The aprevo® Digital Planning software is intended to be used by trained, medically knowledgeable design personnel to generate surgical plans for skeletally mature patients. The device processes a 3D spine model in conjunction with inputs from healthcare professionals to produce 3D models of spinal corrections and anatomical measurements.

Device Description

The aprevo® Digital Planning, is a rules-based, semi-automated surgical planning software that, based on surgeon input, measures the 3D spine model and results in a spinal correction plan. The outputs consist of a surgical plan and 3D spinal correction assets, which are then reviewed by the surgeon. The device is operated by trained, medically knowledgeable Carlsmed design personnel.

AI/ML Overview

The provided document is a 510(k) summary for the aprevo® Digital Planning software. While it describes the software and its intended use, it does not contain specific details on acceptance criteria or a comprehensive study report with quantitative performance metrics that would typically be found in a detailed validation study.

The relevant section for performance criteria and testing is under "Non-clinical Testing" (page 6). It states: "The surgical plans generated by aprevo® Digital Planning were shown to be substantially equivalent, with 90% confidence and reliability, to plans manually created by medically knowledgeable operators." This is a summary statement of a study result, but it lacks the detailed breakdown requested.

Therefore, many of the requested fields cannot be filled directly from the provided text. I will fill in what can be inferred or explicitly stated and highlight where information is missing.

Acceptance Criteria and Study for aprevo® Digital Planning Software

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Quantitative / Qualitative)	Reported Device Performance
Surgical plans generated by aprevo® Digital Planning are substantially equivalent to plans manually created by medically knowledgeable operators	Substantially equivalent with 90% confidence and reliability to manually created plans.
Software performs according to specifications.	Verified.
Software performs according to user requirements.	Verified.

Missing Information:

Specific quantitative metrics for "substantial equivalence" (e.g., specific measurement tolerances for anatomical landmarks, angular measurements, or correctional values). The document states "90% confidence and reliability," which is a statistical measure of the comparison, not the quantitative metric itself.

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

Sample Size for Test Set: Not explicitly stated in the provided text.
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved comparing software-generated plans to "plans manually created by medically knowledgeable operators," implying retrospective data processed by operators.

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Described as "medically knowledgeable operators" and "Internal Carlsmed personnel only" (page 6). Specific qualifications like "radiologist with 10 years of experience" are not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. The comparison is between the automated software plans and "manually created plans," but how discrepancies, if any, were resolved for the ground truth is not detailed.

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

MRMC Study Done? Not explicitly mentioned as an MRMC study in the standard sense (human readers assisting with/without AI). The study described is a comparison between software-generated plans and manually created plans. It's not a study on how human readers improve with AI assistance, but rather a performance validation comparing the AI's output to human-generated output.
Effect Size of Human Reader Improvement: Not applicable given the type of study described.

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

Standalone Study Done? Yes, in a sense. The "Non-clinical Testing" section validates the performance of the software-generated surgical plans against manually created plans. While the software takes "inputs from healthcare professionals" and trained personnel operate it, the evaluation seems to focus on the output of the algorithms ("surgical plans generated by aprevo® Digital Planning") compared to a human-derived ground truth. The device is described as "rules-based, semi-automated."

7. Type of Ground Truth Used

Ground Truth Type: "Plans manually created by medically knowledgeable operators" (page 6). This is a form of expert consensus or expert-derived ground truth.

8. Sample Size for the Training Set

Sample Size for Training Set: Not explicitly stated in the provided text. The document describes the software as "rules-based, semi-automated" and uses algorithms for landmark determination and surgical plan generation. This implies a rule-based system or potentially a machine learning model, but training set details are not provided.

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

Ground Truth Establishment for Training Set: Not explicitly stated. Given the description of the device as "rules-based, semi-automated," it suggests that the "rules" and "algorithms" were likely developed based on medical knowledge and potentially expert-verified data, but the specific process for establishing ground truth for any potential training data is not detailed.

Summary

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Carlsmed, Inc. Karen Liu VP Quality and Regulatory 1800 Aston Ave. Suite 100 Carlsbad, CA 92008

December 20, 2024

Re: K242599

Trade/Device Name: aprevo® Digital Planning Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: November 22, 2024 Received: November 25, 2024

Dear Karen Liu:

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"

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(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).

