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510(k) Data Aggregation
(267 days)
The NSite Scoliosis Assessment App is intended as an adjunct tool for qualified healthcare professionals to provide deformity measurements and guide management recommendations based on a calculated Asymmetry Index for patients with or at risk for idiopathic scoliosis, which will yield an output of clinically significant scoliosis, which is defined as a Cobb Angle greater than 20 degrees.
NSite Medical leverages 3D scanning on a mobile device for scoliosis screening and monitoring. NSite's proprietary algorithm calculates the risk of having clinically significant scoliosis that may require treatment by a specialist.
The NSite Scoliosis Assessment App generates a 3D scan of the individual using a mobile device camera. Using the 3D scan, the application analyzes the asymmetry of the individual's back surface and calculates an Asymmetry Index (AI). The Asymmetry Index is a quantitative measure of the back asymmetry. The Asymmetry Index is then used to calculate a high/low risk stratification that a patient will have clinically significant scoliosis (defined as Cobb angle > 20 degrees) using a logistic regression model. This risk stratification, when considered in combination with the stated NSite Scoliosis Assessment App performance, is intended to provide health care providers with information that can be used for management recommendations. The model was developed using a database of patient Asymmetry Indexes with known Cobb angles.
The provided text describes the NSite Scoliosis Assessment App, an adjunct tool for qualified healthcare professionals to assess scoliosis risk, and its clinical study to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study proving device performance, based only on the provided text, as some details are not explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "All predefined acceptance criteria for the performance testing were met." However, the specific acceptance criteria (e.g., sensitivity, specificity thresholds) and the numerical results for the device's performance (e.g., actual sensitivity and specificity achieved) are not detailed in the provided text. The output is described as a "low or high risk of clinically significant scoliosis, which is defined as a Cobb Angle greater than 20 degrees."
| Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|
| All predefined acceptance criteria for performance testing were met. | "The results from the performance testing executed on the NSite Scoliosis Assessment App produced results consistently according to its intended use." The study "validated the accuracy of the predicated probability of major Cobb angle as compared to a Cobb angle obtained via radiograph." Specific performance metrics (e.g., sensitivity, specificity, AUC) are not provided in this document. |
| Reproducibility of scanning functionality | Assessed in clinical study; details of results not provided. |
| Reliability of scanning functionality | Assessed in clinical study; details of results not provided. |
| Accuracy of predicated probability of major Cobb angle vs. radiograph Cobb angle | Validated in clinical study; details of results not provided. |
| Safety and effectiveness for intended use | Demonstrated in clinical study. |
| Substantial equivalence to predicate device (K923792) | Demonstrated in clinical study. |
| No new questions of safety and effectiveness | Demonstrated in clinical study. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the numerical sample size of the test set used in the clinical study. It mentions the study was performed using "adolescent patients spanning the age range where Adolescent Idiopathic Scoliosis (AIS) commonly presents and remains treatable" and "adolescents of gender and race at ratios where AIS is commonly observed."
- Data Provenance: The text does not specify the country of origin of the data. The study is described as a "clinical study," suggesting it was prospective, but this is not explicitly stated as retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. It mentions "radiograph" as the basis for the Cobb angle, implying radiologists were involved, but details are absent.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided. The app is intended as an "adjunct tool," implying human-in-the-loop, but a comparative effectiveness study is not detailed.
6. Standalone (Algorithm Only) Performance
The document does not explicitly state if a standalone (algorithm-only) performance study was conducted with specific metrics for that mode of operation. The primary intention is as an "adjunct tool" for healthcare professionals. The study "validated the accuracy of the predicated probability of major Cobb angle," which implies an algorithm output, but whether this was evaluated without human interaction or review is not clarified.
7. Type of Ground Truth Used
The ground truth used was:
- Cobb Angle obtained via radiograph: This is the primary stated ground truth for validating the accuracy of the device's "predicated probability of major Cobb angle." This typically implies expert consensus (e.g., radiologists) on these radiographic measurements.
