(15 days)
Quantra™ is a software application intended for use with Hologic digital mammography systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra provides these numerical values for each breast to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid.
Quantra is a software application which runs on the Hologic Cenova DICOM server (Class I exempt per 21 CFR § 892.2010 and 21 CFR § 892.2020).
Quantra is a software application that estimates breast tissue volumes. The estimations are made from mammography images produced by full-field digital mammography (FFDM) systems.
Here's an analysis of the provided text regarding the Quantra™ device's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific numerical acceptance criteria for the Quantra™ device's performance. It primarily focuses on the device's intended use, regulatory classification, and substantial equivalence to predicate devices. The "performance of the software" is mentioned as being tested "in accordance with Hologic's SOPs and testing procedures to demonstrate adequate performance," but no specific metrics or thresholds for "adequate performance" are detailed in this summary.
Therefore, a table of acceptance criteria and reported device performance cannot be created from the given information.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide any information regarding the sample size used for a test set or the data provenance (e.g., country of origin, retrospective or prospective nature) of any study data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set:
The document does not provide any information about an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any information on the effect size of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
The document does not explicitly detail a standalone performance study. While it describes the software's functionality in "calculating volumetric breast density," it doesn't present data from a study that solely evaluates the algorithm's performance against a ground truth without human interaction.
7. Type of Ground Truth Used:
The document does not specify the type of ground truth used for any potential testing or validation.
8. Sample Size for the Training Set:
The document does not provide any information regarding the sample size used for a training set.
9. How Ground Truth for the Training Set Was Established:
The document does not provide any information on how ground truth for a training set was established.
Summary of what is present in the document versus what is missing regarding a performance study:
The provided 510(k) summary primarily focuses on the regulatory aspects of the Quantra™ device:
- Intended Use: Calculating volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates, to aid radiologists in assessment (adjunctive, not diagnostic).
- Regulatory Classification: Class II, Picture Archiving and Communications System.
- Predicate Devices: Sectra IDS5 Workstation and WorkstationOne™ Breast Imaging Workstation.
- Safety and Effectiveness Concerns: Covered by instructions for use, cautions, warnings, risk analysis, software development, verification, and validation testing.
- Conclusion: Substantial equivalence to predicate devices.
Critical Missing Information for a Performance Study:
The document is notably lacking specific details about any clinical validation or performance study that would typically include:
- Defined acceptance criteria (e.g., accuracy, precision, correlation with a gold standard).
- Details of a test dataset (size, characteristics, provenance).
- Methodology for establishing ground truth.
- Results of any performance metrics.
- Information on reader studies or standalone algorithm performance.
This suggests that for this 510(k) submission, the primary evidence for substantial equivalence was likely based on the technological characteristics and intended use being similar to existing cleared predicate devices, supported by internal Hologic SOPs and testing procedures for software performance, rather than a full-scale clinical performance study with detailed numerical results presented in the summary.
§ 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).