The Praezis Plus system is computer software intended to be used in planning intracranial stereotactic surgeries such as biopsies and treatment of lesions. The intended user of Praezis Plus is a medical doctor - neurosurgeon.

Device Description

Praezis Plus is a software tool intended to help the surgeon plan stereotactic treatments. It enables the user to select optimally fitting stereotactic trajectory positions by digitizing the entry (trephination) and target points of the trajectory. If both points define a trajectory which can be set on the operating device, the corresponding device settings are calculated and displayed in the trajectory window. Any trajectory can be defined and displayed in CT and/or MRI slices or reconstructions or angiographic images if they are available. Trajectories are always stored in stereotactic coordinates and can be digitized and displayed in available patient's modalities (CT, MR or Angiographic). The software can project the selected trajectory to any slices or sections and generate surgeon's eye views. For any possible needle position, the angle settings for either the Riechert/Mundinger (RM) or Zamorano/Dujovny (ZD) stereotactic operating devices can be displayed. Praezis Plus supports the transfer of stereotactic coordinates between angiographic, CT and MR images. Regions of Interest ("ROIs") and Volumes of Interest ("VOIs") can be defined, transferred and displayed between angiographic, CT and MR images. Their area and volume can be calculated. Global stereotactical transformation is available to improve the planning. Image fusion, based on various methods of correlation, allows a combination of valuable information from different modalities. Several types of reconstructed sections such as arbitrary, along and perpendicular to trajectory together with 3D reconstructions are also available. It is possible to print out all the images and protocols and together with patient data archive them on a CD. The output from Praezis Plus is a printed stereotactical plan defining the trajectory and the setup of the stereotactical device. The treatment plans may be used to administer treatments after review and approval by the neurosurgeon.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device software, Praezis Plus, and its comparison to a predicate device, Stereoplan Plus. The information focuses on substantial equivalence based on intended use, technological characteristics, and performance data. However, the document does not contain specific acceptance criteria, a detailed quantitative study of device performance against these criteria, or information regarding AI/ML components.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text, nor can I answer questions related to AI/ML specific study designs such as MRMC studies, standalone algorithm performance, or training/test set details for an AI model.

The document primarily discusses:

System Validation: This involved internal testing by the manufacturer.
Benchmark Tests: Comparing Praezis Plus to the predicate device (Stereoplan Plus) quantitatively for computation accuracy.
Beta Site Testing: Qualitative evaluation in a "near-clinic (virtual) environment" at two hospitals to confirm it "fulfills the declared requirements and is consistently safe and accurate comparing to the bench mark device."

Here's what can be extracted and inferred from the document based on the information it does provide:

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

The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the quantitative sense typically seen for AI/ML device studies. Instead, it refers to:

Acceptance Criterion (Inferred from Validation/Benchmark)	Reported Device Performance	Comments
Computational Accuracy as good as predicate device	The test results support the safe and effective use of the Praezis Plus to guide a device to a brain target with an error less than 1mm. This indicates it met the same level of accuracy as the predicate device.	This is the closest to a quantitative performance metric provided. It's not stated as an explicit acceptance criterion, but as a conclusion from benchmark tests.
Compliance with declared requirements (Beta Site)	"Praezis Plus fulfills the declared requirements and is consistently safe and accurate comparing to the bench mark device, thus suitable for use in the scope of its declared intended use."	This is a qualitative assessment from beta testing, indicating functional and safety equivalence to the predicate.

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

Sample Size for Test Set: Not explicitly stated. The "System Validation" involved a "set of test cases" using "test data," and "benchmark tests" compared calculations against the Stereoplan Plus. The "Beta Site Testing" was conducted at two hospitals, but the number of cases or operations tested is not specified.
Data Provenance: Not explicitly stated. The "Beta Site Testing" was done at "Beth Israel Deaconess Medical Center - Harvard Medical School, Boston" and "University of Chicago Medical Center - Section Of Neurosurgery, Chicago," implying the data, if collected during these beta tests, would be from the USA. However, the specific origin (retrospective or prospective) of the clinical scenarios or data used for testing is not detailed. The "test data" for system validation and benchmark tests is also not described.

