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Sentinella 102 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 may be used intraoperatively if a protective sheath is used. Sentinella 102 may be used at the patient's bedside, or in Emergency Room or Intensive Care Unit.

Device Description

Sentinella 102 is a portable gamma camera system including 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.

AI/ML Overview

This is a submission for a 510(k) premarket notification for a medical device called Sentinella 102, a portable gamma camera system. The submission aims to demonstrate substantial equivalence to predicate devices, namely the LumaGEM™ Scintillation Camera (K993813) and Anzai eZ-Scope AN Portable Gamma Camera (K022342).

The core of the submission relies on comparing technical specifications and performance characteristics of the Sentinella 102 with the predicate devices. The document tables these comparisons, highlighting similarities and providing justifications for any differences.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly define "acceptance criteria" in a typical quantitative pass/fail format for a clinical study with a specified statistical power. Instead, the "acceptance criteria" in this context are demonstrating substantial equivalence to the predicate devices across various technical specifications and functional aspects. The performance of Sentinella 102 is reported as part of a comparative table against two predicate devices.

The table below summarizes the reported performance of the Sentinella 102 and implicitly its "acceptance criteria" through comparison with predicate devices. The "Justification of Substantially Equivalence" column serves as the explanation for how Sentinella 102 meets the implicit acceptance criteria by being equivalent or improved without compromising safety and effectiveness.

Feature	Sentinella 102 Performance	Justification of Substantially Equivalence (Acceptance Criteria Met)
Indications for Use	Mobile gamma camera system for imaging radionuclide distribution in the human body by photon detection, interpreted by qualified personnel. May be used intraoperatively (with sheath) or at patient's bedside/ER/ICU.	Same as predicates. implicitly accepted by matching predicate's indications.
Target Population	Same as predicates	Same as predicates. implicitly accepted.
Anatomical Sites	Same as predicates	Same as predicates. implicitly accepted.
Where Used	Same as predicates	Same as predicates. implicitly accepted.
Personnel	Same as predicates	Same as predicates. implicitly accepted.
Energy Used/Delivered	Same as predicates	Same as predicates. implicitly accepted.
Human Factors	Mobile ergonomic arm and cart, highly adaptable. User autonomous screens with touch-screen. Plug and play. Two screens for simultaneous viewing by surgeon and physician.	Substantially equivalent, allows positioning on interest area. Simultaneous display is an improvement without compromising equivalence.
Design	Ergonomic cart, articulated arm with laser positioning (635nm, 4mW, Class IIIR), handheld gamma camera, 2 pinhole and 1 divergent collimator, 2x 19" screens (one touch), PC, mouse, keyboard, software, QC kit.	Laser positioning system helps locate points more precisely (improvement). Laser risk mitigated by low power, labeled warning, and activation only by user, thus not adding appreciable safety concerns. Quality control kit is an improvement.
Computer Specifications	PC with Intel Core Duo, 1024 MB RAM, 80 GB HDD, Windows XP.	No substantial difference noted; assumed equivalent in function.
Display LCD Specification	Screen size: 19", Resolution: 1280 x 1024.	Equivalent to or better than predicate (LumaGEM 15" screen, 800x600 resolution).
Patient Database Management	Stores patient and intervention info, uses standard SQL (PostgreSQL), local HDD with automatic backups, can be LAN-accessed (not configured by default). Based on Microsoft ADO.net.	Structure different but functioning similar to LumaGEM. Allows patient/visit registration and image display. Accessible locally or via LAN. Based on Microsoft ADO.net, equivalent to DAO. Considered equivalent.
Arm Vertical Movement	65 cm	Range greater than LumaGEM (50.8 cm), allowing precise location. Considered an improvement/equivalent.
Electrical Safety and EMC	Compliance with EN 60601-1, UL 60601-1, EN 60601-1-2.	Complies with FDA-recognized standards. Considered equivalent regarding safety.
Compatibility with Environment	Compliance with DIRECTIVE 2002/96/EC (WEEE).	Same as predicates or environmentally conscious; considered equivalent.
Sterility	Not sterile, not to be sterilized by user. Cleaning standard procedure. Can be used intraoperatively with sterile cover.	Same as predicates. implicitly accepted.
Planar Imaging / Tomography	Planar: Yes, Tomography: No	Planar imaging capability matches LumaGEM. Anzai offers tomography, but Sentinella 102 still offers planar imaging like LumaGEM, thus equivalence is claimed based on LumaGEM's capabilities.
Energy Range	50-200 keVs	Covers major radionuclides (Tc, Co, Ba, Am, Gd) commonly used in surgery. Deemed equivalent despite numerical differences from predicates (LumaGEM: 30-300 keVs, Anzai: 71-364 keVs).
Energy Resolution	15.9 %	Although numerically larger than predicates (LumaGEM: 5%, Anzai: 7%), the energy window is about 10% per NEMA, resulting in detection of same events as predicates. Considered functionally equivalent.
Crystal Technology	Continuous CsI (Na)	Has less electronic noise, better performance in spatial resolution and sensitivity compared to pixelized CZT of predicates. Considered an improvement without compromising equivalence.
Intrinsic Spatial Resolution	1.8 mm	Difference from predicates (2 mm) is not appreciable. Considered equivalent.
Spatial Resolution	Green collimator: 5.4mm @ 3cm, 7.3mm @ 5cm; Blue collimator: 8.2mm @ 3cm, 11.1mm @ 5cm; Grey divergent collimator: 6.3mm@ 3cm, 8.2mm @ 5cm.	Values are within the same range as predicates, although dependent on collimator type. Considered equivalent.
Sensitivity (cpm/uCi)	Green collimator: ~300 @ 3cm, 110 @ 5cm, 38 @ 10cm; Blue collimator: ~600 @ 3cm, 233 @ 5cm, 87 @ 10cm; Grey divergent collimator: 104 @ 5cm, 72 @ 10cm.	Values are within the same range as predicates, although dependent on collimator type and distance. Considered equivalent.
Flood Field Uniformity	5 %	Equivalent with predicates (LumaGEM: < 4%). The difference is acceptable for equivalence.
Field Of View	15 x 15 cm at 20 cm from collimator.	Equivalent with predicates (LumaGEM: 13x13 cm, Anzai: 3.2x3.2 cm). While numerically larger than Anzai, it is equivalent to LumaGEM and therefore considered substantially equivalent.
Height	160 - 215 cm	Taller than LumaGEM (139.7 cm), but allows transport in any medical center. Considered acceptable and not compromising equivalence.
Communication / Power	DICOM / AC100-240V, 50/60 Hz	Equivalent to LumaGEM (DICOM, Interfile). Acceptable.
Compatible Accessories	Gamma Probe S-Probe, Sterile covers, Radioactive Pointer (153Gd, 60 µCi).	Gamma Probe S-Probe and radioactive pointer are improvements not found in predicates. Radioactive pointer deemed safe (exempted activity, negligible patient dose, no safety concerns relative to predicates).

