For Total Hip Replacement (THR) procedures
The Brainlab hip system 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 either on a patient's preoperative image data being processed by Brainlab IGS platforms, or 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, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position.
Example orthopedic surgical procedures include but are not limited to:
Total Joint Replacement
Minimally invasive orthopedic surgery
Tumor resection and bone/joint reconstruction

For Surface Replacement (SR) procedures
The Brainlab hip system 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 Brainlab IGS platforms. 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

The Brainlab hip system is intended to enable operational planning and navigation in orthopedic hip replacement surgery. It links a surgical instrument, tracked by passive markers to virtual computer image space on an individual three-dimensional model of the patient's bone, which is generated through acquiring multiple landmarks either directly on the bone surface or by palpating bony landmarks through soft tissue and defining them directly on skin. The Brainlab hip system uses the registered landmarks to navigate the necessary surgical tools, e.g., cup reamer, cup inserter, stem broach handles and k-wires, to the planned position and orientation. Additionally, it enables to intra-operative measurement of implant position, including measurement of the changes in leg length and offset.
The Brainlab hip system provides a three-dimensional reconstruction of the relevant anatomical axes and planes of the femur and pelvis to aid the alignment of the implants and to determine leg length and offset parameters. Based on the selected procedure, the Brainlab hip system loads implant and instrument data that has been provided by the implant manufacturer. It is possible to individually choose the prostheses for each surgery, which are shown in the software in relation to the determined anatomical structures. If no implant data is available, to the user can enter

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance Study for Brainlab Hip

The Brainlab Hip system is an intraoperative image-guided localization system for Total Hip Replacement (THR) and Surface Replacement (SR) procedures.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" for the quantitative accuracy metrics in a tabular format. However, it presents the results of a clinical validation study and implicitly defines the desired performance by comparing it against a "gold standard" and a "safe zone."

Implicit Acceptance Criteria (Based on Study Results and "Safe Zone"):

Metric	Acceptance Criteria (Implicit)	Reported Device Performance (Mean ± Standard Deviation)	Percentage of cases outside ±10° safe zone (Statistical)	Percentage of cases outside ±10° safe zone (Actual)
Lateral Registration
Inclination	Minimal deviation from gold standard; >95% within ±10° safe zone	-1.1° ± 3.1°	0.25%	0%
Anteversion	Minimal deviation from gold standard; >95% within ±10° safe zone	0.9° ± 4.3°	2.32%	0%
Supine Registration
Inclination	Minimal deviation from gold standard; >95% within ±10° safe zone	0.5° ± 2.2°	0.0%	0%
Anteversion	Minimal deviation from gold standard; >95% within ±10° safe zone	-0.9° ± 3.9°	1.2%	0%

Interpretation: The implicit acceptance criterion appears to be that the deviation from the gold standard should be small, and crucially, that the percentage of cases falling outside a clinically recognized ±10° safe zone should be very low (ideally 0% in actual cases). The device met these criteria, reporting 0% of actual cases falling outside the safe zone for both registration methods.

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: The clinical validation study included 50 total hip replacement surgeries. Two patients were excluded (one for data loss, one for pelvic reference array loosening), resulting in 48 cases for analysis.
Data Provenance: The study was a prospective clinical validation study. The document does not specify the country of origin, but given the manufacturer is Brainlab AG based in Germany, it is highly probable the study was conducted in a European country, although this is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their specific qualifications (e.g., radiologist with 10 years of experience) for establishing the ground truth.
However, it does mention that the "gold standard" registration was determined by defining the APP points directly on bone from post-operative CT scans. This implies a process where medical professionals (likely surgeons or radiologists specialized in orthopedic imaging) would interpret these CT scans to establish the bone-based ground truth.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1) for establishing the ground truth.
The "gold standard" was determined by defining points directly on bone from post-operative CT scans. This suggests a direct measurement from imaging rather than a consensus process involving multiple human observers for classification, which is typical for image interpretation tasks.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance.
This study focused on the accuracy of the Brainlab Hip itself in determining cup orientation compared to a gold standard, rather than its impact on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

A standalone performance study was done. The entire clinical validation study detailed in the document assesses the accuracy of the Brainlab Hip system (the device/algorithm) in measuring cup orientation.
The system's measurements were compared directly to a "gold standard" derived from post-operative CT scans, indicating an evaluation of the device's inherent accuracy in a standalone capacity for the critical task of orientation measurement. The "virtually adapted cup orientation" based on Brainlab Hip's registration methods was compared to the CT-derived gold standard.

7. Type of Ground Truth Used

The ground truth used was outcomes data / reference truth derived from post-operative CT scans combined with expert-defined anatomical landmarks.
Specifically, the "gold standard registration" was established by defining the anterior pelvic plane (APP) points directly on bone from post-operative CT scans. This is a highly accurate, objective measurement based on direct anatomical information.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. The provided information pertains to the verification and validation of the device, focusing on a clinical validation study rather than the development or training of an underlying machine learning model (though the "Brainlab Hip has changed in the following from the predicate devices: ... Modified registration techniques have been integrated..." hints at potential algorithmic improvements).

