a photon beam. The design for a .decimal Photon Block is generated out of a customer's treatment planning system (TPS) or physician's specifications and is unique to each patient. The device functions as a beam shaping block. The block fits into a customer's linear accelerator. As radiation is passed through the collimator, the beam passes through cerrobend and it will be blocked the opening of the photon block where there is no ccrrobend, the radiation will pass through targeted area defined by the radiation therapy professional.
The provided document describes the .decimal Photon Block, a device used in radiation therapy to shape and focus photon beams. It details the device's description, intended use, and indications for use, and also includes a 510(k) summary for regulatory approval.
However, 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."
Instead, the document mentions: "Clinically oriented validation test cases were written and excelled in house by .decimal personnel including a Board Certified Medical Physicist where Photon Blocks were deemed safe and effective for clinical medical. The tests show that .decimal Photon Blocks performed as well as the predicate device."
This indicates that the manufacturer performed non-clinical testing to demonstrate substantial equivalence to a predicate device (.decimal Electron Aperture K111759) rather than a study with acceptance criteria and a detailed performance report in the manner expected for a device proving its efficacy via clinical trials.
Therefore, most of the requested information regarding acceptance criteria, study details involving human subjects, ground truth, expert involvement, and sample sizes for test and training sets cannot be extracted from this document because such a study was explicitly not performed.
Here's what can be inferred or extracted based on the provided text, acknowledging the absence of a typical clinical study:
1. A table of acceptance criteria and the reported device performance
Since no specified acceptance criteria or detailed performance metrics from a formal clinical study are provided, this section cannot be completed as requested. The document only broadly states that the device "performed as well as the predicate device."
No specific acceptance criteria or performance metrics were detailed in the provided document, as no clinical study was performed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable, as no clinical test set was used. "Clinically oriented validation test cases" were performed in-house, but the sample size of these test cases is not specified, nor is their provenance.
- Data provenance: Not applicable. The validation was described as "in house."
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)
- Number of experts: The document mentions "in house by .decimal personnel including a Board Certified Medical Physicist." It doesn't specify if multiple experts were involved or just one for establishing ground truth for the validation test cases.
- Qualifications of experts: "Board Certified Medical Physicist." No years of experience are specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. The in-house validation did not describe a formal adjudication method.
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
- No MRMC comparative effectiveness study was done. The device described (Photon Block) is a physical beam-shaping device, not an AI-assisted diagnostic or therapeutic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an algorithm. The device is a physical component. Its "performance" was likely assessed against physical specifications and its ability to shape the beam accurately, which would be a standalone evaluation of the physical device. The document mentions "validation test cases," suggesting a standalone performance evaluation of the device's manufacturing and function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the "clinically oriented validation test cases," the ground truth was established by ".decimal personnel including a Board Certified Medical Physicist." This suggests an expert-driven assessment of whether the Photon Blocks met their design specifications and functioned correctly to achieve the intended beam shaping, likely comparing actual block dimensions and beam profiles against design specifications.
8. The sample size for the training set
- Not applicable, as this is a physical device and no machine learning model requiring a training set is described.
9. How the ground truth for the training set was established
- Not applicable, as no machine learning model requiring a training set is described.
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Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K', '1', '2', '3', '0', '1', and 'S'. The characters are written in a simple, handwritten style.
Image /page/0/Picture/1 description: The image shows the word "decimal" in bold, black font. There is a small circle with a line through it to the right of the word. Below the word "decimal" is the phrase "The benchmark for custom radiation th" in a smaller font.