Study Information to Prove Acceptance Criteria:

The provided document describes a technical comparison and performance verification study, rather than a clinical trial with patient outcomes. The study aims to demonstrate that the Sentinella 102 system performs comparably to the predicate devices and adheres to relevant safety and performance standards.

Sample Size used for the test set and the data provenance:
- Test Set: The document does not specify a "test set" in terms of patient samples or images for a diagnostic study. Instead, the "test set" implicitly refers to the technical performance metrics measured on the Sentinella 102 device itself (e.g., energy resolution, spatial resolution, sensitivity). These measurements are typically performed by engineers or physicists under controlled laboratory conditions using phantoms or calibrated radioactive sources.
- Data Provenance: The data appears to be prospective technical performance measurements conducted by the manufacturer, OncoVision GEM-Imaging SA, to characterize their device. There is no information regarding country of origin of patient data or retrospective analysis, as the submission does not detail a clinical study with patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for technical performance metrics (like spatial resolution or energy range) is established by physical laws and established measurement standards (e.g., NEMA), not by expert interpretation of clinical data. For instance, the "true" spatial resolution of a gamma camera is measured using a phantom with known features, not by consensus of radiologists on patient images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods are used in clinical studies where expert consensus is needed to establish ground truth for ambiguous cases. As this is a technical performance assessment, such adjudication is not performed.
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, an MRMC comparative effectiveness study was not done. This submission is for a gamma camera, not an AI-powered diagnostic algorithm. The device's images are "intended to be interpreted by qualified personnel," implying human interpretation, but no study on human reader performance with or without AI assistance is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. The Sentinella 102 is a hardware device (gamma camera) that produces images for human interpretation. It is not an algorithm designed for standalone diagnostic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance metrics reported (e.g., spatial resolution, energy resolution, sensitivity, flood field uniformity, field of view) is based on physical phantom measurements and engineering standards (e.g., NEMA NJ 1: 2007). These are objective, quantifiable measurements of the device's technical capabilities, not clinical ground truth derived from patient diagnostics.
The sample size for the training set:
- This is not applicable. The Sentinella 102 is a gamma camera hardware system, not a machine learning or AI algorithm that requires a "training set" of data.
How the ground truth for the training set was established:
- This is not applicable for the same reason as above. There is no training set for this device.

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