1. To provide CT images to determine the size and location of internal structures.
1. To provide CT images to be used by the dosimetrist to determine the location of isocenter.
1. To provide tissue density information via Hounsfield numbers, which allows for more accurate calculations of the dose by accounting for variations in tissue densities. The intended use is the same as the predicate devices.

Device Description

The SIMPLI C.T. Option for the SIMVIEW™ 3000 provides therapeutic quality CT images at simulation for use by the trained medical practitioner. It is similar in design to other such radiation therapy CT imaging simulation devices. The SIMVIEW™ 3000 has microprocessor controlled solid state electronics, rotating gantry, patient support couch and accessories.

AI/ML Overview

This document is a "Summary of Safety and Effectiveness" for the Siemens SIMPLI C.T. Option for the SIMVIEW™ 3000 radiation therapy simulation system, submitted to the FDA. It declares substantial equivalence to predicate devices. However, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and device performance as a standalone AI or deep learning model.

The document discusses the device's adherence to general safety and performance standards relevant to medical electrical equipment and radiotherapy simulators, but it does not provide quantitative "acceptance criteria" in terms of clinical accuracy metrics (e.g., sensitivity, specificity, dice score) for a specific diagnostic task, nor does it present a study detailing such performance.

Therefore, I cannot populate the table or answer the specific questions about standalone performance, ground truth, expert consensus, sample sizes for test/training sets, or MRMC studies, as the provided text does not contain this information.

Here's what I can extract based on the provided text, and where I must state that the information is not available:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Quantitative/Clinical)	Reported Device Performance (Quantitative/Clinical)
Not specified in terms of clinical accuracy or performance metrics for a diagnostic task.	Not specified in terms of clinical accuracy or performance metrics for a diagnostic task.
Acceptance Criteria (Standards-based, from document)	Reported Device Performance (Standards-based, from document)
IEC 601-1: Medical electrical equipment - General requirements for safety	System consistently performed within design parameters.
IEC 601-1.1: Safety requirements for medical electrical systems	System consistently performed within design parameters.
IEC 601-2-29: Particular requirements for the safety of radiotherapy simulators	System consistently performed within design parameters.
IEC 1168: Radiotherapy simulators - Functional performance characteristics	System consistently performed within design parameters and equivalently to predicate devices.
IEC 878: Graphical symbols for electrical equipment in medical practice	System consistently performed within design parameters.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not available. The document states "Performance tests were conducted," but provides no details on the nature of these tests (e.g., if they involved a test set of patient data), sample size, or data provenance.

3. 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 available. The document does not describe the establishment of a ground truth for a test set using expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not available. No details on test set adjudication are 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

Not available. The document describes a CT option as part of a simulation system; it does not present it as an AI-assissted reading tool for human readers, nor does it mention an MRMC study.

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

Not available. The document describes a "CT Option" for a simulation system, not a standalone algorithm with reported performance metrics. The performance tests mentioned refer to the system's operational parameters, not clinical diagnostic accuracy.

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

Not available. As no specific clinical test set and ground truth establishment are described, this information is not present.

8. The sample size for the training set

Not available. The document does not describe a "training set" as this device is presented as a CT imaging system, not a machine learning model.

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

Not available. Not applicable, as no training set for a machine learning model is described.

Summary of what the document does provide:

Device Description: The SIMPLI C.T. Option for the SIMVIEW™ 3000 provides therapeutic quality CT images at simulation.
Intended Use: To obtain CT images in the same position as treatment, determine patient contour, size and location of internal structures, determine isocenter, and provide tissue density information (Hounsfield numbers) for dose calculations.
Technological Characteristics: No significant change in design, materials, energy source, or other technological characteristics compared to predicate devices.
Performance Claim: "Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate devices."
Compliance: Designed and manufactured to meet IEC standards (IEC 601-1, 601-1.1, 601-2-29, 1168, 878).

The document's purpose is to demonstrate substantial equivalence to existing devices for FDA clearance, focusing on safety, intended use, and technological characteristics rather than providing a detailed clinical performance study with AI-specific metrics.

Summary

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STEMENS

NOV 2 9 1996

K953233

ATTACHMENT E

SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 based on the format in the interim rule for 21 CFR § 807.92 as published in the Federal Register, April 28, 1992.

{1}------------------------------------------------

SIEMENS

SUMMARY OF SAFETY AND EFFECTIVENESS

1.	Submitter's Information:	Dated: June 22, 1995Siemens Medical SystemsOncology Care Systems Group4040 Nelson AvenueConcord, CA 94520
	Contact Person:	Kenneth R. Michael, Pharm.D.Vice President Regulatory Affairs and Quality Assurance
2.	Common or Usual Name:	CT Option for Radiation Therapy Simulation System
	Proprietary Name:	SIMPLI C.T.
	Classification Names:	Radiation Therapy Simulation System - 21 CFR § 892.5840Class II, Product Code: RA 90 KPQ
3.	Predicate Devices:	• SIMULIX-MC-CT-EXTENSION Oldelft Corporation ofAmericaTreatment Planning Simulator, K912466

· XIMATRON /CT, Varian Associates Treatment Planning Simulator, K 853349, 82K0274

4. Description of Device:

ર્ડ Statement of intended use:

The SIMPLI C.T. Option for the SIMVIEW™ 3000 radiation therapy is used for the following:

To obtain CT images in the same position as the treatment.
To provide CT images to determine the contour of the patient.

1. To provide CT images to determine the size and location of internal structures.
1. To provide CT images to be used by the dosimetrist to determine the location of isocenter.
1. To provide tissue density information via Hounsfield numbers, which allows for more accurate calculations of the dose by accounting for variations in tissue densities. The intended use is the same as the predicate devices.

6. Statement of technological characteristics:

The SIMPLI C.T. for the SIMVIEW™ 3000 radiation therapy simulation system has no significant change in design, materials, energy source or other technological characteristics compared to the predicate devices.

The intended use and the technological characteristics are the predicate devices and therefore we believe it is substantially equivalent to them.

7. Differences:

The minor configuration differences between the SIMPLI C.T. for the SIMVIEW" 3000 and the predicate devices do not alter the intended use or affect the safety and effectiveness of the SIMPLI C.T. when used as labeled.

ﺖ

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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in bold, black letters. The letters are slightly distressed, giving them a textured appearance. The background is plain white, which makes the word stand out.

Special Controls:

Although there are no performance standards established by the FDA for these devices, the SIMPLI C.T. Option for the SIMVIEW™ 3000 has been designed, and manufactured to meet the following standards:

IEC 601-1	Medical electrical equipment - General requirements for safety
IEC 601-1.1	Safety requirements for medical electrical systems
IEC 601-2-29	Particular requirements for the safety of radiotherapy simulators
IEC 1168	Radiotherapy simulators - Functional performance characteristics
IEC 878	Graphical symbols for electrical equipment in medical practice

Performance tests were conducted and the results indicated that the system consistently performed within the design parameters and equivalently to the predicate devices.

Regulation Number and Section

§ 892.5840 Radiation therapy simulation system.

(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. 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.