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The SpotLight CT Computed Tomography X-ray is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac CT scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.

The system is indicated for X-ray Computed Tomography imaging of organs that fit in a 25cm field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

The SpotLight CT is a third generation rotate-rotate CT scanner, designed and built based on technologies and principles of operation of the predicate device and other legally marketed CT scanners. The SpotLight CT is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software for operator interface and image handling.

The provided document describes the Arineta Ltd. SpotLight CT device and its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance." Instead, it describes various performance specifications and how the device performed against them. I've re-framed the reported performance metrics as if they were acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set (Clinical Testing): 38 subjects
• Data Provenance: Not explicitly stated, but the study was conducted at "one site," and the readers were "US certified." This suggests the data was collected in the US.
• Retrospective or Prospective: The clinical testing describes "data were collected," which could mean either. However, the phrase "The study protocol was designed to test the scanner across different patient populations, clinical scenarios and scan techniques" implies a prospective study design for collecting new data specifically for this evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Four (4)
• Qualifications: "US certified readers who are qualified radiologists or cardiologists." Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

The document states, "The images were evaluated and rated by four US certified readers." It does not specify an adjudication method like 2+1 or 3+1 for resolving discrepancies. It implies independent evaluation by each reader.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No, a multi-reader multi-case (MRMC) comparative effectiveness study (comparing human readers with and without AI assistance) was not done. The clinical testing focused on evaluating the device's diagnostic image quality for standalone performance.
• Effect size of human readers with AI vs without AI assistance: Not applicable, as no such study was conducted or reported.

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Yes, the described "Non-clinical Performance Testing" and "Clinical Testing" primarily focus on the standalone performance of the SpotLight CT system. The image quality, temporal resolution, dose performance, and diagnostic quality evaluations are all measures of the device's inherent capabilities without human intervention during the image generation or initial analysis phase. The "clinical diagnostic value and image quality" evaluated by the readers are also assessing the output of the device itself.

7. Type of Ground Truth Used

• Non-clinical/Phantom Testing: The ground truth for these tests would be objective physical measurements and known parameters of the phantoms used to evaluate image quality metrics (e.g., spatial resolution targets, known low contrast objects, CT number uniformity).
• Animal Testing: The "diagnostic quality" evaluation in animal models likely used established veterinary diagnostic criteria and potentially post-mortem examination or other correlative imaging as ground truth.
• Clinical Testing: The "clinical diagnostic value and image quality" in human subjects were evaluated by "qualified radiologists or cardiologists" against established clinical diagnostic criteria. While not explicitly stated as "expert consensus ground truth," the assessment by multiple, qualified experts serves as the de-facto ground truth for evaluating diagnostic utility. It does not mention pathology or long-term outcomes data for ground truth.

8. Sample Size for the Training Set

The document does not provide any information about a training set since this is a hardware device (CT scanner) with associated imaging software, not typically an AI/ML algorithm that requires a distinct "training set" in the common sense. The image reconstruction algorithm is described as "Stereo CT reconstruction algorithm based on common algorithms used in single source scanners that are modified to combine the data acquired from the two sources." This implies an engineered algorithm, not one trained on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of an AI/ML algorithm requiring a training set in the document. The device uses an engineered image reconstruction algorithm.

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The "Philips Plus" is a Whole Body Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
The "Philips Plus" is a Computed Tomography X-Ray System intended to produce images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

The "Philips Plus" is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability of up to 40 slices simultaneously. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.

The provided text is a 510(k) summary for the "Philips Plus" CT Scanner. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study outlining specific acceptance criteria and performance metrics for the device itself against a defined ground truth.

Therefore, the information requested as per your prompt (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types for test/training, and training set size/ground truth establishment) is not available in the provided text.

The document states:

• "The safety of the device is assured by adherence to GMP practices and to International Standards."
• "Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures were adhered to, and test results demonstrate that the option specifications and functional requirements were met."
• "Electrical and Mechanical safety is assured by adherence to IEC 60601-1 standards."
• "Radiation safety is assured by compliance with 21 CFR, Subchapter J performance standards."

These statements indicate adherence to general regulatory and industry standards for safety and manufacturing, but they do not detail specific clinical performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or the results of a study designed to demonstrate those.

In summary, the provided text does not contain the information required to answer your specific questions about acceptance criteria and a performance study. It's a regulatory submission for substantial equivalence, not a clinical validation report.

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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

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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