(247 days)
BoneMetrics US is a fully automated radiological image processing software device intended to aid users in the measurement of Cobb angles on frontal spine radiographs of individuals of at least 4 years old for patients with suspected or present spinal deformities, such as scoliosis. It should not be used instead of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is to be used by healthcare professionals trained in radiology.
BoneMetrics US is intended to analyze radiographs using machine learning techniques to provide fully automated measurements of cobb angles during the review of frontal spine radiographs. BoneMetrics US can be deployed on cloud and be connected to several computing platforms and X-ray imaging platforms such as radiographic systems, or PACS. More precisely, BoneMetrics US can be deployed in the cloud connected to a DICOM Source/Destination with a DICOM Viewer, i.e. a PACS. After the acquisition of the radiographs on the patient and their storage in the DICOM Source, the radiographs are automatically received by BoneMetrics US from the user's DICOM Source through intermediate DICOM node(s) (for example, a specific Gateway, or a dedicated API). The DICOM Source can be the user's image storage system (for example, the Picture Archiving and Communication System, or PACS), or other radiological equipment (for example X-ray systems). Once received by BoneMetrics US, the radiographs are automatically processed by the Al algorithm without requiring any user inputs. The algorithm identifies the keypoints corresponding to the corners of all the vertebras that are seen on the images and calculates all possible angles between vertebras. Only Cobb Angles that are above 7° are retained. Based on the processing result, BoneMetrics US generates result files in DICOM format. These result files consist of annotated images with the measurements plotted on a copy of all images (as an overlay) and angle values displayed in degrees. BoneMetrics US does not alter the original images, nor does it change the order of original images or delete any image from the DICOM Source. Once available, the result files are sent by BoneMetrics US to the DICOM Destination through the same intermediate DICOM node(s). Similar to the DICOM Source, the DICOM Destination can be the user's image storage system (for example, the Picture Archiving and Communication System, or PACS), or other radiological equipment (for example X-ray systems). The DICOM Source and the DICOM Destination are not necessarily identical. The DICOM Destination can be used to visualize the result files provided by BoneMetrics US or to transfer the results to another DICOM host for visualization. The users are then able to use them as a concurrent reading aid to provide their diagnosis. The displayed result for the BoneMetrics US is a summary in a unique Secondary Capture with the following information: The image with the angle(s) in degree drawn as an overlay (if any), A table with the angle(s) measurement(s) and value(s) in degree (if any), At the bottom, the "Gleamer" logo and the "BoneMetrics" mention.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Endpoint | Metric | Reported Mean Absolute Error (95% CI) | Acceptance Criteria (Upper bound of the MAE 95% CI) | Device Meets Criteria? |
|---|---|---|---|---|
| Cobb angle with the largest curvature (n = 212) | Mean Absolute Error (°) | 2.56° (2.0° - 3.28°) | < 6.34° | Yes (3.28° < 6.34°) |
| Minor Cobb angle (n = 189) | Mean Absolute Error (°) | 2.78° (2.29° - 3.33°) | < 6.34° | Yes (3.33° < 6.34°) |
Subgroup Analysis for Acceptance Criteria and Performance:
| Population | Endpoint | Metric | Reported Mean Absolute Error (95% CI) | Acceptance Criteria (Upper bound of the MAE 95% CI) | Device Meets Criteria? |
|---|---|---|---|---|---|
| Adults | Cobb angle with the largest curvature (n=100) | Mean Absolute Error (°) | 3.31° (2.21° - 4.87°) | < 6.34° | Yes (4.87° < 6.34°) |
| Adults | Minor Cobb angle (n=90) | Mean Absolute Error (°) | 2.91° (2.29° - 3.68°) | < 6.34° | Yes (3.68° < 6.34°) |
| Children | Cobb angle with the largest curvature (n=32) | Mean Absolute Error (°) | 1.34° (0.88° - 1.86°) | < 6.34° | Yes (1.86° < 6.34°) |
| Children | Minor Cobb angle (n=18) | Mean Absolute Error (°) | 1.95° (1.01° - 3.21°) | < 6.34° | Yes (3.21° < 6.34°) |
| Adolescent | Cobb angle with the largest curvature (n=80) | Mean Absolute Error (°) | 2.11° (1.71° - 2.56°) | < 6.34° | Yes (2.56° < 6.34°) |
| Adolescent | Minor Cobb angle (n=81) | Mean Absolute Error (°) | 2.83° (1.96° - 3.85°) | < 6.34° | Yes (3.85° < 6.34°) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: 345 frontal spine radiographs.