8. Sample Size for the Training Set
The document does not state the specific sample size used for the training set. It mentions: "The model was developed using a database of patient Asymmetry Indexes with known Cobb angles."
9. How Ground Truth for the Training Set Was Established
The document states: "The model was developed using a database of patient Asymmetry Indexes with known Cobb angles." It implies that the Cobb angles for the training data were also established through similar means as the test set ground truth (i.e., likely from radiographs). However, the precise method for establishing the ground truth for the training set (e.g., number of readers, adjudication) is not detailed.
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(89 days)
The Momentum Spine app is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians.
The device is intended for use in patients 8 years and older.
Momentum Spine is an optical contour sensing mobile application intended to quantify asymmetries, assess body angles and curve progression related to postural asymmetries, including scoliosis. The device is available directly to lay users (Over-the-Counter) and may also be prescribed for use by physicians.
From a simple video taken on a mobile device. Momentum Spine ('app') reconstructs a 3D model of the torso to quantify asymmetry using 3D imaging and artificial intelligence. The app is intended to be used by a combination of lay users (parents, guardians etc.) and health care professionals. The patients do not use the device on themselves.
The app is intended to be used on patients 8 years and older to scan and monitor postural asymmetries. The app can be used by patient populations suffering from postural deformities mainly scoliosis. Additionally, the device can also be used by an otherwise healthy population to scan for and monitor their overall spinal health.
Here's a breakdown of the acceptance criteria and study details for the Momentum Spine device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Cobb Angle Prediction) | Reported Device Performance |
|---|---|
| Predicted Cobb angle within 10 degrees of X-ray derived Cobb Angle. | The document states this is the appropriateness of performance, implying this is the acceptance criterion, but it does not directly state a reported performance metric against this criterion in terms of accuracy (e.g., how many predictions met this criterion). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 212 individuals (split as 60/20/20 for training/validation/test, so 20% of 212 = 42 individuals for the test set).
- Data Provenance:
- Timeframe of Data Collection: April 2021 to June 2023
- Country of Origin: Canada
- Retrospective or Prospective: Not explicitly stated, but the collection timeframe and demographic details suggest a retrospective dataset was compiled.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only mentions that the ground truth is a "cobb angle derived from an X-ray (radiograph)." It does not detail who derived this Cobb angle or their qualifications.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. As the number of experts is not stated, an adjudication method like 2+1 or 3+1 cannot be determined.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study Done: No. The document does not mention any MRMC study or comparative effectiveness study involving human readers with and without AI assistance. The testing focused on the AI algorithm's standalone performance against a ground truth.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance Done: Yes. The AI testing summary explicitly states: "Predicted cobb angle is derived from our machine learning model." This indicates a standalone performance evaluation of the algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Expert consensus (implied) from X-ray data. Specifically, "Ground truth is a cobb angle derived from an X-ray (radiograph)." While the number and qualifications of experts are not given, the derivation of a Cobb angle from an X-ray typically involves a skilled radiologist or orthopedic specialist.
8. The Sample Size for the Training Set
- Sample Size for Training Set: 212 individuals total, with a 60/20/20 split for training/validation/test. Therefore, 60% of 212 = 127 individuals were used for the training set. (An additional 20% or 42 individuals would be for the validation set, which is also used during training).
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: The same method as the test set: "Ground truth is a cobb angle derived from an X-ray (radiograph)." This implies that for all individuals in the dataset (training, validation, and test), their ground truth Cobb angles were obtained from X-ray radiographs.
