(134 days)
Not Found
Yes
The document explicitly mentions "AI models" and describes training and testing data used for these models.
No
The device is described as a software for analyzing X-ray images to support clinical decision-making, not for treating or preventing disease.
Yes
The device analyzes X-ray images to produce reports containing metrics that characterize and assess spinal health, supporting qualified healthcare practitioners in clinical decision-making for conditions such as spinal stability, alignment, and degeneration.
Yes
The device description explicitly states "Spine CAMP™ is a fully-automated image processing software device." and the entire summary focuses on the software's functionality and validation without mentioning any associated hardware components included with the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: Spine CAMP™ analyzes X-ray images, which are a form of medical imaging, not biological samples.
- The intended use is image analysis for clinical decision support: The description clearly states that the software analyzes X-ray images to produce reports and metrics to support healthcare practitioners in clinical decision-making.
Therefore, Spine CAMP™ falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
No
The input text does not contain any statement indicating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
QIH
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
X-ray images
Anatomical Site
lumbar and/or cervical spine
Indicated Patient Age Range
skeletally mature patients of age 18 and above.
Intended User / Care Setting
qualified and licensed professional healthcare practitioners / Not Found.
Description of the training set, sample size, data source, and annotation protocol
The data labels used to train Spine CAMP™'s AI models were derived directly from the KIMAX QMA® technology.
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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests (non-clinical) were conducted.
Software verification and validation testing demonstrated 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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KIMAX QMA® (K022585)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.
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
1
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)
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.
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 300 | |
| Houston, Texas 77056 | ||
| Phone number | +1 713 850-7500 | |
| Fax number | +1 713 850-7527 | |
| Establishment Registration | ||
| Number | 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 which | ||
| equivalence 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 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. | ||
| 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 Image | |
| Processing 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 landmark | ||
| specification; Vertebral body | ||
| registration | Landmark specification; rigid 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 |
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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.