Search Results
Found 1 results
510(k) Data Aggregation
(191 days)
The Scout is a combination digital camera and long-wave infrared camera. The digital camera is indicated for the use of capturing visual images to measure the diameter, surface area, and perimeter of a part of the body or two body surfaces. The long-wave infrared camera is indicated for the use of capturing thermal images to measure the thermal intensity data of a part of the body or two body surfaces. Both components of the Scout are non-contact with respect to the patient and provide an adjunctive tool to help a trained and qualified health care professional measure and record external wound and body surface data.
Intended for qualified healthcare professionals who are trained in its use, the Scout is a non-invasive and non-radiating device.
The Scout is to be used on a patient population that includes non-pregnant female or male patients 18 years of age or older. The Scout is intended to be used in hospital, acute and sub-acute care settings, long term care, surgery, health care practitioner facilities, outpatient, home healthcare, or in any environment where health care is provided by a qualified health care professional.
The Scout does not provide a diagnosis or therapy.
The Scout is a combination digital camera and long-wave infrared camera. The clinician simultaneously captures a visual and infrared image that can be uploaded and stored with a patient's electronic medical record. Body surface size and thermal intensity data can be measured and recorded.
The digital camera captures the visible light wavelengths from the electromagnetic spectrum that is visible to the human eye. The infrared camera captures the infrared radiation emitted by the human body from the electromagnetic spectrum that is not visible to the human eye.
Both cameras are housed in a plastic casing which transmits captured data to a PC.
Here's a breakdown of the acceptance criteria and the studies conducted for the WoundVision Scout device, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The acceptance criteria for the WoundVision Scout primarily revolve around the accuracy and precision (reliability and repeatability) of its measurement functions for both visual and thermal imaging.
Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implicit from Study Outcomes if not explicitly stated as "passing") | Reported Device Performance (from WV13CL-0004 & WV13CL-00061) |
|---|---|---|
| Visual Measurement Accuracy (Area) | Scout LxW equivalent to clinical reference standard ruler LxW method (Psi_R =.77, 95% CI (0.53, 1.02)). | Scout LxW: Psi_R =.77, 95% CI (0.53, 1.02) (Equivalent to ruler LxW). Overestimates true area by ~37-40%. |
| Scout Trace desired to be closer to true area than LxW methods. | Scout Trace: Approximately 4% different from the true area. | |
| Visual Measurement Accuracy (Perimeter) | Scout Trace desired to be closer to true perimeter. | Scout Trace: Approximately 2% different from the true perimeter. |
| Within-Operator Precision (Simulated Wounds) | Median %CV < 5 for all measurements. | Scout Perimeter: 1.94 %CV < 5% |
| Scout Trace Area: 2.54 %CV < 5% | ||
| Scout LxW Area: 3.87 %CV < 5% | ||
| Between-Operator Precision (Simulated Wounds) | Median %CV < 5 for all measurements. | Scout Perimeter: 1.97 %CV < 5% |
| Scout Trace Area: 2.80 %CV < 5% | ||
| Scout LxW Area: 4.20 %CV < 5% | ||
| Within-Operator Precision (Actual Wounds) | Median %CV < 10 for all measurements. | Scout Perimeter: 2.35 %CV < 10% |
| Scout Trace Area: 3.72 %CV < 10% | ||
| Scout LxW Area: 6.26 %CV < 10% | ||
| Between-Operator Precision (Actual Wounds) | Median %CV < 10 for all measurements. | Scout Perimeter: 3.71 %CV < 10% |
| Scout Trace Area: 9.29 %CV < 10% | ||
| Scout LxW Area: 9.82 %CV < 10% | ||
| Thermal Image Data Consistency (Varied Camera Angles) | Variation under +/- 6 pixels of the target temperature. | Hypothesized confirmed: Variation under +/- 6 pixels of the target temperature. |
| Thermal Image Data Consistency (Over Time) | Variation pattern similar amongst all imagers/target temperatures. | Hypothesized confirmed: Variation pattern similar amongst all imagers/target temperatures. |
| Thermal Intensity Scale Accuracy | Difference in pixel value between each degree C is 12.7 (+/- 2 pixels) throughout the temperature range. | Hypothesized confirmed: Difference was 12.7 (+/- 2 pixels) throughout the temperature range. |
| Thermal Intensity Distance Impact | Variation no greater than +/- 6 mean pixel value per 6" of distance change. | Hypothesized confirmed: Variation not greater than +/- 6 mode pixel value per 6" of distance change (largest recorded +3 pixels). |
| Thermal Intensity Environmental Temperature Impact | Environmental temperature affects thermal intensity pixel value when image captured. | Hypothesized confirmed: Environmental temperature affects thermal pixel value. Need for relative pixel value confirmed. |
| Thermal Image FOV Correction Impact | Thermal intensity not affected by applied FOV correction. | Hypothesized confirmed: Only two out of 30 data points showed slight mode difference of 1 pixel value. |
| Thermal Image Size Correction Accuracy | Low average % change between Visual Image and Thermal Image after scale correction. | Average % change after correction: -3.29% (vs. 15.58% without correction). |
Study Details for WoundVision Scout
The information provided describes several clinical and bench testing studies that prove the device meets the acceptance criteria.
