The Zeta Cranial Navigation System is a stereotaxic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments used by surgeons. The device is indicated only for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient. The system is intended to be used in operating rooms and in less acute surgical settings such as interventional procedure suites.

Device Description

The Zeta Cranial Navigation System is a stereotaxic, image guided planning and intraoperative guidance system enabling computer-assisted cranial interventional procedures. The system assists surgeons with the precise positioning of surgical instruments relative to patient anatomy by displaying the position of navigated surgical instruments relative to 3D preoperative medical scans.

AI/ML Overview

The provided FDA 510(k) summary for the Zeta Cranial Navigation System (K233903) describes its performance data and the studies conducted to demonstrate substantial equivalence to its predicate device (K230661). However, it does not contain the specific statistical acceptance criteria or detailed results of a comparative effectiveness study (like an MRMC study) for human readers, or a standalone AI performance study.

The document primarily focuses on technical performance testing (accuracy, electrical safety, EMC, software V&V, and human factors) rather than clinical performance or AI algorithm-specific metrics.

Based on the provided text, here's what can be extracted and what information is not available:

Acceptance Criteria and Reported Device Performance

The document states that "The device passed all tests" for electrical safety, EMC, and software verification and validation. For bench testing, it indicates "Accuracy testing under different conditions," but does not specify the quantitative acceptance criteria for "accuracy" or the achieved performance values.

Table 1: Acceptance Criteria and Reported Device Performance (as inferred and stated)

Performance Metric	Acceptance Criteria (Inferred/Stated)	Reported Device Performance
Accuracy Testing	Sufficient accuracy for neurosurgical instrument spatial positioning and orientation (implied by "demonstrate substantial equivalence").	Not explicitly quantified in this document. Described as "passed".
Electrical Safety (IEC 60601-1)	Compliance with IEC 60601-1:2005 (3rd ed) + A1:2012	Device passed all tests.
Software Life Cycle (IEC 62304)	Compliance with IEC 62304:2006+Amd 1:2015	Device passed all tests.
EMC (IEC 60601-1-2)	Compliance with IEC 60601-1-2:2014+A1:2021	Device passed all tests.
Usability (IEC 60601-1-6)	Compliance with IEC 60601-1-6, Edition 3.2 2020-07	Device passed all tests.
Software Concern Level (V&V)	Software considered "Major level of concern" requiring specific V&V documentation.	Documentation provided as recommended by FDA guidance.
Cybersecurity	Documentation provided as recommended by FDA guidance.	Documentation provided as recommended by FDA guidance.
Shelf-Life	Low likelihood of time-dependent product degradation.	Not applicable; no shelf-life specified, as degradation is considered low.
Navigation Frames per Second (fps)	Likely linked to sufficient update rate for real-time guidance.	Uncapped (mean 21fps).

Study Details

The document details various types of testing, but does not describe a study involving human readers or an AI algorithm in the way typically associated with diagnostic AI tools (e.g., for image interpretation). The "Zeta Cranial Navigation System" is a stereotaxic image guidance system, where the "AI" or "machine vision" component likely refers to the system's ability to perform automatic, pinless, and markerless patient registration and instrument tracking, rather than an AI that interprets medical images for diagnostic purposes.

Therefore, many of the questions below related to AI study specifics (training sets, ground truth methodology for AI, MRMC studies) are not applicable (N/A) to the information provided in this 510(k) summary, as it does not describe such a study.

Sample size used for the test set and the data provenance:
- N/A (for clinical AI performance evaluation): The document mentions "accuracy testing under different conditions" including "simulated clinical procedures using virtual targets" and "dynamic patient motion," but it does not specify a "test set" in the context of patient data or clinical images for an AI diagnostic algorithm. The testing described is bench testing.
- Data Provenance: The nature of the "virtual targets" and "simulated clinical procedures" means the data is synthetically generated or simulated in a lab setting, not from clinical patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A: As this is bench testing of a navigation system's mechanical and software accuracy (e.g., tracking instruments relative to a known position), the "ground truth" is established through engineering and metrology standards rather than expert medical interpretations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A: Not relevant for the type of bench testing described.
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:
- No: The document explicitly states "Clinical Data: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." This confirms that an MRMC study comparing human performance with and without AI assistance was not performed or deemed necessary for this 510(k) submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes (for specific functions): The document describes "Accuracy testing" and "Software Verification and Validation." The system's intrinsic functions like "automatic, pinless, and markerless" registration and "optical tracking" of instruments would have been tested in a standalone manner to demonstrate their performance against defined metrics. However, "standalone" in this context refers to the system's technical performance characteristics, not an AI interpreting medical images.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering/Metrology Standards: For accuracy testing of a navigation system, ground truth is typically established through precise measurement devices (e.g., coordinate measuring machines, high-precision optical tracking systems) and simulated conditions. It's not based on medical expert consensus or pathological findings.
The sample size for the training set:
- N/A: The document does not describe an AI model that requires a "training set" in the context of machine learning for diagnostic image analysis. The "machine vision" and "structured light" technologies employed are likely more akin to traditional computer vision algorithms for feature recognition and localization, which might be "calibrated" or "tuned" but not typically "trained" on large datasets in the way a deep learning model would be.
How the ground truth for the training set was established:
- N/A: See point 7.

