The PTW DAVID is a transparent multiple wire or multiple segment ionization chamber with attached electronics. It is intended to be used as an IMRT QC check device to make verification measurements and provide documentation of the leaf positions and doses from medical accelerators used for IMRT radiotherapy sequences. Data acquired by the PTW DAVID is used to compare and to verify a treatment dose to a prescribed dose and to compile radiation bear data, consistency, over time as part of a quality assurance program.

Device Description

The PTW DAVID system MLC-29 is a transparent, segmented, multi-wire ionization chamber with 37 wires or segments. It is designed for operation in medical hierar accelerators with 29 multi-leaf collimator pairs.

The PTW DAVID system MLC-80 is a transparent, segmented, multi-wire ionization chamber with 40 wires or segments. It is designed for operation in medical hiear accelerators with 40 multi-leaf collimator pairs.

The PTW DAVID system MLC-120 and MLC-80 are transparent, segmented, multiwire ionization chamber with 80 and 40 wires or segments. They are desioned for operation in medical linear accelerators with 60 or 40 multi-leaf collimator pairs.

The software for the PTW DAVID is for recording or logging measurement data only.

AI/ML Overview

This document is a 510(k) premarket notification for the PTW DAVID, an IMRT QC check device. The device is intended for quality control verification measurements and documentation of leaf positions and doses from medical accelerators used for IMRT radiotherapy.

Based on the provided document, the following information regarding acceptance criteria and the study that proves the device meets them can be extracted:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
General
Compliance with IEC 60601-1	Met
Compliance with IEC 60601-1-2	Met
Compliance with UL 60601-1	Met
Compliance with ISO 9001 certification (manufacturing, testing, process, procedures)	Met
CE marked	Met (CE 0124)
Technological Characteristics
Meet or exceed predicate device specifications (PTW QC6Plus, K972211)	Met (stated that it "meet or exceed that of the predicate device since both devices are produced by the same manufacturer")
Safety and Effectiveness
No issues with regard to safety and effectiveness compared to predicate device	Met (based on compliance with standards and technological characteristics)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not provide details on a specific test set sample size or data provenance for proving the device's performance directly. The basis for acceptance is stated as compliance with relevant medical device standards and a comparison of technological characteristics to a predicate device.
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):
This information is not provided in the document. The acceptance is based on adherence to recognized standards and comparison to a predicate device, rather than a clinical trial with expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
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:
This information is not provided in the document. The PTW DAVID is an IMRT QC check device, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study demonstrating human reader improvement with AI assistance would not be applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document describes the PTW DAVID as an ionization chamber for QC verification measurements. Its performance evaluation, as described, is based on meeting technical specifications and compliance with standards, rather than an "algorithm-only" performance study in the context of diagnostic AI. The software is "for recording or logging measurement data only" (page 0), implying it processes raw data from the chamber. No specific standalone algorithm performance study is described in the document in the way it would be for an AI diagnostic device. The device's performance is intrinsically linked to the physical measurement capability of the ionization chamber.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as typically used in AI diagnostic studies (e.g., pathology for cancer detection) is not directly applicable or mentioned here. The "ground truth" for this device's performance would be the physically accurate measurement of leaf positions and doses from medical accelerators, verified by established calibration methods and adherence to industry standards for dosimetry devices.
The sample size for the training set:
This information is not provided in the document. The PTW DAVID is a physical measurement device, not a machine learning model that requires a training set in the conventional sense.
How the ground truth for the training set was established:
This information is not provided in the document, as it is not a machine learning device requiring a training set with established ground truth.

Summary of the study/evidence presented for acceptance:

The approval of the PTW DAVID device by the FDA (K062817) is based on a Substantial Equivalence (SE) determination to a legally marketed predicate device, the PTW QC6Plus (K972211). The manufacturer's argument for substantial equivalence is primarily founded on:

Comparison of Technological Characteristics: The PTW DAVID is stated to "meet or exceed that of the predicate device" because both are produced by the same manufacturer.
Compliance with Recognized Standards: The device is designed in full accordance with IEC 60601-1, IEC 60601-1-2, and UL 60601-1 for medical electrical equipment safety and electromagnetic compatibility.
Quality System Compliance: The manufacturing, testing, process, and procedures comply with ISO 9001 certification.
CE Marking: Both the device and its predicate are CE marked (CE 0124).
Intended Use Equivalence: The intended use of the PTW DAVID is consistent with its function as an IMRT QC check device for verification measurements and documentation, comparing treatment dose to prescribed dose, and compiling radiation beam data for quality assurance.

