The Coregistration function is intended for use as part of an RT planning system (such as CORVUS) in procedures which could benefit from the ability to correlate between multiple image sets regardless of the modality used for scanning. In addition this function may be used to coregister earlier patient scans without a localization system. The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT.

Device Description

AI/ML Overview

The provided text is a 510(k) summary for a medical device, specifically a "Coregistration function" for an RT planning system. This document aims to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device.

Crucially, this document does not contain detailed information about acceptance criteria or specific study results showing the device meets those criteria in the way a clinical trial report or a performance validation study would.

It is a regulatory submission for pre-market notification, which focuses on demonstrating substantial equivalence, not on providing granular performance metrics against pre-defined acceptance criteria with statistical power.

Therefore, I cannot fill out the table and answer all the questions as requested, because the information is simply not present in the provided text.

However, I can extract what is available:

Here's what can be inferred or directly stated from the provided text, along with explanations for what cannot be found:

Acceptance Criteria and Device Performance (Limited Information)

Acceptance Criteria	Reported Device Performance	Comments/Source
Implicit: Similar performance specifications to predicate devices.	"Testing shows that the device meets similar performance specifications as those for the predicate devices."	Section 7, "Summary of Substantial Equivalence"
Implicit: Maintaining geometric accuracy and tissue density information from CT.	"The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT."	Section 5, "Intended Use and Device Description"
Explicit: Safety	"No new issues of safety or effectiveness are introduced by using this device."	Section 7, "Summary of Substantial Equivalence"
Explicit: Effectiveness	"No new issues of safety or effectiveness are introduced by using this device."	Section 7, "Summary of Substantial Equivalence"
Quantitative Acceptance Criteria (e.g., specific accuracy metrics, error thresholds)	Not reported in this document.	The document states "similar performance specifications" but does not quantify these or what the device achieved against them.

Detailed Study Information (Based on Available Text)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document states "Testing shows..." but does not detail the methodology, sample sizes, or data provenance of any specific test set.
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)
- Not provided. As no specific "test set" study methodology is detailed, there's no mention of how ground truth was established, or by whom.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
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 provided. The device is a "coregistration function," which automates image alignment. It is not described as a diagnostic AI that would assist human readers in interpretation. There is no mention of an MRMC study or assistance to human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The coregistration function itself is an algorithm. The phrase "Testing shows that the device meets similar performance specifications as those for the predicate devices" implies some form of standalone evaluation of the algorithm's performance against historical data or benchmarks, but no details about such a study are provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided.
The sample size for the training set
- Not provided. This type of document (510k summary for substantial equivalence) typically focuses on the final product's performance and equivalence, not on the developmental training data or methodologies.
How the ground truth for the training set was established
- Not provided.

Summary of Limitations:

This 510(k) submission is a regulatory document focused on demonstrating "substantial equivalence" to a predicate device (ImageFusion - Radionics Software Applications (RSA), Inc. (K960071)). It is not a detailed scientific publication of a performance study. Therefore, the granular details about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement are not included in this type of document. The statement "Testing shows that the device meets similar performance specifications as those for the predicate devices" is the primary evidence provided for performance, without elaboration on the specifics of that testing.

Summary

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972451
JAN.22, 1998

ry of Safety and Effectivenes I) of the Federal Food, Drug and Cosmetic Compliance w

June 27, 1997

General Provisions 1.

Common/Usual Name Image Correlation System Proprietary Name Coregistration function Applicant Name and Address NOMOS Corporation 2591 Wexford Bavne Road

Name of Predicate Devices 2.

ImageFusion - Radionics Software Applications (RSA), Inc. (K960071)'

Sewickley, PA 15143

3. Classification

]

CORVUS™ (Cleared as PEACOCK® Plan (K940663) is classified as class II devices according to 21 CFR 882.5050 (90 IYE). These devices are reviewed by the Radiological Devices Panel of the Reproductive, Abdominal, Ear, Nose, and Throat and Radiological Division of the Office of Device Evaluation.

The predicate Radionics ImageFusion Software is unclassified by FDA but was grouped in LLZ with no CFR designation by the Radiological Devices Division.

4. Performance Standards

Performance standards for treatment planning systems have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.

Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, " ... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).

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re Intended Use and Device Description

The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue density information from the CT.

6. Biocompatibility

Not applicable.

7. Summary of Substantial Equivalence

This device is similar in design, intended use and performance characteristics to the predicate devices. Testing shows that the device meets similar performance specifications as those for the predicate devices. No new issues of safety or effectiveness are introduced by using this device.

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Public Health Service

Image /page/2/Picture/1 description: The image shows a logo with a circular shape on the lower left and a stylized bird-like figure on the upper right. The text "DEPARTMENT OF HEALTH &" is arranged in a curved manner around the top and right side of the circle. The logo appears to be a vintage or older design, possibly representing a health organization or government department.

DEPARTMENT OF HEATTH & HUMAN SERVICE:

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 1998

Marvin L. Sussman, Ph.D. Vice President Product Assurance NOMOS Corporation 2591 Wexford Bayne Road Suite 400 Sewickley, PA 15143

Re: K972451

Coregistration Function Dated: October 27, 1997 Received: October 28, 1997 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Dr. Sussman:

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 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 reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 fequirement, 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 does not affect any obligation you might have under sections 531 through 542 of the Act for devices under 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 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/cdrh/dsmamain.html".

Sincerely yours.

W.Liau Yu

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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510(k) Number (if known)

Device Name: Coregistration

Indications for Use:

能

The Coregistration function enables the use of complementary image data while maintaining the geometric accuracy and tissue ............ density information from the CT.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

OR Over-The Counter Use (Optional Format 1-2-96)

Ekinl A. Seysson

Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devjo 510(k) Number

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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.