The 3D Scanner system, model 1230, is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program.

Device Description

The 3D Scanner Model 1230 is an electromechanical and software system that includes:

a cylindrical tank to contain the water:
a 3 axis computer controlled scanning mechanism that is mounted on the tank,
a field detector mount that moves with the scan mechanism,
a reference detector mount that remains stationary during a scan,
electrometers with chamber polarization voltage supplies for said mounted detectors,
motor controllers for the 3 axis scanning mechanism,
a water level sensor that locates the water surface,
computer code that controls the detector location and records the detector's dosimetry data,
a user interface to the computer that enables
a. automatic data collection at pre-programmed field detector locations,
b. data processing and analysis that enable data transfer to the TPS system,
an optional EDGE detector (diode) for waterproof Field scanning and Reference
an optional leveling platform
an optional lift table accessory to support the tank

AI/ML Overview

Here's an analysis of the provided text regarding the 3D Scanner Model 1230, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Premarket Notification Summary from 2010. For this type of device (a medical physics tool for radiation oncology dosimetry), the "acceptance criteria" and "device performance" are typically related to its ability to accurately measure radiation beams and provide data compatible with treatment planning systems, rather than clinical outcomes on patients. The "study" here refers to the demonstration of substantial equivalence to a predicate device. This is not a clinical trial with patient data or a typical AI/ML study.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets in the way one might see for, say, an imaging device's sensitivity or specificity. Instead, the substantial equivalence hinges on functional similarity and intended use compared to the predicate device. The "performance" is implicitly demonstrated by comparing the device's capabilities to the predicate.

The core "acceptance criteria" can be inferred from the "Similarities with Marketed Devices" section, which outlines the functional capabilities that make the new device equivalent to the predicate. The "reported device performance" is the statement that the SNC 3D Scanner Model 1230 possesses these same capabilities.

Acceptance Criteria (Inferred from Similarities)	Reported Device Performance (as described for SNC 3D Scanner Model 1230)
Functional Equivalence to Predicate Device (IBA RFA-200):
1. Ability to move and position a water-resistant radiation detector in a tank containing water.	Provides a field detector mount that moves with the scan mechanism. Incorporates a 3-axis computer-controlled scanning mechanism.
2. Ability to measure the response of the detector to quantify relative dose distribution.	Utilizes electrometers with chamber polarization voltage supplies for mounted detectors. Measures the response of the detector to quantify the relative dose distribution resulting from therapeutic radiation beam interaction in water.
3. Ability to record position and response data systematically for TPS commissioning.	Provides computer code that controls detector location and records dosimetry data. Enables automatic data collection at pre-programmed field detector locations. Enables data processing and analysis to transfer data to the TPS system.
4. Field detector mount that moves with the scan mechanism.	Present.
5. One axis for profile scans (in-plane and cross-plane) keeping detector orientation to beam edge.	Present. (The 3D Scanner Model 1230 provides a ring axis for rotation of the profile scan axis, which is an improvement over manual rotation, but still meets the core function of enabling profile scans).
6. Reference detector mount that remains stationary during a scan.	Present.
7. Electrometers with chamber polarization voltage supplies.	Present. (Specifically mentions PC Electrometer Model 1014).
8. Motor controllers for scanning mechanisms.	Present.
9. Computer code controlling detector location and recording dosimetry data.	Present.
10. User interface for automatic data collection, processing, analysis, and TPS data transfer.	Present. (Includes features for automatic data collection, data processing/analysis, basic analysis of beam data tools (e.g., symmetry, flatness, penumbra), and export of beam data to the Treatment Planning System).
11. Intended Use: Radiotherapy dosimetry measurements for TPS commissioning and periodic QA.	Present. The system "is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program." This directly matches the predicate's inferred intended use.

Study Details

This document describes a substantial equivalence submission, not a clinical study in the traditional sense, especially not for an AI/ML device. The "study" is a comparison of the new device to a legally marketed predicate device to demonstrate that it is as safe and effective.

