(15 days)
The Aloka DAS-RS1 is intended to acquire, read, display, store and review DICOM image and data, including the ability to analyze and print reports primarily for Aloka diagnostic ultrasound systems.
The Aloka DAS-RS1 system is a software based medical image system. This system receives, reviews and store patient exam images and data, prepare/print reports and communicates with Aloka Ultrasound systems. This system has a PC workstation that can be used to analyze the data for report generation. The software allows for the download of DICOM files to a single PC from a single Aloka Ultrasound system located within the same facility.
Acceptance Criteria and Study for Aloka DAS-RS1
Based on the provided 510(k) summary for the Aloka DAS-RS1, the device did not undergo a clinical study with specific acceptance criteria that translate to performance metrics (e.g., sensitivity, specificity). The submission explicitly states:
"Clinical Tests: None Required to confirm safety and effectiveness. However, evaluation in a clinical setting was performed to ensure usability, reliability, reliability and compatibility within the intended environment."
This indicates that the Aloka DAS-RS1, as a Picture Archiving and Communication System (PACS) device, was cleared based on its substantial equivalence to a predicate device (Philips Medical Systems QLAB Software, K021966) and adherence to general safety and effectiveness standards, rather than specific performance benchmarks derived from a clinical trial.
Therefore, many of the requested details regarding acceptance criteria and a study proving their attainment cannot be provided as they were not part of this clearance process.
Here's an analysis of the provided information concerning the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the submission ("None Required to confirm safety and effectiveness" in a clinical context), there are no specific quantitative acceptance criteria or reported device performance metrics in the document that would typically be found in a study proving clinical efficacy (e.g., sensitivity, specificity, accuracy). The acceptance was based on:
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Functional Equivalence to Predicate Device | "functionally comparable and substantially equivalent to the Philips Medical Systems QLAB Software (K021966)" |
| Similar Technological Characteristics to Predicate Device | "similar technological characteristics" |
| Similar Key Safety and Effectiveness Features to Predicate Device | "key safety and effectiveness features" |
| Essentially Same Intended Use as Predicate Device | "essentially the same intended use" |
| Conformance to Design Specifications | "evaluated for conformance to its design specifications" |
| Conformance to Applicable Industry Standards for Software Development | "evaluated for conformance to... applicable industry standards for software development" |
| Risk Management/Hazard Control | "Risk management is ensured via risk analysis which is used to identify potential hazards. The potential hazards are controlled via software development, verification and validation." |
| System Compatibility | "verified for system compatibility with the Aloka Ultrasound device that it communicates to." |
| Compliance with Safety Standards for Hardware | "Computer hardware is certified to applicable safety standards." |
| Usability, Reliability, Compatibility in Clinical Setting | "evaluation in a clinical setting was performed to ensure usability, reliability, reliability and compatibility within the intended environment." |
| Conformance to Quality Systems | "conforms to 21 CFR 820, ISO 9001:2000 and ISO 13485: 2003 quality systems." |
| DICOM Compliance | "The device is DICOM compliant" |
| Conformance to Medical Safety Standards | "conforms to applicable medical safety standards" |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. No specific test set for clinical performance evaluation (e.g., disease detection) was described. The "evaluation in a clinical setting" was for usability, reliability, and compatibility, but no details on sample size for this were provided.
- Data Provenance: Not applicable, as no data for clinical performance metrics were presented or required for this 510(k). The "evaluation in a clinical setting" would likely have involved internal testing or limited pilot use, but specific origins (e.g., country) are not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No ground truth for clinical performance was established as part of this 510(k) for the reasons stated above.
- Qualifications: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No specific test set requiring adjudication of clinical outcomes was part of this submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- Was it done?: No. An MRMC study was not conducted or required for this submission. The device is a PACS system, not an AI diagnostic tool intended to improve human reader performance in a comparative study setup.
- Effect size of improvement: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Was it done?: Not applicable in the context of an AI algorithm's performance. The DAS-RS1 is a software system for image handling and analysis, not an AI algorithm performing a diagnostic task independently. Its "standalone" function refers to its ability to process and store images, which was verified through non-clinical tests and compatibility assessments.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable for clinical performance. The "ground truth" for this device's clearance was its ability to perform its intended functions (acquire, read, display, store, review DICOM data, analyze, print reports) reliably and safely, and its substantial equivalence to a predicate device. This was verified through design specifications, software development standards, risk analysis, and compatibility testing.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. The Aloka DAS-RS1 is a data analysis and archiving system, not a machine learning model that requires a training set in the conventional sense for a diagnostic algorithm. Its development involved traditional software engineering and testing, not AI model training.
9. How the Ground Truth for the Training Set Was Established
- How Established: Not applicable, as there was no training set for an AI model.
In summary, the Aloka DAS-RS1 received 510(k) clearance as a "Picture Archiving and Communication System" based on substantial equivalence to a predicate device and adherence to software development, quality system, and safety standards. It was not cleared as an AI-powered diagnostic tool, and therefore, the type of performance data typically associated with such tools (e.g., sensitivity, specificity, MRMC studies) was neither required nor provided.
§ 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).