(302 days)
The epi-Scope Option will be used in a Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device may include signal analysis and display equipment, patient equipment supports, components and accessories.
The epi-Scope Option will be used in a Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This device may include signal analysis and display equipment, patient equipment supports, components and accessories.
This 510(k) notice for the Picker epi-Scope Option provides very limited information regarding acceptance criteria and performance studies. It primarily focuses on demonstrating substantial equivalence to a previously marketed device (GE Advantage 3D Navigator Option) and adherence to regulatory standards. Therefore, most of the requested information cannot be extracted from the provided text.
Here's an attempt to answer based on the available information, noting where details are missing:
Acceptance Criteria and Performance Study Analysis for Picker epi-Scope Option
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Specifications Met | "The product will perform in accordance with the development specifications." (Specific functional specifications are not provided in this document). |
| Substantial Equivalence to Legally Marketed Device | "The epi-Scope Option represents the current state-of- the-art technology, therefore, is equivalent to legally marketed Advantage 3D Navigator Option manufactured by General Electric in Document Control No. K954355." |
| Compliance with Federal Diagnostic X-ray Performance Standards | "The epi-Scope Option will be used in certified CT Systems that comply with Federal Diagnostic X-ray Performance Standards." (This refers to the system it integrates with, not necessarily a direct performance metric of the epi-Scope itself). |
| Compliance with FDA GMPs | "Picker adheres to FDA GMPs, 21 CFR 1020.30-31." |
| Compliance with Voluntary Standards for Safety/Effectiveness | "voluntary standards for safety/effectiveness (UL 187) all of which mandate that components are tested to minimize hazards (electrical, mechanical, and radiation)." |
2. Sample size used for the test set and the data provenance:
- Not provided. The document states "Effectiveness is established by Picker's evaluation throughout all phases of the epi-Scope Option development," but no details on specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not provided. There is no mention of "ground truth" establishment or expert involvement in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. No information regarding adjudication methods is included.
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 evidence of an MRMC study. The document does not describe any studies involving human readers or comparative effectiveness with or without AI assistance. The epi-Scope Option is presented as a component of a CT system, not an AI-assisted diagnostic tool in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated, but implied. The statement "The product will perform in accordance with the development specifications" suggests internal testing to confirm the device's functional performance in a standalone context (as a component). However, no specific details of such tests are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. Given the nature of the device (a CT system option) and the lack of specific performance study details, there is no mention of how "ground truth" for clinical accuracy would be established. The focus is on meeting functional and safety specifications.
8. The sample size for the training set:
- Not applicable/Not provided. This is not an AI/machine learning device in the contemporary sense that would involve a "training set" for an algorithm. It is a hardware/software option for a CT system.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As stated above, there is no indication of a "training set" or algorithm learning in this context.
§ 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).