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 QS 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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/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,

Jessica Lamb

Jessica Lamb, Ph.D Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242599

Device Name

aprevo® Digital Planning

Indications for Use (Describe)

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

Applicant Contact Information

Company Name	Carlsmed, Inc.
Company Address	1800 Aston Ave, Ste 100Carlsbad, CA 92008
Company Telephone	760-766-1926
Contact Person	Karen Liu, VP Quality and RegulatoryCarlsmed, Inc.1800 Aston Ave, Ste 100Carlsbad, CA 92008Phone: 760-766-1926Email: regulatory@carlsmed.com
Date Prepared	November 22, 2024

Device Name

Trade or proprietaryname	aprevo® Digital Planning
Device classificationregulation	§892.2050
Common name	Image processing system
Classification	Class II
Product code	LLZ
Classification panel	Radiology

Predicate Device

510(k) number	Product code	Trade name	Manufacturer
K222195	LLZ	aprevo® DigitalWorkflow	Carlsmed, Inc.

Description of the Device

Indications for Use

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Technological Characteristics

The aprevo® Digital Planning software offers the option to semi-automatically place landmarking points and apply a series of correctional operations. The aprevo® Digital Planning software is substantially equivalent to the predicate devices through a comparison including the intended use, design, technological characteristics, and functionality.

Substantial Equivalence

The software functionality is equivalent to the predicate device (K222195) based on the intended use and technological characteristics and does not raise any new question of safety and effectiveness. The table below includes details on a comparison between the subject and predicate devices.

Characteristic	Subject Device	Primary Predicate Device	SubstantialEquivalence?
Name	aprevo® Digital Planning	aprevo® Digital Workflow
ClearanceNumber	K242599	K222195
RegulationNumber	892.2050	892.2050	Identical
Device Class	II	II	Identical
Product Code	LLZ	LLZ	Identical
Intended Useand Indicationsfor Use	The aprevo® Digital Planningsoftware is intended to be used bytrained, medically knowledgeabledesign personnel to generatesurgical plans for skeletally maturepatients. The device processes a 3Dspine model in conjunction withinputs from healthcare professionalsto produce 3D models of spinalcorrections and anatomicalmeasurements.	aprevo® Digital Workflow software isintended to view, store, and manipulate3-D models to visualize surgical plans forspinal alignment. The device inputs a 3-Dspine model which is used by trained,medically knowledgeable designpersonnel in conjunction with inputs fromhealthcare professionals to produce 3-Dmodels of spinal correction andanatomical measurements. The deviceoutputs are used by healthcareprofessionals for placement of surgicalimplants.	SubstantiallyEquivalent
		Technological Characteristics
Algorithms	●Landmark determinationalgorithm●Surgical plan generationalgorithm	● Landmarking and correction plangeneration is manually conducted byoperators	SubstantiallyEquivalent
Compatible InputFile Types	DICOM	DICOM	Identical
ProcessFunctionality	Semi-automatic landmark andsurgical plan generation	Manual landmark and surgical plangeneration	SubstantiallyEquivalent
User Interaction	User interaction is that the operatorprovides the surgical inputs, theninitiates the landmarking andsurgical plan generation algorithms	User interaction is that the operator mustmanually place landmarking points andperform a series of operations to create asurgical plan	SubstantiallyEquivalent
Export Outputs	Surgical plan	Surgical plan	Identical
Intended UserPopulation	Internal Carlsmed personnel only	Internal Carlsmed personnel only	Identical

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Non-clinical Testing

The aprevo® Digital Planning software has been evaluated in accordance with internal software specifications and applicable performance standards. The surgical plans generated by aprevo® Digital Planning were shown to be substantially equivalent, with 90% confidence and reliability, to plans manually created by medically knowledgeable operators. In addition, the software development, verification and validation procedures ensure that the device performs according to specifications, user requirements, and the FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Conclusion

Based on the intended use, indications for use, functions, technological characteristics, performance testing, and comparison to the predicate device, the subject aprevo® Digital Planning device has been shown to be substantially equivalent to the predicate.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).