- Data Provenance: Obtained from US data providers. The text doesn't explicitly state whether the data was retrospective or prospective, but for regulatory studies, it is typically well-defined.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Three (3) experts.
- Qualifications of Experts: Two US board-certified musculoskeletal radiologists and one US board-certified orthopedic surgeon.
4. Adjudication method for the test set:
- The ground truth was initially defined as the mean of the Cobb angles measured by the 3 ground truthers to establish a consensus-based ground truth.
- For cases with discrepancies exceeding a predetermined threshold, an adjudication process was implemented where the three experts mutually agreed on a value for the ground truth. This is a 3-expert consensus with adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done in this submission. The study described is a "Clinical Standalone Performance Study" comparing the device's measurements against a ground truth.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The text explicitly states, "A Clinical Standalone Performance Study was conducted..." The experts establishing ground truth were kept unaware of the outputs from BoneMetrics US.
7. The type of ground truth used:
- The ground truth was established by expert consensus (mean of three expert measurements with adjudication for discrepancies).
8. The sample size for the training set:
- The document does not specify the sample size for the training set. It only mentions "dedicated training of the algorithm for the indications and the patient population" as a control in the discussion of differences from the predicate device.
9. How the ground truth for the training set was established:
- The document does not specify how the ground truth for the training set was established. It only mentions "dedicated training of the algorithm" without details on the ground truth process for training data.
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Gleamer SAS Antoine Tournier Chief Compliance Officer 47bis, rue des Vinaigriers PARIS, 75010 FRANCE
February 5, 2025
Re: K241593
Trade/Device Name: BoneMetrics (US) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: OIH Dated: January 7, 2025 Received: January 7, 2025
Dear Antoine Tournier:
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.
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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" (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 OS 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 (QS) 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 Re"). 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-devices/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 mediation-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
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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, PhD 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
BoneMetrics (US)
Indications for Use (Describe)
BoneMetrics US is a fully automated radiological image processing software device intended to aid users in the measurement of Cobb angles on frontal spine radiographs of individuals of at least 4 years old for patients with suspected or present spinal deformities, such as scoliosis. It should not be used instead of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is to be used by healthcare professionals trained in radiology.
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/4/Picture/1 description: The image contains the logo for Gleamer. On the left side of the image is a blue circle with a pattern of dots. To the right of the circle is the word "Gleamer" in a sans-serif font. The word is also blue, matching the color of the circle.
Date prepared: February 4th, 2025
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for BoneMetrics US is provided below.
1. Submitter
| Submitter | GLEAMER SAS47bis, rue des Vinaigriers75010, Paris 10, FRANCE |
|---|---|
| Primary Contact Person | Antoine TournierChief Compliance OfficerTel: 0033 6 15 81 23 45Email: antoine.tournier@gleamer.aiAlternate email: qara@gleamer.ai |
2. Device
| Trade Name | BoneMetrics (US) |
|---|---|
| 510(k) reference | K241593 |
| Common Name | Automated Radiological Image Processing Software |
| Regulation | 21 CFR 892.2050 |
| Product Code | QIH |
| Classification | Class II |
3. Predicate Device
| Predicate Device | IB Lab LAMA |
|---|---|
| 510(k) Reference | K223646 |
4. Device Description
BoneMetrics US is intended to analyze radiographs using machine learning techniques to provide fully automated measurements of cobb angles during the review of frontal spine radiographs.
BoneMetrics US can be deployed on cloud and be connected to several computing platforms and X-ray imaging platforms such as radiographic systems, or PACS. More precisely, BoneMetrics US can be deployed in the cloud connected to a DICOM Source/Destination with a DICOM Viewer, i.e. a PACS.
After the acquisition of the radiographs on the patient and their storage in the DICOM Source, the radiographs are automatically received by BoneMetrics US from the user's DICOM Source through intermediate DICOM node(s) (for example, a specific Gateway, or a dedicated API). The DICOM Source can be the user's image storage system (for example, the Picture Archiving and Communication System, or PACS), or other radiological equipment (for example X-ray systems).
