(71 days)
QLAB Advanced Quantification Software is a software application package. It is designed to view and quantify image data acquired on Philips ultrasound systems
Philips QLAB Advanced Quantification software (QLAB) is designed to view and quantify image data acquired on Philips ultrasound systems. QLAB is available either as a stand-alone product that can function on a standard PC, a dedicated workstation, and on-board Philips' ultrasound systems. It can be used for the off-line review and quantification of ultrasound studies. QLAB software provides basic and advanced quantification capabilities across a family of PC and cart based platforms. OLAB software functions through O-App modules, each of which provides specific capabilities. QLAB builds upon a simple and thoroughly modular design to provide smaller and more easily leveraged products.
The provided document describes the FDA 510(k) clearance for Philips Healthcare's QLAB Advanced Quantification Software 13.0, primarily focusing on its substantial equivalence to previously cleared predicate devices. The modifications in QLAB 13.0 involve integrating existing TomTec-Arena applications (AutoSTRAIN LV, AutoSTRAIN LA, AutoSTRAIN RV) into the Philips QLAB platform.
However, the document does not contain specific details about acceptance criteria or a dedicated study design that proves the device meets specific performance criteria. Instead, it relies on the concept of substantial equivalence to predicate devices that have already undergone prior clearance.
Based on the information provided, here's what can be extracted and what is missing:
Key Takeaways from the Document:
- Device: QLAB Advanced Quantification Software 13.0
- Purpose: To view and quantify image data acquired on Philips ultrasound systems.
- Modifications: Integration of AutoStrain LV, LA, and RV modules from TomTec-Arena (previously cleared under K150122) with "workflow improvements."
- Regulatory Pathway: 510(k) premarket notification, based on substantial equivalence.
- Clinical Testing: "QLAB 13.0 does not introduce new indications for use, modes, or features relative to the predicate (K181264) that require clinical testing." This explicitly states that no new clinical study was performed for this specific 510(k) submission.
- Performance Data: Relies on "Verification and software validation data" and "Design Control activities" (Requirements Review, Design Review, Risk Management, Software Verification and Validation) to support substantial equivalence.
Therefore, it's not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study (with the specified details) was explicitly stated as not required and not performed for this 510(k) submission.
The document justifies its clearance based on the following:
- The new functionalities (AutoStrain LV, LA, RV) are derived from applications (TomTec-Arena AutoSTRAIN and 2D CPA) that were already cleared under K150122.
- The current modifications primarily focus on integrating these existing functionalities into the QLAB platform and making "workflow improvements."
- The intended use remains the same as the predicate device.
- The manufacturer performed non-clinical performance testing including software verification and validation, design control activities, and risk management to ensure the modified software performs safely and effectively relative to the predicate device and meets defined requirements.
If a hypothetical scenario were to involve a new device or a significant change requiring a de novo clearance or a more involved 510(k) where clinical performance needed to be demonstrated, the requested information would be crucial. However, for this specific 510(k) for QLAB 13.0, the provided document indicates that the performance evaluation was based on demonstrating equivalence, not on new clinical performance studies with acceptance criteria for the new features.
To answer your prompt directly, given the provided text, the answer to most of your questions is that this information is not present because a new comparative effectiveness study or standalone performance study with new ground truth establishment was explicitly deemed unnecessary due to the nature of the submission (integration of already cleared components and "workflow improvements").
Here's a breakdown of the requested information, indicating what is not available from this document due to the nature of the 510(k) submission:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided document. The submission relies on substantial equivalence to predicate devices, not on demonstrating new performance against defined acceptance criteria for the integrated features. The document states: "QLAB 13.0 does not introduce new indications for use, modes, or features relative to the predicate (K181264) that require clinical testing."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided document. No specific clinical test set data is described for QLAB 13.0. The "Verification and software validation data" mentioned are non-clinical, likely internal testing using synthetic data, simulated data, or existing clinical data from the development of the predicate/reference devices, but details are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not available in the provided document. No new ground truth establishment process is described for QLAB 13.0 as no new clinical study was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided document. No new clinical test set 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
- Not available in the provided document, and explicitly stated as not required/done. The document explicitly states: "QLAB 13.0 does not introduce new indications for use, modes, or features relative to the predicate (K181264) that require clinical testing." Therefore, no MRMC study was performed as part of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not available in the provided document. Similarly, no new standalone performance study for the integrated algorithms is described beyond the assertion that the underlying algorithms (from K150122) were previously cleared.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not available in the provided document. As no new clinical study requiring ground truth was conducted for QLAB 13.0, this information is not provided. The ground truth for the original cleared components (TomTec-Arena AutoSTRAIN and 2D CPA) would have been established at their time of clearance (K150122), but those details are not in this document.
8. The sample size for the training set
- Not available in the provided document. This document describes a 510(k) clearance for a software update integrating existing, cleared algorithms. It doesn't detail the training data for the original development of those algorithms.
9. How the ground truth for the training set was established
- Not available in the provided document. (See point 8).
§ 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).