MedicLung I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semiautomatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROI. MedicLunq I provides quantative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes in the physician-indicated nodules or lesions.

Device Description

MedicLung™ 1 is a software tool designed to assist radiologists and other clinicians in the evaluation of nodules and other lesions in the lug. The software allows the user to select Regions of Interest either manually or by selecting a single or double seed point, followed by semi-automatic detection of the ROI boundary. It provides 2D and 3D visualisation of nodules and other lesions, and measurement of nodule characteristics such as size and volume.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the MedicLung™ Release 1 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics for MedicLung™ Release 1. It primarily focuses on demonstrating substantial equivalence to predicate devices through functional similarity and safety assessments.

However, based on the description, the implicit "acceptance criteria" are tied to demonstrating the device's ability to assist in the evaluation of lung lesions, measure nodule characteristics, and track changes over time, consistent with the performance of its predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Assist Radiologists in Lung Lesion Evaluation: The device should effectively aid clinicians in identifying and evaluating nodules and other lesions in the lung.	"MedicLung™ 1 is a software tool designed to assist radiologists and other clinicians in the evaluation of nodules and other lesions in the lung." It "assists users in assessing CT images for the identification and evaluation of nodules and other lesions in the colon." The "Intended Use" also states it is "for the purpose of assisting radiologists and other clinicians in the evaluation of lung lesions (e.g. nodules)."
Provide 2D and 3D Visualization: The device should offer both 2D and 3D views of nodules and lesions.	"It provides 2D and 3D visualisation of nodules and other lesions."
Enable Nodule Measurement: The device should allow for the measurement of nodule characteristics.	"measurement of nodule characteristics such as size and volume." "MedicLung I provides quantative information for measurement of lesion volume and other measured characteristics over time."
Facilitate Region of Interest (ROI) Selection: The device should offer manual and semi-automatic ROI selection.	"The software allows the user to select Regions of Interest either manually or by selecting a single or double seed point, followed by sem_autonatic detection of the ROI boundary." The "Intended Use" reiterates this: "The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROL."
Track Changes Over Time: The device should allow for reviewing and tracking changes in physician-indicated lesions.	"allowing the user to review and track any changes in the physician-indicated nodules or lesions."
Safety: The device should not introduce new safety risks and residual risks should be acceptable.	"A comprehensive hazard analysis was carried out on MedicLung 1, which concluded that any residual risks were as low as reasonably practicable and judged as acceptable when weighed against the intended benefits of use of the system." "MedicLung 1 docs not raisc any new potcntial safety risks."
Equivalence to Predicate Devices: The functional features and intended use should be substantially equivalent to predicate devices.	"As in the predicate devices, GE Advanced LungAnalysis-1 and Siemens LunCarcC'1, Mediclung 1 assists users in assessing CT images for the identification and evaluation of nodules and other lesions in the colon." "The functional features and the intended use of MedicLung 1 are substantially equivalent to the predicate devices."

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

The document states: "'I'cst data are provided to validate the performance of the system and its substantial equivalence to the predicate devices."

However, it does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective).

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

The document does not specify the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, nor does it provide an effect size for human readers improving with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is described as a "software tool designed to assist radiologists and other clinicians." The functionality includes user selection of ROIs and "interactive fine-tuning." This strongly suggests a human-in-the-loop system. The document does not provide information about a standalone (algorithm-only) performance study. Its intended use implies it's an assistive tool, not a fully autonomous diagnostic system.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the nature of a 510(k) submission for an assistive evaluation tool, it's highly probable that some form of expert consensus or clinically validated findings would have been used as a reference, but this is not confirmed in the provided text.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set.

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

The document does not describe how the ground truth for the training set was established.

Summary

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K03 34/2

Image /page/0/Picture/1 description: The image shows a logo for a company called "medicsight". The logo is a square shape that is divided into nine smaller squares. The center square is white, and the surrounding squares are black. The company name is written in lowercase letters below the square logo.

DEC 3 0 2003

Appendix E

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92( c ).

Submitted by:Name:	Medicsight PLC.
Address:	46 Berkeley SquareLondon W1J 5ATUK
Telephone:	44 (0) 207 598 4070
Facsimile:	44 (0) 207 598 4071
Contact:	Carol MacDonald, RA QA Manager
Date of summary:	22 September 2003

Device Information:

Trade Name:	MedicLung™ Release 1
Common Name:	Medical imaging software for CT scanners
Classification Name:	Computed Tomography X-Ray System, Accessor
Regulation Number:	892.1750

Predicate Devices:

Medicsight MedicLung 1 is substantially equivalent to the following devices:

Manufacturer	Device	510(k) No
GE	GE ADVANCED LUNG ANALYSIS-1	K013381
SIEMENS	LUNGCARE CT SOFTWARE PACKAGE	K022013

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Image /page/1/Picture/0 description: The image shows a logo for a company called "medicsight". The logo consists of a square shape with a circle in the center. The square is made up of smaller squares, and the circle is white. The text "medicsight" is written in a sans-serif font below the square.

Device Description:

K037412

Intended Use:

MedicLung I is a PC-based, stand-alone, non-invasive, image analysis software application for the display and visualization of 2D and 3D medical image data of the lung derived from CT scans, for the purpose of assisting radiologists and other clinicians in the cvaluation of lung lesions (e.g. nodules). The software provides functionality for the user to extract the region of interest (ROI) either manually using a drawing tool, or "semi-automatically" through the user selecting either a single or double seed point followed by interactive fine-tuning the boundaries of the ROL. MedicLung I provides quantative information for measurement of lesion volume and other measured characteristics over time allowing the user to review and track any changes in the physician-indicated nodules or lesions.

Comparison to Predicate Device:

As in the predicate devices, GE Advanced LungAnalysis-1 and Siemens LunCarcC'1, Mediclung 1 assists users in assessing CT images for the identification and evaluation of nodules and other lesions in the colon.

'I'cst data are provided to validate the performance of the system and its substantial equivalence to the predicate devices. The functional features and the intended use of MedicLung 1 are substantially equivalent to the predicate devices.

Safety:

A comprehensive hazard analysis was carried out on MedicLung 1, which concluded that any residual risks were as low as reasonably practicable and judged as acceptable when weighed against the intended benefits of use of the system.

Conclusion:

MedicLung 1 docs not raisc any new potcntial safety risks and is equivalent in performance to existing legally marketed devices. MedicLung 1 is therefore substantially cquivalent with respect to safety and effectiveness to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2009

Ms. Carol MacDonald Regulatory & Quality Director Medicsight 46 Berkeley Square London W1J5AT UNITED KINGDOM

Re: K033412

Trade/Device Name: Medicsight MedicLung 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: OEB Dated: October 24, 2003 Received: November 5, 2003

Dear Ms. MacDonald:

This letter corrects our substantially equivalent letter of December 30, 2003.

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 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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Page 2

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 (OS) 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 os 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 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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/cdrh/industry.suppot/index.html.

Sincerely yours.

Janine M. Morris

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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APPENDIX A

Page of

510(k) Number (if known): 长ひろろくくこ

Medicsight MedicLung 1.0 Device Name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Nancy C. Broadbent

(Division Sign-Off) 0
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number Ko 33412

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).