The p.d software is used by radiation therapy professionals to assist in the design, manufacturing, and quality assurance testing of various radiation therapy devices used for cancer patients. The p.d software performs three distinct, primary functions which each are described below.

The p.d software takes a design of a compensating filter from a Treatment Planning System and converts the Treatment Planning System compensator filter files into a .decimal file format. This file can then be electronically submitted to .decimal through the software, so that we can manufacture the device.
The p.d software can design a beam shaping and compensating filters based on Treatment Planning System and other user supplied data. The device designs for compensating filters will be transferred back into the Treatment Planning System for final dose verification before devices are ordered and used for patient treatment.
The p.d software can perform quality assurance testing of the physical characteristics of treatment devices using data from various types of scanned images, including computed tomography images.

Device Description

The .decimal p.d device is a software application that will enable users of various radiation treatment planning systems (TPS) to design, measure, and order beam shaping and modulating devices used in the delivery of various types of radiotherapy, including photon, electron, and particle therapy. The input from the treatment planning systems to the p.d product is generally received in DICOM file format. but other vendor specific or generic file formats are also utilized. p.d will also provide a simplified radiation dose calculator for the purpose of improving its ability to accurately create/modify patientspecific radiation beam modifying devices without the need for iteration with other treatment planning systems. However, all modulating devices will have final dose verification performed in a commissioned Treatment Planning System before devices are used for patient treatment. Additionally, the p.d software contains tools for analyzing scanned image data that aids users in performing quality assurance measurement and testing of radiotherapy devices.

AI/ML Overview

The provided text describes the p.d 5.1 software, a device used in radiation therapy. However, it does not contain the detailed information required to fully answer your request regarding acceptance criteria and a specific study proving the device meets them. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria.

While the document indicates some testing was done, it doesn't provide the specifics you're asking for. Here's what can be inferred and what's missing:

1. A table of acceptance criteria and the reported device performance

Missing Information: The document does not provide a table of acceptance criteria with specific quantitative thresholds or reported device performance metrics. The testing described is more qualitative and focused on comparing to predicate devices and general software validation.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information:

Sample Size: Not specified.
Data Provenance: Not specified. The document mentions "hospital-based testing partners" but doesn't detail the origin or nature of the data used in validation.
Retrospective/Prospective: Not specified.

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)

Missing Information: The document does not specify the number or qualifications of experts used for establishing ground truth in the test set. It mentions "Clinically oriented validation tests were written and executed by .decimal personnel and hospital-based testing partners," but this doesn't detail specific expert involvement for ground truth adjudication.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Missing Information: The document does not describe any specific adjudication method for establishing ground truth for the 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

Missing Information:

MRMC Study: No MRMC comparative effectiveness study is mentioned.
Effect Size: Not applicable, as no MRMC study was described. The focus is on demonstrating substantial equivalence of the software's functionality to existing tools. This device is an aid to radiation therapy professionals, not an AI to improve human reader performance in a diagnostic context.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Information Available (Inferred): The testing seems to have been primarily standalone, focusing on the software's ability to perform its functions (design filters, convert files, perform QA measurements) and comparing its output to predicate devices. The document states "Clinical testing was not performed... since testing can be performed such that no human subjects are exposed to risk." This suggests the validation was primarily of the software's internal logic and output, rather than its performance in conjunction with a human user in a clinical setting with real patient outcomes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Information Available: The ground truth for the validation tests was established by:

Comparing results to those of known predicate devices (p.d software version 5.0 and Eclipse TPS).
Performing quality assurance measurements on devices of known quality.

This implies a form of "reference standard" or "known truth" derived from established systems and manufactured devices, rather than clinical pathology or patient outcomes.

8. The sample size for the training set

Not Applicable/Missing Information: The document describes software validation and verification, not the training of a machine learning model. Therefore, there is no "training set" in the context of AI/ML. If the "p.d software" incorporates algorithms that are based on machine learning, this information is not provided. The phrasing "using nearly identical algorithms and processes" to the predicate software suggests it's more of a deterministic software rather than a trained AI model.

9. How the ground truth for the training set was established

Not Applicable/Missing Information: As there's no mention of a training set for an AI/ML model, this question is not applicable.

Summary of Device Performance (from the document):

The document concludes with: "These tests show that the p.d software performed equivalently to the predicate device when appropriate and that the software is deemed safe and effective for clinical use."

This is a general statement of performance, but it lacks the specific, quantifiable acceptance criteria and corresponding reported performance metrics that your request specifies. The 510(k) process primarily aims to demonstrate substantial equivalence, and the provided document reflects that focus.