Summary

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January 10, 2024

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Zeta Surgical Inc Roman Stolyarov, Ph.D. Chief Product Officer 115 Kingston Street, Floor 2 Boston, Massachusetts 02111

Re: K233903

Trade/Device Name: Zeta Cranial Navigation System (ZNS131-US) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: HAW Dated: December 11, 2023 Received: December 11, 2023

Dear Dr. Stolyarov:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Digitally signed by Adam D. Adam D. Pierce -S Date: 2024.01.10 Pierce -S 12:34:35 -05'00'

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological

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and Physical Medicine 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) K233903

Device Name Zeta Cranial Navigation System (ZNS131-US)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Zeta Cranial Navigation System is provided below.

1. SUBMITTER

Applicant:	Zeta Surgical Inc.115 Kingston Street, Floor 2Boston, MA 02111
Contact:	Roman Stolyarov, PhDChief Product OfficerZeta Surgical Inc.115 Kingston Street, Floor 2Boston, MA 02111+1 (214) 284-7990roman.stolyarov@zetasurgical.com
Submission Correspondent:	Roman Stolyarov, PhDChief Product OfficerZeta Surgical Inc.115 Kingston Street, Floor 2Boston, MA 02111+1 (214) 284-7990roman.stolyarov@zetasurgical.com
Date Prepared:	January 10, 2024

2. DEVICE

Device Trade Name:	Zeta Cranial Navigation System
Device Common Name:	Neurological Stereotaxic Instrument
Classification Name:	Stereotaxic instrument, 21 CFR 882.4560
Regulatory Class:	Class II
Product Code:	HAW

3. PREDICATE DEVICE

Predicate Device: Zeta Cranial Navigation System [K230661]

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DEVICE DESCRIPTION 4.

INDICATIONS FOR USE ર.

6. SUBSTANTIAL EQUIVALENCE

Comparison of Indications

Subject Device	Predicate Device
The Zeta Cranial Navigation System is a stereotaxic	The Zeta Cranial Navigation System is a stereotaxic
image guidance system intended for the spatial	image guidance system intended for the spatial
positioning and orientation of neurosurgical	positioning and orientation of neurosurgical
instruments used by surgeons. The device is indicated	instruments used by surgeons. The device is indicated
only for cranial surgery where reference to a rigid	only for cranial surgery where reference to a rigid
anatomical structure can be identified, does not	anatomical structure can be identified, does not
require rigid fixation of the patient, and does not	require rigid fixation of the patient, and does not
require fixation of a navigated instrument guide to the	require fixation of a navigated instrument guide to the
patient. The system is intended to be used in operating	patient. The system is intended to be used in operating
rooms and in less acute surgical settings such as	rooms and in less acute surgical settings such as
interventional procedure suites.	interventional procedure suites.

Technological Comparisons

The table below compares the key technological features of the subject device to the predicate device (Zeta Cranial Navigation System, K230661).

