The ACQPLAN is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan is intended to be used to plan radiation therapy treatments on linear accelerators and other similar teletherapy devices with x-ray beams of energies from 4 to 50 MV, cobalt-60, and electron beams with energies from 4 to 50 MeV of the entire human anatomy. It allows the treatment planner to employ such techniques as asymmetrically collimated fields, irregular fields, multi-leaf collimators, non-coplanar fields, bolus, fixed wedges, and Varian's enhanced dynamic wedges. It allows the treatment planner to take heterogeneities into account for photon beams using two versions of the Batho method or the Equivalent TAR (ETAR) method, and it uses a generalized Gaussian pencil beam model for electron beams. Using AcQPlan, the treatment planner can simultaneously visualize target and normal tissues and the computed 3-D dose distributions in great detail, on a real-time basis. The treatment planner develops treatment plans in a coordinate system accurately fixed to set-up marks on the patient, using CT and multi-modality information made possible by volumetric 3-D image processing. Tools for managing competing and complementary plans are provided. Tools, based on DVH plots, are provided for comparing competing plans. High quality DRRs and DCRs (digitally composited radiographs), with BEV and beam graphics superimposed, are generated to replace conventional simulator films. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

Device Description

The ACQPLAN is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan is intended to be used to plan radiation therapy treatments on linear accelerators and other similar teletherapy devices with x-ray beams of energies from 4 to 50 MV, cobalt-60, and electron beams with energies from 4 to 50 MeV of the entire human anatomy. It allows the treatment planner to employ such techniques as asymmetrically collimated fields, irregular fields, multi-leaf collimators, non-coplanar fields, bolus, fixed wedges, and Varian's enhanced dynamic wedges. It allows the treatment planner to take heterogeneities into account for photon beams using two versions of the Batho method or the Equivalent TAR (ETAR) method, and it uses a generalized Gaussian pencil beam model for electron beams. Using AcQPlan, the treatment planner can simultaneously visualize target and the computed 3-D dose distributions in great detail, on a real-time basis. The treatment planner develops treatment plans in a coordinate system accurately fixed to set-up marks on the patient, using CT and multi-modality information made possible by volumetric 3-D image processing. Tools for managing competing and complementary plans are provided. Tools, based on DVH plots, are provided for comparing competing plans. High quality DRRs and DCRs (digitally composited radiographs), with BEV and beam graphics superimposed, are generated to replace conventional simulator films. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

AI/ML Overview

The provided text for the Picker K974770 ACQPLAN describes a radiation therapy treatment planning system. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving device performance.

The document is a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results for novel performance claims.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Functional Specifications:
Plan radiation therapy treatments on linear accelerators, teletherapy devices (x-ray: 4-50 MV, cobalt-60, electron: 4-50 MeV) for entire human anatomy.	The device is intended to perform these functions. The statement "The product will perform in accordance with the development specifications" indicates internal testing, but no specific performance metrics or thresholds are provided for review.
Support techniques: asymmetrically collimated fields, irregular fields, multi-leaf collimators, non-coplanar fields, bolus, fixed wedges, Varian's enhanced dynamic wedges.	The device allows for these techniques. Similar to above, no performance metrics are given.
Account for heterogeneities (photon beams) using Batho method (two versions) or Equivalent TAR (ETAR) method.	The device allows for these methods. No specific accuracy or precision of heterogeneity correction is reported.
Use generalized Gaussian pencil beam model for electron beams.	The device uses this model. No specific accuracy or precision of the electron beam calculations is reported.
Simultaneously visualize target, normal tissues, and computed 3-D dose distributions in real-time.	The device allows for this visualization. "Great detail" is a qualitative claim.
Develop treatment plans in a coordinate system accurately fixed to set-up marks (using CT and multi-modality info).	The device develops plans this way. No quantitative accuracy is given.
Provide tools for managing competing/complementary plans and comparing plans (based on DVH plots).	The device provides these tools. No performance metrics are given for the effectiveness or accuracy of these tools.
Generate high-quality DRRs and DCRs (with BEV and beam graphics superimposed) to replace conventional simulator films.	The device generates these. "High quality" is a qualitative claim. No specific image quality metrics or comparisons to conventional films are provided.
Safety and Effectiveness:
Conformity to FDA 21 CFR 820 (Quality System Regulation).	Picker "adheres to FDA 21 CFR 820".
Conformity to UL 187 (voluntary standard for safety and effectiveness, minimizing electrical, mechanical, radiation hazards).	Picker "adheres to... UL 187".
Conformity to IEC 601-1.	System "designed to conform to IEC 601-1".
Substantial equivalence to legally marketed devices.	FDA reviewed and determined the device is substantially equivalent (K974770). This is the primary "effectiveness" claim in a 510(k).

