Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain static and/or motion metrics. Spine CAMP™ can be used to obtain metrics from sagittal plane radiographs of the lumbar and/or cervical spine and it can be used to visualize intervertebral motion via an image registration method referred to as "stabilization". The radiographic metrics can be used to characterize and assess spinal health in accordance with established guidance. For example, common clinical uses include assessing spinal stability, alignment, degeneration, fusion, motion preservation, and implant performance. The metrics produced by Spine CAMP™ are intended to be used to support qualified and licensed professional healthcare practitioners in clinical decision-making for skeletally mature patients of age 18 and above.

Device Description

Spine CAMP™ is a fully-automated image processing software device. It is designed to be used with X-ray images and is intended to aid medical professionals in the measurement and assessment of spinal parameters. Spine CAMP™ is capable of calculating distances, angles, linear displacements, angular displacements, and mathematical combinations of these metrics to characterize the morphology, alignment, and motion of the spine. These analysis results are presented in the form of reports, annotated images, and visualizations of intervertebral motion to support their interpretation.

AI/ML Overview

The Spine CAMP™ device uses automated software to analyze X-ray images of the spine and produce reports containing static and/or motion metrics. It can be used to obtain metrics from sagittal plane radiographs of the lumbar and/or cervical spine and visualize intervertebral motion. The metrics characterize and assess spinal health, including stability, alignment, degeneration, fusion, motion preservation, and implant performance. These metrics support clinical decision-making for skeletally mature patients aged 18 and above.

Here's an analysis of the acceptance criteria and study proving its efficacy:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of thresholds (e.g., "accuracy > X%"). Instead, it focuses on demonstrating statistical correlation and equivalence with the predicate device, KIMAX QMA®. The performance is evaluated by comparing the outputs of Spine CAMPTM with those of the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Device functions as intended.	"The software functioned as intended and all results observed were as expected."
Correlation and Statistical Equivalence with Predicate Device:	"Statistical correlations and equivalence tests were performed by directly comparing vertebral landmark coordinates, image calibration, and radiographic metrics between Spine CAMP™ and the predicate device. This analysis demonstrated correlation and statistical equivalence for all variables evaluated." This indicates that the Spine CAMP™'s automated measurements (vertebral landmark coordinates, image calibration, and radiographic metrics) are highly consistent with and statistically indistinguishable from those produced manually by experienced operators using the predicate device. The "acceptance" is implicitly that these correlations and equivalences meet appropriate statistical thresholds for clinical interchangeability.
No New or Different Safety/Effectiveness Questions:	"The minor differences between the subject and predicate devices (i.e., methods by which the inputs to the results calculator are produced) do not raise new or different questions regarding safety and effectiveness when used as labeled."

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

Test Set Sample Size: 215 lateral cervical spine radiographs and 232 lateral lumbar spine radiographs.
Data Provenance: The document does not explicitly state the country of origin. It indicates that the data was previously analyzed by experienced operators using the predicate device, suggesting it is retrospective data.

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

Number of Experts: Five experienced operators.
Qualifications: The document states "experienced operators" without further specific qualifications (e.g., radiologist, years of experience). However, their role was to generate ground truth using the predicate device.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method like 2+1 or 3+1. The ground truth for the test set was established by having "five experienced operators using the predicate device." It's implied that these outputs from the predicate device (manual analysis) were directly used as the ground truth. There's no mention of a consensus process among the five operators to define a single ground truth per case if their results differed.

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

No, a traditional MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance was not done. The study focused on demonstrating that the device itself performs comparably to the predicate device, which is operated manually by humans. The comparison is between the Spine CAMPTM (AI-driven automated measurements) and the predicate device (human-driven manual measurements). Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable to the design of this particular study.

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

Yes, the primary study described is a standalone performance evaluation. The Spine CAMPTM is a "fully-automated software." The study directly compared its automated outputs to the manually generated ground truth from the predicate device. While the device's output is intended to "support qualified and licensed professional healthcare practitioners in clinical decision-making," the performance assessment itself is of the algorithm's standalone capabilities.

7. The Type of Ground Truth Used

The ground truth used was expert assessment using a predicate device. Specifically, it was derived from "experienced operators using the predicate device" (KIMAX QMA®) who manually obtained measurements.

8. The Sample Size for the Training Set

The document does not specify the sample size for the training set. It mentions that "The data labels used to train Spine CAMP™'s AI models were derived directly from the KIMAX QMA® technology," but no numbers are provided for this training data.

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

The ground truth for the training set was established by manual analysis using the predicate device, KIMAX QMA®. "The data labels used to train Spine CAMP™'s AI models were derived directly from the KIMAX QMA® technology." This implies that experienced users of the predicate device generated the "ground truth" labels that were then used to train the AI models within Spine CAMPTM.