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(254 days)
The CryoVizion is indicated as a tool to quantify angles on digital photograph depictions such as body angles related to postural asymmetries. It is intended for use in professional health specialists such as podiatrists, orthopedist, physiotherapists, chiropractors, osteopaths, and kinesiotherapists
The CryoVizion System is a non-invasive and radiation-free system. Patients, suitably undressed, are placed in an observation booth. Two digital colour cameras mounted on a column are placed facing the patient booth. Patients are illuminated by two LED lighting units-one on each side of the imaging column. Using the CryoVizion System, the health specialist can then take images of the patient at various heights and in different positions. These images are then saved in the patient's file. The health specialists can then visually review anatomical and morphological features related to the patient's posture. To do this, the CryoVizion System provides an image analysis toolbox including a palette of six graphic filters. Surface markers corresponding to the anatomical body landmarks placed using palpation by healthcare professionals, prior to taking the photographs, may also be used to help identify and reference anatomical landmarks in the photographs. The CryoVizion System is composed of two sections: hardware and software. The data and the images collected with the CryoVizion System are available immediately for clinical use and may be downloaded to a computer for storage or further analysis or comparison. The hardware section comprises the above noted two digital colour cameras and two LED lighting units, mounted on a column and a positioning booth. The two cameras are mounted in the central tube of the imaging column. The LED lighting systems are vertically disposed to each side of the column. The column also houses the control centre which, linked to a computer, controls the two digital cameras and the intensity of the lighting. The software comprises image manipulation functions, including the user selectable filters noted above and controls to operate each of the cameras.
The CryoVizion System is intended to quantify angles on digital photographs of body angles related to postural asymmetries for use by healthcare specialists.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document implicitly defines acceptance criteria through the performance tests conducted, specifically for "Angle Measurement Accuracy and Single Tester's Measurement Repeatability." However, explicit numerical acceptance thresholds for accuracy and repeatability are not provided in the summary.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Angle Measurement Accuracy (compared to goniometer) | Verified for accuracy by comparing its output relative to that of a manual goniometer ("gold standard"). |
| Single Tester's Measurement Repeatability | Assessed through two variance analysis (ANOVA) studies to evaluate intra- and inter-user accuracy variability, and a bias and linearity study of repeated measurements, all compared to goniometer measurements. The method was found to be appropriate and reproducible for its intended use per a clinical study. Specific numerical values for accuracy deviation or repeatability coefficients (e.g., standard deviation, ICC values) are not detailed in this summary. |
| Electrical Safety and EMC | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6. |
| Software Verification and Validation | Performed in accordance with IEC 62304:2006 and FDA Guidance documents ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices"). |
2. Sample Size for Test Set and Data Provenance:
The document mentions "a clinical study specific to the CryoVizion System" complementing information from literature. However, the exact sample size for the test set used to determine angle measurement accuracy and repeatability is not explicitly stated. The data provenance (country of origin, retrospective/prospective) for this clinical study is also not specified.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):
The document mentions that the system's output was compared to a "manual goniometer which is a 'gold standard' method currently used for body segment angle measurements." This implies that measurements using goniometers, presumably performed by trained professionals, served as a surrogate for ground truth. However, the number of experts used to establish this goniometer-based ground truth for the test set and their specific qualifications are not detailed.
4. Adjudication Method:
The document does not describe an adjudication method for establishing ground truth for the test set. It relies on comparison to "gold standard" manual goniometer measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A MRMC comparative effectiveness study was not performed that compares human readers with and without AI assistance. The study focuses on the device's performance against a manual "gold standard" and within-device (intra- and inter-user) variability.
6. Standalone Performance:
Yes, a standalone performance study was done for the algorithm's angle measurement functionality. The study verified the system's output for accuracy and assessed repeatability, comparing it to manual goniometer measurements. This evaluates the algorithm's ability to quantify angles independently.
7. Type of Ground Truth Used:
The primary type of ground truth used for the angle measurement accuracy study was expert consensus / reference standard based on manual goniometer measurements. The goniometer is referred to as a "gold standard" for body segment angle measurements.
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size for a training set. As the device is primarily described as a measurement tool with image filters for analysis rather than an AI-driven diagnostic system requiring extensive machine learning training data, a traditional "training set" might not be applicable in the same way. However, if any internal algorithms were trained, this information is not disclosed.
9. How Ground Truth for the Training Set Was Established:
Since no training set information is provided, how ground truth for a training set was established is not detailed.
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