DASH hip 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 a long bone, can be identified relative to the anatomy. The system aids the surgeon in controlling leg length and offset discrepancies.

Example orthopedic surgical procedures include but are not limited to:

Total Hip Replacement (THR) Revision surgery of THR Minimally Invasive THR Surgery

Device Description

DASH hip is intended to enable operational navigation in minimally invasive orthopedic surgery. It links a surgical instrument, tracked by 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. DASH hip uses the registered landmarks to determine postoperative changes in leg length and offset,

DASH hip software intraoperatively registers the patient data needed for navigating the surgery. No preoperative CT-scanning is necessary.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the BrainLAB DASH hip, based on the provided text:

BrainLAB DASH hip: Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format. However, it states the overall performance goal and the conclusion of the pivotal study.

Acceptance Criteria (Implied)	Reported Device Performance
Accuracy of navigation measurements for leg length and offset.	"The navigation accuracy of the leg length and offset measurements were evaluated in a prospective clinical study... it is shown that the accuracy relating purely to the navigation measurements for leg length and offset is comparable to the previously used leg length and offset technique from the predicate device... Thus, both techniques are considered to be equivalent."
Equivalence to predicate device (BrainLAB hip unlimited K083483).	"Dash hip has been verified and validated... The information provided... was found to be substantially equivalent with the predicate device BrainLAB hip unlimited (K083483) and Kolibri Image Guided Surgery System (K014256)."
Correct system functionality (registration, post-operative point acquisition, analysis).	"All tests have been successfully completed." (Referring to design verification activities)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 43 consecutive Total Hip Replacement (THR) surgeries.
Data Provenance: The study was a "prospective clinical study," implying the data was collected specifically for this purpose in a real-world clinical setting. No specific country of origin is mentioned for the clinical study data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number of experts or their qualifications for establishing ground truth within the clinical study. It states that the study evaluated "navigation accuracy," implying a comparison to some established measurement standard, but doesn't specify who performed or validated these standards. Given the context of surgical navigation, it's highly probable that orthopedic surgeons were involved in the procedures and likely in assessing outcomes, but this is not explicitly stated as "ground truth establishment" by independent experts.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed based on the provided text. The study compared the navigation accuracy of the DASH hip (which aids the surgeon) to a previously used predicate device's technique, not the improvement of human readers with AI vs. without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes "verification of the software algorithm itself" as part of the design verification activities. This suggests a standalone evaluation of the algorithm's performance prior to integration with instrumentation and human interaction. However, detailed results of this standalone testing are not provided, only that it was "successfully verified." The primary clinical study focuses on the system's navigation accuracy, which inherently includes human interaction in using the system to measure.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the prospective clinical study, the ground truth for "leg length and offset measurements" would likely be derived from:

Intraoperative measurements: Taken by the surgeon using conventional or established methods, possibly compared against pre-operative plans or fluoroscopic images.
Radiographic measurements: Post-operative X-rays interpreted to determine actual leg length and offset changes.

The document states the study showed "the accuracy relating purely to the navigation measurements... is comparable to the previously used leg length and offset technique from the predicate device." This implies the "ground truth" was a reliable, established method of measuring these parameters, against which the DASH hip's measurements were compared.

8. The Sample Size for the Training Set

The document does not mention a specific "training set" or sample size for training. The DASH hip is a navigation system that uses landmarks acquired intraoperatively to generate a patient-specific 3D model. It does not appear to be a machine learning or AI system that requires a distinct "training set" in the conventional sense for image analysis or diagnostic tasks. Its core algorithm, though, would have been developed and refined using various data, potentially from predicate devices or simulated scenarios, but this is not described as a "training set."

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

As noted above, a "training set" in the traditional machine learning sense is not explicitly described. The development and verification process included:

Design verification: Covered instrument and system accuracy during registration, post-operative point acquisition, and analysis by comparing values to "externally-measured reference values." This implicitly establishes ground truth for verification tasks.
Non-clinical validation: Performed with plastic bone models (sawbones) in "Usability Workshops (use labs)." Ground truth here would be the known anatomical dimensions of the models and the physical measurements taken.
Pre-clinical validation: Performed in a "cadaver lab." Ground truth here would again be actual anatomical measurements and established surgical reference points.

These pre-clinical and verification steps provided data and a basis for establishing the correctness and accuracy of the device's measurements, which could be considered akin to establishing "ground truth" for development and early testing, distinct from a statistical "training set" for AI model development.

Summary

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KII 0021

510 (k) Summary of Safety and Effectiveness for DASH hip

. . .