Summary

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Medical Metrics, Inc. c/o Kirk Johnson Director of Regulatory and Quality Affairs 2121 Sage Road HOUSTON, TEXAS 77056

October 18, 2022

Re: K221632

Trade/Device Name: Spine CAMPTM Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: September 12, 2022 Received: September 12, 2022

Dear Kirk Johnson:

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

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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 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 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-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,

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

510(k) Number (if known) K221632

Device Name Spine CAMPTM

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

510(K) # K221632

Submitter Information [21 CFR 807.929(a)(1)]
Name	Medical Metrics, Inc.
Address	2121 Sage Road, Suite 300Houston, Texas 77056
Phone number	+1 713 850-7500
Fax number	+1 713 850-7527
Establishment RegistrationNumber	Pending 510(k) clearance and marketing of device
Name of contact person	Kirk Johnson
Date prepared	17-October-2022
Name of the device [21 CFR 807.92(a)(2)]
Trade name	Spine CAMP™
Classification name	Automated Radiological Image Processing Software
Review panel	Radiology
Regulation Number	892.2050
Product Code	QIH
Legally marketed device to whichequivalence is claimed[21 CFR 807.92(a)(3)]	KIMAX QMA® (K022585)
Device description[21 CFR 807.92(a)(4)]	Spine CAMP™ is a fully-automated image processing softwaredevice. It is designed to be used with X-ray images and isintended to aid medical professionals in the measurement andassessment of spinal parameters. Spine CAMP™ is capable ofcalculating distances, angles, linear displacements, angulardisplacements, and mathematical combinations of these metricsto characterize the morphology, alignment, and motion of thespine. These analysis results are presented in the form ofreports, annotated images, and visualizations of intervertebralmotion to support their interpretation.
Indications for use[21 CFR 807.92(a)(5)]	Spine CAMP™ is a fully-automated software that analyzes X-ray images of the spine to produce reports that contain staticand/or motion metrics. Spine CAMP™ can be used to obtainmetrics from sagittal plane radiographs of the lumbar and/orcervical spine and it can be used to visualize intervertebralmotion via an image registration method referred to as"stabilization." The radiographic metrics can be used tocharacterize and assess spinal health in accordance withestablished guidance. For example, common clinical usesinclude assessing spinal stability, alignment, degeneration,fusion, motion preservation, and implant performance. Themetrics produced by Spine CAMP™ are intended to be used tosupport qualified and licensed professional healthcarepractitioners in clinical decision-making for skeletally maturepatients of age 18 and above.
Summary of the technological characteristics of the device compared to the predicate device[21 CFR 807.92(a)(6)]
Feature	Spine CAMP™(Subject Device)	KIMAX QMA®(Predicate Device K022585)
Classification Name	Automated Radiological ImageProcessing Software	System, Image Processing,Radiological
Product Code	QIH*	LLZ
	* The product code for the predicate device is LLZ. The QIH product code was created subsequent to clearance of the predicate device and appears to be a better match for Spine CAMP™ than LLZ since Spine CAMP™ employs non-adaptive machine learning algorithms that were trained from data generated by the predicate device to automate the radiological image processing and analysis.
Runs on Server	Yes	Yes
Image Input	DICOM	AVI, DICOM, JPEG, TIFF, BMP
Anatomical Area	Spine	Musculoskeletal (including Spine)
Image Processing	Vertebral body detection;Vertebral body landmarkspecification; Vertebral bodyregistration	Landmark specification; rigid bodyregistration
Linear Measurements	Yes	Yes
Angular Measurements	Yes	Yes
2D Motion Analysis	Yes	Yes
Image Registration	Yes	Yes
Display of Image Alignment /Stabilization	Yes	Yes
Clinical Reporting	Yes	Yes
Human Intervention forInterpretation	Required	Required
Intended User	Trained professionals	Trained professionals
Comparison Summary

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Spine CAMP™ is designed to utilize the same analysis methodology as the predicate device, KIMAX QMA®, except that software operations performed manually in the predicate device software are automated in Spine CAMP™ through the use of non-adaptive Al models – specifically for lumbar and cervical spine X-rays. The types of inputs and outputs are identical between the two devices. The data labels used to train Spine CAMP™'s AI models were derived directly from the KIMAX QMA® technology. Similarly, substantial equivalence between Spine CAMP™ and the predicate device was established by directly running the same images through both systems and evaluating the correlation and statistical equivalence of their outputs.

Performance Data [21 CFR 807.92(b)]

Summary of bench tests (non-clinical) conducted for determination of substantial equivalence [21 CFR 807.92(b)(1)]

Software verification and validation testing was completed to demonstrate functionality of the device across multiple datasets that had not been used to train any of the Al models and that had ground truth established directly from the predicate device. Ground-truth results for these validation datasets were obtained from experienced operators using the predicate device. The software functioned as intended and all results observed were as expected.

Additional bench testing was performed by evaluating Spine CAMP™'s performance on a large dataset that was previously analyzed by five experienced operators using the predicate device. This dataset included 215 lateral cervical spine radiographs and 232 lateral lumbar spine radiographs. Statistical correlations and equivalence tests were performed by directly comparing vertebral landmark coordinates, image calibration, and radiographic metrics between Spine CAMP™ and the predicate device. This analysis demonstrated correlation and statistical equivalence for all variables evaluated.

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Summary of clinical tests conducted for determination of substantial equivalence or of clinical information [21 CFR 807.92(b)(2)]

This section is not applicable to this submission. Clinical Data are not included.

Conclusions drawn [21 CFR 807.92(b)(3)]

Spine CAMP™ is as safe and effective as the predicate device. The subject device has the same intended use and indications for use as its predicate device. Their technological characteristics and principles of operations are very similar. The minor differences between the subject and predicate devices (i.e., methods by which the inputs to the results calculator are produced) do not raise new or different questions regarding safety and effectiveness when used as labeled. Performance data was evaluated by providing the same input images to both the subject device and the predicate device and demonstrated that the outputs were statistically equivalent.

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).