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510(k) Data Aggregation
(29 days)
The Presero 3D Scanning System is an imaging tool that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a 3D imaging device. It is indicated for the use of capturing visual images to measure the diameter, surface area, perimeter and volume of wounds. The Presero 3D Scanning System is designed for use by health care professionals and is intended to assist the healthcare professional who is responsible for making all final patient management decisions.
The Presero 3D Scanning System is a tablet-based system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a 3D imaging device. The Presero 3D Scanning System, does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. The Presero 3D Scanning System is comprised of a commercial off the shelf 3D camera fitted on a commercial off the shelf tablet, equipped with a proprietary software application that enables a health care professional to visualize and interact with 3D wound images, via a pen-like stylus, to assist in clinical decision making. The complete system (tablet, camera and software) integrates with a cloud back-end system. The cloud back-end system stores all patient data, operator details and other information allowing 2-way synchronization between the Presero 3D Scanning System and the cloud with the ability to fully support multiple systems within a single clinical facility.
Here's a breakdown of the acceptance criteria and study information for the Presero 3D Scanning System, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria or quantifiable device performance results for wound measurement accuracy. Instead, it makes a general statement about meeting design requirements and user needs.
| Metric/Criteria (Implicit) | Reported Device Performance |
|---|---|
| Ability to process, review, analyze, communicate, and interchange multi-dimensional digital images. | The Presero 3D Scanning System is capable of these functions. |
| Ability to capture visual images to measure diameter, surface area, perimeter, and volume of wounds. | The device is indicated for this use. |
| Compliance with relevant medical device standards (e.g., IEC 62304, NEMA PS 3.1, IEC 60601-1-2). | "Every specification of the Presero® 3D Scanning Software has been validated according to the company's documented development and test procedures. The verification and validation testing conducted included testing to the following applicable standards: [List of standards provided]." Additionally, "Verification and validation testing were completed in accordance with the company's Design Control process in compliance with 21 CFR Part 820.30, which included testing that fulfills the requirements of FDA “Guidance on Software Contained in Medical Devices”." |
| Mitigation of potential risks. | "Potential risks were analyzed and satisfactorily mitigated in the device design." |
| Meets design requirements and user needs. | "Results of performance testing demonstrated that the device met the design requirements and as well as the user needs." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" and its sample size for evaluating the device's performance in measuring wounds. It mentions "verification and validation testing... in simulated use conditions," but provides no details on the number of cases or the nature of the data. The data provenance (country of origin, retrospective/prospective) is also not stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The method for establishing ground truth for any performance evaluation is not detailed.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study comparing human readers with and without AI assistance is mentioned. The device is described as an "imaging tool" to "assist the healthcare professional," implying it provides measurements rather than assisting in diagnosis like some AI tools.
6. Standalone (Algorithm Only) Performance Study
While the document indicates that the device has undergone "verification and validation testing," it does not explicitly detail a standalone performance study in terms of specific metrics like sensitivity, specificity, or accuracy compared to a ground truth for wound measurements. The focus seems to be on the system's ability to perform its stated functions and comply with regulatory standards.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for any performance evaluation. Given the device's function to measure wound characteristics, it is likely that a physical measurement (e.g., manual measurement with rulers, digital planimetry from other validated systems, or 3D models) would be used as a ground truth, but this is not confirmed in the provided text.
8. Sample Size for the Training Set
The document does not provide information on the sample size of a training set. This is often the case for 510(k) submissions of devices that are not primarily AI/machine learning diagnosis or detection tools where extensive training data might be discussed. The Presero 3D Scanning System is described as having "proprietary software application" and uses a "commercial off the shelf 3D camera," suggesting its primary function is measurement based on 3D scanning, which may rely more on geometric algorithms than machine learning requiring a large training set for image interpretation.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or detailed, there is no information on how its ground truth might have been established.
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