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510(k) Data Aggregation
(48 days)
Adani
The UNIEXPERT 2 PLUS is a stationary general-purpose radiographic imaging system indicated for use in acquiring diagnostic X-Ray images of osseous structures and soft tissues of the human body to aid physicians with patient diagnosis. The system has analogue, computed radiography (CR) as well as digital radiography (DR) imaging capabilities. The UNIEXPERT 2 PLUS is not indicated for use in mammography.
The UNIEXPERT 2 PLUS is a diagnostic X-Ray system intended for radiographic imaging of osseous structures and soft tissues of the human body. The system may be used for analogue film imaging as well as digital image acquisition.
The UNIEXPERT 2 PLUS is comprised of an X-Ray generator with user interface, X-Ray tube, beam limiting device, vertical column tube stand, radiographic table, vertical wall stand, digital X-Ray image detector.
The provided text describes a 510(k) premarket notification for the Adani UNIEXPERT 2 PLUS, a stationary general-purpose radiographic imaging system. The submission aims to demonstrate substantial equivalence to a predicate device, the Q-Rad Radiographic System (K011486).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria alongside specific device performance metrics for the UNIEXPERT 2 PLUS. Instead, it states that:
| Acceptance Criteria Category | Description of Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional & Mechanical | All mechanical and electrical functions as intended. | "Results confirmed all performance criteria were met satisfactorily and fell within predetermined acceptance criteria." |
| Imaging Performance | Appropriate image quality and capabilities for diagnostic X-Ray images of osseous structures and soft tissues. | "Sample clinical images covering a range of anatomical areas were provided to demonstrate the overall imaging capabilities of the device." "Results confirmed all performance criteria were met satisfactorily and fell within predetermined acceptance criteria." |
| Safety | Compliance with relevant safety standards (IEC 60601-1-2:2014, IEC 60601-1:2012, IEC 60601-1-3:2013, IEC 60601-1-6:2013, IEC 6234:2006, IEC 60601-2-54:2015). | "System performance testing including functional testing of all mechanical and electrical functions, imaging performance, safety and EMC testing of the UNIEXPERT 2 PLUS system was conducted in accordance with [listed IEC standards]." "The output of the verification and validation process confirmed functionality and safety to be within acceptable limits." |
| EMC Testing | Compliance with Electromagnetic Compatibility standards. | "System performance testing including functional testing of all mechanical and electrical functions, imaging performance, safety and EMC testing of the UNIEXPERT 2 PLUS system was conducted in accordance with IEC 60601-1-2:2014." |
| Software Functionality | StudyWorks Software Complex enables operation, controls components, manages image acquisition, and communicates via DICOM effectively. | "Software/Firmware verification and validation, as well as acceptance testing were conducted to verify that all features of the StudyWorks Software Complex functioned as intended and that results fell within pre-determined acceptance criteria." |
| Risk Analysis | Identification of hazards, mitigation of risks, and evaluation of acceptance criteria for residual risks. | "Risk analysis was performed on the entire system." "Risk analysis was performed to identify potential hazards, mitigate risks and evaluate acceptance criteria for residual risks." "The level of concern for this software has been determined to be 'moderate'." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Sample clinical images covering a range of anatomical areas were provided to demonstrate the overall imaging capabilities of the device." However, it does not specify the sample size (number of images or patients) used for this clinical image evaluation.
- Data Provenance: The document does not explicitly state the country of origin for the clinical images used for testing. It also does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document mentions that "Sample clinical images covering a range of anatomical areas were provided to demonstrate the overall imaging capabilities of the device." However, it does not specify the number of experts used, nor their qualifications, for establishing ground truth for these clinical images.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method used for establishing ground truth for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This submission is for an imaging system, not an AI-powered diagnostic aid. The purpose is to demonstrate substantial equivalence to a predicate X-ray system, not to prove clinical effectiveness or improvement over human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
N/A. This device is a radiographic imaging system, which is intended for human operation and interpretation. It is not an AI algorithm that would operate in a standalone manner without human involvement. The "software" (StudyWorks Software Complex) mentioned performs operational control and image management, not autonomous diagnostic analysis.
7. The Type of Ground Truth Used
Based on the context of an imaging system intended for acquiring diagnostic X-ray images, the "ground truth" for evaluating image quality and diagnostic capability would implicitly be based on expert interpretation of the acquired images to confirm they allow for accurate diagnosis as intended (e.g., clear visualization of osseous structures and soft tissues). However, the document does not explicitly detail how this "ground truth" was established or what specific modalities (e.g., pathology, outcomes) were used to confirm it for the provided clinical images.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is expected as the UNIEXPERT 2 PLUS is a general X-ray imaging system, not an AI-powered diagnostic algorithm that typically undergoes machine learning training. Its performance is evaluated based on its ability to produce diagnostic quality images, not on its ability to learn from a dataset to perform a specific task.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, the document does not describe how ground truth for a training set was established.
