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Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel.

Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) may be used intraoperatively if a protective sheath is used.

Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.

Sentinella 102 is a currently marketed portable gamma camera system which includes a small gamma camera designed to obtain images from small organs and structures labeled using radionuclides emitting gamma-rays.

The Sentinella system also includes analysis and display equipment, a cart and ergonomic arm, which facilitates the equipment portability and positioning, and accessories.

Due to the difficulty which may involve indentifying the physical location in the body of the patient of the structures observed in the gammagraphy, the model Sentinella 102 Horus incorporates an optical camera that registers the same area that it is being observed by the gamma camera. Both images are coregistered and shown in real time. During this process, the gammagraphy is not reprocessed or modified in any way, so remains unaltered at the end of the process.

This FDA 510(k) summary (K162052) primarily addresses a modification to an existing device, the Sentinella 102 (models Sentinella 102 and Sentinella 102 Horus), specifically the introduction of a new collimator model. The document explicitly states that no new clinical testing has been carried out because there are no new indications for use. Therefore, a comprehensive study proving acceptance criteria for a new device or algorithm is not present in this document.

Instead, the document asserts substantial equivalence based on the fact that the new collimator does not change the indications for use, biocompatibility, electrical safety, electromagnetic compatibility, software, or overall performance specifications compared to the previously cleared predicate device (K143156).

Here's an attempt to answer the questions based on the provided text, acknowledging that a full "study" as requested isn't detailed for this specific submission:

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

The document does not provide a table with specific acceptance criteria and reported device performance for this submission. It states that the device has the same performance specifications as the previous models already certified by the FDA (predicates). It mentions that "no new NEMA performance tests were necessary for the present submission" and that "The previous NEMA test report was carried out using the NEMA NU-1:2007."

To create such a table, one would need to refer to the K143156 submission for the specific performance criteria and results based on NEMA NU-1:2007. Without that previous document, the exact metrics are unavailable here.

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

Not applicable. No new clinical or performance test set was used for this 510(k) submission, as it relies on the performance of the predicate device (K143156).

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. No new test set requiring expert ground truth establishment was used for this submission. The interpretation of images is generally intended to be by "qualified personnel" as stated in the Indications for Use, but this refers to clinical use, not a specific study methodology outlined here.

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

Not applicable. No new test set requiring adjudication was used for this submission.

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

Not applicable. This device is a gamma camera system, not an AI-powered diagnostic or assistive tool. No MRMC study or AI-related effectiveness study was performed or mentioned in this document.

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

Not applicable. This device is a gamma camera system and not an algorithm. Therefore, "standalone" algorithm performance is not relevant to this submission.

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

Not applicable for this specific 510(k) due to the nature of the submission (modification of an existing device without new clinical testing). For the original predicate device (K143156), performance testing would likely have involved phantom studies and possibly clinical validation leading to NEMA NU-1:2007 compliance, which uses established physical and technical metrics rather than clinical "ground truth" like pathology for image interpretation.

8. The sample size for the training set

Not applicable. As a physical medical imaging device, it does not involve a "training set" in the context of machine learning or AI.

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

Not applicable. As a physical medical imaging device, it does not involve a "training set" in the context of machine learning or AI.

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Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. The images are intended to be interpreted by qualified personnel.

Sentinella 102 (Models Sentinella 102 Horus) may be used intraoperatively, if a protective sterile sheath is used.

Sentinella 102 (Models Sentinella 102 Horus) may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.

Sentinella 102 (Models Sentinella 102 Horus) is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection.

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Sentinella 102 and 102 Horus" gamma camera system. This document grants market clearance based on substantial equivalence to a predicate device.

Crucially, this document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of clinical performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI.

The letter confirms the device's regulatory classification, its intended use (imaging the distribution of radionuclides in the human body), and outlines the general controls and regulations it must comply with. It does not include the results of performance studies that would typically define acceptance criteria for diagnostic efficacy.

Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them from this document. The document primarily addresses regulatory clearance, not clinical performance metrics or studies using AI.

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MAMMI (Models: FP-0202 and FP-0203) is intended to obtain Positron Emission Tomography (PET) images of breast to detect abnormal metabolic activities, when the patient was injected with FDA approved PET agent. MAMMI should not be used for breast cancer screening.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device named MAMMI, an Emission Computed Tomography system. While it indicates the device's intended use and substantial equivalence, it does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

Therefore, I cannot provide the requested information based on the given input.

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