(259 days)
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.
§ 892.1320 Nuclear uptake probe.
(a)
Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.