The PC Electrometer Model 1014 is a dosimetry electrometer intended for measuring the output charge of an ion chamber in a radiotherapy beam and using these measurements in dosimetry protocols, such as Report 67 as recommended by the AAPM Task Group #51. . In addition the PC Electrometer Model 1014 is intended for measurements with ion chamber or diode detectors as recommended during periodic QA testing protocols such as Report 46, Comprehensive QA for Radiation Oncology, as recommended by the AAPM Task Group #40. as well as AAPM Report 13 (TG-22, 24 and soon to be published TG-142, an update to TG-40.

Device Description

The PC Electrometer Model 1014 has two triaxial BNC inputs for connection to ion chambers for dosimetric measurements. The ion chamber voltage bias can be adjusted to various levels at either polarity. For air density correction, there are internal temperature and pressure sensors that measure ambient conditions and an input for an external remote temperature sensor. A USB port provides power and data communication with a Personal Computer (PC) which runs the application software to display and record data; an auxiliary power jack is also provided in case USB power is not available. The conductive enclosure (4cm x 10.5cm x 14cm) provides EMI shielding and LED status indicators. The PC Electrometer Model 1014 is a Radiation Oncology Medical Physics tool used to measure ion current from either ion chambers or diode dosimeter. These applications include periodic or annual calibration of the radiation output of the delivery machine when a calibrated ion chamber is connected such as AAPM Report 67 (TG-51) as well as periodic QA applications that do not require calibrated radiation detectors, such as described in AAPM Report 13 (TG-22, 24), AAPM Report 46 (TG-40) TG-40 and soon to be published TG-142, an update to TG-40.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the PC Electrometer Model 1014 does not explicitly state acceptance criteria in a quantitative format, nor does it present device performance data in a dedicated table. Instead, it establishes substantial equivalence to a predicate device (Sun Nuclear Model 1010 Dosimetry Electrometer #K002444) based on functional similarities and intended use. The performance evaluation is implied through the comparison of features and intended applications, demonstrating that the new device is suitable for the same tasks as the predicate.

However, based on the description of the device and its intended use, the implicit acceptance criteria would revolve around its ability to accurately measure the output charge of ion chambers and diode detectors for dosimetry protocols and QA testing in radiation oncology. The reported performance is that it meets the same intended uses and performs similar functions to the predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance (Implied from Substantial Equivalence)
Accurate Measurement of Ion Chamber Output Charge: Capable of measuring output charge from ion chambers for dosimetry protocols like AAPM Report 67 (TG-51).	The device is intended for measuring the output charge of an ion chamber in a radiotherapy beam and using these measurements in dosimetry protocols, such as Report 67 as recommended by the AAPM Task Group #51. This implies it performs this function with acceptable accuracy, similar to the predicate device which is legally marketed for the same purpose.
Accurate Measurement of Diode Detector Output: Capable of measuring output from diode detectors for QA testing protocols like AAPM Report 46 (TG-40) and Report 13 (TG-22, 24, and TG-142).	The device is intended for measurements with ion chamber or diode detectors as recommended during periodic QA testing protocols such as Report 46, Comprehensive QA for Radiation Oncology, as recommended by the AAPM Task Group #40. as well as AAPM Report 13 (TG-22, 24 and soon to be published TG-142, an update to TG-40. This indicates similar performance to the predicate for these applications.
Adjustable Ion Chamber Voltage Bias: Ability to adjust voltage bias at either polarity.	Stated as a similarity: Both have ion chamber voltage bias that can be adjusted to various levels at either polarity.
Data Communication/Logging Capability: Ability to power and communicate with a PC for data display and recording.	Stated as a difference and improvement over the predicate, indicating this functionality is present: 1014 has data logging ability to the PC; the 1010 required a SNC Data Bridge for data logging. (Power comes from USB connection).
Temperature and Pressure Compensation: Internal and external temperature and internal pressure sensors for air density correction.	Stated as a difference and improvement over the predicate, indicating this functionality is present: 1014 has (internal and external) temperature sensors and an internal pressure sensor, 1010 has none unless it was connected to the SNC Data Bridge.
Dual Detector Inputs:	Stated as a difference and enhancement over the predicate, indicating this functionality is present: 1014 has 2 detector inputs, 1010 has one.
EMI Shielding: Provision of EMI shielding for stable measurements.	Stated as a feature: The conductive enclosure (4cm x 10.5cm x 14cm) provides EMI shielding and LED status indicators.