Manufacturer/Submitter:

Address:	BrainLAB AGKapellenstrasse 1285622 Feldkirchen
	Germany
Phone:	+49 89 99 15 68 0
Fax:	+49 89 99 15 68 33
Contact Person:	Mr. Alexander Schwiersch

August 11, 2011 Summary Date:

Device Name:

Trade name:

DASH hip

Common/Classification Name:

BrainLAB DASH, BrainLAB Image Guided Surgery System / Instrument, Stereotaxic

Predicate Device:

BrainLAB hip unlimited (K083483) Kolibri Image Guided Surgery System (K014256)

Device Classification Name: Instrument, Stereotaxic Regulatory Class: Class II Regulation Number: 21 CFR 882.4560 Product Code: OLO

Device Description:

DASH hip software intraoperatively registers the patient data needed for navigating the surgery. No preoperative CT-scanning is necessary.

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KII00ZI

Intended Use:

Example orthopedic surgical procedures include but are not limited to:

Total Hip Replacement (THR) Revision surgery of THR Minimally Invasive THR Surgery

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KII0021

Changes made to the predicate device:

Reduced SW complexity: The spectrum of possible workflows in BrainLAB hip unlimited has been reduced to one single workflow. The initial version of the implemented workflow and algorithm for determining the changes in Leg Length and Offset, taken from BrainLAB hip unlimited, has been improved and adapted for use as Dash hip. This workflow employs a method which uses a non-invasive, externallyfixed femoral reference array. No further implant navigation steps are performed.

Reduced Platform: Compared to predicate device, the main calculation unit is part of the camera stand. The smaller separated display, represented by an iPod touch, acts as an embedded display within the instrumentation for used navigation.

Wireless communication between embedded display (iPod touch) and main calculation unit (integrated in camera stand).

Completed verification activities:

The following design verification activities have been performed to ensure correct system functionality according to its specifications:

The first part of the verification covered the instrument and system accuracy during registration, post-operative point acquisition, and analysis. The registration values have been compared to externally-measured reference values. This has been completed for the registration (pre-operative) and postoperative repositioning and point acquisition (for final result analysis) to ensure the correct behavior of the pointer unit in conjunction with the software.
In addition to the verification of the instruments in combination with the software, the verification of the software algorithm itself has been performed. With this step, the main software functionality has been successfully verified.
Part three of the verification includes the testing of the workflow to ensure the correct behavior of the system.
-With the knowledge of the above named points, the current device was compared to the predicate device. This was done by comparing two systems directly during a simulated standard case, and a direct comparison of the used computer system.
-The next step was the detailed verification of the signed specifications covering the detailed functionality of the buttons, for example.
Finally, the measures against the defined risks of the Risk Analysis have been tested.

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This strategy ensures the verification of the software algorithm, the combination of the software with the instrumentation, the comparison to the predicate device, and the safety of the defined measures of the Risk Analysis. All tests have been successfully completed.

Completed validation activities:

10021

The following design validation activities have been performed:

Literature research of Brainlab computer assisted total hip replacement software has been performed to ensure that Dash hip conforms to user needs and intended uses as well.
The Non-clinical Validation was performed to confirm the system targets and to - . supplement requirement specifications where necessary. OR setups and surgical procedures have been simulated with plastic bone models (sawbones) in Usability Workshops (use labs).
A Pre-clinical Validation was performed to confirm/ complete detailed specification for each requirement. Here, OR setups and surgical procedures were simulated in a cadaver lab. Testing persons went through the same procedure as for the Non-clinical use lab sessions.
-To prove that all validation issues are addressed, a Non-Clinical validation was performed under non-clinical conditions. This took place in three phases; the first phase occurring in St. Gallen, Switzerland, and the second in Portland, OR, USA, and the third, final phase in Feldkirchen, Germany. The final phase in Feldkirchen, Germany was used to confirm that any outstanding change requests from previous validation phases have been sufficiently implemented.
The navigation accuracy of the leg length and offset measurements were evaluated in a prospective clinical study. Forty-three consecutive THR surgeries were analyzed. In this study, it is shown that the accuracy relating purely to the navigation measurements for leg length and offset is comparable to the previously used leg length and offset technique from the predicate device, which necessitated a femoral reference array invasively fixed within the bone. Thus, both techniques are considered to be equivalent.

Substantial equivalence:

Dash hip has been verified and validated according to BrainLAB's procedures for product design and development. The information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with the predicate device BrainLAB hip unlimited (K083483) and Kolibri Image Guided Surgery System (K014256).

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

OCT 1 8 2011

BrainLAB AG % Mr. Alexander Schwiersch Kapellenstrasse 12 85622 Feldkirchen, Germany

Re: K110021

Trade/Device Name: DASH Hip Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: September 19, 2011 Received: September 26, 2011

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. 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.

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

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Page 2 - Mr. Alexander Schwiersch

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 (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.

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/CDRH/CDRHOffices/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/ReportalProblem/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.

Sincerely yours,

Erinl Keith

Co Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: K110021

Device Name: DASH hip

Indications For Use:

Example orthopedic surgical procedures include but are not limited to:

Total Hip Replacement (THR) Revision surgery of THR Minimally Invasive THR Surgery

Prescription Use

(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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K10021

Page of

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).