.decimal's Aperture manufacturing service manufactures the ring and solid core apertures for intensity modulation of external beam proton radiation therapy. The apertures 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.

Device Description

The .decimal Proton Aperture is a Brass Core encased in a reusable steel ring (or material with similar attenuating properties) with a 2D hole cut from it, which defines the area that is to be treated with a proton beam. The design for a .decimal Proton Aperture 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 apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. As radiation is passed through the gantry, the beam passes through aperture and it will be blocked. The opening of the aperture where there is no brass, the radiation will pass through targeted area defined by the radiation therapy professional.

AI/ML Overview

The provided text does not contain specific acceptance criteria, reported device performance metrics, or details about a study that quantitatively measures the device's performance against such criteria.

The document 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. Clinically oriented validation test cases were written and executed in house by .decimal personnel where Proton Apertures were deemed safe and effective for clinical use. The tests show that .decimal Proton Apertures performed as well as the predicate device."
The device is a ".decimal Proton Aperture," which is a physical device (a brass core encased in a steel ring) used to shape proton beams in radiation therapy. Its performance is related to its physical dimensions and ability to block radiation as designed by a treatment planning system.

Therefore, many of the requested categories of information are not present in the provided text, as this is a 510(k) summary for a physical medical device, not an AI/software-as-a-medical-device (SaMD) that typically relies on the detailed performance studies described in your query.

Here's an attempt to answer based on the available information, with many points noted as "Not applicable" or "Not provided":

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implied)	Reported Device Performance
Performance "as well as the predicate device" (K121657)	Tests show .decimal Proton Apertures performed as well as the predicate device.
Deemed "safe and effective for clinical use"	Clinically oriented validation test cases executed in-house deemed them safe and effective.
Manufactured to customer's treatment planning system (TPS) design	The device is described as being "designed by the customer's treatment planning system" and "unique to each patient."
Blocks radiation from critical structures/healthy tissue, guides to targeted area	Intended Use and Indications for Use confirm this function.

2. Sample size used for the test set and the data provenance
Not provided. The text mentions "clinically oriented validation test cases" but does not specify the sample size or their provenance. Given it's a physical device, these "test cases" likely refer to physical prototypes or manufactured units rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/SaMD (e.g., radiologist consensus on images) is not relevant for this physical device. "Clinical use" and "safety and effectiveness" were "deemed" by ".decimal personnel."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No expert adjudication method is described for a test set.

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
Not applicable. This is a physical radiation therapy beam-shaping block, not an AI system or software. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of typical AI/SaMD studies. For this physical device, "ground truth" would relate to its manufacturing accuracy and material properties, ensuring it matches the design output from the TPS. The document states "clinically oriented validation test cases were written and executed in house by .decimal personnel." This implies internal testing against design specifications and functional requirements.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. No "training set" in that sense was used.

9. How the ground truth for the training set was established
Not applicable, as no training set was used.

Summary

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K132236
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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:

July 17, 2013

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 Proton Aperture

Classification Name:

IXI 21 CFR 892.5710 "Radiation Therapy Beam Shaping Block" Class II

Device Description:

OCT 16 2013

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block. The apertures are inserted into the gantry's snout to shape and focus the beam as it exits the gantry en route to the targeted area. As radiation is passed through the gantry, the beam passes through aperture and it will be blocked. The opening of the aperture where there is no brass, 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 Proton Aperture (K121657), .decimal Inc., . decimal, Inc.

Intended Use:

Indications for Use:

Summary of Technological Characteristics:

The device features of .decimal's Apertures are similar to the predicate device .decimal Proton Aperture. They both are used for external beam radiation therapy treatments, they both are used to block radiation and guide it to affected areas. The target population is identical and the use parameters are also very 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 executed in house by .decimal personnel where Proton Apertures were deemed safe and effective for clinical use. The tests show that .decimal Proton Apertures performed as well as the

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K132236
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predicate device. A declaration of conformity to this requirement can be found in section 18 of this document.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 16, 2013

.decimal, Inc. % Ms. Kimberly Rupp Ouality & Regulatory Affairs Manager 121 Central Park Place SANFORD FL 32771

Re: K132236

Trade/Device Name: .decimal Proton aperture Regulation Number: 21 CFR 21 CFR 892.5710 Regulation Name: Radiation therapy beam-shaping block Regulatory Class: Class II Product Code: IXI Dated: July 17, 2013 Received: July 18, 2013

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. 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 (2 l 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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Page 2- Ms. Kimberly Rupp

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.

t. D/offara for

Janine M. Morris 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): K132236

.decimal Proton Aperture Device Name:

Indications for Use:

Prescription Use X (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 In Vitro Diagnostics and Radiological Health (OIR)

Michael D'Hara

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

રા ભૂત (K) K132236

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Regulation Number and Section

§ 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.