2. Sample Size Used for the Test Set and the Data Provenance

The provided document is a 510(k) premarket notification summary. For devices of this nature (electrometers not considered imaging AI devices), the "test set" in the context of clinical studies (like those for AI/ML) is not applicable or described in this document. Substantial equivalence for this type of device is typically established through engineering bench testing, performance verification against specifications, and comparison to a predicate device, rather than patient-level data.

Sample Size for Test Set: Not applicable/not specified in the provided document. The evaluation relies on comparing the device's technical specifications and functionalities to a legally marketed predicate device.
Data Provenance: Not applicable, as there are no clinical data sets described. The "data" evaluated would be performance metrics gathered during engineering and functional validation, compared to the predicate's known performance and specifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is an electrometer, a measurement tool used in medical physics. Its "ground truth" is defined by physical principles and established measurement standards (e.g., AAPM reports), not by expert interpretation of patient data or images. Therefore, the concept of experts establishing ground truth for a test set in this context is not relevant to the information provided.

4. Adjudication Method for the Test Set

Not applicable. Since there is no "test set" in the context of clinical images or patient data requiring expert ground truth and adjudication, no such method is described.

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. The PC Electrometer Model 1014 is a standalone medical physics measurement device, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, an MRMC study or an AI assistance evaluation is not relevant to this submission.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in essence, the fundamental evaluation of an electrometer is its "standalone" performance. The device itself (the PC Electrometer Model 1014) is designed to perform its function (measuring charge) independently of real-time human interpretation needing "assistance" from an AI algorithm. Its performance is assessed based on its ability to accurately and reliably measure physical quantities, as demonstrated through engineering testing and comparison to the predicate device's established performance under specified conditions.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established by physical measurement standards, calibration protocols, and established dosimetry guidelines (e.g., AAPM Report 67, Report 46, Report 13). The device's performance is validated against these accepted physical principles and the known performance of a legally marketed predicate device that also adheres to these standards. It is not based on expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set. Its development involves traditional engineering design, manufacturing, and calibration processes.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is used for this type of device.

Summary

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SEP 1 5 2009

510k Premarket Notification Summary

1692019

Submitted by:

Sun Nuclear Corporation 425-A Pineda Court Melbourne, FL 32940 Ph: 321-259-6862 Fax: 321-259-7979

Classification Name: Unknown

Common Name: Electrometer

Proprietary Name: PC Electrometer - Model 1014

Establishment Registration Number: 1038814

Classification: Class II, Classification 901YE

To our knowledge, none have been established Performance Standards:

Substantial Equivalence: This instrument is similar in function to Sun Nuclear Model 1010 Dosimetry Electrometer #K002444

Description and Use:

5-1

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Intended Use:

Similarities and Differences between SNC Model 1010 and SNC Model 1014:

Similarities:

1. Both designed and manufactured by Sun Nuclear.
1. Both have similar Intended Uses
1. Both use high impedance operational amplifiers with capacitors to measure charge
1. Both measure bi-polar charge (current) from ion chambers and diode radiation detectors
1. Both have ion chamber voltage bias that can be adjusted to various levels at either polarity.

Differences:

1. 1014 has 2 detector inputs, 1010 has one
1. 1014 has (internal and external) temperature sensors and an internal pressure sensor, 1010 has none unless it was connected to the SNC Data Bridge.
1. 1014 has data logging ability to the PC; the 1010 required a SNC Data Bridge for data logging.
1. 1014 power comes from USB connection. 1010 uses internal batteries for power.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle.

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

SEP 1 5 2009

Ms. Noel Downey Project Manager Sun Nuclear Corporation 425-A Pineda Court MELBOURNE FL 32940

Re: K092019

Trade/Device Name: 1014 - PC Electrometer Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 24, 2009 Received: July 6, 2009

Dear Ms. 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 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/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,

[signature]

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K092019

Device Name: 1014-PC Electrometer

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Perseription Use

ार

Over-The-Counter Use

Norri hothang

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number

4-1

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.