The Model 580-006 Radiation Therapy Ionization Chamber is modeled after the traditional 0.6cm Farmer-type chamber used for absolute dosimetry measurements of medical linear accelerators and 900 machines. Each chamber includes an energy response chart, a PMMA 600 buildup cap, a convenient low noise one meter cable with triaxial BNC connector and a custom carrying case.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Summary for a medical device, the Model 580-006 Radiation Therapy Ionization Chamber. This type of document is for demonstrating substantial equivalence to a predicate device, not for a study proving device performance against acceptance criteria in the way a clinical trial or AI algorithm validation would.

Therefore, many of the requested categories (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance for AI, and ground truth establishment for training) are not applicable to this type of regulatory submission for a physical medical device like an ionization chamber. The "study" here is essentially the comparison of specifications and characteristics to a predicate device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not present or not applicable to this type of device submission:

Acceptance Criteria and Device Performance Study Summary

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

The document provides a "Specification Comparison Table" where the new device (Model 580-006) specifications are presented alongside the predicate device (Model 500-6) specifications. In the context of a 510(k) submission, the "acceptance criteria" are generally that the new device's specifications and performance fall within an acceptable range, demonstrating substantial equivalence to the predicate device, or that any differences do not raise new questions of safety or effectiveness. The table below presents the new device's specifications as its "reported performance" and the predicate device's specifications as the "benchmark" for substantial equivalence.

Feature	Predicate Device (Model 500-6) (Acceptance/Benchmark)	New Device (Model 580-006) (Reported Performance)
Volume	0.6 cm³	0.61 cm³
Sensitivity	2 x 10⁻¹⁰ A/R/s	2.0 x 10⁻⁸ cGy⁻¹
Leakage	< 10⁻¹⁵ A	< 4 x 10⁻¹⁵ A
Wall Material	Tissue equivalent plastic	PMMA acrylic with graphite layer
Wall area material density	58 mg/cm²	78.5 mg/cm²
Collector	Tissue equivalent plastic	Pure aluminum, 1mm diameter x 20.0mm long
Cable length	15 meters	1 meter
Range of Temperature	+10°C to +40°C	+10°C to +40°C
Relative air humidity	20% to 75%, non-condensing	75%, non-condensing
Build-up cap material	Acrylic 1.2 g/cm³	PMMA for ⁶⁰Co
Chamber length	24.4 mm	23.6 mm
Chamber diameter	7.1 mm	5.95 mm
Build-up cap diameter	13.3 mm	16.3 mm
Probe length	124 mm	157 mm
Energy Range without build-up cap	70keV to 662 keV	21keV to 662 keV
Energy Range with build-up cap	1.2 MeV to 1.5 MeV	662 keV to 1.5 MeV
Maximum exposure range for 99.5% efficiency @ 300 V	4000 R/min	3.0Gy s⁻¹

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. This document describes a physical device and its specifications, not a study involving a test set of data/patients. The "test" is the device's adherence to its own design specifications and comparison to a predicate device.
Data provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth in this context would refer to the physical and electrical properties of the device, which are established through engineering design, manufacturing, and calibration, not by expert consensus on a test set of data. The document mentions manufacturing in compliance with standards and calibration by an approved calibration lab.

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

Not applicable. There is no test set or adjudication process in the sense of expert review of data for this device submission.

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 not an AI/software device and does not involve human readers interpreting data.

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

Not applicable. This is not an algorithm or AI device. The device's "standalone" performance is its ability to meet its technical specifications, which are implicitly demonstrated by the specification table and the claim of substantial equivalence.

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

The "ground truth" for this device, regarding its performance, is its physical and electrical specifications as measured and calibrated against established physical standards (e.g., NIST techniques M50, M250, Cesium 137, and Cobalt 60, as mentioned under "Calibration"). The substantial equivalence is based on engineering and performance characteristics compared to the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary

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Victoreen, LLC

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EXHIBIT A

Image /page/0/Picture/4 description: The image shows the word "VICTOREEN" in bold, black letters. The letters are capitalized and evenly spaced. The word is set against a white background and is enclosed in a black border.

Premarket notification [510(k)] Summary as required by section 807.92 (c)

Date Summary was prepared:

August 18, 1998

Submitter's Name:

Victoreen, LLC 6000 Cochran Road Cleveland, OH 44139-3395

Contact Person:

Mary Jo Nero Quality Assurance Associate Phone: (440) 248-9300 ext. 215 Fax: (440) 248-9301

Device Name:

Model 580-006 Radiation Therapy Ionization Chamber

Classification Name:

Medical Charged-Particle Radiation Therapy System

Predicate Device Name:

Model 500-6 Radiation Therapy Ionization Chamber 510(k) Number: K932342

6000 Cochran Road Cleveland. Ohio 44139-3395 (440) 248-9300 FAX (440) 248-9301 (800) 850-4608

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Performance Standards Under Section 514:

Labeling:

Label: Advertising Brochure: (Product Data Sheet)

Model 580-006 New Device No Performance Standard established for this device

Reference Exhibit C

Model 500-6 Predicate Device

No Performance Standard established for this device

500-6 Reference Exhibit B

Intended Use:

This instrument is intended for the purpose of calibrating and measuring the ionizing radiation outputs from medical therapy machines.

