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510(k) Data Aggregation
(28 days)
General Equipment for Medical Imaging, S.A.
CareMiBrain is dedicated brain PET scanner, and intended to obtain Position Emission Tomography (PET) inages of human brain to detect abnormal pattern of distribution of radioactivity after injection of a position emitting radiopharmaceutical. This device is to be used by trained healthcare professionals. This information can assist in research, diagnosis, therapeutic planning and therapeutic outcome assessment.
CareMiBrain is a small aperture Positron Emission Tomography (PET) scanner to image the distribution of injected positron emitting radiopharmaceuticals in the head of live humans in seating/reclined position. CareMiBrain is a PET (Positron Emission Tomography) dedicated to brain imaging. All elements of the system are integrated into a compact volume, containing the detection system, acquisition and control electronics and software. All elements of the system are integrated into a compact volume, containing the detection system, acquisition and control electronics and software. The scanner consists of 48 monolithic Lutetium OrthoSilicate (LYSO) crystals arranged in 3 rings of 16 modules each. Physical ring diameter is 260mm, with an effective 220 mm transaxial and 152 mm axial FOV. Crystal dimensions are 50x50x15mm (width x height x thickness). Crystals are coupled to a photosensor array of 12x12 silicon photo-multiplier (SiPM), 3x3 mm each. The detectors of the equipment are integrated in a circular housing with the appropriate dimensions so that the patient can insert the head. The software that integrates the equipment allows the acquisition, reconstruction and export of tomographic images of the brain, as well as to make a diagnosis of the state of the detectors.
Here's a breakdown of the acceptance criteria and the studies proving the CareMiBrain device meets them, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Criteria (CareMiBrain - PET scanner) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Spatial Resolution (NEMA NU 4-2008) | ||
| Transverse Resolution FWHM @5mm | 2 mm | 1.55 mm |
| Transverse Resolution FWHM @10mm | 2 mm | 1.45 mm |
| Transverse Resolution FWHM @15mm | 2 mm | 1.52 mm |
| Transverse Resolution FWHM @25mm | 2 mm | 1.59 mm |
| Axial Resolution FWHM @5mm | 2 mm | 1.45 mm |
| Axial Resolution FWHM @10mm | 2 mm | 1.40 mm |
| Axial Resolution FWHM @15mm | 2 mm | 1.58 mm |
| Axial Resolution FWHM @25mm | 2 mm | 1.41 mm |
| Radial Resolution FWHM @5mm | 2 mm | 1.51 mm |
| Radial Resolution FWHM @10mm | 2 mm | 1.58 mm |
| Radial Resolution FWHM @15mm | 2 mm | 1.64 mm |
| Radial Resolution FWHM @25mm | 2 mm | 1.52 mm |
| Extra Spatial Resolution (NEMA NU 4-2008) | ||
| Transverse Resolution FWHM @0 mm | 2 mm | 1.53 mm |
| Transverse Resolution FWHM @50 mm | 2 mm | 1.51 mm |
| Transverse Resolution FWHM @75 mm | 2 mm | 1.76 mm |
| Transverse Resolution FWHM @100mm | 2 mm | 1.66 mm |
| Axial Resolution FWHM @0 mm | 2 mm | 1.36 mm |
| Axial Resolution FWHM @50 mm | 2 mm | 1.44 mm |
| Axial Resolution FWHM @75 mm | 2 mm | 1.44 mm |
| Axial Resolution FWHM @100mm | 2 mm | 1.44 mm |
| Radial Resolution FWHM @0 mm | 2 mm | 1.57 mm |
| Radial Resolution FWHM @50 mm | 2 mm | 1.67 mm |
| Radial Resolution FWHM @75 mm | 2 mm | 1.64 mm |
| Radial Resolution FWHM @100mm | 2 mm | 1.64 mm |
| Spatial Resolution (NEMA NU 2-2012) | ||
| Transverse Resolution FWHM @10mm | 2 mm | 1.68 mm |
| Transverse Resolution FWHM @100mm | 2 mm | 1.86 mm |
| Axial Resolution FWHM @10 mm | 2 mm | 1.39 mm |
| Axial Resolution FWHM @100 mm | 2 mm | 1.40 mm |
| Radial Resolution FWHM @10 mm | 2 mm | 1.87 mm |
| Radial Resolution FWHM @100 mm | 2 mm | 1.86 mm |
| Count Rate Evaluation and Sensitivity (NEMA NU 2-2012) | ||
| Sensitivity along transverse center | 15 cps/kBq | 17.83 cps/kBq |
| Sensitivity off center | 12 cps/kBq | 13.82 cps/kBq |
| Count rate peak NECR | 30 kcps | 49 kcps |
| Count rate peak trues | 160 kcps | 193 kcps |
| Scatter fraction at peak NECR | 9.25 MBq | 7.4 MBq |
| Scatter fraction Mean | 60 % | 48 % |
| Image Quality - % contrast/background variability (NEMA NU 4-2008) | ||
| 4.5 mm | 0.65 | 0.73 |
| 6 mm | 0.65 | 0.78 |
| 9 mm | 0.65 | 1.14 |
| 12 mm | 0.65 | 1.01 |
