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510(k) Data Aggregation
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Philips CT 3500
The Philips CT 3500 is a Computed Tomography X-Ray System intended to produce images of the head and body by computer reconstruction of X-Ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipments and accessories. The Philips CT 3500 is indicated for head, whole body, cardiac (Cardiac Calcium Scoring) and vascular X-ray Computed Tomography applications in patients of all ages.
These scanners are intended to be used for diagnostic imaging and for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
The proposed Philips CT 3500 is a whole-body computed tomography (CT) X-Ray System featuring a continuously rotating x-ray tube, detectors, and gantry with multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This system also includes signal analvsis and display equipment, patient and equipment supports, components, and accessories. The Philips CT 3500 has a 72cm bore and includes a detector array that provides 50cm scan field of view (FOV). Besides installed in hospital, the proposed Philips CT 3500 may also be installed on trailer and be transported to designed locations for use. And Philips CT 3500 installed on trailer has the same intended use as installed in hospital. The key components that are used in the proposed Philips CT 3500 have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Incisive CT (K212441 - April 27, 2022). CT on Trailer Kit that is used in the proposed Philips CT 3500 to install and secure the CT system on trailers have the same fundamental design characteristics and are based on comparable technologies as the current market predicate Philips Incisive CT on trailer (K211168 - November 22, 2021). Trailers are provided by trailer manufactures and are not components of the proposed Philips CT 3500. The key system modules and functionalities are: 1. Gantry. The Gantry consists of 4 main internal units: a) X-Ray Tube – produce X-ray necessary for scanning. b) High voltage generator - produce high voltage power supply to X-ray tube. consists of system Interface Unit, Power Block Unit and Anode Drive Unit. c) A-plane: adjust the slice thickness during axial scan and monitors the changes of X-ray d) DMS (Data Measurement System) – absorb X-ray radiation by detectors and convert it to digital readout. 2. Patient Table (Couch) Couch is used to position the patient. Carries the patient in and out through the Gantry bore synchronized with the scan. 3. Console It is used to operate the system and monitor the scan. The Operator console includes computer, monitor and CTBOX. 4. CT on Trailer Kit Philips CT 3500 installed and secured on trailer requires locking motion parts during trailer transportation and unlocking motion parts before CT operations. CT on Trailer Kit is used to install and secure the CT system on trailers, trailers are provided by trailer manufactures and are not components of the proposed Philips CT 3500. In addition to the above components and the software operating them, each system includes hardware and software for data acquisition, display, manipulation, storage and filming as well as post-processing into views other than the original axial images.
It appears there might be a misunderstanding of the provided text. The document is an FDA 510(k) clearance letter for the Philips CT 3500. This type of document declares a device substantially equivalent to a predicate device, based on non-clinical performance data (e.g., adherence to standards, design verification and validation), rather than a clinical study with specific acceptance criteria related to AI performance, human reader improvement, or detailed ground truth establishment for a test set.
The document does not describe an AI/algorithm-driven device requiring a study with acceptance criteria of the type typically seen for CADe/CADx devices (e.g., sensitivity, specificity, FROC analysis, MRMC studies). Instead, it's for a Computed Tomography X-Ray System (a hardware device), where "acceptance criteria" are related to its physical performance, safety, and adherence to established regulatory standards, demonstrating substantial equivalence to a previously cleared CT system.
Therefore, most of the requested information (e.g., acceptance criteria for AI performance, sample sizes for AI test sets, number of experts for AI ground truth, MRMC study effect size) is not present in the provided text because it's not relevant to this type of device clearance.
However, I can extract the information that is relevant to the device clearance as described in the document, framed in the context of "acceptance criteria" through compliance with standards and a comparison with a predicate device.
Here's an interpretation based on the provided document:
Device: Philips CT 3500 (Computed Tomography X-Ray System)
Purpose of the Study (for 510(k) Clearance): To demonstrate substantial equivalence of the Philips CT 3500 to a legally marketed predicate device (Philips Incisive CT - K212441, K211168) through non-clinical performance data (design verification, design validation, and adherence to consensus standards).
Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document primarily relies on demonstrating equivalence to predicate devices and compliance with recognized standards. There isn't a direct table of "acceptance criteria" and "reported performance" as one might see for AI algorithm metrics. Instead, the acceptance is based on meeting the criteria set by these standards and showing comparable characteristics to the predicate device.
