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510(k) Data Aggregation
(90 days)
The RFX Fluoroscopic digital imaging system is a high resolution, digital imaging system designed for digital videography. It is intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed.
The RFX fluoroscopic digital imaging system allows the use of digital imaging to be applied to conventional X-ray system used in general fluoroscopy, interventional fluoroscopy, angiography and cardiac imaging areas. The system works by installing a CCD camera on the output port of the imaging intensifier and digitizing the video output of the image intensifier. The digital image can be displayed on the monitor; it can be stored to the hard drive, or sent to an external device such as a laser imager or Dicom Network Service Provider. The image can also be processed, including brightness and contrast, edge enhancement, zoom, and subtraction.
The provided text is a 510(k) summary for the RFX Fluoroscopic Digital Imaging System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, it does not include detailed information regarding specific acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth methodologies that would typically demonstrate a device meets acceptance criteria.
The purpose of a 510(k) summary is to demonstrate substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study report with specific performance metrics and acceptance criteria. Therefore, the requested information, particularly quantitative data on acceptance criteria and study design, is largely absent from this document.
Below is a response attempting to extract as much relevant information as possible from the provided text, while also noting what is missing.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The provided 510(k) summary for the RFX Fluoroscopic Digital Imaging System focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics. Therefore, explicit acceptance criteria and a study design proving the device meets those criteria are not detailed in this document.
Instead, the summary asserts that the RFX system offers "virtually all of the features" offered by the predicate devices, implying that its performance would be comparable and therefore acceptable for its intended use. The "Conclusion drawn from comparison" states: "The RFX fluoroscopy digital imaging system can be considered to be substantially equivalent to: INFIMED Inc. GOLDONE Fluoroscopic System (510K) ~ K963037 CMT Medical Technologies. SPOT / RAD System (510K), K991578 and K003434 and, virtually all of the features offered by the predicate devices are offered by the RFX product."
The core "acceptance" here is the FDA's determination of substantial equivalence, which is typically based on comparing the new device's technological characteristics, intended use, and performance claims to those of a legally marketed predicate device. The document does not contain a specific study proving it meets quantitative acceptance criteria beyond this equivalence claim.
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative acceptance criteria are not explicitly stated in the document, a table cannot be fully constructed. The document's primary "performance claim" is its equivalence in features and intended use to predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Image Resolution: Capable of 1000 line fluoroscopy and 1000 x 1000 digital spot images, comparable to predicate devices. | The RFX system allows the operator to view and enhance 1000 line fluoroscopy. High resolution digital spot images (1000 x 1000) may be acquired at single or rapid acquisition rates. |
| Image Enhancement Capabilities: Ability to process images (brightness, contrast, edge enhancement, zoom, subtraction) for improved diagnostic details, similar to predicate devices. | Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Image can also be processed, including brightness and contrast, edge enhancement, zoom, and subtraction. |
| Storage & Output: Ability to store images (hard drive, medium term) and output to external devices (laser imager, DICOM Network Service Provider, network for longer term storage), comparable to predicate devices. | The digital image can be displayed on the monitor; it can be stored to the hard drive, or sent to an external device such as a laser imager or Dicom Network Service Provider. Images can be stored locally for medium term storage. The RFX system enables the operator to print hardcopy images with a laser printer or send images over a network for longer term storage. |
| Intended Use Equivalence: Applicable to general fluoroscopy, interventional fluoroscopy, angiography, and cardiac imaging, replacing conventional film techniques. | Intended to replace conventional film techniques in multipurpose or dedicated applications where general fluoroscopy, interventional fluoroscopy or angiography or cardiac imaging procedures are performed. Substantially equivalent to predicate devices with similar indications. |
| Safety: General safety and effectiveness profile comparable to predicate devices. | Not explicitly detailed, but implied by substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. The document does not describe a specific "test set" of data used for performance evaluation. The comparison is primarily based on device specifications and intended use against predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. No expert involvement in establishing ground truth for a test set is mentioned.
4. Adjudication Method for the Test Set
This information is not provided. No test set or related adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC study is mentioned in the document.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The RFX system is described as a digital imaging system that assists a human operator by digitizing, displaying, and enhancing fluoroscopic images. It is not an "algorithm only" device in the sense of making independent diagnostic decisions. Its performance is inherently tied to human use and interpretation. No standalone performance study, as typically understood for AI algorithms, is mentioned.
7. The Type of Ground Truth Used
This information is not provided. The document does not describe any specific ground truth used for evaluation. The "ground truth" for a 510(k) submission like this is often regulatory compliance and substantial equivalence to established predicate devices, rather than clinical outcomes or pathology for novel diagnostic claims.
