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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

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.

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PictZar is indicated for wound measurement and documentation and can be used on all external wound types.

PictZar® is digital planimetry software used for the measurement and tracking

The provided text is a 510(k) summary for the PictZar® Digital Planimetry Software Application. It does not contain the detailed study information required to fully answer all aspects of your request, such as specific acceptance criteria and the comprehensive study data. It primarily focuses on equivalence claims to predicate devices and general regulatory information.

However, based on the available information, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria for performance metrics (e.g., accuracy thresholds). It broadly claims that "Measurements made PictZar® are equal to or more accurate than those made with the predicate devices." Without the actual study report, specific performance data (e.g., mean accuracy, standard deviation, correlation coefficients) are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). To obtain this, one would need to review the full submission to the FDA, which would include the detailed clinical study report. The summary states that "Clinical data were obtained to demonstrate that the PictZar® device performed as intended."

3. Number of Experts Used to Establish Ground Truth and Qualifications

The 510(k) summary does not provide information on the number of experts used or their qualifications for establishing ground truth in any test set. This type of detail would typically be found in the clinical study protocol and report.

4. Adjudication Method

The 510(k) summary does not describe any adjudication method (e.g., 2+1, 3+1). This detail would be part of the study design.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on comparing the PictZar® device's accuracy to predicate devices, not on the improvement of human readers with AI assistance.

6. Standalone Performance Study

The 510(k) summary implies a standalone performance study was conducted to demonstrate the device's accuracy, stating "Measurements made PictZar® are equal to or more accurate than those made with the predicate devices. The differences do not raise any questions of safety and effectiveness over the predicate devices." This suggests the algorithm's performance was evaluated independently. However, the details of this study are not provided.

7. Type of Ground Truth Used

The 510(k) summary does not explicitly state the type of ground truth used. Given the nature of wound measurement, it's highly likely that ground truth would be established through a combination of:

• Manual measurements: Precise manual measurements performed by trained clinicians using traditional methods (e.g., rulers, transparent grids) or other validated photographic planimetry tools.
• Expert Consensus: Agreement among multiple qualified experts on the accurate wound boundaries and dimensions.

8. Sample Size for the Training Set

The 510(k) summary does not provide information on the sample size for the training set. This information would be crucial for understanding the robustness of the underlying algorithms, but it is not part of this regulatory summary.

9. How Ground Truth for the Training Set Was Established

The 510(k) summary does not explain how ground truth for the training set was established. Similar to the test set, it would likely involve highly accurate manual measurements or expert annotations.

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Silhouette is indicated for wound measurement and documentation and can be used on all external wound types.

Silhouette consists of a camera connected to a PDA, for the measurement and tracking of wounds

The provided text describes the Silhouette Wound Measurement and Documentation System (K070426) and its 510(k) summary, but it does not contain the specific acceptance criteria or the study details to prove the device meets those criteria.

The document primarily focuses on:

• Device identification and classification.
• Comparison to predicate devices.
• Indications for use.
• FDA's substantial equivalence determination.

Therefore, many of the requested details cannot be extracted from this text.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Cannot be extracted. The document mentions that "Standard wound measurements made with Silhouette are more accurate than those made with the predicate devices," but it does not specify what "more accurate" quantitatively means, nor does it list specific acceptance criteria (e.g., minimum accuracy, precision, or other performance metrics) or precise reported device performance values.

2. Sample Size Used for the Test Set and Data Provenance:

• Cannot be extracted. The document does not provide details about any specific test set, its sample size, or the provenance of the data used for performance claims.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Cannot be extracted. The document makes no mention of expert involvement in establishing ground truth for any test or validation.

4. Adjudication Method:

• Cannot be extracted. No information is provided regarding adjudication methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Cannot be extracted. There is no mention of an MRMC study or quantitative effect sizes for human readers with/without AI assistance. The device is a "Wound measurement and documentation system" that includes a camera and PDA, implying that it assists human measurement rather than being a standalone AI system in the modern sense.

6. Standalone Performance Study:

• Cannot be extracted. While the system itself could be considered "standalone" in its function of acquiring images and measuring wounds, the document does not describe a formal standalone performance study with specific metrics, particularly in the context of an AI algorithm as implied by the question. Its comparison to predicate devices is noted, but not in the format of a standalone study against defined criteria.

7. Type of Ground Truth Used:

• Cannot be extracted. The document does not specify how "ground truth" for wound measurements was established or what type it was (e.g., manual caliper measurements, pathology, etc.).

8. Sample Size for the Training Set:

• Cannot be extracted. There is no mention of a "training set" as this device predates the widespread use of machine learning that requires such sets, or at least the explicit reporting of them in 510(k) summaries. The device performs measurement and documentation based on image capture, not an AI model trained on a large dataset.

9. How Ground Truth for the Training Set was Established:

• Cannot be extracted. Similar to point 8, no training set is described.

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Ask a specific question about this device