9. How the Ground Truth for the Training Set Was Established

Since the document does not specify a training set or its sample size, it does not describe how the ground truth for any training set was established.

Summary

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K!2011

510 (K) SUMMARY FOR BRAINLAB HIP

Manufacturer:	Brainlab AGKapellenstrasse 1285622 FeldkirchenGermany
	Phone: +49 89 99 15 68 0Fax: +49 89 99 15 68 33
	NOV 1 5 2012
Submitter:	Rainer Birkenbach
Contact Person:	Alexander Schwiersch
Summary Date:	10/17/2012
Device:	Brainlab Hip
Trade Name:	Navigation Software Hip - UniversalNavigation Software Hip THR - AesculapNavigation Software Hip THR - Biomet USNavigation Software Hip THR - DePuy USNavigation Software Hip THR - Smith&Nephew USNavigation Software Hip THR - ZimmerNavigation Software Hip ExpressNavigation Software Hip SR UniversalNavigation Software Hip SR - Biomet USNavigation Software Hip SR - Corin USNavigation Software Hip SR - Wright MedicalNavigation Software Hip SR - ZimmerNavigation Package Hip Unlimited US
Common/ClassificationName:	Brainlab Hip, Brainlab Image Guided Surgery System / Instrument, Stereotaxic
Predicate Device:	BrainLAB hip unlimited (K083483)Vector Vision® hip SR (K063028)DASH hip (K110021)Brainlab Knee (K102990)Brainlab Trauma (K110204)
Device ClassificationName:	Instrument, Stereotaxic
Regulatory Class:	Class II
Regulation Number:	21 CFR 882.4560
Product Code:	OLO / HAW
Intended Use:	For Total Hip Replacement (THR) proceduresThe Brainlab hip system is intended to be an intraoperative image-guidedlocalization system to enable minimally invasive surgery. It links afreehand probe, tracked by a passive marker sensor system, to virtualcomputer image space either on a patient's preoperative image data beingprocessed by Brainlab IGS platforms, or on an individual 3D-model of thepatient's bone, which is generated through acquiring multiple landmarks

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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, or MR-based model of the anatomy. The system aids the surgeon to accurately navigate a hip endoprosthesis to the preoperatively or intraoperatively planned position.

Example orthopedic surgical procedures include but are not limited to:

Total Joint Replacement

Minimally invasive orthopedic surgery

Tumor resection and bone/joint reconstruction

For Surface Replacement (SR) procedures

The Brainlab hip system 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 Brainlab IGS platforms. 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:

The Brainlab hip system provides a three-dimensional reconstruction of the relevant anatomical axes and planes of the femur and pelvis to aid the alignment of the implants and to determine leg length and offset parameters. Based on the selected procedure, the Brainlab hip system loads implant and instrument data that has been provided by the implant manufacturer. It is possible to individually choose the prostheses for each surgery, which are shown in the software in relation to the determined anatomical structures. If no implant data is available, to the user can enter

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SubstantialEquivalence:	Brainlab hip system has been verified and validated according to Brainlab'sprocedures for product design and development. The information providedby Brainlab in this 510 (k) application was found to be substantiallyequivalent with the predicate devices:• BrainLAB hip unlimited (K083483)• Vector Vision® hip SR (K063028)• DASH hip (K110021)• Brainlab Knee (K102990)• Brainlab Trauma (K110204)
Changes to PredicateDevice:	Brainlab Hip has changed in the following from the predicate devices:• Elements of the user interface and workflows have beenredesigned to reduce the user interaction with the systemand enable a faster run through the registration andnavigation procedures.• Modified registration techniques have been integrated whichreduce the number of landmarks to be acquired. For thepelvis, an indirect reconstruction of the anterior pelvic planecan be performed based on a reduced set of landmarks.Information about pelvic tilt can be used to adapt the cuporientation, e.g., to a coronal plane when the patient isstanding upright.• A distance measurement tool has been integrated whichallows to check how well seated a cup implant is on theacetabular floor during cup insertion.• For hip surface replacement procedures, a method for theverification of the head implant has been integrated.• New implants and instruments have been integrated(including a new pointer device, a caliper to measureanatomical relationships of the pelvis, and new data ofFDA-cleared implants provided by the implantmanufacturers).All modifications of the new device are covered by the indications foruse of new and predicate devices and are only minor changes, asthe basic technology has not changed.
TechnologicalCharacteristics:	The literature research and the comparison to the predicate devices show thatthe device makes use of equivalent technological characteristics andfunctionality and is intended for equivalent surgical procedures as compared tothe predicate devices.
Non-clinicalPerformance Data	The following non-clinical tests have been performed to ensure correct systemfunctionality according to its specifications:

. .