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)

Number of Experts: Not specified.
Qualifications of Experts: The intended user is "a medical doctor - neurosurgeon." It can be inferred that neurosurgeons were involved in the beta site testing to evaluate the device in a "near-clinic (virtual) environment" by following "existing relevant procedures." However, their specific role in establishing "ground truth" (as typically defined for AI/ML studies) or their qualifications are not detailed. For the benchmark tests, "reference values were measured digitally using the benchmark software (Stereoplan Plus)" and considered "ideally exact," implying no human expert "ground truth" was established for these specific numerical comparisons.

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

Adjudication Method: Not described. The beta site testing involved a comparison to the benchmark device, rather than a formal adjudication process for interpreting results or reaching a consensus on ground truth.

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, an MRMC comparative effectiveness study was not done and is not mentioned in the document. This device is described as "software intended to help the surgeon plan stereotactic treatments," not an AI-assisted diagnostic tool that would typically involve a comparative effectiveness study with human readers. The comparison is primarily between the new software and an existing predicate software.

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

The document implies that the device's computational accuracy was tested in a standalone manner during system validation and benchmark tests, as it aimed for "absolute equality" or "error less than 1mm" compared to the predicate software's calculations. However, this is not an "algorithm only performance" in the context of an AI/ML algorithm making a decision or interpretation independently. Praezis Plus is a "planning system" used by a "neurosurgeon," indicating its role is always human-in-the-loop.

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

For benchmark tests, the "ground truth" was the "reference values measured digitally using the benchmark software (Stereoplan Plus)," considered "ideally exact." This is a software-generated computational ground truth rather than a clinical or pathological ground truth.
For beta site testing, the "ground truth" was effectively the performance and experience with the predicate device, against which the Praezis Plus was compared in a "virtual" clinical environment. No specific clinical outcome data or pathology was used as ground truth for evaluating the software's planning capabilities directly within the scope of this submission.
The output of the software (stereotactical plan) still requires "review and approval by the neurosurgeon" for actual treatment.

8. The sample size for the training set

This information is not applicable and not provided. Praezis Plus is described as a "software tool" for planning, not an AI/ML system that would require a "training set" in the context of machine learning. Its functionality seems to be based on computational geometry and image processing principles, rather than learning from data.

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

This information is not applicable and not provided, as the device is not described as an AI/ML system requiring a training set.

Summary

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Section 5 - 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in MAY 2 4 2012 accordance with the requirements of 21 CFR §807.92.

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

TATRAMED spol. s r.o. Líščie údolie 7, 84104 Bratislava, Slovak republic +421-2-60202301 Tel: Fax: +421-2-60202351

Date Summary Prepared: October 28, 2011

Contact Person:	Jan Hanzel, Dipl.Ing.
e-mail:	jan.hanzel@tatramed.sk
Tel:	+421-2-60202329, +421-2-6020230
Fax:	+421-2-60202351

Name of Device:

Trade Name(s): Praezis Plus 3.1 Classification Name: Planning system/Stereotaxic instrument Classification: 21 C.F.R §882.4560 Panel: Neurological Product Code: HAW

Predicate Device:

Leibinger Stereoplan Plus Stereotactic Treatment Planning Software Package, Leibinger LP (K946033)

Intended Use/Indications for Use

Technological Characteristics

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KII 06444

a trajectory which can be set on the operating device, the corresponding device settings are calculated and displayed in the trajectory window. Any trajectory can be defined and displaved in CT and/or MRI slices or reconstructions or angiographic images if they are available. Trajectories are always stored in stereotactic coordinates and can be digitized and displayed in available patient's modalities (CT, MR or Angiographic). The software can project the selected trajectory to any slices or sections and generate surgeon's eye views. For any possible needle position, the angle settings for either the

Riechert/Mundinger (RM) or Zamorano/Dujovny (ZD) stereotactic operating devices can be displayed.

Praezis Plus supports the transfer of stereotactic coordinates between angiographic, CT and MR images. Regions of Interest ("ROIs") and Volumes of Interest ("VOIs") can be defined, transferred and displayed between angiographic, CT and MR images. Their area and volume can be calculated.

