(54 days)
The Ultrasound Capture System™ (UCS) system captures analog video and audio from any ultrasound with a composite or S-video output and converts the captured video to DICOM image and audio files. UCS software runs on a standard "off-the-shelf" personal computer running the Windows XP operating system and a high-resolution video acquisition interface.
The Ultrasound Capture System™ (UCS) system captures analog video and audio from any ultrasound with a composite or S-video output and converts the captured video to DICOM image and audio files. UCS software runs on a standard "off-the-shelf" personal computer running the Windows XP operating system and a high-resolution video acquisition interface.
- Allows demographic (Patient Name, ID etc.) input consistent with the DICOM standard for image storage.
- Performs automatic image acquisition triggered by the cine-pedal.
- Performs network transmission of images in DICOM format to a DICOM compatible storage system.
The provided text describes the Heartlab Inc. Ultrasound Capture System (UCS), a device for capturing analog ultrasound video and audio and converting it to DICOM files.
Here's an analysis of the acceptance criteria and the study (or lack thereof) based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the design control activities that were performed to ensure the device met its specifications. However, it does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., image quality, conversion speed, accuracy of DICOM conversion) and their corresponding reported device performance values in a direct comparison.
Instead, the document states:
"All verification and validation activities were performed by the designated individual(s), and the results demonstrated that the predetermined acceptance criteria were met."
This implies that acceptance criteria were established internally as part of the design control process, but the specific details and the performance against them are not disclosed in this 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices based on functional characteristics and adherence to industry standards.
The closest to "acceptance criteria" are the mentioned design control measures and adherence to standards:
| Acceptance Criteria (Inferred from Standards & Design Control) | Reported Device Performance (Summary Statement) |
|---|---|
| Conformance to DICOM standard (image format, demographic input, network transmission) | "Allows demographic (Patient Name, ID etc.) input consistent with the DICOM standard for image storage." |
| "Performs network transmission of images in DICOM format to a DICOM compatible storage system." | |
| "Image Format: Lossy JPEG, DICOM 3.0" | |
| Compliance with 21 CFR 1020.10 (Video Monitor Performance) | Device designed in accordance with this standard. (No specific performance data given) |
| Compliance with 21 CFR 1040.10 (Fiberoptic communications Performance) | Device designed in accordance with this standard. (No specific performance data given) |
| Compliance with SMPTE standards | Device designed in accordance with this standard. (No specific performance data given) |
| Compliance with ACR/NEMA Data Compression Standard | Device designed in accordance with this standard. (No specific performance data given) |
| Compliance with UL Standards 544 & 1950 (Safety) | Device designed in accordance with these standards. (No specific performance data given) |
| Compliance with ISO/IEC 10918-1 (JPEG compression) | Device designed in accordance with this standard. (No specific performance data given) |
| "Compression: Variable, 10-12:1 recommended compression" | |
| Software designed, developed, tested, and validated according to written Design Control procedures. | "The software utilized was designed, developed, tested and validated according to written Design Control procedures." |
| "All verification and validation activities were performed... results demonstrated that the predetermined acceptance criteria were met." | |
| Risk analysis performed and hazards controlled by Risk Management Plan. | "Potential hazards have been studied and controlled by a Risk Management Plan." |
2. Sample size used for the test set and the data provenance:
The document does not specify a sample size for a test set in the context of clinical performance or diagnostic accuracy. The testing described (unit, integration, acceptance, performance) likely refers to software and system functionality testing, not a clinical study involving a dataset of patient images. Therefore, details like country of origin or retrospective/prospective nature are not applicable for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since there's no mention of a clinical or image-based test set requiring ground truth established by experts, this information is not provided. The device converts analog signals to DICOM; it does not perform diagnostic interpretation.
4. Adjudication method for the test set:
Not applicable, as no clinical or image-based test set requiring expert adjudication is described.
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 study was conducted or mentioned. This device is an image capture and conversion system, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a standalone system in terms of its function (capturing and converting). The performance testing mentioned ("Performance testing" under Design Control) would assess its ability to perform these functions independently. However, this is not an "algorithm only" in the sense of an AI algorithm performing a diagnostic task. The document implies that the system's performance (e.g., successful capture, correct DICOM conversion, maintaining specified compression ratios) was verified, but specific quantitative results are not provided in this public summary.
7. The type of ground truth used:
Given the nature of the device (capture and conversion), the "ground truth" for its verification and validation would likely involve:
- Known input signals: Using standardized analog video/audio signals (e.g., test patterns, known cine loops from an ultrasound machine) to verify correct capture.
- DICOM standard conformance: Verifying that the output files adhere strictly to the DICOM 3.0 standard.
- Data integrity: Comparing captured digital images/audio with the original analog source to ensure no loss or degradation beyond expected compression.
- Metadata accuracy: Verifying that demographic and study information is correctly embedded in the DICOM headers.
No clinical "ground truth" (e.g., pathology, outcomes data, expert consensus on disease presence) is relevant for this type of device.
8. The sample size for the training set:
Not applicable. This device is an image capture and conversion system, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 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).