The Siemens SOMATOM P30L systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles. (*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Device Description

The Siemens SOMATOM P30L is a whole body X-ray computed tomography systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

AI/ML Overview

The provided text is a 510(k) summary for a Computed Tomography (CT) system (SOMATOM Project P30L) and does not contain detailed information about a study proving the device meets specific acceptance criteria in the way a clinical performance study for an AI/ML device would.

The document focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM P30) for regulatory clearance, primarily based on the device's technical specifications and intended use. It describes the device's functionality and general safety measures taken during development.

Therefore, many of the requested items (acceptance criteria table, sample sizes, expert ground truth, MRMC study, standalone performance, training set details) are not present in this 510(k) summary.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as pass/fail metrics in the context of a performance study. The "acceptance criteria" here implicitly revolve around demonstrating that the new device (SOMATOM Project P30L) is as safe and effective as the predicate device (Siemens SOMATOM P30) in its intended use of producing cross-sectional images.
Reported Device Performance: The document does not report specific quantitative performance metrics like sensitivity, specificity, accuracy, or image quality scores that would usually be found in a performance study. Its "performance" is implicitly deemed equivalent to the predicate device.

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance (from text)
Device functions as intended (produces cross-sectional images via CT).	The SOMATOM P30L is a whole body X-ray computed tomography system that "features a continuously rotating tube-detector system and functions according to the fan beam principle." It's "intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data."
Device is as safe and effective as the predicate device.	"Substantially equivalent to... Siemens SOMATOM P30... K013522." "Risk management is ensured via a hazard analysis... to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." Adherence to "recognized and established industry practice and standards" to minimize hazards.
Compliance with relevant regulations and standards.	Adheres to SMDA 1990 and 21 CFR §807.92. Assumed compliance with 21 CFR §892.1750 and general controls.

2. Sample size used for the test set and the data provenance:

Not Applicable / Not Provided. This document is a 510(k) summary for a CT scanner hardware/software system, not an AI/ML device requiring a clinical performance study with a test set of patient data to evaluate algorithmic performance. The "test set" would refer to performance validation during engineering and manufacturing, not clinical data for diagnostic accuracy.

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

Not Applicable/Not Provided. Ground truth establishment by experts is typically for clinical performance evaluation of diagnostic algorithms. This document doesn't detail such a study for the CT scanner itself.

4. Adjudication method for the test set:

Not Applicable/Not Provided.

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:

No. This is not an AI-assisted diagnostic device. It's a CT scanner.

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

No. This question is largely irrelevant for a CT scanner, which is a foundational imaging device. Its "performance" is inherent in its image acquisition and reconstruction capabilities, not in an independent diagnostic algorithm.

7. The type of ground truth used:

Not Applicable/Not Provided. For a CT scanner, the "ground truth" during its development and testing would likely relate to objective physical phantom measurements (e.g., spatial resolution, contrast resolution, noise), dose accuracy, and adherence to engineering specifications, rather than clinical diagnostic ground truth.

8. The sample size for the training set:

Not Applicable/Not Provided. The software described is for "patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation." It's an operational software suite for a medical device, not an AI/ML algorithm that undergoes "training" on a dataset in the machine learning sense.

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

Not Applicable/Not Provided.

In summary: The provided 510(k) summary for the SOMATOM Project P30L is for a Computed Tomography X-ray system. The regulatory pathway chosen (510(k)) relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical performance study with defined acceptance criteria and ground truth in the way one would for a novel diagnostic AI/ML algorithm. Therefore, much of the requested information regarding study design and performance metrics is not present in this type of regulatory submission.

Summary

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KOH0577

Section 1: 510(k) Summary

510(K) SUMMARY FOR SOMATOM PROJECT P30L

Submitted by: Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway Malvern, PA 19355

March 1, 2004

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. Contact Person:

Ms. Nealie Hartman Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway J-15 Malvern, PA 19355 Phone:(601) 448-1769 Fax: (601) 448-1787

Device Name and Classification 2.

Product Name:	SOMATOM Project P30L
Classification Name:	Computed Tomography System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	90 JAK

Substantial Equivalence: 3.

Siemens SOMATOM P30L Computed Tomography X-ray systems, configured with software version SOMARIS/5 is substantially equivalent to the following medical device in commercial distribution:

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
Siemens SOMATOM P30	K013522	11/07/01

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4. Device Description:

Indications for Use: 5.

The SOMATOM P301, is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes* taken at different angles.

(*spiral planes: the axial plancs resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

General Safety and Effectiveness Concerns: 6.

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle's head and neck, represented by a few curved lines. The eagle faces to the left, and the overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2004

Ms. Nealie Hartman Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355

Re: K040577 Trade/Device Name: SOMATOM Project P30L Sensation OPEN Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: March 1, 2004 Received: March 4, 2004

Dear Ms. Hartman:

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.

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.

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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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. boyden

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

Enclosure

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SECTION 3 INDICATION FOR USE

510(k) Number (if known):

040577

Device Name:

SOMATOM Project P30L

(Sensation OPEN)

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

(Please do not write below this line - continue on another page if needed)

Concurrence of the CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21 CFR §801.109)

OR Over-The-Counter Use

Nancy Brogdon

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

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.