Global stereotactical transformation is available to improve the planning. Image fusion, based on various methods of correlation, allows a combination of valuable information from different modalities. Several types of reconstructed sections such as arbitrary, along and perpendicular to trajectory together with 3D reconstructions are also available. It is possible to print out all the images and protocols and together with patient data archive them on a CD.

The output from Praezis Plus is a printed stereotactical plan defining the trajectory and the setup of the stereotactical device. The treatment plans may be used to administer treatments after review and approval by the neurosurgeon.

See the table below for a detailed comparison of the technological characteristics of Praezis Plus and the predicate device.

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Characteristic	Praezis Plus	Stereoplan Plus (K946033)
Product CodeClassification RegulationIndication for Use	21 CFR 882.4560The Praezis Plus system is computer software intended to be used in planning intracranial stereotactic surgeries such as biopsies and treatment of lesions. The intended user of Praezis Plus is a medical doctor - neurosurgeon.	HAW21 CFR 882.4560The Stereoplan Plus is intended to be used in planning stereotactic treatment of intracerebral lesions.Specifically, the Stereoplan Plus system is intended for planning stereotactic punctures. This indication for use is cleared for the predicate device the STP Complete Module Set, also developed and marketed by Leibinger under K892425/D.
Brief Device Description	Praezis Plus is a software tool intended to help the surgeon plan stereotactic treatments. It enables the user to select optimally fitting stereotactic trajectory positions by digitizing the entry (trephination) and target points of the trajectory. If both points define a trajectory which can be set on the operating device, the corresponding device settings are calculated and displayed in the trajectory window. Any trajectory can be defined and displayed in CT and/or MRI slices or reconstructions or angiographic images if they are available. Trajectories are always stored in stereotactic coordinates and can be digitized and displayed in available patient's modalities (CT, MR or Angiographic). The software can project the selected trajectory to any slices or sections and generate surgeon's eye views. For any possible needle position, the angle settings for either the Riechert/Mundinger (RM) or Zamorano/Dujovny (ZD) stereotactic operating devices can be displayed.	Stereoplan Plus is a software tool intended to help the surgeon plan stereotactic treatments. It enables the user to select optimally fitting stereotactic catheter positions by digitizing the entry (trephination) and target points of the catheter needle. If both points define a needle which can be set on the operating device, the corresponding angles are calculated and displayed in the needle window. Any needle can be defined and displayed in CT slices or sections or angiographic images if they are available. Needles are always stored in stereotactic coordinates and can be digitized and displayed in any space of patient's images (CT, MR or Angiographic). The software can project the selected needle to any slices or sections and generate surgeon's eye views. For any possible needle position, the angle settings for either the Riechert/Mundinger or Zamorano/Dujovny stereotactic operating devices can be displayed.Stereoplan Plus supports the transfer of stereotactic
Characteristic	Praezis Plus	Stereoplan Plus (K946033)
	Praezis Plus supports the transfer of stereotacticcoordinates between angiographic, CT and MR images.Regions of Interest ("ROIs") and Volumes of Interest("VOIs") can be defined, transferred and displayedbetween angiographic, CT and MR images. Their areaand volume can be calculated.Global stereotactical transformation is available toimprove the planning. Image fusion, based on variousmethods of correlation, allows a combination ofvaluable information from different modalities. Severaltypes of reconstructed sections such as arbitrary, alongand perpendicular to trajectory together with 3Dreconstructions are also available.It is possible to print out all the images and protocolsand together with patient data archive them on a CD.The output from Praezis Plus is a printed stereotacticalplan defining the trajectory and the setup of thestereotactical device. The treatment plans may be usedto administer treatments after review and approval bythe neurosurgeon.	coordinates between angiographic, CT and MR images.Regions of Interest ("ROIs") and Volumes of Interest("VOIs") can be defined, transferred and displayedbetween angiographic, CT and MR images. Their areaand volume can be calculated.There are two major components of the Stereoplan PlusSystem: the hardware utilized to position and restraintthe patient's head; and the software used to position thehardware.
Intended User	Neurosurgeon	Neurosurgeon
Operating principle	Stereotactic planning software	Stereotactic planning software
Stand alone softwareapplication	Yes	Yes
CharacteristicSoftware features	Praezis Plus	Stereoplan Plus (K946033)
DICOM image loading	DICOM image loading
Image presentation	Image presentation
Stereotactical image registration	Stereotactical image registration
Multimodal registration	Identity based Multimodal registration on the stereotactical ring
Automatic multimodal registration	Atlas registration
Atlas registration	Image reconstructions
Image reconstructions	3D reconstructions
Image fusion	Contouring the patient – create ROIs
3D reconstructions	Trajectory planning
Contouring the patient - create ROIs	Trajectory planning functional
Trajectory planning	Stereotactical device calculation
Trajectory planning functional	Print images
Stereotactical device calculation	Registrations archived in private groups of DICOM files
Print images
Registrations archived in private groups of DICOM files
Image reslicing
DICOM export