enchmark for custom radiation therapy
NOV 2 1 2012
Section 5
510(k) Summary
Section 807.87 (h) A 510(k) Summary as described in Section 807.92
Premarket Notification [510(k)] Summary as required by 21 CFR 807.92
Date summary was prepared:
September 26, 2012
Submitter's Name:
.decimal, Inc. 121 Central Park Pl Sanford, Florida 32771
Contact Person:
Kimberly Rupp Quality and Regulatory Affairs Manager Phone: 407-330-3300 407-322-7546 Fax: Email: krupp@dotdecimal.com
Device Name:
.decimal Photon Block
Classification Name:
IXI 21 CFR 892.5710 "Radiation Therapy Beam Shaping Block" Class II
Device Description:
The .decimal Photon Block is a Cerrobend block (or material with similar attenuating properties) with a 2D pattern/hole made from it, which defines the area that is to be treated with a photon beam. The design for a .decimal Photon Block is generated out of a customer's treatment planning system (TPS) or physician's specifications and is unique to each patient. The device functions as a beam shaping block. The block fits into a
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customer's linear accelerator. As radiation is passed through the collimator, the beam passes through cerrobend and it will be blocked the opening of the photon block where there is no ccrrobend, the radiation will pass through targeted area defined by the radiation therapy professional. The operating principles are explained in section 12 of this submittal.
Predicate Device(s):
.decimal Electron Aperture (K111759), .decimal Inc.
Intended Use:
.decimal's Photon Block manufacturing service manufactures Photon Blocks for external beam photon radiation therapy. The Photon Block is designed by the customer's treatment planning system or physician specifications to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.
Photon Blocks are intended for use by healthcare professionals.
Indications for Use:
In IMRT therapy for cancer, a photon beam is aimed at the cancerous tissue using a linear accelerator. The linear accelerator is rotated around the patient while the patient lies on a treatment table; the linear accelerator consists of the gantry, which rotates around the patient. The gantry contains a collimator, which points at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires custom-made, beam modifying, patient specific devices called: Photon Block.
The Photon Block is inserted into the gantry's collimator to shape and focus the beam as it exits the gantry en route to the targeted area. The photon block is also called a cerrobend block, which defines the area that is to be treated with the photon bean. Photon Blocks are generated out of the treatment planning system or physician's specifications and are unique to each patient and each gantry angle.
Summary of Technological Characteristics:
The device features of the .decimal Photon Block are similar to the predicate device (.decimal Electron Aperture K111759 cleared in 2011). 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 previous version was made using brass used solely in proton radiation therapy, this version is made using cerrobend and is used for photon radiation therapy. Like .decimal Apertures used in proton therapy, each .decimal Photon Block must be validated and approved by the radiation therapy professional prior
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to use on a patient. The target population is identical and the use parameters are also very a similar.
A detailed comparison can be found in section 10 of this submittal.
Summary of Non-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 excelled in house by .decimal personnel including a Board Certified Medical Physicist where Photon Blocks were deemed safe and effective for clinical modical modical The tests show that .decimal Photon Blocks performed as well as the predicate device. A declaration of conformity to this requirement can be found in section 18 of this document.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO-66 Silver Spring, MD 20993-002
November 21, 2012
Ms. Kym Rupp Ouality & Regulatory Affairs Manager decimal. Inc. 121 Central Park Place SANFORD FL 32771
Re: K123015
Trade/Device Name: . DECIMAL Photon Block Regulation Number: 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping device Regulatory Class: II Product Code: IXI Dated: September 26, 2012 Received: September 28, 2012
Dear Ms. Rupp:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to (2017) 196 - 150. Thiss 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 I ou may ovain other generational 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,
Michael D. O'Hara
2012.12.03
07:27:41 -05'00'
Janine M. Morris 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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510(k) Number (if known): K123015
Device Name: . decimal Photon Block
Indications for Use:
In IMRT therapy for cancer, a photon beam is aimed at the cancerous tissue using a linear accelerator. The linear accelerator is rotated around the patient while the patient lies on a treatment table; the linear accelerator consists of the gantry, which rotates around the patient. The gantry contains a collimator, which points at pre-determined positions to maximize efficiency and dose delivery to the tumor volume. Each gantry angle, or "port", requires custom-made, beam modifying, patient specific devices called: Photon Block.
The Photon Block is inserted into the gantry's collimator to shape and focus the beam as it exits the gantry en route to the targeted area. The photon block is also called a cerrobend block, which defines the area that is to be treated with the photon beam. Photon Blocks are generated out of the treatment planning system or physician's specifications and are unique to each patient and each gantry angle.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
William Jung 2012.11.21 13:54:00
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K123015 510(k)
Page 1 of
§ 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.