The joimax® Intracs® m Navigation System is intended to continuously display the position and orientation of joimax® surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures.

The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the access to the access to the area of interest, is a rigid landmark, such as:

· Transforaminal procedure

• Interlaminar procedure

Device Description

The joimax® Intracs® em System is a surgical navigation system based on electromagnetic (EM) tracking technology, designed specifically for applications in minimally invasive spine surgery. The system displays instrument position relative to the patient's anatomy.

AI/ML Overview

The joimax® Intracs® em System is a surgical navigation system. The provided text, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to a predicate device (StealthStation S8 Spine Software) rather than detailing a specific clinical study with granular acceptance criteria and performance data for a standalone AI algorithm.

However, based on the performance data section and the comparison table, we can infer the primary performance metric for this stereotaxic instrument: System Accuracy.

Here's an attempt to structure the information based on the provided text, recognizing that this document is a regulatory submission for substantial equivalence, not a detailed research paper on an AI's performance for a diagnostic task. The AI component here is implied within the "surgical navigation system" which uses electromagnetic tracking to continuously display instrument position relative to anatomy. The "device performance" in this context is its accuracy in tracking.

Acceptance Criteria and Device Performance Study for joimax® Intracs® em System

The joimax® Intracs® em System is a surgical navigation system primarily focused on continuously displaying the position and orientation of surgical instruments relative to anatomical structures using electromagnetic tracking. The "performance data" supplied in support of its substantial equivalence to a predicate device focuses on its accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the joimax® Intracs® em System are directly compared to the performance characteristics of its predicate device, the StealthStation S8 Spine Software. The primary performance metric detailed is System Accuracy.

Type of Acceptance Criteria	Acceptance Criteria (from Predicate)	Reported Device Performance (joimax® Intracs® em System)
System Level Accuracy	Mean positional error of ≤2.0 mm	Mean positional error of ≤2.0 mm
System Trajectory Accuracy	Mean trajectory error of ≤2°	Mean trajectory error of ≤2°

Note: The K192663 document states the predicate has 'mean positional error of 2.0 mm and a mean trajectory error of 2°', implying these were the benchmarks for the subject device.

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

The provided document does not specify the exact sample size used for the performance testing related to accuracy (e.g., number of measurements, number of phantoms/cadavers).

Test Set Description: Performance testing was conducted using phantoms and human cadavers.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the context of a 510(k) submission, these would typically be conducted prospectively as part of product development and validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth during the performance testing. In the context of a navigation system's accuracy, the ground truth would likely be established by precise measurements (e.g., CMM, optical tracking gold standard) rather than subjective expert consensus.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method as it's not a reader study or a diagnostic performance evaluation in the typical sense of AI for image interpretation. The "ground truth" for system accuracy would be based on physical measurements against known values and not on human interpretation needing adjudication.

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

An MRMC study was not conducted/mentioned as this device is a surgical navigation system, not a diagnostic imaging AI designed to assist human readers in interpreting medical images. Its performance is about the accuracy of instrument localization, not diagnostic accuracy requiring human reader comparison.

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

The "performance testing (accuracy)" mentioned in the document is effectively the standalone performance of the algorithm and hardware system. The reported values for positional and trajectory error (≤2.0 mm and ≤2°) are the standalone performance metrics. The nature of a surgical navigation system means the "in-the-loop" performance is the surgeon using the system, and the accuracy metrics directly reflect the system's ability to provide correct information to the surgeon.

7. Type of Ground Truth Used

The ground truth for the performance testing (accuracy) was established through physical measurements against known values in phantoms and human cadavers. This is implicitly derived from the types of "Performance testing with phantoms and human cadavers" and the quantified "System Accuracy" metrics (positional and trajectory error). It is not expert consensus, pathology, or outcomes data in the usual sense.

8. Sample Size for the Training Set

The document does not specify a separate "training set" as this is not a deep learning or machine learning model that undergoes a distinct training phase on a large dataset for image analysis. The system's "training" refers to its engineering design, calibration, and validation, not a data-driven machine learning training set in the typical AI sense.

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

As there's no mention of a traditional machine learning "training set," this question is not applicable in the context of the information provided for this specific device. The system's underlying principles (electromagnetic tracking) are based on established physics and engineering, validated through rigorous testing and calibration.

