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510(k) Data Aggregation
(24 days)
Sentinella 102, Sentinella 102 Horus
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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(15 days)
Sentinella 102; Sentinella 102 Horus
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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(16 days)
SENTINELLA 102
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(52 days)
MODEL SENTINELLA 102
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.
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.
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: |
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