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Image /page/5/Picture/1 description: The image shows the logo for Gleamer. The logo consists of a blue sphere made up of many small dots on the left, followed by the word "Gleamer" in black, bold font on the right. The sphere has a lighter area in the center, giving it a three-dimensional appearance.
Once received by BoneMetrics US, the radiographs are automatically processed by the Al algorithm without requiring any user inputs. The algorithm identifies the keypoints corresponding to the corners of all the vertebras that are seen on the images and calculates all possible angles between vertebras. Only Cobb Angles that are above 7° are retained. Based on the processing result, BoneMetrics US generates result files in DICOM format. These result files consist of annotated images with the measurements plotted on a copy of all images (as an overlay) and angle values displayed in degrees. BoneMetrics US does not alter the original images, nor does it change the order of original images or delete any image from the DICOM Source.
Once available, the result files are sent by BoneMetrics US to the DICOM Destination through the same intermediate DICOM node(s). Similar to the DICOM Source, the DICOM Destination can be the user's image storage system (for example, the Picture Archiving and Communication System, or PACS), or other radiological equipment (for example X-ray systems). The DICOM Source and the DICOM Destination are not necessarily identical.
The DICOM Destination can be used to visualize the result files provided by BoneMetrics US or to transfer the results to another DICOM host for visualization. The users are then able to use them as a concurrent reading aid to provide their diagnosis.
The displayed result for the BoneMetrics US is a summary in a unique Secondary Capture with the following information:
- The image with the angle(s) in degree drawn as an overlay (if any),
- . A table with the angle(s) measurement(s) and value(s) in degree (if any),
- . At the bottom, the "Gleamer" logo and the "BoneMetrics" mention
5. Intended use/ Indications for Use
BoneMetrics US is a fully automated radiological image processing software device intended to aid users in the measurement of Cobb angles on frontal spine radiographs of individuals of at least 4 years old for patients with suspected or present spinal deformities, such as scoliosis. It should not be used instead of full patient evaluation or solely relied upon to make or confirm a diagnosis. The software device is to be used by healthcare professionals trained in radiology.
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6. Substantial equivalence
| Features andCharacteristics | Subject DeviceGleamer- BoneMetrics US | Predicate DeviceIb Lab GmbH - Ib Lab LAMA (K223646) | Discussion of Differences and Comments |
|---|---|---|---|
| Regulation Information | |||
| Classificationregulation | 21 CFR 892.2050- Medical image managementand processing system | Same | N/A |
| Product Code | QIH | Same | N/A |
| RegulationDescription | A medical image management and processingsystem is a device that provides one or morecapabilities relating to the review and digitalprocessing of medical images for the purposes ofinterpretation by a trained practitioner ofdisease detection, diagnosis, or patientmanagement. The software components mayprovide advanced or complex image processingfunctions for image manipulation, enhancement,or quantification that are intended for use in theinterpretation and analysis of medical images.Advanced image manipulation functions mayinclude image segmentation, multimodalityimage registration, or 3D visualization. Complexquantitative functions may include semi-automated measurements or time-seriesmeasurements. | Same | N/A |
| Indications for use | |||
| Features andCharacteristics | Subject Device | Predicate Device | Discussion of Differences and Comments |
| Gleamer- BoneMetrics US | Ib Lab GmbH - Ib Lab LAMA (K223646) | ||
| Indications foruse | BoneMetrics US is a fully automated radiologicalimage processing software device intended toaid users in the measurement of Cobb angles onfrontal spine radiographs of individuals of atleast 4 years old for patients with suspected orpresent spinal deformities, such as scoliosis. Itshould not be used instead of full patientevaluation or solely relied upon to make orconfirm a diagnosis. The software device is to beused by healthcare professionals trained inradiology. | IB Lab LAMA is a fully-automated radiologicalimage processing software device intended to aidusers in the measurement of limb-lengthdiscrepancy and quantitative knee alignmentparameters on uni- and bilateral AP full legradiographs of individuals at least 22 years of age.It should not be used in-lieu of full patientevaluation or solely relied upon to make orconfirm a diagnosis. The software device isintended to be used by healthcare professionalstrained