Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and planning of spinal implants like screws and rods.

Device Description

The Spine Planning software allows the user to plan spinal surgery pre-operatively or intra-operatively. The software is able to display 2D X-Ray images and 3D datasets (e.g. CT or MR scans). The software consists of features for automated labelling of vertebrae and proposals for screw and rod implants, proposals for measurement of spinal parameters.

The device can be used in combination with spinal navigation software during surgery, where preplanned or intra-operatively created information can be displayed, or solely as a pre-operative tool to prepare the surgery.

AI/ML algorithms are used in Spine Planning for

. Detection of landmarks on 2D images for vertebrae labeling and measurement and
. Vertebra detection on Digitally Reconstructed Radiograph (DRR) images of 3D datasets for atlas reqistration (labeling of the vertebra).

The AI/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach. The algorithm was developed using a controlled internal process that defines from the inspection of input data to the training and verification of the algorithm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the Spine Planning 2.0 device, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. However, based on the Performance Data section, we can infer the areas of assessment and general performance claims. The "Reported Device Performance" column will reflect the general findings described in the text.

Acceptance Criteria (Inferred from Performance Data)	Reported Device Performance
Software Verification:	Requirements met through integration and unit tests, including SOUP items and cybersecurity. Newly added components underwent integration tests.
AI/ML Detected X-Ray Landmarks Assessment:	- Quantified object detection. - Quantified quality of vertebra level assignment. - Quantified quality of landmark predictions. - Quantified performance of observer view direction for 2D X-rays.
Screw Proposal Algorithm Evaluation (Comparison to Predicate):	Thoracic and lumbar pedicle screw proposals generated by the new algorithm were found to be similar to those generated by the predicate algorithm.
Usability Evaluation:	No critical use-related problems identified.

Study Details

The provided text describes several evaluations rather than a single, unified study with a comprehensive design. Information for some of the requested points is not explicitly stated in the document.

2. Sample size used for the test set and the data provenance:

AI/ML Detected X-Ray Landmarks Assessment:
- Sample Size: Not explicitly stated.
- Data Provenance: "2D X-rays from the Universal Atlas Transfer Performer 6.0." This suggests either a curated dataset or potentially synthetic data within a software environment, but specific origin (e.g., country, hospital) or whether it was retrospective/prospective is not provided.
Screw Proposal Algorithm Evaluation:
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated, but implies the use of test cases to generate screw proposals for comparison.
Usability Evaluation:
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

AI/ML Detected X-Ray Landmarks Assessment: Not explicitly stated in the provided text. The document mentions "quantifying" various quality aspects, which implies a comparison to a known standard or expert annotation, but details are missing.
Screw Proposal Algorithm Evaluation: Not explicitly stated. The comparison is "to the predicate and back-up algorithms," suggesting an algorithmic ground truth or comparison standard rather than human expert ground truth for individual screw proposals.
Usability Evaluation: Not applicable, as usability testing focuses on user interaction rather than ground truth for clinical accuracy.

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

Not explicitly stated for any of the described evaluations.

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:

No MRMC comparative effectiveness study involving human readers with and without AI assistance is described in the provided text. The evaluations focus on the algorithm's performance or similarity to a predicate, and usability for the intended user group.

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

Yes, the AI/ML Detected X-Ray Landmarks Assessment and the Screw Proposal Algorithm Evaluation appear to be standalone algorithm performance assessments.
- The "AI/ML Detected X-Ray Landmarks Assessment" explicitly evaluates the AI/ML detected landmarks.
- The "Screw Proposal Algorithm Evaluation" compares the new algorithm's proposals to existing algorithms, indicating a standalone algorithmic assessment.

