Search Results

declipseSPECT Laparoscopy is an enhancement of the declipseSPECT system for minimal invasive surgery using a laparoscopic gamma probe. declipseSPECT Laparoscopy works in conjunction with a laparoscopic nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Laparoscopy is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT.

declipseSPECT Laparoscopy is used intraoperatively or on pathological specimens. For any intraoperative usage the laparoscopic gamma probe needs to be covered by a protective sterile cover. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicians that are trained to use the system.

The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel. declipseSPECT Laparoscopy is compatible currently to following nuclear uptake detectors:

| Probe
Manufacturer | Probe Model | Probe Handle Model | Energy range of
gamma rays |
|-----------------------|-------------|--------------------|-------------------------------|
| Crystal Photonics: | SG04 | CXS-OP-SZL-45 | 60-245 keV |

Not Found

The provided documentation describes the declipseSPECT Laparoscopy device, but it lacks the specific details required to complete a comprehensive acceptance criteria and study report. The document is a 510(k) clearance letter from the FDA, indicating substantial equivalence to a predicate device, but it does not contain the detailed performance study results or acceptance criteria themselves.

Therefore, I cannot provide the requested information from the given text. The document states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not include the detailed performance metrics or the studies used to demonstrate that equivalence beyond a general statement of intent and indications for use.

To answer your request, a much more detailed technical document, such as a summary of safety and effectiveness, clinical study report, or design validation report, would be needed.

Ask a specific question about this device

declipseSPECT Viewer works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. declipseSPECT Viewer is intended to use the said detector and generate images of the distribution of radionuclides in the human body and determine the 3D localization of these radionuclides relative to surgical instruments by means of tracking technologies and image reconstruction techniques. The declipseSPECT Viewer is also intended to be used for hybrid nuclear medicine image viewing in-situ, such as SPECT/CT and PET/CT.

declipseSPECT Viewer may also be used intraoperatively or on pathological specimens if a protective cover is used to cover the nuclear uptake detector. dedipseSPECT Viewer may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The scan and operation of the system can be performed by medical staff, including technicians, nurses, physicist and physicians that are trained to use the system.

The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

Not Found

This document is a 510(k) clearance letter from the FDA for the "declipseSPECT Viewer" device. It does not contain the detailed information required to answer the prompt regarding acceptance criteria and performance studies.

The prompt asks for specific details about the study design (sample sizes, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, training set details), which are typically found in the summary of safety and effectiveness or in the full submission, not in the clearance letter itself.

Therefore, I cannot provide the requested information based solely on the provided text.

Ask a specific question about this device

Confident Surgery Suite 300 (CSS300) works in conjunction with a nuclear uptake detector capable of measuring the amount of radionuclide taken up by a particular organ or body region. CSS300 is intended to extend the said detector and generate images of the distribution of radionuclides in the human body by means of tracking technologies and image reconstruction techniques. CSS300 extends currently all nuclear uptake detectors by Crystal Photonics. CSS300 may also be used intraoperatively or on pathological specimens if a protective sheath is used to cover the nuclear uptake detector. CSS300 may be used at the patient's bedside, or in an Emergency Room or Intensive Care Unit. The generated images can be used also for documentation and reporting. The interpretation and use of the images generated is intended to be done by trained personnel.

CSS300 is an extension for nuclear uptake detectors designed to obtain 3D images from small organs and structures labeled using radionuclides emitting gamma rays by acquiring data while moving freely with the hand the said detectors. Examples of nuclear uptake detectors compatible with CSS300 are the nuclear uptake detectors by Crystal Photonics. CSS300 includes also analysis and display equipment, an optical camera, a cart and an ergonomic arm which allows positioning the required positioning sensor and camera in a suitable position while using the device.

This document focuses on the 510(k) summary for the "Confident Surgery Suite 300 (CSS300)" system and primarily discusses its intended use and substantial equivalence to predicate devices. It does not contain information about acceptance criteria, detailed study designs, or performance metrics that would be typically found in a clinical study report or a more comprehensive technical document.

Therefore, I cannot fully complete the table and answer all questions as the requested information is not present in the provided text.

Based on the available information, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

This information is not present in the provided document. The document lists safety standards met (EN 60601-1, UL 60601-1, EN 60601-1-2:2007) and indicates CE Mark compliance, which are general regulatory requirements, not specific performance acceptance criteria for the imaging capabilities.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not present in the provided document.

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

There is no mention of an MRMC study or AI in the context of improving human reader performance. The CSS300 is described as an "extension for nuclear uptake detectors designed to obtain 3D images" and "make their use more intuitive and thus enable better patient treatment," but it doesn't describe AI-assisted interpretation. Therefore, this information is not present.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as "working in conjunction with a nuclear uptake detector" and generating images for interpretation by "trained personnel." This implies a human-in-the-loop system. There is no mention of a standalone algorithm performance study. This information is not present.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not present in the provided document.

8. The sample size for the training set

This information is not present in the provided document.

9. How the ground truth for the training set was established

This information is not present in the provided document.

Summary of what is available from the document:

• Device Name: Confident Surgery Suite 300 (CSS300)
• Intended Use: Extends nuclear uptake detectors to generate 3D images of radionuclide distribution in the human body using tracking technologies and image reconstruction. Images are for documentation and reporting, and interpretation is by trained personnel.
• Regulatory Basis: 510(k) clearance based on substantial equivalence to predicate devices (Neoprobe Model 1500, SI-Handheld Gamma Finder, VectorVision2, Nexstim Eximia).
• Technology: Combines nuclear uptake detection with an infrared tracking system and image reconstruction.
• Safety Standards: Meets EN 60601-1, UL 60601-1, EN 60601-1-2:2007, and bears the CE mark.

To provide the requested details, a different type of document, such as a validation study report, clinical trial summary, or a more detailed section of the 510(k) submission focusing on performance characterization, would be required.

Ask a specific question about this device