| Acceptance Criteria Category (based on regulatory standards/predicate comparison) | Reported Device Performance (or comparison result) |
|---|---|
| Electrical Safety | Complies with AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD). |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 Edition 4.0 2014-02. |
| Radiation Protection | Complies with IEC 60601-1-3 Edition 2.1 2013-04. Also complies with 21 CFR 1020.33 for CT Equipment and 21 CFR 1040.10 for Laser products. |
| Usability | Complies with IEC 60601-1-6 Edition 3.2 2020-07 and IEC 62366-1 Edition 1.1 2020-06. |
| Software Life Cycle Processes | Complies with IEC 62304 Edition 1.1 2015-06. |
| Risk Management | Complies with ISO 14971 Third Edition 2019-12. All risks are sufficiently mitigated, no new risks introduced, overall residual risks acceptable. |
| Biological Evaluation (if applicable to patient contact parts) | Complies with ISO 10993-1 Fifth edition 2018-08. |
| CT Dose Reporting & Management | Complies with NEMA XR 25 -2019, NEMA XR 26-2020, NEMA XR 28-2013, and NEMA XR 29-2013. Note: Philips CT 3500 complies with more NEMA standards than its predicate, which is deemed not to affect safety and effectiveness. |
| Design Verification (vs. System Requirements) | Passed. System meets established system design input requirements. |
| Design Validation (vs. Intended Use/Commercial Claims) | Passed. Covered intended use, commercial claims, and workflow validation. |
| Installed Environment | Identical to predicate (In hospital, on trailer). |
| CT on Trailer | Functionally identical to predicate for securing the CT system on trailers. Gantry has no tilt function (differs from predicate, but all motion parts fixable, safety and effectiveness not affected). |
| Number of Slices | 32/64. (Predicate: 64/128). "The Philips CT 3500 uses the same DMS (20mm) as the Philips Incisive CT to support 64 slices." Deemed substantially equivalent. |
| Scan Modes | Identical to predicate (Surview, Axial Scan, Helical Scan). |
| Minimum Scan Time | 0.5 sec for 360° rotation. (Predicate: 0.35 sec for 360° rotation). "The proposed Philips CT 3500 rotation speed lower than Philips Incisive CT. Safety and effectiveness are not affected." |
| Image (Spatial) Resolution | Identical to predicate (High resolution mode: 16 lp/cm, Standard resolution mode: 13 lp/cm). |
| Image Noise | Identical to predicate (≤0.18% at 120kV, CTDIcenter (head) ≤ 33mGy, 10mm image thickness, iDose4). |
| Slice Thicknesses | Identical to predicate (Helical: 0.67mm - 5mm; Axial: 0.625mm – 10.0mm). |
| Scan Field of View | Identical to predicate (Up to 500 mm). |
| Image Matrix | Identical to predicate (Up to 1024 * 1024). |
| Display | Identical to predicate (1920 * 1080). |
| Host Infrastructure | Identical to predicate (Windows 10). |
| Communication | Identical to predicate (Compliance with DICOM). |
| Imaging Features (e.g., 2D Viewer, MPR, 3D, Virtual Endoscope, O-MAR, DoseRight Index, 3D-DOM, Bolus Tracking, Filming, Worklist, MPPS, Reporting, CCT, Brain Perfusion, Dental planning, Axial Gating, Parallel workflow, Precise image, Precise position, Direct results, CT Colonoscopy, Vessel Analysis, Lung Nodule Analysis, Dual Energy, Precise intervention, iDose4, Cardiac calcium scoring, Adaptive Filtering, Precise Brain) | All listed features are either identical ("Yes" indicates presence and equivalence to predicate) or have minor name changes/added capabilities (e.g., Precise Planning vs. iPlanning, Oblique MPR adding tilt capability, OnPlan vs. iStation, Precise Spine vs. iBatch) that are deemed not to affect safety and effectiveness, thus demonstrating substantial equivalence. |
Study Information (Based on 510(k) Non-Clinical Data Submission):
- Sample size used for the test set and the data provenance: Not applicable in the context of a "test set" for an AI algorithm. The validation was a non-clinical evaluation comparing the device to a predicate and established standards. The data provenance would be internal performance testing data and compliance documentation. The document doesn't specify a "test set" size or data origin in the sense of clinical images for an AI study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not established in this type of 510(k) for a CT system itself, as it is a hardware device. The "ground truth" for the clearance is compliance with engineering specifications, safety standards, and performance benchmarks compared to an existing device.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 MRMC study was done, as this is a CT scanner, not an AI-assisted diagnostic software. The document explicitly states: "The proposed Philips CT 3500 did not require clinical study since substantial equivalence to the legally marketed predicate device was proven with the verification/validation testing."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical imaging system, not an AI algorithm.
- The type of ground truth used: The "ground truth" for this clearance is defined by:
- Consensus Standards: Compliance with dozens of established national and international standards for medical electrical equipment, radiation protection, software, risk management, etc. (e.g., IEC 60601 series, ISO 14971, NEMA XR series).
- Predicate Device Performance: Direct comparison of fundamental design characteristics, key components, features, and technical specifications with the legally marketed Philips Incisive CT (K212441, K211168).
- Internal Verification and Validation: System verification against system requirement specifications (SRS) and validation testing covering intended use and commercial claims, including workflow validation.
- The sample size for the training set: Not applicable. This is not an AI algorithm clearance.
- How the ground truth for the training set was established: Not applicable. This is not an AI algorithm clearance.
In summary, the provided document details a 510(k) clearance for a CT imaging system, which is a hardware device. The "study" proving it meets "acceptance criteria" primarily involved non-clinical engineering and performance testing to demonstrate safety, effectiveness, and substantial equivalence to existing predicate devices and compliance with regulatory standards, rather than clinical studies of an AI algorithm's diagnostic performance.
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