Missing Information/Cannot Answer Based on Text:

The provided text does not include information on the following, as it is a 510(k) summary focused on substantial equivalence rather than a detailed clinical or performance study report:

Specific study proving the device meets acceptance criteria: The document states, "Effectiveness is established by Picker's evaluation throughout all phases of the ACQPLAN development. The product will perform in accordance with the development specifications." This describes internal development and verification, not a formal, independent study with reported metrics. It also mentions a review of "all known information and performed an investigation," but no details of this investigation are provided.
Sample size used for the test set and data provenance: No information on a specific test set is provided beyond internal development testing.
Number of experts used to establish ground truth for the test set and their qualifications: Not applicable, as no external test set is detailed.
Adjudication method for the test set: Not applicable.
Multi Reader Multi Case (MRMC) comparative effectiveness study: Not mentioned. There is no information about human readers or comparisons with AI assistance.
Standalone (algorithm-only) performance: While the ACQPLAN is an "integrated 3-D RTP and simulation system," the text describes its intended functions, not a standalone performance evaluation against a specific metric.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not detailed for any specific performance study.
Sample size for the training set: Not applicable, as no machine learning algorithm development (in the modern sense) or specific training set is discussed or implied for performance claims.
How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) notice establishes the ACQPLAN's intended use and claims substantial equivalence to predicate devices, supported by adherence to regulatory and voluntary standards and internal development processes. However, it does not include the detailed performance study data, acceptance criteria with quantitative metrics, or methodological specifics (like sample sizes, expert qualifications, or ground truth establishment) that would be present in a comprehensive study report for a new device claiming specific performance metrics.

Summary

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2 1898 SEP

K974770

Picker 510(k) Notice

ACQPLAN Summary of Safety and Effectiveness

This is a summary of the information submitted by Picker International, Inc. to the Office of Device Evaluation (ODE), specifically DRAERD of the FDA as required by the Federal Food, Drug, and Cosmetic Act as amended on November 18, 1990 in section 513(f)(3).

The ACQPLAN is an integrated 3-D RTP and simulation system embedded in a volumetric image processing computer environment. AcQPlan is intended to be used to plan radiation therapy treatments on linear accelerators and other similar teletherapy devices with x-ray beams of energies from 4 to 50 MV, cobalt-60, and electron beams with energies from 4 to 50 MeV of the entire human anatomy. It allows the treatment planner to employ such techniques as asymmetrically collimated fields, irregular fields, multi-leaf collimators, non-coplanar fields, bolus, fixed wedges, and Varian's enhanced dynamic wedges. It allows the treatment planner to take heterogeneities into account for photon beams using two versions of the Batho method or the Equivalent TAR (ETAR) method, and it uses a generalized Gaussian pencil beam model for electron beams. Using AcQPlan, the treatment planner can simultaneously visualize target and the computed 3-D dose distributions in great detail, on a real-time basis. The treatment planner develops treatment plans in a coordinate system accurately fixed to set-up marks on the patient, using CT and multi-modality information made possible by volumetric 3-D image processing. Tools for managing competing and complementary plans are provided. Tools, based on DVH plots, are provided for comparing competing plans. High quality DRRs and DCRs (digitally composited radiographs), with BEV and beam graphics superimposed, are generated to replace conventional simulator films. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

Preliminary functional specifications and operator's instructions are included in the Attachments "B" and "C" respectively. Final documentation will be provided with production units.

The ACQPLAN is substantially equivalent to legally marketed devices and is under control of health care professionals who are trained and responsible for computed tomography examinations. Labeling (Product Specification and Operator's Manual) will be provided to the user of the equipment.

Picker adheres to FDA 21 CFR 820 and voluntary standards for safety and effectiveness (UL 187) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation). In addition, the system is designed to conform to IEC 601-1.

Effectiveness is established by Picker's evaluation throughout all phases of the ACQPLAN development. The product will perform in accordance with the development specifications. The ACQPLAN represents the current state-of- the-art technology, therefore, is equivalent to legally marketed devices.

Picker has reviewed all known information and performed an investigation as to the causes of safety and effectiveness concerning the ACQPLAN. In addition, all information contained in this 510(k) Notice is accurate and complete.

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Image /page/1/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re:

K974770

ACQPLAN

Dated: June 5, 1998

Regulatory Class: II

Received: June 9, 1998

21 CFR 892.5050/Procode: 90 MUJ

Robert L. Turocy Regulatory Affairs and Compliance Manager Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143

2 1998

Dear Mr. Turocy:

SEP

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 Device Amendments, or to devices that have been reclassified 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) 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 vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion 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/cdrh/dsmaldsmam.html".

Sincerely yours,

Lillian Yin, Ph.D.

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

Enclosure

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page 1 of 1

510(K) Number (if known): K97 47 7 0

Device Name: ACQPLAN

Indications for Use:

)

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

(Division Sign Off)

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices

510(k) Number R974770

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

(Optional Format 1-2-96)

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.