Sample size used for the test set and the data provenance:
- There is no "test set" in the context of patient data or clinical images. The "test" consists of comparing the features and specifications of the SNC 3D Scanner Model 1230 against those of the predicate device (IBA RFA-200) and ensuring the intended use is the same.
- Data Provenance: The comparison is based on the functional description and intended use of the predicate device, as obtained from IBA literature (manuals, datasheets, system manuals). It does not involve experimental data from the predicate device itself, nor does it specify country of origin for such data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in this context. "Ground truth" for this regulatory submission is established by reference to the predicate device's documented functions and specifications, and potentially by widely accepted standards for radiation dosimetry (e.g., AAPM TG-142), rather than expert adjudication of clinical cases.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no "test set" of cases requiring adjudication by experts.
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 study was done, as this is not an AI/ML diagnostic device with human readers. This device is a measurement tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a measurement system, not a standalone algorithm. While its "computer code" controls functions automatically, its performance is evaluated based on its functional equivalence as a dosimetry tool, not as an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission is the functional definition and intended use of the predicate device (IBA RFA-200), as well as the generally accepted principles and guidelines for medical accelerator quality assurance (e.g., AAPM TG-142). The new device is substantially equivalent if it performs the same function in a similar manner for the same intended use.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set. The device's design and engineering are based on established physics and engineering principles for radiation dosimetry.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML model. The "truth" for the development of such a device is rooted in physics and engineering standards for accurately measuring radiation.

Summary

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510k Premarket Notification Summary

Date: July 13, 2010

K101992

Submitted by:

OCT 1 2010

Classification Name: Accelerator, Linear, Medical

Sun Nuclear Corporation 425-A Pineda Court

Melbourne. FL 32940 Ph: 321-259-6862 Fax: 321-259-7979 Attn: Noel Downey

Common Name: Water Phantom lonizing Radiation Dosimetry Scanner

Proprietary Name: 3D Scanner

Establishment Registration Number: 1038814

Classification: Class II, Classification IYE

Performance Standards: To our knowledge, none have been established

Substantial Equivalence: This instrument is similar in function to IBA RFA- 200. SNC was not able to specifically identify the RFA-200 510k identification number in the FDA database, it may be a subset of the RFA-300 510k (Scanditronix RFA A-300), K934303. This is substantiated by references to RFA-200 in RFA-300 documentation.

Description and Use:

The 3D Scanner Model 1230 is an electromechanical and software system that includes:

1. a cvlindrical tank to contain the water:
1. a 3 axis computer controlled scanning mechanism that is mounted on the tank,
a field detector mount that moves with the scan mechanism, ဘဲ့
a reference detector mount that remains stationary during a scan, ধ:
electrometers with chamber polarization voltage supplies for said mounted detectors, 5.
motor controllers for the 3 axis scanning mechanism, ర్.
a water level sensor that locates the water surface, 7.
computer code that controls the detector location and records the detector's dosimetry 8. data,
1. a user interface to the computer that enables
- a. automatic data collection at pre-programmed field detector locations,
- b. data processing and analysis that enable data transfer to the TPS system,
1. an optional EDGE detector (diode) for waterproof Field scanning and Reference
1. an optional leveling platform

an optional lift table accessory to support the tank

4- | -

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The Sun Nuclear 3D Scanner (Three Dimensional Scanner), Model 1230, is a Radiation Oncology Medical Physics tool used to measure in water the beam characteristics from a delivery machine, such as percent dose curves and beam profiles. The application includes radiotherapy Cobalt 60 and/or LINAC beam acceptance data collection for the treatment planning system (TPS) commissioning of the beam models, as well as periodic or annual measurements of the radiation beams from the delivery machine as described in guidelines such as AAPM TG-142: Quality Assurance of medical accelerators, Med. Phys, 36 (9), Sept 2009. pp 4197 - 4212.

The 3D Scanner electrometer (PC Electrometer Model 1014, 510(k) # K092019) was developed by SNC with functionality that envisioned eventual use in a dosimetry scanner. It incorporates high impedance circuitry that provides the basic means for radiation detection measurement from the same types of detectors that are used in a dosimetry scanner as well as data logging and communication that is essential to the scanner function.

Intended Use:

ﺗﺮ

The 3D Scanner system, model 1230, is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) fests as defined by the medical physicist responsible for the QA program.

Similarities and Differences between SNC Model 1230 and IBA RFA-200:

The SNC 3D Scanner Model 1230 conforms to existing technologies that map dose distributions in water.