	Cleared Device	Subject Device
General
510(k)Number	K230661	K233903
Device Name	Zeta Cranial Navigation System	Zeta Cranial Navigation System
ClassificationRegulation	21 CFR 882.4560	21 CFR 882.4560
Product Code	HAW	HAW
	Cleared Device	Subject Device
Classification	Class II	Class II
IndicationsFor Use	The Zeta Cranial Navigation System is astereotaxic image guidance system intended forthe spatial positioning and orientation ofneurosurgical instruments used by surgeons.The device is indicated only for cranial surgerywhere reference to a rigid anatomical structurecan be identified, does not require rigid fixationof the patient, and does not require fixation of anavigated instrument guide to the patient. Thesystem is intended to be used in operatingrooms and in less acute surgical settings suchas interventional procedure suites.	The Zeta Cranial Navigation System is astereotaxic image guidance system intended forthe spatial positioning and orientation ofneurosurgical instruments used by surgeons.The device is indicated only for cranial surgerywhere reference to a rigid anatomical structurecan be identified, does not require rigid fixationof the patient, and does not require fixation of anavigated instrument guide to the patient. Thesystem is intended to be used in operating roomsand in less acute surgical settings such asinterventional procedure suites.
IntendedUser	Neurosurgeons and neurosurgical procedurestaff	Neurosurgeons and neurosurgical procedurestaff
Intended UseEnvironment	Neurosurgical operating room and facilitiesequipped for interventional cranial procedures	Neurosurgical operating room and facilitiesequipped for interventional cranial procedures
AnatomicalSite	Head	Head
Principle ofOperation	Preoperative image upload, Surgical planning,Patient registration, and Instrument guidance	Preoperative image upload, Surgical planning,Patient registration, and Instrument guidance
Technology
AcceptedImagingModalities	3D DICOM CT and MRI	3D DICOM CT and MRI
Data Input	USB and CD-ROM	USB and CD-ROM
InstrumentTrackingTechnology	Optical tracking of wireless, unpoweredinstruments	Optical tracking of wireless, unpoweredinstruments
InstrumentCompatibility	Brainlab Disposable Stylet only	Brainlab Disposable Stylet only
RegistrationTechnology	Structured light and machine vision	Structured light and machine vision
GuidanceTechnology	Image based, provides real-time display ofinstrument position relative to patient anatomy	Image based, provides real-time display ofinstrument position relative to patient anatomy
MajorSystemComponents	Cart, Sensor head, Sensor head positioningarm, Monitor, Monitor positioning arm,Tracked instruments, Software	Cart, Sensor head, Sensor head positioning arm,Monitor, Monitor positioning arm, Trackedinstruments, Software
UserInterface	Non-sterile touchscreen monitor that is coveredwith a transparent sterile cover during theprocedure	Non-sterile touchscreen monitor that is coveredwith a transparent sterile cover during theprocedure
WorkflowComponents	Upload, Segmentation, Planning,Staging/Positioning, Registration, InstrumentCalibration, Navigation	Upload, Segmentation, Planning,Staging/Positioning, Registration, InstrumentCalibration, Navigation
PlanningFeatures	Multiple target point selection, multipleinstrument selection	Multiple target point selection, multipleinstrument selection
Navigation	Target point projection, instrument rendering,	Target point projection, instrument rendering,
	Cleared Device	Subject Device
Features	instrument extended trajectory, physicaldistance measurement, multiple perspectives	instrument extended trajectory, physicaldistance measurement, multiple perspectives
RegistrationMethod	Automatic, pinless, and markerless	Automatic, pinless, and markerless
NavigationFrames perSecond	5Hz	Uncapped (mean 21fps)
Component and accessory modifications
InstrumentTracker	NDI Polaris Vicra	NDI Polaris Lyra
3D Camera	Ensenso N35-804-16-IR	Ensenso N36-804-16-IR
Suggesteddrapingaccessories	Welmed Protect5 Fenestrated Drape	Welmed Protect5 Fenestrated Drape and ExactCranial Drape
Other modification
Instrumentcalibration	Required	Recommended for Brainlab Disposable Stylet

Table 1: Technological Comparison

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510(k) Summary

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510(k) Summary

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PERFORMANCE DATA 7.

Biocompatibility Testing

There are no direct or indirect patient-contacting components of the subject device. Therefore, patient contact information is not needed for this device.

Electrical safety and electromagnetic compatibility (EMC)

The Zeta Cranial Navigation System was tested in accordance with the following standards:

. IEC 60601-1:2005 (3rd ed) + CORR. 1:2006 + CORR.2:2007+A1:2012 Medical electrical equipment: Part 1: General requirements for basic safety and essential performance including US deviations, with the exception of Clause 11.7 regarding biocompatibility. The device passed all tests.
IEC 62304:2006+ Amd 1:2015, Medical device software Software life cycle . processes. The device passed all tests.
IEC 60601-1-2:2014+A1:2021, Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests. The device passed all tests.
IEC 60601-1-6, Edition 3.2 2020-07, Medical electrical equipment Part 1-6: General ● requirements for basic safety and essential performance - Collateral standard: Usability. The device passed all tests.

Software Verification and Validation Testing

Software verification and validation testing was conducted, and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device was considered a Major level of concern.

Cybersecurity documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

Sterilization, Cleaning, and Shelf Life

Sterilization and Cleaning

The device is reusable, provided non-sterile, and is not sterile when used. Cleaning instructions are provided in the labeling.

Shelf-Life

Shelf-life is not applicable due to the low likelihood of time-dependent product degradation.

Bench Testing

The following bench testing was performed to demonstrate substantial equivalence:

Accuracy testing under different conditions, including: ●
- . Simulated clinical procedures using virtual targets that can be located only with the guidance system
- Surgical illumination levels .

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Dynamic patient motion ●
Other worst-case physical and environmental conditions
. Design validation testing
Human factors testing, following the FDA Guidance Document, "Applying . Human Factors and Usability Engineering to Medical Devices"

Animal Testing

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Data

Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.

8. CONCLUSION

The results of testing described above demonstrate that the Zeta Cranial Navigation System is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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).