580-006

Product Description

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Specification Comparison Table

Feature	New DeviceModel 580-006	Predicate DeviceModel 500-6
Volume	0.61 cm³	0.6 cm³
Sensitivity	2.0 x 10⁻⁸ cGy⁻¹	2 x 10⁻¹⁰ A/R/s
Leakage	<4 x 10⁻¹⁵ A	< 10⁻¹⁵ A
Wall Material	PMMA acrylic withgraphite layer	Tissue equivalent plastic
Wall area material density	78.5 mg/cm²	58 mg/cm²
Collector	Pure aluminum, 1mmdiameter x 20.0mm long	Tissue equivalent plastic
Cable length	1 meter	15 meters
Range of Temperature	+10°C to +40°C	+10°C to +40°C
Relative air humidity	75%, non-condensing	20% to 75%, non-condensing
Build-up cap material	PMMA for ⁶⁰Co	Acrylic 1.2 g/cm³
Chamber length	23.6 mm	24.4 mm
Chamber diameter	5.95 mm	7.1
Build-up cap diameter	16.3 mm	13.3 mm
Probe length	157 mm	124 mm
Energy Range without build-up cap	21keV to 662 keV	70keV to 662 keV
Energy Range with build-upcap	662 keV to 1.5 MeV	1.2 MeV to 1.5 MeV
Maximum exposure range for99.5% efficiency @ 300 V	3.0Gy s⁻¹	4000 R/min

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Similarities to predicate device (500-6)

The 580-006 and the predicate device are similar. Both units are an air filled ionization chamber that produce a current when exposed to ionizing radiation produced by a medical therapy machine. The 580-006 and the 500-6 are connected to an approved electrometer by a triaxial BNC connector.

Differences to predicate device

The 580-006 uses a pure aluminum electrode while the 500-6 uses a tissue equivalent plastic electrode. Also the 580-006 uses a PMMA acrylic chamber material coated with a graphite material while the 500-6 uses a tissue equivalent plastic for it's chamber material. The 580-006 has a wider energy response range ( 21 keV to 662 keV) than the 500-6. (70 keV to 662 keV)

Possible Customer Use and Misuse

The customer may use this devise as a quality assurance or a absolute dosimetry measurement of a medical therapy machine, with the appropriate electrometer, when calibrated by the necessary approved calibration lab. A misuse may occur if the user forgets or does not use the appropriate build-up material for the energy of the radiation that they are measuring.

Fail Safe / Safety

The 580-006 will not produce the appropriate current if it is not connect properly to an electrometer. The 300-500VDC bias voltage is present only on the inside of the chamber and can not be touched by the operator.

Risk / Hazard Analysis

A Risk / Hazard Analysis has been conducted on this product per Victoreen product development procedures.

This product is used to measure the absolute dose outputs from medical therapy machines. The device is not used to monitor the dose delivered to the patient during treatment. Since the devise is used only by a qualified medical physicist and must be calibrated on a periodic cycle, by a qualified calibration lab, it does not affect the administration of radiation to the patient or the performance of the therapy machine.

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Failure Mode

The 580-006 triaxial connector may fail electrically. This failure will be evident to the user by either physically touching the connector or the electrometer failure to measure the correct current.

Labeling. Warnings, Standard Identification

Product marking will include: Victoreen. Model Number and serial number.

All advertising, brochures, sales literature, etc. will conform to FDA and Victoreen Standards.

Warning:

This device is intended to be used for the detection and measurment of ionizing radiation. It should be used only by persons who have been trained in the proper interpretation of its readings and the appropriate safety procedures to be followed in the presence of radiation.

Although the equipment was designed and manufactured in compliance with all applicable safety standards, certain hazards are inherent in the use of electronic and radiometric equipment.

Calibration

Factory calibration of the product will, at a minimum, consist of a calibration factor for the following NIST techniques M50, M250, Cesium 137 and Cobalt 60, This calibration will not be used as a substitute for an approved calibration facility for the measurement of absolute dose.

Storage Needs / Shelf Life / Disposability

Shelf life is indefinite. Storage shall be in a cool, dry environment free of corrosive materials, fluctuation in temperature and humidity, or vibration and shock. There are no disposability restrictions.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 1000

Edward W. Siurek III Director of Regulatory Affairs & Quality Assurance Victoreen, LLC 6000 Cochran Road Cleveland, Ohio 44139

Re: K982937

Model 580-006 Radiation Therapy Ionization Chamber Dated: August 19, 1998 Received: August 21, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 LHN

Dear Mr. Siurek:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been resided in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Fecteral Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in riting diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrf/dsmadsmamain.html".

Sincerely yours,

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE STATEMENT

Page 1 of 1 _

510(k) Number (if known): __Unknown ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

This instrument is intended for the purpose of calibrating and measuring the ionizating radiation outputs for medicas therapy machines.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

David L. Bryson
Revision Sign-Off

Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number _

Prescription Use X
(Per 21CFR801.109)

Over-the-Counter Use____________ OL

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.