KII 0644
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Consensus Standards

Praezis Plus complies with the following recognized consensus standards:

ISO 14971:2007 Medical devices Application of risk management to medical . devices (FDA Recognition number 5-40)
NEMA PS 3.1-3.18 2008 Digital Imaging and Communications in Medicine . (DICOM) (FDA Recognition number 12-183 )
EN 62304 EN 62304:2006 Medical device software Software life cycle . processes (FDA Recognition number 13-8 )

Performance Data

System Validation

The system validation of Praezis Plus was performed by manufacturer during the validation phase. The relevant features of the pre-released product were tested according to the test plan (a set of test cases) using the test data and the results were recorded to the validation protocol.

Some of the tests were designed as benchmark tests to compare validated system to the benchmark system. All the reference values were measured digitally using the benchmark software (Stereoplan Plus), therefore the reference values were considered to be ideally exact. The measured values were taken the same way; therefore absolute equality would be expected. The allowed inaccuracy was enabled only to accept possible cumulative error resulting from limited resolution of imaging and pointing devices. If no tolerance was allowed then only exactly equal results were allowed.

These benchmark test results demonstrate that the computation accuracy of Praezis Plus is as good as Stereoplan Plus. The test results support the safe and effective use of the Praezis Plus to guide a device to a brain target with an error less than Imm.

Beta Site Testing

The beta site testing of Praezis Plus was conducted at two hospitals:

Beth Israel Deaconess Medical Center - Harvard Medical School, Boston and
University of Chicago Medical Center - Section Of Neurosurgery, Chicago.

The basic concept of the beta site testing method was to compare the currently validating version of the product with the bench mark device (Stereoplan Plus) in the near-clinic (virtual) environment. It means all the existing relevant procedures in the hospital were followed in addition to using the features of Praezis Plus software. Thus, the product was not used for reference during the making a diagnosis - it was used in parallel path for result comparison only.

The conclusion of the both testing was that Praezis Plus fulfills the declared requirements and is consistently safe and accurate comparing to the bench mark device, thus suitable for use in the scope of its declared intended use.

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Substantial Equivalence

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Praezis Plus and its predicate device are stand-alone software systems that are equivalent in indications for use and technology.

Praezis Plus supports all of the features of the Stereoplan Plus (including DICOM image loading, image presentation, reconstruction contouring, 3D reconstruction, stereotactical images, and atlas registration; trajectory planning, and stereotactical device calculation). Moreover, Praezis Plus supports automatic multimodal registration and image fusion; image reslicing, and DICOM export.

Praezis Plus is as safe and effective as the Stereoplan Plus. Praezis Plus has the same intended use and similar indications, technological characteristics. The minor technological differences between Praezis Plus and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate Praezis Plus is as safe and effective as the predicate device. Thus, Praezis Plus is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff entwined with a serpent, and is accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted with three wing-like shapes above the staff and serpent.

Public Health Service

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

TatraMed spol. s.r.o. c/o Ms. Caroline Tontini Project Manager Emergo Group 611 W. 5th St., Third Floor Austin, TX 78701

Re: K110644

Trade/Device Name: Praezis Plus Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: May 21, 2012 Received: May 22, 2012

MAY 2 4 2012

Dear Ms. Tontini:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 - Ms. Caroline Tontini

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcestoYou/Industry/default.htm.

Sincerely yours,

Melvin R. Felder, MD

Malvina B. Eydelman, M, Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K110644

Device Name: Praezis Plus

Indications for Use:

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

John Zineit

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110644

Prescription Use
(Per 21 CFR 801.109)

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).