BrainLAB VectorVision is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprothesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

Total Joint Replacement (TJR) Revision surgery of TJR Minimal Invasive Orthopedic Surgery Tumor resection and bone/joint reconstruction

Device Description

BrainLAB VectorVision® hip Software is intended to enable operational planning and navigation in orthopedic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, generated through acquiring multiple landmarks on the bone surface either by a pointer probe or by acquiring pairs of registered fluoroscopic images. VectorVision® hip Software uses the registered landmarks to navigate the needed surgical tools like cup reamer, cup inserter, stem rasp, bone saw and the implant to the planned position. If no implant data is available it is possible to provide information in order to achieve a generally targeted alignment relative to the bone orientation as defined by the operating surgeon.

Vector\Vision® hip Software allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur and pelvis and alignment of the implants. The VectorVision® hip Software has been designed to read in data of implants and tools if provided by the implant manufacturer and offers to individually choose the prosthesis during each surgery. The VectorVision® hip Software registers the patient data needed for planning and navigating the surgery intra-operatively within the CT free module. The System can be used to generally align tool orientations according to the anatomy described and defined by the landmarks acquired by the surgeon.

AI/ML Overview

The provided document is a 510(k) summary for the BrainLAB VectorVision® hip Software, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics. Therefore, much of the requested information about a study proving the device meets acceptance criteria is not explicitly stated in this document.

However, I can extract the information that is present and indicate where the requested details are missing based on the content provided.

Here's an attempt to answer your request based only on the provided text:

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

The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics (e.g., accuracy in angle or translation measurements) from a validation study. It broadly claims "The validation proves the safety and effectiveness of the system."

Acceptance Criteria (Not explicitly stated as quantitative values in the document)	Reported Device Performance (Not explicitly stated as quantitative values in the document)
Safety and Effectiveness of the system	The validation proves the safety and effectiveness of the system.
Substantial equivalence to predicate devices (VectorVision® Hip 3.0, VectorVision® Trauma, Hip Module for the StealthStation System)	The information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with predicate devices.
Ability to enable operational planning and navigation in orthopedic surgery	The device is intended to enable operational planning and navigation in orthopedic surgery.
Ability to link a surgical instrument, tracked by flexible passive markers, to virtual computer image space on an individual 3D-model.	The device links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone.
Ability to register landmarks to navigate surgical tools and implants.	VectorVision® hip Software uses the registered landmarks to navigate the needed surgical tools like cup reamer, cup inserter, stem rasp, bone saw and the implant to the planned position.
Ability for 3-dimensional reconstruction of mechanical axes/planes and implant alignment.	VectorVision® hip Software allows 3-dimensional reconstruction of the relevant mechanical axes and planes of femur and pelvis and alignment of the implants.
Ability to read in implant and tool data.	The VectorVision® hip Software has been designed to read in data of implants and tools if provided by the implant manufacturer.

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

The document does not provide details on any specific test set, sample size, or data provenance (country of origin, retrospective/prospective). It mentions "BrainLAB VectorVision® hip Software has been verified and validated according to BrainLABs procedures for product design and development," but no specifics on the validation study are given.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

The document does not describe an MRMC comparative effectiveness study or assess human reader improvement with AI assistance. The device is a surgical navigation system, not an AI diagnostic tool for interpreting medical images by human readers.

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

The document does not explicitly present data from a standalone performance study. The entire description of the device implies human-in-the-loop usage (surgeon using the system to navigate). The "validation" broadly states safety and effectiveness, but no specific study design or results are provided.

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

The document does not specify the type of ground truth used for any validation testing. It mentions the system's ability to navigate to a "preoperatively or intraoperatively planned position," suggesting that surgical plans and intraoperative reality would be relevant for ground truth, but this is not detailed.

8. The sample size for the training set

The document does not mention a training set or its sample size. This type of detail is typically associated with machine learning model development, which is not the primary focus of this 510(k) summary (focused on a navigation system).

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

As no training set is mentioned, information on how its ground truth was established is also not present.

Summary

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1-06-0727

510 (k) Summary of Safety and Effectiveness for VectorVision® hip Software

Manufacturer:	BrainLAB AG
Address:	Kapellenstr. 1285622 FeldkirchenGermanyPhone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33			AUG 2 1 2006
Contact Person:	Mr. Per Persson
Summary Date:	July 7th, 2006
Device Name:
Trade name:		VectorVision® hip Software
Common/Classification Name:	VectorVision, BrainLAB Image Guided Surgery System / Instrument,		Stereotaxic

Predicate Device: Vector Vision® HIP 3.0 (K040368)

Device Classification Name: Instrument, Stereotaxic Requiatory Class: Class II

Intended Use:

Example orthopedic surgical procedures include but are not limited to:

Total Joint Replacement (TJR) Revision surgery of TJR Minimal Invasive Orthopedic Surgery Tumor resection and bone/joint reconstruction

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Device Description:

Substantial equivalence:

VectorVision® hip Software has been verified and validated according to BrainLABs procedures for product design and development. The validation proves the safety and effectiveness of the system. The information provided by BrainLAB in this 510 {k} application was found to be substantially equivalent with predicate devices such as the 510(k)-clearance of:

VectorVision® Hip 3.0 (K040368) -
VectorVision® Trauma (K012448) -
-Hip Module for the StealthStation System (K021980)

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, and it is used to represent the Department of Health and Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 1 2006

BrainLAB AG % Mr. Peter Drumm Project Manager Ammerthalstrasse 8 85551 Heimstetten Germany

Re: K060727

Trade/Device Name: VectorVision® hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: July 28, 2006 Received: August 3, 2006

Dear Mr. Drumm:

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. This letter will allow you to

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Page 2 - Mr. Peter Drumm ﯨﭗ ﺑ

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 (240) 276-0115. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

F.N. D.P.L.

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ﻧﺴﻌﺮ 510(k) Number (if known):

K 060727

Device Name:

VectorVision® hip

Indications For Use:

Example orthopedic surgical procedures include but are not limited to:

Total Joint Replacement (TJR) Revision surgery of TJR Minimal Invasive Orthopedic Surgery Tumor resection and bone/joint reconstruction

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

Over - The - Counter Use

(Optional Format 1-2-96)

Fision Sign-Off) Division of General, Restorative Devices

3(k) Number K060727

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).