K Number

Device Name

Spine CAMP (1.1)

Manufacturer

Medical Metrics, Inc.

Date Cleared

2023-07-07

(30 days)

Product Code

QIH OIH

Regulation Number

892.2050

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K221632

Reference Devices

QMA

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The summary explicitly mentions an "AI Engine" and the retraining of "AI models."

Therapeutic

No.
The device is described as software that analyzes X-ray images to produce reports and metrics to support clinical decision-making, not to directly provide therapy.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the metrics produced by Spine CAMP can be used to "characterize and assess spinal health" and "to support qualified and licensed professional healthcare practitioners in clinical decision making." This indicates that the device is intended to assist in the diagnosis or assessment of medical conditions related to the spine.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states that Spine CAMP™ is a "fully-automated image processing software device." There is no mention of any accompanying hardware components being part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
Spine CAMP's Function: Spine CAMP analyzes X-ray images of the spine. It does not analyze biological samples taken from the body.
Intended Use: The intended use is to analyze medical images to produce reports and metrics to support clinical decision-making regarding spinal health. This is a function of medical imaging analysis software, not an IVD.

Therefore, Spine CAMP falls under the category of medical imaging analysis software, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.

Overview

Intended Use / Indications for Use

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.

Product codes

OIH

Device Description

Mentions image processing

Yes

Mentions AI, DNN, or ML

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.
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 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.

Input Imaging Modality

X-ray

Anatomical Site

Spine

sagittal plane radiographs of the lumbar and/or cervical spine
lateral lumbar X-rays
lateral cervical spine radiographs

Indicated Patient Age Range

skeletally mature patients of age 18 and above

Intended User / Care Setting

qualified and licensed professional healthcare practitioners / Clinical decision making
Trained professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

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.
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 radiographs and 232 lateral lumbar spine radiographs.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Bench tests (non-clinical software verification and validation testing, statistical correlation and equivalence tests).
Sample Size: 215 lateral cervical spine radiographs and 232 lateral lumbar spine radiographs for the comparative analysis.
Key Results: The software functioned as intended and all results observed were as expected. 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. The subject device and the predicate device produced outputs that were statistically equivalent.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Spine CAMP™ v1.0 (K221632)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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

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

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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 Registration
Number	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 which
equivalence 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 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.
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 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.

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 Image
Processing Software	Automated Radiological Image
Processing 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 landmark
specification; Vertebral body
registration	Vertebral body detection; Vertebral
body 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 for
Interpretation	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

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.