Summary

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

August 7, 2015

.decimal, LLC % Kevin Erhart, Ph.D. Senior Engineer 121 Central Park Place SANFORD FL 32771

Re: K151369 Trade/Device Name: p.d 5.1 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: May 15, 2015 Received: May 21, 2015

Dear Dr. Erhart:

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/Resourcesfor You/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. Acting 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

K151369

Device Name p.d 5.1

Indications for Use (Describe)

I) The p.d software takes a design of a compensating filter from a Treatment Planning System and converts the Treatment Planning System compensator filter file format. This file can then be electronically submitted to .decimal through the software, so that we can manufacture the device.

The p.d software can design a beam shaping and compensating filters based on Treatment Planning System and other user supplied data. The device designs for compensating filters will be transferred back into the Treatment Planning System for final dose verification before devices are ordered and used for patient treatment.
The p.d software can perform quality assurance testing of the physical characteristics of treatment devices using data from various types of scanned images, including computed tomography images.

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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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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:

May 15, 2015

Submitter's Name:

.decimal, LLC 121 Central Park PL Sanford, Florida 32771

Contact Person:

Kevin Erhart Senior Engineer Phone: 407-330-3300 407-322-7546 Fax: Email:kerhart@dotdecimal.com

Device Name:

p.d 5.1

Classification Name and Code:

Class II, MUJ, 21 CFR 892.5050 Medical charged-particle radiation therapy systems

Device Description:

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scanned image data that aids users in performing quality assurance measurement and testing of radiotherapy devices.

Predicate Device(s):

K083672 - p.d software (version 5.0) - .decimal, LLC (Primary Predicate Device) K141283 - Eclipse Treatment Planning System - Varian Medical Systems, Inc. (Reference Predicate Device)

Intended Use:

The intended use of the p.d software is to aid radiation therapy professionals in the design, construction, and testing of radiotherapy beam modifying devices. The software is intended to interface with most major treatment planning systems and design devices that are compatible with most major radiotherapy linear accelerators and particle therapy delivery systems. And while the primary intent is for the software to design and measure devices that are manufactured by .decimal, this does not exclude, in some cases, the software being used with devices that are constructed on-site or by other vendors (with explicit permission from .decimal).

Indications for Use:

1. The p.d software takes a design of a compensating filter from a Treatment Planning System and converts the Treatment Planning System compensator filter files into a .decimal file format. This file can then be electronically submitted to .decimal through the software, so that we can manufacture the device.
1. The p.d software can design a beam shaping and compensating filters based on Treatment Planning System and other user supplied data. The device designs for compensating filters will be transferred back into the Treatment Planning System for final dose verification before devices are ordered and used for patient treatment.
1. The p.d software can perform quality assurance testing of the physical characteristics of treatment devices using data from various types of scanned images, including computed tomography images.

Summary of Technological Characteristics:

The device features of p.d are similar to the predicate device p.d (K083672) as both are software applications that design and order the same types of radiotherapy beam modifying devices, using nearly identical algorithms and processes. The new version however incorporates additional quality assurance measurement tools that are

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Image /page/5/Picture/0 description: The image shows the logo for ".decimal" in a simple, modern design. The word "decimal" is written in a sans-serif font, with the "." in blue and the rest of the word in gray. Below the logo is the tagline "The benchmark for custom radiation therapy" in a smaller font.

substantially equivalent to functionality found in most all major treatment planning systems (TPS), including the Eclipse TPS from Varian Medical Systems (K141283), which is used here as the predicate device for comparison of this functionality of our p.d software. It should be noted that the p.d device contains are very small subset of the functionality present in the Eclipse TPS, so specifically, the quality assurance measurements performed in p.d use algorithms that are similar to those used to build Digitally Reconstructed Radiographs (DRRs), which is a tool present in the Eclipse TPS. In addition, the semi-automatic image contouring tools of Eclipse utilize similar image processing and recognition techniques as those employed within p.d.

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.

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

The software for this device was considered as a "Major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator. Clinically oriented validation tests were written and executed by .decimal personnel and hospital-based testing partners. Validation tests included comparing results to those of known predicate devices as well as performing quality assurance measurements on devices of known quality. In addition this device was evaluated and conforms to ISO 14971, IEC 62083, IEC 61217, IEC 62304 and IEC 62366 standards. These tests show that the p.d software performed equivalently to the predicate device when appropriate and that the software is deemed safe and effective for clinical use.

Regulation Number and Section

§ 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.