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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 |

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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.

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