in radiology. IB Lab LAMA is not indicatedfor use on radiographs on which AnkleArthroplasties and/or Unicompartmental KneeArthroplasties are present. | The subject device performs measurements ofCobb angles on frontal spine images for patientsof at least 4 years old. The predicate deviceperforms measurements of lengths and angleson full leg images on patients of at least 22years of age.This difference in anatomical measurements,anatomical locations, and patient populationdoes not raise new types of questions for safetyor effectiveness and therefore does not inducechanges in the intended use. For both devices,the key question is whether the software is ableto generate accurate and reproducibleanatomical measurements within the targetpopulation.This is confirmed through additional controlsthat are in place to mitigate any risk for thisdifference:dedicated training of the algorithm forthe indications and the patientpopulation performance testing for all indicationsand populations |
| Features andCharacteristics | Subject DeviceGleamer- BoneMetrics US | Predicate DeviceIb Lab GmbH - Ib Lab LAMA (K223646) | Discussion of Differences and Comments |
| HumanIntervention forinterpretation | Required | Same | N/A |
| Imagerequirements | DICOM compliant plain radiographs collected inother devices in the CR, DX formats. | Same | N/A |
| Anatomical area | Frontal Spine | Full leg | The anatomical area supported by the subjectdevice (frontal spine) is different from thepredicate device (full leg).This difference does not raise new questionsregarding safety or effectiveness with respect tothe technological characteristics. Thetechniques used for capturing full leg imagesand frontal spine images are both standardprocedures.However, additional controls are in place tomitigate any risk for this difference:dedicated training of the algorithm for●the indications and the patientpopulationperformance testing for all indications●and populations |
| Features andCharacteristics | Subject DeviceGleamer- BoneMetrics US | Predicate DeviceIb Lab GmbH - Ib Lab LAMA (K223646) | Discussion of Differences and Comments |
| Workflow/Principle ofOperaion | 1. User or PACS send image to the device2. Device performs analysis3. Image is sent back to PACS4. User reviews the results | 1. User or PACS send image to the device2. Device performs analysis3. Image is sent back to PACS4. User reviews and accepts/rejects the results | N/A |
| ProcessingArchitecture | 1. Pre-process the input image2. Classification of the image3. Detect landmarks4. Compute angles5. Generate results | 1. Pre-process the input image2. Classify uni or bilateral image3. Compute regions of interest for each side.4. Detect landmarks and segmentations5. Compute lines and distances6. Compute angles7. Generate reports | The Processing architecture is different betwee the subject and the predicate device:- The subject device does not perform a classification of uni or bilateral images.BMUS only process unilateral frontal spine images- The subject device does not compute regions of interest nor detected segmentations- The subject device only computes and does not compute distances or linesThese differences are linked with the difference of indications for use mentionned above and the same additional controls are in place to mitigate these differences:- dedicated training of the algorithm for the indications and the patient population |
| Features andCharacteristics | Subject DeviceGleamer- BoneMetrics US | Predicate DeviceIb Lab GmbH - Ib Lab LAMA (K223646) | Discussion of Differences and Comments |
| Technology | Convolutional neural networks for:• classification• landmarkingClassical methods for computing:• angles | Convolutional neural networks for:• classification• landmarking• segmentationClassical methods for computing:• auxiliary points• lengths• angles | The technology behind the subject and thereference device is different:• The subject device does not providesegmentation or auxiliary points andlengths computing technologyThese differences are linked with the differenceof indications for use mentionned above andthe same additional controls are in place tomitigate these differences:• dedicated training of the algorithm forthe indications and the patientpopulation• performance testing for all indicationsand populations |
| Output | Human and machine readable results in theDICOM format. | Human and machine readable reports in theDICOM format. | N/A |
| PhysicalCharacteristics | Software application. | Software application operated on OTS software. | N/A |
| Safety | Displayed warningsIntended Users: qualified and trained healthcareprofessionalsAutomated input checks: DICOM Tags check | Same | N/A |
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Technological Information
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7. Performance data
Note: no animal testing or clinical testing is included in the current 510(k) submission.