Summary

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July 30, 2020

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joimax GmbH Gary Mocnik Official Correspondent Amalienbadstrasse 41, RaumFabrik 61 Karlsruhe, 76227 Germany

Re: K192663

Trade/Device Name: Joimax Intracs System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: June 26, 2020 Received: June 30, 2020

Dear Gary Mocnik:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192663

Device Name joimax® Intracs® em System

Indications for Use (Describe)

· Transforaminal procedure

• Interlaminar procedure

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

I. SUBMITTER
joimax® GmbH Amalienbadstrasse 41 RaumFabrik 61 76227 Karlsruhe, Germany

Contact person: Gary Mocnik Phone: (949) 433-0413 Date prepared: September 23, 2019

II. DEVICE

Name of the device: joimax® Intracs® em System Common or usual name: Surgical navigation system Classification name: Orthopedic Stereotaxic Instrument Regulatory Class: 2 Regulation Number: 21 CFR 882.4560 Product Code: OLO

III. PREDICATE DEVICE StealthStation S8 Spine Software (K170011)

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The joimax® Intracs® em Navigation System is intended to continuously display the position and orientation of joimax® surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures. The use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the procedure itself or for the access to the area of interest, is a rigid landmark, such as:

Transforaminal procedure .
. Interlaminar procedure
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

At a high level, the subject and predicate device are based on the following same technological elements:

Both devices are design to facilitate spinal surgical procedures by .

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localization of surgical instruments and patient anatomy

. Both devices utilize electromagnetic (EM) technology to facilitate localization of the instruments and patient anatomy
The subject joimax® Intracs® em System has the same technological characteristics as the predicate device including design, intended use, major system components and function. The similarities and differences are summarized in the table below:

	joimax® Intracs® em System	StealthStation S8 SpineSoftware (K170011).
Principle of Operation	Localization of sensors attached toinstruments within a definedelectromagnetic field	Localization of sensors attachedto instruments within a definedelectromagnetic field orlocalization of reflectors bycameras
Anatomical Site	Spine	Spine
Surgical type	Minimally invasive	Minimally invasive,open
Imaging modalities (Spine)	X-Ray (fluoroscopy)	X-Ray (fluoroscopy)
Control Mechanism(hardware)	Tracked instruments, touch screen or mouse	touch screen or mouse
Scanner interfaceTechnology	Network Connectivity CD, DVD, USBDICOM Import	Network Connectivity CD,DVD, USB DICOM ImportDICOM Export
View (display features)	AP and Lateral View,Video Input	Look Sideways 3D AnatomicOrthogonal Trajectory 1 and 2Trajectory Guidance LookAhead Probe's Eye AP andLateral Synthetic AP and LateralMaximum Intensity ProjectionVideo Input
Localization Technology	EM	Optical or EM
Instrument interface	EM	Optical or EM
EM Emitter Types	Side	Side, Flat
EM Instrumentation	joimax® instruments are tracked byelectromagnetic sensors which can beattached to the instrument	Medtronic instruments trackedvia electromagnetic localizationtechnology located within theinstrument and patient trackers
Software Interface (GUI)	Basic white and black-style with 4 mainworkflow steps.Controls are located on the right side ofeach view	Basic gray and black style with4 main tasks and tab interface toaccess tools. Controls on theright.
Computer	Intel-based PC	Intel-based PC
Network Connectivity	Connection Type: Standard Ethernet	Connection Type: StandardEthernet 2.4 gHz and 5.0 gHzWireless connection
System Accuracy	System Level Accuracy with a meanpositional error of ≤2.0 mm and a meantrajectory error of ≤2°.	System Level Accuracy with amean positional error of 2.0 mmand a mean trajectory error of2°.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence.

Electrical safety (IEC 60601-1) I
Electromagnetic compatibility (IEC 60601-1-2)
Usability
트 Performance testing (accuracy)
I Functional testing
Software verification
I Performance testing with phantoms and human cadavers
Biocompatibility evaluation (ISO 10993-1)
I Cleaning and disinfection validation
I Sterilization validation

The joimax® Intracs® em System met all specified criteria and did not raise new safety or performance questions. Based on the performance testing, the joimax® Intracs® em System was found to have a safety and effectiveness profile that is similar to the predicate device.

VIII. CONCLUSIONS

The testing performed for the joimax® Intracs® em System demonstrated, that the performance of the device is equal to the legally marketed predicate device.

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).