(57 days)
The CT BiopsyView option is intended to be used for instant display of CT images during interventional procedures. The instant display of images allows the operating physician to watch the placement of an interventional instrument in real-time.
CT BiopsyView is an option to the TOMOSCAN family of CT systems. TOMOSCAN systems are whole body Computed Tomography (CT) systems which are diagnostic X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission of data from the same axial plane taken at different angles. They includes signal analysis and display equipment, patient and equipment supports, component parts and accessories which are used in combination with signal and image processing software to facilitate the relative localization of anatomy with gray-scale representation of density relative to water utilizing Houndsfield indices with or without contrast mediums. They are used for the display, storage and analysis of digital diagnostic CT images. They are intended for use by a physician in the diagnosis and planning phases of patient conditions and treatment.
The CT BiopsyView option extends the intended use of a TOMOSCAN CT system to include its use by a physician in the interventional phases of patient conditions and treatment.
CT BiopsyView is a software option to the Philips TOMOSCAN product family of computed tomography systems.
The TOMOSCAN products are whole body scanners. These systems are already provided with the RapidView Reconstructor (512 x 512 image matrix) option which allows the reconstruction of one image per second.
The CT BiopsyView option provides real-time CT fluoroscopy (6 images per second) for a TOMOSCAN CT system equipped with the RapidView reconstructor. The scan parameters are imited to 15. 25. 50 and 75 mA and 120 and 140 KV. The maximum exposure time is 100 seconds and the remaining time is displayed on the monitor for quick reference.
The CT BiopsyView option is used for interventional procedures, such as biopsy, drainage procedures, therapy control and functional studies.
This submission (K983140) describes the Philips CT BiopsyView, a software option that provides real-time CT fluoroscopy for interventional procedures. The document, however, does not contain information related to specific acceptance criteria or a dedicated study proving the device meets said criteria as would be expected for an AI/ML device submission.
Instead, the submission focuses on demonstrating substantial equivalence to previously cleared predicate devices and addressing safety information related to the overall CT system and radiation control. The information provided is characteristic of a submission for a traditional medical device software option that extends the functionality of an existing, cleared hardware system rather than a new AI/ML-driven diagnostic or assistive device that requires performance validation through studies against a ground truth.
Therefore, many of the requested elements for an AI/ML study (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not present in this document.
Here is a breakdown of what can be extracted and what is missing based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/ML component. The "acceptance criteria" for this device appear to be primarily focused on functionality and safety equivalence to predicate devices.
- Functional Criteria (Implied): Provides real-time CT fluoroscopy (6 images per second) for a TOMOSCAN CT system equipped with the RapidView reconstructor. Scan parameters are limited to 15, 25, 50, and 75 mA and 120 and 140 KV. Maximum exposure time is 100 seconds.
- Safety Criteria (Implied): Introduces no new safety issues beyond existing TOMOSCAN systems, compliance with Radiation Control for Health and Safety Act, Federal X-ray Performance standards (21 CFR 1020.30, 1020.33), UL-2601/UL-187, and IEC601-1. Hazard analysis indicates a minor level of concern.
- Reported Device Performance:
- Image Reconstruction Speed: 6 images per second (for CT BiopsyView), in contrast to the RapidView Reconstructor's 1 image per second.
- Scan Parameters: 15, 25, 50, 75 mA; 120, 140 KV.
- Max Exposure Time: 100 seconds (with remaining time displayed).
- Safety: Device classified as "minor level of concern" based on hazard analysis.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. This document does not describe a clinical performance study using a test set of patient data to validate the performance of an AI/ML algorithm. The "testing" implied is functional verification and validation of the software's ability to display images at a certain speed and within specified parameters, and its compliance with safety standards, rather than performance in a diagnostic or interventional context that would require a patient data test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. As there's no clinical performance study on a test set, there is no mention of experts establishing ground truth.
4. Adjudication method for the test set:
- Not applicable / Not provided.
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. This is not an AI-assisted diagnostic or assistive device that would typically undergo an MRMC study. It is a real-time imaging display tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided. This device is an imaging option for a CT system, not a standalone algorithm. Its function is to facilitate real-time image display for physician-led interventional procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. For a functional device like this, "ground truth" would relate to the accuracy of image reconstruction and display according to engineering specifications, rather than clinical outcomes or diagnostic categories.
8. The sample size for the training set:
- Not applicable / Not provided. This device is described as a software option for real-time image reconstruction and display. It is not an AI/ML device that would typically involve a "training set" in the sense of machine learning.
9. How the ground truth for the training set was established:
- Not applicable / Not provided.
Summary of the Study that "Proves" Device Meets Criteria:
The "study" or justification for this device's safety and effectiveness, as described in the 510(k) submission, relies primarily on:
- Substantial Equivalence: The primary method for proving the device meets criteria is by demonstrating its substantial equivalence to two predicate devices already cleared by the FDA:
- Real-Time Reconstruction System option for the Toshiba Xpress/SX CT System (K950972)
- C.A.R.E. Vision option to the Siemens SOMOTOM Plus 4 CT System (K965004)
The argument is that since these predicate devices perform similar real-time CT fluoroscopy functions and have been deemed safe and effective, the CT BiopsyView, with its similar technological characteristics and intended use, is also safe and effective.
- Compliance with Standards and Regulations: The document states compliance with:
- Radiation Control for Health and Safety Act.
- Federal X-ray Performance standards 21CFR 1020.30, 1020.33.
- UL-2601 or UL-187 (Underwriters Laboratories standards for medical electrical/X-ray equipment).
- IEC601-1 (Medical Electrical Equipment).
- Hazard Analysis: A hazard analysis was conducted, which concluded the device is of "minor level of concern," indicating that potential risks were identified and mitigated.
- Functional Specifications: The device's ability to reconstruct 6 images per second and operate within specified scan parameters (mA, KV, exposure time) indicates it meets its functional design requirements.
In essence, this is a traditional 510(k) summary focused on hardware/software feature addition and regulatory compliance through substantial equivalence, not an AI/ML performance study as implied by the detailed questions.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic 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 generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.