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510(k) Data Aggregation
(28 days)
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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(24 days)
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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(45 days)
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.
MAMMI is a high spatial resolution, small field-of-view breast PET dedicated (PEM) imaging system, specifically developed for close-range, spot, i.e. limited field, imaging. MAMMI is a ring PET scanner, equipped with lutetium-containing gamma-ray detectors (LYSO), which collects gamma rays emitted by injected positron-emitting radiopharmaceuticals, and generates images corresponding to concentration of these radiopharmaceuticals in the body. MAMMI is designed to collect gamma rays from a patient's body part with high efficiency and resolution. In order to achieve this high efficiency, the detectors are positioned around and must cover the body part under examination.
This document is a 510(k) summary for the MAMMI device and does not contain the detailed study information required to answer your request about acceptance criteria and device performance. The summary states that "no new testing was performed as no hardware changes were made from the predicate device" for performance testing (Section H), and "No new clinical images have been included" (Section J).
Therefore, specific acceptance criteria and detailed study results proving the device meets those criteria are not provided in this document. The document refers to software testing as having been "rigorously verified and validated" and that "Test results indicated that MAMMI complies with its predetermined specification," but it does not present the specifications or the results in detail.
To answer your request, one would need access to the full 510(k) submission (K161631) and potentially the submission for the predicate device (K140996), which might contain the relevant performance data and clinical study details.
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(15 days)
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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(55 days)
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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(16 days)
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(52 days)
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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