K Number

Device Name

Manufacturer

BRAINLAB AG

Date Cleared

2007-10-11

(29 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

BrainLAB´s VectorVision® hip SR is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a VectorVision® navigation station. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by 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 appropriate 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, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a hip endoprothesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

· Partial/hemi-hip resurfacing

Device Description

BrainLAB's VectorVision® hip SR is intended to enable operational planning and navigation in orthopedic hemi resurfacing 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, which is generated through acquiring multiple landmarks on the bone surface. VectorVision® hip SR uses the registered landmarks to navigate the initial pin insertion into the femur with a pre-calibrated drillguide to the planned position.

VectorVision® hip SR allows 3-dimensional reconstruction of the relevant anatomical axes and planes of the femur and alignment of the implants. The VectorVision® hip SR 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. 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. The VectorVision® hip SR software registers the patient data needed for planning and navigating the surgery intraoperatively without CT-based imaging. 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 VectorVision® hip SR device and does not contain detailed information about specific acceptance criteria, study methodologies, or performance metrics in a structured experimental study. The document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use and description.

Therefore, many of the requested fields cannot be directly extracted from the provided text. However, I can infer some general information about the validation process as stated in the document.

Here's an attempt to answer your questions based on the available information:

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

The document states: "VectorVision® hip SR has been verified and validated according to the BrainLAB procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate devices Vector Vision® Hip 3.0 (K 040368) and Vector Vision® Hip SR 1.0 (K 063028)."

This indicates that the acceptance criteria are tied to demonstrating substantial equivalence to its predicate devices. However, specific quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) and reported performance metrics against those criteria are not detailed in this summary. The summary implies that the device meets the functional and safety requirements comparable to its predicates.

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Safety and Effectiveness comparable to predicate devices.	"Safety and effectiveness... was found to be substantially equivalent with the predicate devices Vector Vision® Hip 3.0 (K 040368) and Vector Vision® Hip SR 1.0 (K 063028)."
Functional capability for image-guided localization in hip resurfacing surgery.	The device enables operational planning and navigation, links instruments to virtual computer image space, and aids in accurately navigating a hip endoprosthesis.

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

This information is not provided in the 510(k) summary. The document does not specify any particular test set size or data provenance for performance validation.

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 510(k) summary. The document does not describe the establishment of a ground truth for a test set.

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

This information is not provided in the 510(k) summary.

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

This document describes a surgical navigation system, not an AI-based diagnostic or analysis tool that would typically involve human "readers" or an MRMC study comparing AI assistance. Therefore, an MRMC study as described is not applicable/not mentioned in this context.

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

The device is an "intraoperative image-guided localization system" designed to "aid the surgeon." This implies a human-in-the-loop system where the surgeon uses the device for navigation. A standalone algorithm-only performance assessment in the context of clinical outcomes is not described or implied in this document. The system's performance is inherently tied to its use by a surgeon during a procedure.

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

The document does not explicitly state the type of ground truth used for validation. Given that it's a surgical navigation system, the "ground truth" for its performance validation would likely relate to the accuracy of instrument positioning relative to planned targets or anatomical landmarks, possibly verified through intraoperative measurements or post-operative imaging, or phantom studies. However, the specific methodology is not detailed.

8. The sample size for the training set

This information is not provided in the 510(k) summary. The document describes a navigation system that generates a 3D model from "acquiring multiple landmarks on the bone surface" rather than a system extensively trained on a large dataset in the sense of modern machine learning.

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

This information is not provided in the 510(k) summary. As mentioned for #8, the concept of a "training set" in the context of recent AI/ML devices might not directly apply here, as the system relies on intraoperative landmark acquisition and established geometric principles for navigation rather than large-scale data training to learn patterns. The "ground truth" for the system's underlying algorithms and models would have been established through engineering principles, calibration, and geometry, rather than an external "training set" of patient data.

Summary

{0}------------------------------------------------

K072573

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

Manufacturer:

Address:	BrainLAB AGKapellenstr. 1285622 FeldkirchenGermany
	Phone: +49 89 99 15 68 0
	Fax: +49 89 99 15 68 33
Contact Person:	Mr. Per Persson
Summary Date:	August 30, 2007

Device Name:

Trade name:

Common/Classification Name:

VectorVision hip SR

VectorVision, BrainLAB Image Guided Surgery System / Instrument. Stereotaxic

Predicate Devices: Vector Vision® Hip 3.0 (K 040368) Vector Vision® Hip SR 1.0 (K 063028)

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

Intended Use:

Example orthopedic surgical procedures include but are not limited to:

· Partial/hemi-hip resurfacing

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

Device Description:

Substantial equivalence:

VectorVision® hip SR has been verified and validated according to the BrainLAB procedures for product design and development. The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate devices Vector Vision® Hip 3.0 (K 040368) and Vector Vision® Hip SR 1.0 (K 063028).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three wavy lines that resemble a caduceus or a symbol of health and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 1 2007

BrainLAB AG % Mr. Benjamin Wagner Mechanical Design Engineer Kapellenstraß 12 85622 Feldkirchen Germany

Re: K072573 Trade/Device Name: VV hip SR Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: September 10, 2007 Received: September 12, 2007

Dear Mr. Wagner:

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

{3}------------------------------------------------

Page 2 - Mr. Benjamin Wagner

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 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 vor

For Polo Rms
Dep D.R
10/10/24
Mark N. Melkerson

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

Enclosure

{4}------------------------------------------------

Page 2011 - of of 1 - 1

510(k) Number (if known):	K072573
---------------------------	---------

Device Name:

VV hip SR

Indications For Use:

BrainLAB's VectorVision® hip SR is intended as an intraoperative image-guided localization system. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a VectorVision® navigation station. The image data is provided either in the form of preoperatively-acquired patient images or in the form of an individual 3D model of the patient's bone, which is generated by 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 appropriate 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, or MR-based model of the anatomy. The system aids the surgeon in accurately navigating a hip endoprosthesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

· Partial/hemi-hip resurfacing

Prescription Use (Per 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use (21 CFR 801 Subpart C)
---------------------------------------------	---	--------	---------------------------------------------

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

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number	L072573
---------------	---------

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).