The Siemens SOMATOM Definition AS Open 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 Definition AS Open is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle.

This system is a modified version of the cleared Somatom Definition AS/AS+ The modification features a larger gantry bore from the original (K081022). Definition AS, In addition, the gantry tilt accuracy is improved and a new HD FoV, will help provide an optimized solution for radiation treatment planning.

AI/ML Overview

The provided text describes a 510(k) summary for the Siemens SOMATOM Definition AS Open CT system. However, it does not include detailed information about specific acceptance criteria and a study proving device performance in the way requested.

The document focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM Definition AS/AS+). Substantial equivalence means the new device is as safe and effective as a legally marketed predicate device, and it typically doesn't require new clinical studies to demonstrate performance against specific quantitative criteria. Instead, it relies on demonstrating that any differences in technological characteristics do not raise new questions of safety or effectiveness.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert qualifications, and adjudication methods are not present in this type of submission.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated as quantitative performance metrics for the device itself in this submission. The acceptance criteria in a 510(k) summary for a substantially equivalent device often revolve around demonstrating that the new device meets the same safety and effectiveness standards as the predicate, often through engineering verification and validation that the modifications do not negatively impact performance.
Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio, spatial resolution) are reported for the SOMATOM Definition AS Open. The submission focuses on describing the changes made from the predicate (larger gantry bore, improved gantry tilt accuracy, new HD FoV) and stating that the Data Measurement System is identical to the 32-row detector layout of the predicate.

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

Not Applicable/Not Provided: This information is typically part of a clinical performance study. Since this is a substantial equivalence submission, such a study with a dedicated "test set" and associated sample size and data provenance is not described. The device's performance is inferred from the predicate device and engineering verification of the modifications.

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

Not Applicable/Not Provided: As no clinical performance study with a distinct "test set" and ground truth establishment is described, this information is not relevant to this submission.

4. Adjudication method for the test set

Not Applicable/Not Provided: See point 3.

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 a CT scanner, not an AI-powered diagnostic device. A MRMC study, especially one involving AI assistance, would not be relevant in this context. The document does not describe any AI component.

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

No: This device is a CT scanner. Its "performance" is about image acquisition, quality, and mechanical accuracy, not the output of a standalone algorithm for diagnosis.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable/Not Provided: As no clinical performance study is described, no "ground truth" for diagnostic accuracy is established in this submission. The "ground truth" for a CT scanner typically relates to its physical and imaging performance (e.g., spatial resolution measured with phantoms, dose accuracy).

8. The sample size for the training set

Not Applicable/Not Provided: There is no mention of a "training set" as this is not an AI/machine learning device. The design and validation of a CT scanner involve engineering design, component testing, and system integration, not training on a dataset in the AI sense.

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

Not Applicable/Not Provided: See point 8.

Summary of what the submission does state regarding device validation:

Substantial Equivalence: The primary method of "proving" the device meets acceptance criteria is by demonstrating its substantial equivalence to a legally marketed predicate device (Siemens SOMATOM Definition AS/AS+ K081022).
Modifications: The device is a modified version of the predicate with:
- A larger gantry bore (80 cm).
- Improved gantry tilt accuracy.
- A new HD FoV (Field of View).
- It uses a modified tube collimator adapted to the 80 cm gantry bore.
- The Data Measurement System (DMS) is identical to the 32-row detector layout of the SOMATOM Definition AS.
Safety and Effectiveness: "Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Somatom Definition AS Open is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed."
Industry Standards: Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing to minimize electrical, mechanical, and radiation hazards.
Intended Use: The intended use remains the same as the predicate: to produce cross-sectional images of the body. The modifications are specifically noted to "provided data that can be used for Radiation Therapy Planning (RTP) by RTP systems."

In essence, for a 510(k) submission showing substantial equivalence for a hardware modification of an existing device, the "study" proving it meets acceptance criteria is often a combination of engineering verification and validation testing to ensure the modifications do not introduce new risks and that the device performs as intended and on par with its predicate. No clinical study with PIs, ground truth, and statistical analysis is described in this document.

Summary

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510(k) Summary

For

SOMATOM Definition AS Open

MAR - 4 2011

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

September 25, 2010

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

1. General Information

Importer / Distributor

Siemens Medical Solutions, Inc. 51 Valley Stream Parkway, E-50 Malvern, PA 19355 Establishment Registration Number 2240869

Manufacturing Site

SIEMENS AG Sector Healthcare Siemens Straße 1 D-91301 Forchheim

2. Contact Person:

Mrs. Alicia Bustos-Juergensen Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:(610) 448-4056 Fax: (610) 448-1778

3. Device Name and Classification

SOMATOM Definition AS Product Name: Propriety Trade Name: SOMATOM Definition AS Open Classification Name: Computed Tomography X- ray System Radiology Classification Panel: 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90 JAK

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SIEMENS

Device Description 4.

The Siemens SOMATOM Definition AS Open is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle.

ડ. Intended Use

The SOMATOM Definition AS Open 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 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. )

6. Substantial Equivalence:

Siemens SOMATOM Definition AS Open Computed Tomography X-ray system, configured with software version SOMARIS/7 is substantially equivalent to the following medical device in commercial distribution:

Predicate Device Name	FDA Clearance Number	FDA Clearance Date
Siemens SOMATOM Definition AS/AS+	K081022	06/05/2008

7. Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Device

SOMATOM Definition AS Open is a modified SOMATOM Definition AS, which offers a larger gantry bore of 80 cm. It uses a modified tube collimator, adapted to the geometry of the 80 cm gantry bore

The Data Measurement System (DMS) of SOMATOM Definition AS Open is identical to the 32 row detector layout of SOMATOM Definition AS; UHR comb is not available for SOMATOM Definition AS Open.

SOMATOM Definition AS Open is designed with the mechanical accuracy necessary to provided data that can be used for Radiation Therapy Planning (RTP) by RTP systems.

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General Safety and Effectiveness Concerns 8.

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Somatom Definition AS Open is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.

Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.

Conclusion as to Substantial Equivalence 9.

The Somatom Definition AS Open is intended for the same indications for use as the predicate Somatom Definition AS/AS+. The Somatom Definition AS Open is substantially equivalent to the Definition AS/AS+ with changes to the gantry opening, improved FoV and improvements to the mechanical accuracy of the gantry tilt system as required when used for Radiation Therapy Planning. The portfolios of accessories are the same as with the predicate Somatom Definition AS/AS+ to compliment the needs of the CT suite. It is Siemens opinion, that the Somatom Definition AS Open is substantially equivalent to the Somatom Definition AS/AS+.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Alicia Bustos-Juergensen Technical Specialist Regulatory Affairs Siemens Healthcare (Siemens Medical Solutions USA, Inc.) 51 Valley Stream Pkwy MALVERN PA 19355

Re: K103127

MAR - 4 2011

Trade/Device Name: Somatom Definition AS Open Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 11, 2011 Received: February 14, 2011

Dear Ms. Bustos-Juergensen:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary S Postel

Mary Pastel. ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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SIEMENS

510(k) Number (if known): K(03/27

Device Name:

Somatom Definition AS Open

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S Patel

Division Sign Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K103127

Siemens Medical Solutions, Inc. USA 510(k) for SOMATOM Definition AS Open CT System

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.