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 quidance. 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 provided text describes the Spine CAMP™ (1.1) device, an automated software for analyzing X-ray images of the spine, and refers to performance data used to demonstrate its substantial equivalence to a predicate device. However, the text does not contain a detailed table of acceptance criteria nor a comprehensive study report with specific performance metrics (e.g., accuracy, sensitivity, specificity etc.) compared against those criteria. It primarily focuses on the comparison to a predicate device and general claims of equivalence.

Based on the information provided, here's what can be extracted and inferred regarding the acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly provide a table of acceptance criteria with specific quantitative thresholds (e.g., "accuracy > X%, sensitivity > Y%") nor detailed reported device performance against such criteria. Instead, it states that "Statistical correlations and equivalence tests were performed by directly comparing vertebral landmark coordinates, image calibration, and intervertebral measurements between Spine CAMP™ v1.1 and the predicate device as well as spinopelvic measurements between Spine CAMP™ v1.1 and the reference device. This analysis demonstrated correlation and statistical equivalence for all variables evaluated."

This implies that the acceptance criteria were based on demonstrating statistical equivalence or strong correlation to the predicate device (Spine CAMP™ v1.0) and a "reference device" (QMA for spinopelvic measurements) for the identified variables. The exact metrics and their thresholds for establishing "statistical equivalence" are not detailed.

What is present regarding "performance":

Performance Goal: "demonstrated correlation and statistical equivalence for all variables evaluated."
Variables Evaluated: Vertebral landmark coordinates, image calibration, intervertebral measurements, spinopelvic measurements.
Result: "This analysis demonstrated correlation and statistical equivalence for all variables evaluated."

Without an explicit table, we cannot populate one.

2. Sample Size for the Test Set and Data Provenance

Sample Size for Test Set:
- 215 lateral cervical spine radiographs
- 232 lateral lumbar spine radiographs
Data Provenance: The text does not explicitly state the country of origin. It indicates that the dataset "had not been used to train any of the AI models," implying it was a test set. The term "retrospective or prospective" is not specified, but the use of an "existing" dataset (previously analyzed by Spine CAMP™ v1.0) suggests it was retrospective.

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

Number of Experts: Five experienced operators.
Qualifications of Experts: Described as "experienced operators." No specific qualifications like "radiologist with 10 years of experience" are provided. It's implied they were trained professionals capable of using the "reference device, QMA, for spinopelvic measurements."

4. Adjudication Method for the Test Set

The text states: "this dataset was analyzed by five experienced operators using the reference device, QMA, for spinopelvic measurements." This implies that the measurements from these five operators using the QMA device were used to establish the reference standard (ground truth) for spinopelvic measurements. It does not specify an adjudication method like 2+1 or 3+1 if there were discrepancies among the operators, or if their measurements were averaged/concatenated to form the ground truth. It simply states they "analyzed" the data.

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

MRMC Study: Yes, an indirect form of comparative effectiveness was conducted by having "five experienced operators" analyze the dataset using a "reference device" (QMA) to provide a ground truth for comparison with the AI's spinopelvic measurements. The primary comparison in the study, however, was between Spine CAMP™ v1.1 and the predicate device (Spine CAMP™ v1.0), and between Spine CAMP™ v1.1 and the human-generated "reference device" (QMA) data.
Effect Size of Human Readers Improving with AI vs. Without AI Assistance: This specific metric is not provided in the text. The study did not appear to be designed as an MRMC study comparing human reader performance with and without AI assistance; rather, it compared the AI's performance to established methods (predicate device and human-operated reference device).

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

Yes, the testing described appears to be a standalone evaluation of the Spine CAMP™ v1.1 algorithm. It mentions "evaluating Spine CAMP™ v1.1 performance on a large dataset" and comparing its outputs to those of the predicate device and the reference device (QMA operated by humans). This focuses on the algorithm's output directly, rather than how it changes human workflow or decision-making.

7. The Type of Ground Truth Used

For Intervertebral & Image Calibration Measurements: The ground truth appears to be implicitly established by the predicate device's (Spine CAMP™ v1.0) outputs. The study performed "statistical correlations and equivalence tests... between Spine CAMP™ v1.1 and the predicate device."
For Spinopelvic Measurements: The ground truth was established by the measurements from five experienced operators using a "reference device" (QMA). This can be considered a form of "expert consensus" or "expert measurement" acting as the reference standard.
No mention of pathology or outcomes data as ground truth.

8. The Sample Size for the Training Set

The text states: "Spine CAMP's primary component, the AI Engine, was updated by retraining its AI models with more imaging for improved generalization and performance." However, the specific sample size for the training set is not provided.