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. Specific test objectives have been used to show the correctness of new features in the Brainlab hip system.
. A detailed verification of the signed specifications was performed covering the detailed functionality of the software (e.g. workflows, GUI elements, usage of instruments).
t The measures have been tested against the defined risks of the Risk Analysis.
Literature research has been performed to ensure that . Brainlab hip conforms to user needs and intended uses as well.
Non-clinical tests were performed to confirm the system . targets. Specific OR setups and surgical procedures were simulated in laboratory environments and cadaver labs.

Clinical Performance Data ·

A prospective clinical validation study was performed to analyze the accuracy of lateral and supine pelvis registration in Brainlab Hip. The study included 50 total hip replacement surgeries on patients over 55 years of age. Patients with previous ipsilateral hip surgery affecting the pelvic or acetabular anatomy, pelvic fracture, ipsilateral acetabular fracture and women with childbearing potential were excluded. Two patients had to be excluded because of a loss of the navigation data (one case) and loosening of the pelvic reference array (one case). No intra- or post-operative complications occurred in the remaining cases except one calcar fissure which was unrelated to the navigation and caused no post-operative problems.

The surgical procedure was performed using the previous version of Brainlab Hip, the Brainlab Hip 5.1 navigation system, including an epicutaneous acquisition of the anterior pelvis plane (APP) as the basic reference for intraoperative navigation. This reflects an established registration procedure. The final position of the cup was verified based on this registration. Additionally, all landmarks required for Brainlab Hip registration procedures were acquired. Based on this information, the verified cup orientation was virtually adapted to the registration methods of Brainlab Hip. Post-operative CT scans were performed to determine a gold standard reqistration by defining the APP points directly on bone. Cup orientation was measured for this reference and then compared to the virtually adapted cup orientation. This enabled a direct comparison of the lateral and supine registration methods in Brainlab Hip with the gold standard.

The descriptive statistics (mean ± standard deviation) of the deviations to the gold standard, as well as the percentage of cases within a ±10° safe zone, as defined by Lewinnek et al in Lewinnek GE, Lewis JL, Tarr R, Compere CL, Zimmerman JR. Dislocations after total hip-replacement arthroplasties. J Bone Joint Surg Am. 1978 Mar;60(2):217-20, were calculated according to the radiographic definition specified by Murray DW in The definition and measurement of acetabular orientation. J Bone Joint Surg Br. 1993 Mar: 75(2): 228-32. The percentages were calculated based on the actual numbers of cases, as well as a statistical calculation where error distribution was modeled as a normal distribution.

. Deviation between gold standard and Brainlab Hip lateral registration:
- Inclination: -1.1° ± 3.1°, statistically 0.25% of the cases were ー

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outside the ±10° safe zone

Anteversion: 0.9° ± 4.3°, statistically 2.32% of the cases were outside the ±10° safe zone
Deviation between gold standard and Brainlab Hip supine registration:
- Inclination: 0.5° ± 2.2°, statistically 0.0% of the cases were outside the ±10° safe zone
- Anteversion: -0.9° ± 3.9°, statistically 1.2% of the cases were outside the ±10° safe zone

The deviation was not outside the safe zone in any of the actual cases. This was true for both lateral and supine registration methods. These results describe the basic accuracy of cup orientation measurement in Brainļab Hip.

Conclusion

All non-clinical and clinical tests have been successfully performed. Thus, it has been demonstrated that the device is as safe, as effective, and performs as well as the predicate device.

Ooh
(Division Sign-Off)
Orthopedic,

(Division Sign-Off)
Division of Surgion : Orthopedic, Division of Surgious Devices Division of Surs.
and Restorative Devices

510(k) Number 2

REVISION 1

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Brainlab AG % Mr. Alexander Schwiersch Regulatory Affairs Manager Kapellenstrasse 12 Feldkirchen, Germany 85622

November 15, 2012

Re: K122011

Trade/Device Name: Brainlab Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: OLO Dated: October 24, 2012 Received: October 26, 2012

Dear Mr. Schwiersch:

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

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Page 2 - Mr. Alexander Schwiersch

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 yours, --

Peter D. Rumm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

510(k) Number (if known):

K122011

Device name: Brainlab Hip

Indication for use:

Total Hip Replacement (THR) procedures

The Brainlab Hip system is intended to be an intraoperative image-guided localization system to enable rice Brunnal This eyettern it links a freehand probe, tracked by a passive marker sensor system, to milling in room of a gol your either on a patient's preoperative image data being processed by Brainlab Virtual computer innage opation 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 r the system to be safe 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 to accurately navigate a hip endoprosthesis to the preoperatively aniatonly. The eyesting and thopedic surgical procedures include but are not limited to: Total Joint Replacement

Minimally invasive orthopedic surgery Tumor resection and bone/joint reconstruction

Surface Replacement (SR) procedures

The Brainlab Hip system 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 Brainlab Institutions. 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 r no system is manage room a reference to a rigid anatomical structure, such as the skull, a oundidored to be appropriate i 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.

Prescription Use X (Per 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)

-Duri/Aw-focMXM

(Division Sign-Off) Division of Surgical, Orthopediatence of CDRH, Office of Device Evaluation (ODE) and Restorative Devices

510(k) Number K122011

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).