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

AI/ML Detected X-Ray Landmarks Assessment: Inferred to be a form of expert-defined or algorithm-defined gold standard given the quantification of object detection, quality of labeling, and landmark predictions. The source "Universal Atlas Transfer Performer 6.0" might imply a reference standard built within that system.
Screw Proposal Algorithm Evaluation: The ground truth used for comparison was the output of the "predicate and back-up algorithms," implying an algorithmic gold standard.
Usability Evaluation: Ground truth is not applicable in the sense of clinical accuracy; rather, the measure is the identification of "critical use-related problems" by users during testing.

8. The sample size for the training set:

Not explicitly stated for the AI/ML algorithms mentioned. The document only mentions that the "AI/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach" and "developed using a controlled internal process that defines from the inspection of input data to the training and verification of the algorithm."

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

Not explicitly stated. Given it's a "Supervised Learning approach," it would imply that the training data was meticulously labeled, likely by experts (e.g., radiologists, orthopedic surgeons) or through a highly curated process, but the document does not elaborate on this.

Summary

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August 2, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Brainlab AG Sadwini Suresh OM Consultant Olof-Palme-Str.9 Munich, BY 81829 Germany

Re: K223553

Trade/Device Name: Spine Planning 2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: June 30, 2023 Received: June 30, 2023

Dear Sadwini Suresh:

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

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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 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 (OS) 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-S

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) K223553

Device Name Spine Planning 2.0

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "BRAINLAB" in pink, with a stylized pink symbol to the left of the word. The symbol appears to be three curved lines stacked on top of each other. The word "BRAINLAB" is written in all capital letters and is in a sans-serif font. The overall image has a clean and modern look.

K223553 510(k) Summary

June 30, 2023

General Information
Manufacturer	Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany
Establishment Registration	8043933
Trade Names	Spine Planning 2.0• Spine Planning• Elements Spine Planning• Elements Planning Spine
Classification Name	Orthopedic Stereotaxic Instrument
Product Code	OLO
Regulation Number	882.4560
Regulatory Class	II
Panel	Orthopedic
Predicate Device	K212245Spine and Trauma Navigation System, Spine & Trauma 3DNavigation, Instrument Selection, Fluoro 3D, Registration SoftwareFluoro 3D, Registration Software Paired Point, Registration SoftwareSpine Surface Matching, Spine Planning, Elements Screw PlanningSpine, Elements Spine Screw Planning
Contact Information
Primary Contact	Sadwini SureshQM ConsultantRegulatory AffairsPhone: +49 89 99 15 68 0Email: regulatory.affairs@brainlab.com
Alternate Contact	Chiara CunicoSenior Manager Regulatory AffairsPhone: +49 89 99 15 68 0Email: chiara.cunico@brainlab.com

INDICATIONS FOR USE 1

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DEVICE DESCRIPTION 2

AI/ML algorithms are used in Spine Planning for

. Detection of landmarks on 2D images for vertebrae labeling and measurement and
. Vertebra detection on Digitally Reconstructed Radiograph (DRR) images of 3D datasets for atlas reqistration (labeling of the vertebra).

SUBSTANTIAL EQUIVALENCE ന

The Subject Device has similar intended use and technological features as the predicate devices. An overview of the similarities and differences can be found in the tables below:

Device	Name
Subject Device	Spine Planning 2.0
Predicate device (K212245)	Spine Planning 1.0

