The EndoMap package is an x-ray imaging system software option, which allows the planning of orthopedic surgeries on a workstation. The software is intended to read in diagnostic images (e.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions. This provides a constructed image of this data, to use in conjunction with the EndoMap software to overlay the constructed images to aid surgeons in their planning of orthopedic surgeries.

Device Description

The EndoMap System is a x-ray imaging software option, which allows the planning of orthopedic surgeries on several Siemens workstations such as the LEONARDO, the syngo® Multimodality Workstation and the Magic View 300. The Leonardo Workstation was described in the 510(k) premarket notification, K992073, which received FDA clearance on Sept. 09, 1999. The syngo® Multimodality Workstation K010938 received FDA clearance on June 26, 2001. The EndoMap program enables exact adaptation of the prosthesis to the existing anatomic conditions based on digital images of the pelvis and the leg skeletal structure. This is accomplished using various help functions such as determination of the rotation center and the rotation of the pelvis, medialization, leg length correction, reflection via the symmetric axis of the body, biomechanical evaluation of the hip geometry and coxometry (analysis of the hip values). The planning data can be saved to the database of the LEONARDO or other workstations and output to a laser or paper printer.

AI/ML Overview

The provided text is a 510(k) summary for the EndoMap system, an X-ray imaging system software option for planning orthopedic surgeries. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details on performance metrics or study methodologies.

The document primarily focuses on:

Identification of the device: EndoMap, its classification, and intended use.
Substantial equivalence: Comparing EndoMap to predicate devices (BrainLabs' VectorVision Hip and Knee) based on functional specifications.
Device description: General features and functionalities.
Regulatory approval: The FDA clearance letter stating substantial equivalence.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and performance studies based on the provided text. The document explicitly states that "Information that substantiates this claim of equivalence is provided throughout this 510(k) submission and specific equivalence information is provided in Attachment 5," and that "the functional specifications and the substantial equivalence comparison matrix proves that the EndoMap Software is substantially equivalent." This suggests that the detailed equivalence information, which would typically contain performance data if such a study were deemed necessary for equivalence, is located in an attachment not provided here.

Based on the provided text, the following information is missing:

A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on substantial equivalence to predicate devices rather than independent performance metrics against predefined criteria.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The device is described as an aid for surgeons in planning, but no studies on reader performance or improvement are detailed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly mentioned or detailed. The nature of the device as a planning aid implies human interaction.
The type of ground truth used: Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary

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510(K) SUMMARY

Submitted by: Siemens Medical Solutions USA, Inc. 186 Wood Avenue South Iselin, NJ 08830

December 12, 2001

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. Contact Person

Ms. Sandra Robinson Phone: (732) 321-3243 Fax: (732) 321-4841

2. Device Name and Classification

EndoMap Trade Name: Template for Clinical Use Classification Name: Classification Panel: Radiology 21 CFR § 888.4800 CFR Section: Class II. though it is defined as class I. exempt Device Class: Device Code: HWT

3. Intended Use

4. Substantial Equivalence

The EndoMap is substantially equivalent to the current, commercially available BrainLabs' Vector Vision Hip, and BrainLabs' Vector Vision Knee.

Device Name	FDA Clearance Number	FDA Clearance Date
VectorVision Knee	K010612	09/06/2001
VectorVision Hip	K010602	09/12/2001

Information that substantiates this claim of equivalence is provided throughout this 510(k) submission and specific equivalence information is provided in Attachment 5.

5. Device Description

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Summary of Technological Characteristics of the Principal Device as Compared with the 6. Predicate Device

The Siemens EndoMap software package and the BrainLabs' VectorVision Hip, and BrainLabs' Vector Vision Knee software packages allows the planning of orthopedic surgeries on a workstation, which reads in diagnostic images (e.g. digitized x-rays) for use with a database of orthopedic implant geometries and dimensions.

7. General Safety and Effectiveness Concerns

Instructions for use are included within the device labeling and the information provided will enable the trained healthcare professional to operate the device in a safe and effective manner. Furthermore the operators are health care professionals familiar with and responsible for the planning of orthopedic surgeries to be performed.

8. Summary of Substantial Equivalence

In the opinion of Siemens Medical Solutions USA, Inc., the functional specifications and the substantial equivalence comparison matrix proves that the EndoMap Software is substantially equivalent to the BrainLab AG predicate Vector Vision Knee and Vector Vision Hip software.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three horizontal lines above them.

Public Health Service

JUN 1 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sandra Robinson Siemens Medical Solutions, Inc. 186 Wood Avenue South Iselin. NJ 08830

Re: K014113

Trade/Device Name: Endomap Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 15, 2002 Received: March 19, 2002

Dear Ms. Robinson :

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. Iisting 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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Page 2 - Ms. Sandra Robinson

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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). 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.

Stipt Pluordu

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ EndoMap

Indications for Use:

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

Prescription Use
(per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Styp Rhode

(Division Sign-Off Division of General, Restorative and Neurological Devices

KO14113 510(k) Number_

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).