The technology consists of

1. the ability to move and position encode a water resistant radiation detector in a fank containing water and
1. the ability to measure the response of the detector so as to quantify the relative dose distribution resulting from the transport interaction of the therapeutic radiation beam in water with
1. the ability to record the position and response data in a systematic manner that allows commissioning work flow of the delivery machine that is consistent with the TPS needs

These are the same technologies that are incorporated in the predicate device IBA RFA-200, as well as other models of dosimetry scanners manufactured by IBA (Scanditronix Wellhofer, Schwarzenbruck, Germany), and PTW (Frieburg, Germany).

RFA-200 Intended Use References:

Since the FDA database did not contain the Intended Use of the RFA-200, we offer the following excerpts from IBA literature on the RFA-200:

1. RFA-200 Manual [DAA100 90006 01] Health and safety pg 14 "The person managing the RFA-200 bears the full responsibility for critically evaluating every measurement result and/or manipulating measurements before transferring the data to a treatment planning system."
1. RFA-200 Datasheet:

"The RFA-200 is a two-dimensional radiation field analyzer, designed for commissioning, acceptance, testing and regular QA of linear accelerators. ... "

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1. RFA-200 is operated with OmniPro™ -- Accept Software, which provides an Intended Use statement in the System Manual [DAA011 90003 07] Overview pg1 "OmniPro Accept is a system software utilizing hardware components to measure radiation dose distribution. The hardware consists of water phantoms, air scanners, film scanner/digitizers, and single or array detectors. The hardware is produced by Scanditronix Wellhofer AB, the sister company Scanditronix Wellhofer Gmbh, and by 30 party vendors.
  OmniPro Accept is used to accurately analyze and handle the measured dose distribution for quality assurance purposes, for calibration of radiation devices as input data to treatment Planning Systems, for acceptance testing, beam tuning, and in research."

Similarities with Marketed Devices:

The SNC 3D Scanner Model 1230 dosimetry Scanner and IBA RFA-200:

1. Both provide a field detector mount that moves with the scan mechanism.
1. Both provide one axis for profile scans on in-plane and cross-plane and keep the detector orientation the same with respect to the beam edge
1. Both provide a reference detector mount that remains stationary during a scan,
1. Both provide a electrometers with chamber polarization voltage supplies for said mounted detectors.
1. Both provide motor controllers for the scanning mechanisms.
1. Both provide computer code that controls the detector location and records the detector's dosimetry data.
1. Both provide a user interface to the computer that enables
- a. automatic data collection at pre-programmed field detector locations.
- b. data processing and analysis that enable data transfer to the TPS system,
- c. basic analysis of beam data tools, e.g. symmetry, flatness, penumbra
- d. export of beam data to the Treatment Planning System
1. Their intended use is essentially the same. The underlined emphasis in the RFA-200 Intended Use References points out the primary points of agreement.

Differences with Marketed Devices

The SNC 3D Scanner Model 1230 and IBA RFA-200 have the following differences:

1. To contain the water.
- A. 3D Scanner Model 1230 provides a cvlindrical tank {676 mm (D) x 485 mm (H)};
- B. RFA-200 provides a rectangular tank (638 mm (L) x 440 mm (W) 440 mm (H)}.
1. 3D Scanner Model 1230 provides Ring axis for rotation of the profile scan axis, the RFA-200 requires manual rotation of the profile scan axis (the user rotates the tank),
1. 3D Scanner Model 1230 provides a water level sensor that locates the water surface, the RFA-200 requires manual location by the user sighting the detector/water interface through the acrylic wall
1. 3D Scanner Model 1230 provides profile scan range of 660 mm and depth scan of 400 mm:, the RFA-200 provides profile scan range of 495 mm and depth scan of 300 mm.
1. 3D Scanner Model 1230 full weight is 218 kg. RFA-200 full weight is 135 kg

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services-USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Noel Downey Project Materials Manager Sun Nuclear Corporation 425 Pineda Court MELBOURNE FL 32940

DCT 1 2010

Re: K101992

Trade/Device Name: 1230-3D Scanner Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: July 1, 2010 Received: July 15, 2010

Dear Mr. Downey:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 200). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally vicinal see predicate device results in a classification for your device and thus, overnits your device to proceed to the market.

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 Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse vents 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/cdrh/industry/support/index.html.

Sincerely vours.

Donald J. Trump

Donald J. St.Pierre Acting 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): _ < 1 0 | 992

Device Name: __ 1230- 3D Scanner

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Bevice Evaluation (SDD) S

Perscription Use

Over-The-Counter Use

(Division Sign-Off) Division of Radiological Devices ്

510K

3-1

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.