Topic/ Feature	Predicate Device (SpinePlanning 1.0 (K212245))	Subject Device (SpinePlanning 2.0)	Comment
Indications for use	Spine Planning is intended for pre- and intraoperative planning of open and minimal invasive spinal procedures. It displays digital bio imaging and allows measurement and planning of spinal implants like screws and rods.	Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and	No change in the indications. Image modalities that are supported have been included.
		planning of spinal implantslike screws and rods.
Intended useenvironment	The planning part of the use caseshall be done in an office or in theoperating room.	The device can be used in anoffice / team room or in theoperating room.	Identical
Supported ImagingModalities	- Computed tomography (CT)	- CT- Magnetic resonance (MR)- Cone Beam CT (XT)- X-ray	Additional modalitieseffect measurementor screw planningfeatures
Vertebra Labeling	Automatic detection of thoracicand lumbar vertebrae. Userapproval of calculated automaticlabeling. No functionality tochange the calculated labeling.	Automatic detection ofcervical, thoracic, lumbar,and sacral vertebrae.Ability to adjust automaticlabeling for correction ifneeded. Automatic labelingcan be discarded andperformed manually. Userapproval of labeling.	New features:- Addition of cervicaland sacral spinalregions in subjectdevice.- Ability to adjustand correct labeling.- Possible to doperformed manuallabeling.Functionality testedduring verificationtesting.
AnatomicalVariations	N/A	Adjustment of anatomicalchain to account foranatomic variations.Depending on patientanatomy, it is possible toexclude T12 and/or L5 andinclude T13 and/or L6.To be added manually byuser.	New feature.
Spinal ParameterProposals	N/A	Able to add spinalparameters on X-rays basedon AI/ML generatedlandmarks. To be manuallyreviewed and approved.	New feature.

ManualMeasurements	N/A	Where AI/ML landmarks areunavailable all spinalparameters can be addedmanually, reviewed, andapproved.	New feature.
Automatic ScrewProposals	Automatic screw proposalsprovided for thoracic and lumbarpedicle screws.	Manual placement andadjustment of angles andopen angles on X-rays.	Similar function topredicate. Newscrew proposalalgorithm withadditionalfunctionality used insubject device.
Screw Planning	Automatic screw proposalsprovided for cervical (lateralmass or pedicle), thoracic(pedicle), lumbar (pedicle),sacral (pedicle and alar iliac),and iliac regions.	Adjustment of screw length,diameter, and position.	Adjustment ofscrews, creation ofmanual screws andscrew approval issimilar to predicate.
	Adjustment of screw length,diameter, and position.	Creation of manual screws.	New features.Possible to changetype of screwbetween lateralmass and pediclescrew types(cervical region) orpedicle and alar iliacscrew types (Sacralregion)
	Creation of manual screws.	Addition of automatic screwproposals.
	Addition of automatic screwproposals.	Change of screw type(cervical and sacral regionsonly)
	User approval of all screwsrequired.	User approval of all screwsrequired.

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Image /page/6/Picture/0 description: The image shows the logo for Brainlab. The logo consists of a stylized pink caduceus symbol on the left, followed by the word "BRAINLAB" in pink, block letters. The caduceus symbol is a medical emblem featuring a staff with two snakes coiled around it.

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Image /page/7/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a medical symbol or abstract figure. To the right of the symbol, the word "BRAINLAB" is written in capital letters, also in pink. The overall design is clean and modern.

4 PERFORMANCE DATA

Software Verification:

Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strateqies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid.

Software verification verifies all specifications, including SOUP items and cybersecurity.

For newly added components, integration tests were carried out, in addition to the individual component verification.

Al/ML Detected X-Ray Landmarks Assessment:

This test was conducted to assess the AI/ML detected landmarks on X-rays which are used by the software for automatic measurement proposals. This was done by quantifying the object detection, quality of vertebra level assignment, the quality of landmark predictions, and the performance of the observer view direction for 2D X-rays from the Universal Atlas Transfer Performer 6.0.

Screw Proposal Alqorithm Evaluation:

The purpose of this testing was to compare the newly proposed screw proposal algorithm to the predicate and back-up algorithms. Thoracic and lumbar pedicle screw proposals generated by the new algorithm were found to be similar to thoracic and lumbar pedicle screw proposals generated by the predicate algorithm.

Usability Evaluation:

Summative usability testing was planned and performed in order to validate that the Spine Planning 2.0 can be used by the intended user group. The summative usability testing identified no critical use related problems.

5 CONCLUSION

The performed verification and validation activities established that the set requirements were met and that the device performs as intended.

The Subject Devices' comparison with the Predicate Device establishes that they have similar functionality, intended use and technological characteristics. Therefore, we consider that the Subject Device can be considered substantially equivalent to the 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).