Note: For Image Quality - % contrast/background variability, the reported values are higher than the acceptance criteria, which suggests better performance (lower variability is generally desired for image quality, but the metric here is contrast/background variability, implying a higher value reflects better contrast relative to background). The document claims these results "comply with its predetermined specification," indicating these values met the intended performance.
2. Sample size used for the test set and the data provenance
Test Set Sample Size: For the clinical effectiveness study, "Sample images from several clinical cases with different PET tracers using the CareMiBrain PET Scanner were provided." The exact number of clinical cases is not specified from this statement, but a previous mention notes that "More than 40 clinical images are provided from CareMiBrain to demonstrate the image capability". This suggests a test set of at least 40 clinical images.
Data Provenance:
- Bench Performance Data: Independently tested by the "Institute for Instrumentation of Molecular Imaging (i3m)" according to NEMA NU 2-2012 and NEMA NU 4-2008 standards. The results were published in Scientific Reports Journal (DOI 10.1038/s41598-019-51898-z). This implies the testing was conducted in a laboratory setting.
- Clinical Effectiveness Data: Tested by "independent hospitals" and the results published in the Spanish Journal of Nuclear Medicine and Molecular Imaging (DOI 10.1016/j.remn.2021.04.002). This indicates prospective data collection from real-world clinical use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not explicitly provided in the document. While clinical effectiveness was assessed and images were provided, there's no detail on how ground truth for these clinical cases was established (e.g., through a panel of qualified radiologists, comparing with other diagnostic methods, or follow-up).
4. Adjudication method for the test set
This information is not explicitly provided in the 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, or at least not described in this document. The purpose of the study was to demonstrate the device's inherent performance and clinical effectiveness for obtaining PET images, not its impact on human reader performance or AI assistance. The device is purely an imaging system, not an AI-powered diagnostic aid that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance assessment was done. The entire bench performance testing, evaluated against NEMA standards, represents the standalone performance of the CareMiBrain device. The clinical images provided also demonstrate the device's output without human interpretation as part of the core performance metrics. The device itself is the "algorithm" in this context, producing images for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Performance: Ground truth was established by adherence to recognized phantom-based testing protocols (NEMA NU 4-2008 and NEMA NU 2-2012) using phantoms with known properties.
- Clinical Effectiveness: The document states "Sample images from several clinical cases with different PET tracers...were provided." While it mentions "clinical effectiveness," the specific type of ground truth for these clinical cases (e.g., confirmed diagnosis by pathology, follow-up outcomes, expert consensus on other imaging modalities) is not explicitly detailed.
8. The sample size for the training set
The document describes the device as a PET scanner (hardware and associated software for acquisition, reconstruction, and export of images), not an AI/Machine Learning model that would typically have a separate training set. Therefore, the concept of a "training set" in the context of an AI algorithm is not applicable to this device as described. The software's development would likely involve standard software engineering verification and validation processes, not machine learning training.
9. How the ground truth for the training set was established
As the concept of a "training set" for an AI algorithm is not applicable to this device as described, this question is not relevant.
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(16 days)
GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A
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(52 days)
GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A
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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