(66 days)
The SECTRA AB, WISE Image Management System device is intended for the management and displaying of x-ray images, other radiological objects, and information. It can manage images from different modalities, single and multiple file servers, and interfaces to various Radiological Information Systems (RIS), image storage and printing devices using DICOM or similar interface standards.
WISE will be used for management of radiological images.
This document is a 510(k) summary for the SECTRA-Imtec WISE Image Management System, submitted in 1997. It explicitly states that the submission aims to demonstrate "substantial equivalence" of WISE to a predicate device, SECTRA-Imtec ImageServer 2000 (K963395).
The submission does not contain specific acceptance criteria, performance metrics, or study details such as sample sizes, ground truth establishment, or human reader studies typically associated with demonstrating clinical efficacy or diagnostic accuracy. Instead, it focuses on regulatory compliance and equivalence to a previously cleared device.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is an attempt to address the points based on the available information, noting where information is absent:
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A table of acceptance criteria and the reported device performance
This information is not provided in the given text. The filing is for demonstrating substantial equivalence, not for presenting performance against specific statistical acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC).
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document does not describe a test set or clinical study of this nature.
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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)
This information is not provided. There is no mention of a test set or ground truth establishment process.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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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
This information is not provided. The device is an "Image Management System," suggesting its primary function is handling and displaying images, not providing diagnostic AI assistance. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant or expected for this type of device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The WISE system is described as an "Image Management System" for displaying and managing images for "trained medical professionals," implying a human-in-the-loop system for image review and interpretation. It is not presented as an AI algorithm providing standalone diagnostic outputs.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
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The sample size for the training set
This information is not provided. The document does not describe any machine learning or AI models requiring a training set.
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How the ground truth for the training set was established
This information is not provided.
Summary of available information related to acceptance criteria and study:
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (SECTRA-Imtec ImageServer 2000, K963395) rather than providing specific performance metrics from a clinical study. The basis for substantial equivalence is listed as:
- Compliance with Federal Performance Standards (21 CFR, part 1000).
- Manufacture in accordance with voluntary standards.
- Comprehensive user guides ensuring safe and effective use.
- Results of a hazard analysis.
The FDA's response letter (JUN 26 1997) confirms that they reviewed the 510(k) and "decemined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This indicates that the device met the regulatory bar for substantial equivalence at the time, which did not necessarily require the same type of clinical performance studies expected for newer AI/ML diagnostic devices.
§ 892.2010 Medical image storage device.
(a)
Identification: A medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images. Examples include electronic hardware devices employing magnetic and optical discs, magnetic tapes, and digital memory.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.