8. The Sample Size for the Training Set
This information is not provided. The document does not describe any machine learning or AI components that would require a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not provided, as no training set is mentioned.
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(15 days)
GEMINI is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. - The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as x-ray transmission images of these areas. The PET and CT images are registered and displayed in a transmission images of these areas: "XX" and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an by trained health professionals: "The RET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.
The GEMINI hybrid PET/CT system is a combined positron emission tomography and X-ray computed tomography scanner. This system uses the ADAC ALLEGRO PET system, K003434, and the Marconi MX8000-v5.0 CT, K010817. The GEMINI integrates the two systems on a single workstation to allow straightforward planning and system operation. The PET and the MX8000 CT system gantries remain intact as major subsydent components fabricated within a common integrated housing. It can be used in any procedures, which have been clinically conducted in a separate CT system end/or a PET system. No modifications have been made to either system, which would affect system performance.
The provided document is a 510(k) summary for the GEMINI PET/CT system. It does not contain a detailed study with acceptance criteria and reported device performance metrics in the format requested.
The document focuses on:
- Device Description and Intended Use: Explaining what the GEMINI system is and what it's used for (combining PET and X-ray computed tomography for imaging).
- Comparison to Predicate Devices: Stating that the GEMINI is similar to existing GE CT-PET and ECAT CT-PET systems.
- System Performance Test (General): This section mentions that the component CT system (MX 8000) and PET system (ALLEGRO) meet certain performance standards (21 CFR 1020.30-33 for CT, NEMA-NU2 for PET) and that "clinical phantoms with clinical protocols were used to evaluate ALLEGRO image quality in terms of the noise texture and contrast of the image." It also states the GEMINI complies with voluntary safety and effectiveness standards.
- Conclusion: The device is substantially equivalent to predicate devices.
Missing Information:
The document lacks the specific details required to complete many sections of your request, such as a table of acceptance criteria with measured device performance, sample sizes for test sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
Based on the provided text, here is what can be extracted and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| CT System (MX 8000 v.5.0): Compliance with Performance Standards in 21 CFR 1020.30 - 33. | "The MX 8000 v.5.0 is manufactured in accordance with Performance Standards in 21 CFR 1020.30 -- 33." (Confirms compliance, but specific performance metrics are not detailed). |
| PET System (ALLEGRO): Performance measured according to NEMA-NU2 standard. Evaluate image quality in terms of noise texture and contrast using clinical phantoms and protocols. | "ALLEGRO system performance was measured according to the NEMA-NU2 standard." "clinical phantoms with clinical protocols were used to evaluate ALLEGRO image quality in terms of the noise texture and contrast of the image." (Confirms methods used, but specific performance metrics - e.g., spatial resolution, sensitivity, noise reduction values - are NOT provided). |
| GEMINI System (Overall): Compliance with voluntary standards for safety and effectiveness (IEC 60601-1, IEC 60601-2, IEC 60825-1, UL 2601-1, & CAN/CSA-C22.2) and demonstration of minimized hazards (electrical, mechanical, radiation). | "The GEMINI complies with voluntary standards for safety and effectiveness... and is tested to demonstrate the hazards, i.e., electrical, mechanical, and radiation have been minimized." (Confirms compliance, but specific test results are not detailed). |
| Substantial Equivalence: Similar intended use, technological comparison, and system performance to predicate devices (GE CT-PET K010641, EXACT CT-PET K002715). | "The GEMINI Imaging System is substantially equivalent to the predicate devices... based upon similar intended use, technological comparison, and system performance." (This is the ultimate conclusion, not a specific performance metric). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified. The document mentions "clinical phantoms" for the ALLEGRO PET system but does not provide a number or mention human subject data for testing the combined GEMINI system's performance metrics.
- Data Provenance: Not specified for any performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document states that the system produces images for "interpretation by trained health professionals," but it does not describe how ground truth was established for any performance evaluation.
4. Adjudication method for the test set
- This information is 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 MRMC study mentioned. The document describes a medical imaging device (PET/CT scanner) rather than an AI-enabled diagnostic algorithm. There is no mention of AI or reader improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / No standalone algorithm performance provided. This document describes a hardware imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified. The document mentions "clinical phantoms" for PET system evaluation, implying a known simulated pathology or reference standard for those tests, but the specific type of ground truth for a test set is not detailed for the integrated system.
8. The sample size for the training set
- Not applicable / Not specified. This document describes a medical imaging hardware system. If any internal algorithms were developed, their training data is not discussed.
9. How the ground truth for the training set was established
- Not applicable / Not specified. As above, this information is not relevant to or provided in the context of this 510(k) for a hardware imaging system.
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