7.1. Bench Testing - Nonclinical Tests
Product verification and validation testing were conducted and documented as per the requirements of the FDA guidance "Content of Premarket Submissions for Device Software Functions" for a Basic Documentation Level. Nonclinical tests include unit, integration and system levels testing for the final software version. BoneMetrics US performed as intended and all results observed were as expected. All software requirements and risk analysis have been successfully verified and traced.
7.2. Bench Testing - Clinical Performance Tests
A Clinical Standalone Performance Study was conducted on a dataset of 345 frontal spine radiographs of children and adults obtained from US data providers to validate the performance of BoneMetrics US.
The ground truth was determined by the expertise of two US board-certified musculoskeletal radiologists and one US board-certified orthopedic surgeon. These experts were kept unaware of the outputs from BoneMetrics US, findings from clinical reports, and readings from other truthers. The ground truth was defined as the mean of the Cobb angles measured by the 3 ground truthers to establish a consensus-based ground truth. Any cases with discrepancies exceeding the predetermined threshold were subjected to an adjudication process, where the three experts mutually agreed on a value for the ground truth.
The clinical standalone performance study compared the performance of BoneMetrics US in the measurements of Cobb angles against a ground truth by computing the Mean Absolute Error (MAE) and an acceptance criteria.
| Endpoint | Metric | Mean (95% CI) | Lower Bound | Upper Bound | Acceptance criteria |
|---|---|---|---|---|---|
| Cobb angle with the largest curvaturen = 212 | Mean Absolute Error (°) | 2.56 | 2.0 | 3.28 | Upper bound of the MAE95% CI < 6.34° |
| Minor Cobb anglen = 189 | Mean Absolute Error (°) | 2.78 | 2.29 | 3.33 | Upper bound of the MAE95% CI < 6.34° |
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A subgroup analysis was performed for the performance accuracy of BoneMetrics US in adults, and children and pediatrics population.
| Population | Endpoint | Metric | Mean(95%CI) | LowerBound | UpperBound | Acceptancecriteria |
|---|---|---|---|---|---|---|
| Adults | Cobb angle withthe largestcurvature(n=100) | MeanAbsoluteError (°) | 3.31 | 2.21 | 4.87 | Upper bound of theMAE 95% Cl < 6.34° |
| Minor Cobbangle(n=90) | MeanAbsoluteError (°) | 2.91 | 2.29 | 3.68 | Upper bound of theMAE 95% Cl < 6.34° | |
| Children | Cobb angle withthe largestcurvature(n=32) | MeanAbsoluteError (°) | 1.34 | 0.88 | 1.86 | Upper bound of theMAE 95% Cl < 6.34° |
| Minor Cobbangle(n=18) | MeanAbsoluteError (°) | 1.95 | 1.01 | 3.21 | Upper bound of theMAE 95% Cl < 6.34° | |
| Adolescent | Cobb angle withthe largestcurvature(n=80) | MeanAbsoluteError (°) | 2.11 | 1.71 | 2.56 | Upper bound of theMAE 95% Cl < 6.34° |
| Minor Cobbangle(n=81) | MeanAbsoluteError (°) | 2.83 | 1.96 | 3.85 | Upper bound of theMAE 95% Cl < 6.34° |
The standalone results indicates that BoneMetrics US was able to meet the pre-defined performance acceptance criteria for Cobb angle measurements, thereby demonstrating its ability to provide clinically relevant measurements. The performance achieved by the device confirms that BoneMetrics US is an effective imaging device capable of providing measurements of Cobb angles on frontal spine radiographs. Consequently, BoneMetrics US perform as intended and is considered substantially equivalent to the predicate device.
7.3. Conclusion
BoneMetrics US is as safe and effective as the predicate device. BoneMetrics US and the predicate device are both fully-automated radiological image processing software device intended to aid users perform measurements of interests on radiographs.
The overall design of the software and the basic functionality that it provides to the end user are the same. The minor differences between the subject and the predicate device in indications do not alter the intended use of the device and do not raise new or different questions regarding its
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safety and effectiveness when used as labelled. Verification and validation testing, including the clinical standalone software performance tests, supports the safety and demonstrates that BoneMetrics US performs as intended. Therefore BoneMetrics US is substantially equivalent.
§ 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).