1. Clinical Study I: Accuracy and Reproducibility of the Scout [WV13CL-0004] (Simulated Wounds)
- Sample Size: 19 metal shapes with known areas, imaged in 3 pre-defined head directions to simulate 57 different wounds.
- Data Provenance: Not explicitly stated, but implies a controlled laboratory setting (simulated wounds). Retrospective or prospective is not specified, but the nature of controlling "pre-defined head directions" suggests a prospective, controlled study design.
- Number of Experts & Qualifications: 3 clinicians. Qualifications not specified beyond "clinicians."
- Adjudication Method: Not applicable as the ground truth was known areas of metal objects.
- MRMC Comparative Effectiveness Study: No. This study assessed the device's accuracy against a known truth and compared its methods against a traditional ruler method.
- Standalone Performance: Yes, this study assessed the algorithmic performance of the Scout's LxW and Trace methods in determining area and perimeter.
- Type of Ground Truth: Known area of metal objects produced by a calibrated CNC Mill (Haas Model VF3) with Mastercam X6 machining software.
- Training Set Sample Size: Not applicable/provided for this test set, as the device's performance was being evaluated. This study assessed the output of the device after its development.
- Training Set Ground Truth: Not applicable/provided.
2. Clinical Study II: Comparison of Standardized Clinical Evaluation of Wounds Using Ruler Length by Width and Scout Length by Width Measure and Scout Perimeter Trace [WV13CL-00061] (Actual Wounds)
- Sample Size: 40 wound images.
- Data Provenance: Captured in clinical outpatient and inpatient settings. Retrospective or prospective is not specified, but the nature of using already "captured" images suggests a retrospective analysis of collected data.
- Number of Experts & Qualifications: 5 independent operators. Qualifications not specified beyond "operators," although the discussion mentions "clinical experts and non-clinicians."
- Adjudication Method: Not applicable for establishing ground truth, as the study focused on within- and between-operator variability of the Scout's measurements on these wound images. The previous study established the accuracy of the methods against a known ground truth.
- MRMC Comparative Effectiveness Study: No, this focused on inter- and intra-reader variability of the device's measurements.
- Standalone Performance: Yes, the study evaluated the precision of the Scout's algorithms (LxW Area, Trace Area, Perimeter) when used by different operators.
- Type of Ground Truth: No direct "ground truth" for area/perimeter measurement was established for these 40 actual wounds within this study. Instead, the study assessed the precision (repeatability and reproducibility) of the device's measurements in a clinical setting when measuring real wounds. The performance metrics were coefficient of variation (CV%).
- Training Set Sample Size: Not applicable/provided.
- Training Set Ground Truth: Not applicable/provided.
3. Bench Testing Studies (WV13REP-0005, WV13REP-0006, WV13REP-0007, WV13REP-0008, WV13REP-0009, WV13REP-0010, WV13REP-0011)
These studies focused on the performance characteristics of the thermal imaging component of the Scout.
- Sample Size: Not explicitly detailed in terms of number of images or targets for each study, but implied to be sufficient for bench testing.
- Data Provenance: Controlled laboratory bench testing environment.
- Number of Experts & Qualifications: Not applicable as these are bench tests of the device's hardware/software performance under controlled conditions.
- Adjudication Method: Not applicable.
- MRMC Comparative Effectiveness Study: No.
- Standalone Performance: Yes, these studies assess the standalone performance of the thermal imaging system under various controlled parameters (angles, distance, environment, FOV correction, size correction).
- Type of Ground Truth: Calibrated targets (e.g., target temperature, known pixel values, or comparisons to unaltered visual images).
- Training Set Sample Size: Not applicable/provided.
- Training Set Ground Truth: Not applicable/provided.
Overall Conclusion from the Summary:
The studies collectively support the substantial equivalence of the Scout's visual camera and measurements to its predicate, demonstrating repeatability and reliability. They also validate the accuracy and performance of the adjunctive long-wave infrared camera. The device's measurement precision (within and between operators) falls within acceptable limits (typically <5% for simulated wounds, <10% for actual wounds) for all measured parameters, with the Scout Trace Perimeter consistently being the most precise. While LxW methods tended to overestimate true area, the Scout Trace method provided a much more accurate estimate.
Ask a specific question about this device
Page 1 of 1