The document implicitly relies on the predicate device's established safety and effectiveness, and the PTW DAVID's adherence to relevant standards and equivalent or superior technological characteristics, to demonstrate its own safety and effectiveness. It does not present a de novo clinical trial or performance study with a specific test set, ground truth acquisition by experts, or AI-specific performance metrics.

Summary

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PTW-New York Corporation 205 Park Ave., Hicksville, New York 11801 (P) 1-516-827-3181 (F) 1-516-827-3184

510(k) Premarket Notification for the PTW DAVID, an IMRT QC Check Device

Manufacturer's 510(k) Summary Certification, 21 CFR 807.92(h):

1. Company:
  PTW-New York Corporation 205Park Avenue Hicksville, New York 11801 (P) 1-516-827-3181 (F) 1-516-827-3184

NOV 2 2 2005

Contact:

Richard D. Barker PTW-New York Corporation (P) 1-516-827-3181 (F) 1-516-827-3184

Date of Submission: July 18, 2006

1. Trade/Proprietary Name: PTW DAVID
  Common/Usual Name: IMRT QC check device
1. Predicate Device(s): PTW QC6Plus, K972211

4. Description(s) of Device:

The software for the PTW DAVID is for recording or logging measurement data only.

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PTW-New York Corporation 205 Park Ave., Hicksville, New York 11801 (P) 1-516-827-3181 (F) 1-516-827-3184

510(k) Premarket Notification for the PTW DAVID, an IMRT QC Check Device

Manufacturer's 510(k) Summary Certification, 21 CFR 807.92(h) (continued):

5. Statement of Intended Use:

The PTW DAVID is a transparent, multiple wire or multiple segment ionization chamber intended to be used for QC verification measurements and documentation of the leaf positions and doses from medical accelerators used for IMRT radiotherapy sequences. Data acquired by the PTW DAVID is used to compare and to verify a treatment dose to a prescribed dose and to compile radiation beam data, consistency, over time as part of a quality assurance program.

6. Comparison of Technological Characteristics to the Predicate Devices:

The technological specifications of the PTW DAVID meet or exceed that of the predicate device since both devices are produced by the same manufacturer.

Safety and effectiveness between the Dosimetry Diode and the predicate device is not an issue since the PTW DAVID is designed in full accordance with the applicable sections of the following standards:

IEC 60601-1:	Medical Electrical Equipment - Part 1: General requirementsfor safety and essential performance,
IEC 60601-1-2:	Medical Electrical Equipment - Electromagnetic emissionscompatibility – Requirements and tests
UL 60601-1:	US Medical Equipment -Part 1: General requirements safetyand essential performance.

The manufacturing, testing, and the process and procedures that are used to produce the PTW DAVID and the predicate device are in full compliance with our ISO 9001 certification. Both devices are CE marked with CE 0124.

It is our opinion that the indications for use, design, materials, manufacturing, and specifications of the PTW DAVID do not raise any issues with regard to safety and effectiveness

PTW considers the PTW DAVID to be substantially equivalent to the predicate device.

Any statement made in conjunction with this Summary regarding substantial equivalence Note: to another product was made in relation to the 510(k) premarket approval process and should not be interpreted as an admission or used as evidence in patient infringement litigation.

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Image /page/2/Picture/1 description: The image shows a circular seal or logo. The text "DEPARTMENT OF HEALTH & HUMAN" is arranged around the left side of the circle. To the right of the text is a symbol consisting of three abstract human figures or shapes, stacked vertically. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

NOV 2 2 2006

Mr. Richard D. Barker Official Correspondent PTW- New York Corporation 205 Park Avenue NICKSVILLE NY 11801

Re: K062817

Trade/Device Name: PTW-DAVID Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 12, 2006 Received: September 26, 2006

Dear Mr. Barker:

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, or and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You most, therefore, market the device, subject to the general controls provisions of the Act. That. 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 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Protecting and Promoting Public Health

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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); 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.

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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2 -

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K062817

510(k) Number (if known):

Device Name:

PTW DAVID

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✓

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K062817

(Optional Format 3-10-98)

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.