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

The text mentions that the AI models were "retrained." It does not describe how the ground truth for this training data was established. It only states that the test dataset "had not been used to train any of the AI models," implying separate data for training and testing.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Medical Metrics, Inc. Kirk Johnson Director of Regulatory and Quality Affairs 2121 Sage Road Suite 300 HOUSTON, TEXAS 77056

Re: K231668

July 7, 2023

Trade/Device Name: Spine CAMPTM (1.1) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: OIH Dated: June 7, 2023 Received: June 7, 2023

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

Jessica Lamb. 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)

K231668

Device Name

Spine CAMP™ (1.1)

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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Image /page/3/Picture/0 description: The image contains the logo for Medical Metrics INC. The logo features a stylized graphic to the left of the company name. Below the company name is the tagline "Insight from Imaging."

Medical Metrics, Inc. 2121 Sage Road, Suite 300 Houston, Texas 77056

P 713-850-7500 F 713-850-7527 www.medicalmetrics.com

510(K) SUMMARY

510(K) #K231668

Submitter Information [21 CFR 807.929(a)(1)]
Name	Medical Metrics, Inc.
Address	2121 Sage Road, Suite 300
	Houston, Texas 77056
Phone number	+1 713 850-7500
Fax number	+1 713 850-7527
Email address	kjohnson@medicalmetrics.com
Establishment RegistrationNumber	Pending 510(k) clearance and marketing of device
Name of contact person	Kirk Johnson
Date prepared	07/05/2023
Name of the device [21 CFR 807.92(a)(2)]
Trade name	Spine CAMP™ (1.1)
Regulation name	Medical Image Management and Processing System
Review panel	Radiology
Regulation Number	892.2050
Product Code	QIH
Legally marketed device to whichequivalence is claimed[21 CFR 807.92(a)(3)]	Spine CAMP™ v1.0 (K221632)
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.

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Image /page/4/Picture/0 description: The image shows the logo for Medical Metrics INC. The logo features a stylized graphic of three curved shapes in blue and white. To the right of the graphic is the company name, "medicalmetricsINC.", in a sans-serif font, with "medicalmetrics" in blue and "INC." in black. Below the company name is the tagline "Insight from Imaging" in a smaller, blue sans-serif font.

Summary of the technological characteristics of the device compared to the predicate device[21 CFR 807.92(a)(6)]
Feature	Spine CAMP™ v1.1(Subject Device)	Spine CAMP™ v1.0(Predicate Device K221632)
Classification Name	Automated Radiological ImageProcessing Software	Automated Radiological ImageProcessing Software
Product Code	QIH	QIH
Runs on Server	Yes	Yes
Image Input	DICOM	DICOM
Anatomical Area	Spine	Spine
Image Processing	Vertebral body detection;Vertebral body landmarkspecification; Vertebral bodyregistration	Vertebral body detection; Vertebralbody landmark specification;Vertebral body registration
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

Spine CAMP™ v1.1 is designed to utilize the same analysis methodology as the predicate device, Spine CAMP™ v1.0 (K221632). The types of inputs and outputs are identical between the two devices. The devices are nearly identical in all respects. The primary differences are:

Spine CAMP's primary component, the Al Engine, was updated by retraining its Al models with . more imaging for improved generalization and performance. Improvements were also made to the Al Engine's logic to address potential failure modes.
. Spine CAMP™ v1.1 is able to identify the femoral heads in lateral lumbar X-rays in order to produce spinopelvic measurements.
. Configuration capabilities were expanded to derive outputs from the existing calculated results and to conditionally format report outputs according to the clinical user's preferences.

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. The same methodology was utilized for the performance qualification (PQ) tests for both Spine CAMP 1.1 and its primary component, the AI Engine v3.2, as had been previously utilized for the predicate device, Spine CAMP v1.0 and its primary component, the Al Enqine v3.1. The software functioned as intended and all results observed were as expected.

Additional bench testing was performed by evaluating Spine CAMP™ v1.1 performance on a large dataset that was previously analyzed by Spine CAMP™ v1.0. Additionally, this dataset was analyzed by five experienced operators using the reference device, QMA, for spinopelvic measurements that Spine CAMP™ v1.0 was not designed to produce. This dataset included 215 lateral cervical spine

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Image /page/5/Picture/0 description: The image shows the logo for Medical Metrics INC. The logo features a stylized graphic of three overlapping shapes in shades of blue and white on the left. To the right of the graphic is the company name, "medicalmetricsINC.", with the "medicalmetrics" part in a darker blue and "INC." in a lighter blue. Below the company name is the tagline "Insight from Imaging" in a smaller, lighter blue font.

radiographs and 232 lateral lumbar spine radiographs. Statistical correlations and equivalence tests were performed by directly comparing vertebral landmark coordinates, image calibration, and intervertebral measurements between Spine CAMP™ v1.1 and the predicate device as well as spinopelvic measurements between Spine CAMP™ v1.1 and the reference device. This analysis demonstrated correlation and statistical equivalence for all variables evaluated.

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 nearly identical. The minor differences between the subject and predicate devices (i.e., retrained Al models and enhanced reporting capabilities) do not raise new or different questions regarding safety and effectiveness when used as labeled. The same performance testing methodology that was used utilized to test the subject device as had been used to test the predicate device. Specifically, for a large dataset of images, the subject device and the predicate device produced outputs that 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).