(71 days)
The ergo Imaging System is intended to image the distribution of radionuclides in the body by means of a photon radiation detector. In so doing, the system produces images depicting the anatomical distribution of radioisotopes within the human body for interpretation by authorized medical personnel. The ergo Imaging System is used by trained medical personnel to perform nuclear medicine studies.
It is indicated for lymphatic scintigraphy and parathyroid scintigraphy, It can be used intraoperatively when protected by sterile drapes. It is also indicated to aid in the evaluation of lesions in the breast and other small body parts. When used for breast imaging, it is indicated to serve as an adjunct to mammography or other primary breast imaging modalities.
The ergo Imaging System incorporates Digirad's Solid State RIM detector design with 3mm pixels for general purpose planar imaging, cleared under K100838. Sterile drapes are specified for intraoperative use. The ergo Imaging System, in conjunction with the optional Breast Imaging Accessory (BIA), enables the user to perform scintimammography and extremity imaging with stabilization.
The provided text is a 510(k) summary for the Digirad ergo Imaging System, which is a gamma camera. The document primarily focuses on demonstrating substantial equivalence to a predicate device and expanding indications for use.
Based on the provided text, the device itself is a gamma camera, not an AI/ML-based device. The "Testing" section (H) explicitly states: "Verification and Validation tests were conducted to demonstrate the ergo Imaging System functions per specification. These tests include Electromagnetic Compatibility, Electrical Safety, and gamma camera performance testing including NEMA standard NU 1-2007 with phantoms."
This indicates that the acceptance criteria and performance evaluation are related to the physical performance of the gamma camera, not to algorithmic performance on image interpretation. Therefore, the requested information elements related to AI/ML device testing (such as ground truth establishment with experts, MRMC studies, standalone algorithm performance, training/test set sample sizes for algorithms, etc.) are not applicable to this submission as described.
The acceptance criteria are likely standard NEMA performance metrics for gamma cameras. While the document broadly states "Testing results demonstrate that the ergo Imaging System continues to meet the specifications," it does not list specific numerical acceptance criteria or performance metrics in a table format within this 510(k) summary.
Therefore, many of the requested items cannot be extracted from this specific document.
Here's an attempt to answer the quantifiable parts based on the provided text, while noting the limitations:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly listed as numerical targets in the summary. Implied to be compliance with NEMA NU 1-2007 standards for gamma camera performance.
- Reported Device Performance: Not explicitly listed as numerical results in the summary. The summary states: "Testing results demonstrate that the ergo Imaging System continues to meet the specifications and is substantially equivalent to the predicate devices, based on comparisons of intended use and technology, and overall system performance."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of an AI/ML test set. The testing described involves physical phantoms and engineering tests, not patient data sets.
- Data Provenance: Not applicable.
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)
- Not applicable. Ground truth was established by physical phantoms and engineering measurements according to NEMA standards for gamma camera performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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. This is not an AI/ML device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Physical phantoms and engineering specifications/measurements (NEMA standard NU 1-2007).
8. The sample size for the training set
- Not applicable. This is not an AI/ML device; there is no training set mentioned.
9. How the ground truth for the training set was established
- Not applicable.
In summary, the provided document describes a traditional medical device (gamma camera) and its regulatory submission, which relies on engineering performance standards (like NEMA) rather than clinical studies involving AI/ML performance on patient data sets with human experts.
§ 892.1100 Scintillation (gamma) camera.
(a)
Identification. A scintillation (gamma) camera is a device intended to image the distribution of radionuclides in the body by means of a photon radiation detector. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class I (general controls).