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(107 days)
ADANI
The MammoScan® Full-Field Digital Mammography System is a device intended to produce planar digital x-ray images of the entire breast. The MammoScan is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MammoScan is intended to be used in the same clinical applications as traditional film/screen systems.
The Adani MammoScan is a full-field type digital mammography system comprised of an image acquisition system, a gantry and an acquisition station, equipped with PC computer, keyboard, mouse, monitor and a protective shield. The image acquisition system includes a built-in digital detector of CCD-TDI technology, x-ray tube (with tungsten target and aluminum filtration), high voltage generator, compression mechanism, and slit collimator. The slit-collimator shapes the beam and limits the x-ray beam to the active width of the detector, which prevents image degradation caused by scattered radiation. During image acquisition, the internal swing arm is motor driven to pivot at the x-ray tube with the slit collimator, causing the detector (at the other end of the swing arm and on the far side of the breast support) to swing in an arc under the breast support from one edge of the breast support to the other. The x-ray, which is shaped into a flat fan-shaped beam by the slit collimator, passes through the compressed breast tissue as it sweeps across the breast support and falls on the image detector underneath. The acquisition workstation is the user interface for preparing and initiating image acquisition, image pre- and post-processing, and image transfer to the desired destination (e.g. PACS) for interpretation and archiving. The MammoScan® Full-Field Digital Mammography System consists of a high-voltage generator, gantry, an acquisition work station with a technologist shield and accessories. The patient is imaged at the gantry contains the diagnostic source (x-ray tube, filter, and collimator), built-in solid state image detector, breast support, and compression assembly. The gantry can be raised, lowered, and rotated, under motorized control, to accommodate patients of all statures, standing and/or sitting, to produce images in all standard views.
The provided document describes the Adani MammoScan, a Full-Field Digital Mammography System, and its submission for FDA 510(k) clearance. The device's acceptance criteria are established through a comparison to a legally marketed predicate device, the Fischer SenoScan Full-Field Digital Mammography System (P010017), and adherence to various medical device safety and performance standards.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for the Adani MammoScan are primarily based on demonstrating substantial equivalence to the predicate device, Fischer SenoScan, and meeting established performance standards for digital mammography systems. The study concludes that the performance of the Adani MammoScan is "as well as or better than" the predicate device and that its images are of "sufficiently acceptable quality for clinical mammographic usage."
| Aspect | Acceptance Criteria (Based on Predicate & Standards) | Reported Device Performance (Adani MammoScan) |
|---|---|---|
| Indications for Use | The device should be indicated for producing radiographic images of the human breast for diagnostic and screening mammography, used in the same clinical applications as traditional film-based mammographic systems. (Matching predicate) | "Produce planar digital x-ray images of the entire breast. Indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. Intended to be used in the same clinical applications as traditional film/screen systems." (Matches predicate) |
| Safety & Effectiveness | Should employ similar technology, materials, and comparable safety and effectiveness features to the predicate device, present no new safety or efficacy issues, and conform to relevant medical device safety standards. | "Employs the same fundamental technological characteristics as its predicate device." "X-ray technology is substantially equivalent to the Fischer SenoScan." "Introduces no new safety or efficacy issues." Conforms to standards: EN 60601-1, EN 60601-1-2, EN 60601-1-3, EN 60601-1-6, IEC 60601-2-45, EN ISO 15223-1, EN ISO 14971, EN 62220-1-2, EN 62304, EN 62366, EN 1041, EN ISO 14155. |
| Detector Information | Should have comparable detector type (Cesium iodide with TDI CCDs), pixel dimensions (27 µm native, 54 µm normal), fill factor (100%), X-Ray interaction material (CsI:Tl), A/D conversion bit depth (12 bits), decay rate of phosphor afterglow (less than 3 µs), image read-out mechanism (CCD TDI), and cooling method (Air/Fan) to the predicate. Some variations in detector area and matrix size are acceptable if overall performance is maintained. | Type: Cesium iodide with 2 TDI CCD's (Predicate had 4 TDI CCD's) |
| Detector Area: 22x0.7 cm (Predicate was 21x1 cm) | ||
| Maximum field size: 22x30 cm (Matches predicate) | ||
| Pixel dimensions: Native pixel size 27 µm, 54 µm in normal operation mode (Matches predicate) | ||
| Fill factor: 100 % (Matches predicate) | ||
| Matrix size: 4096x5560 pixels (Predicate had 4096x5625 pixels) | ||
| X-Ray interaction material: CsI:Tl (Matches predicate) | ||
| A/D conversion bit depth: 16 bits (Predicate had 12 bits) | ||
| Scanning rate: 4.6 Cm/sec (Predicate was "-") | ||
| Decay rate of the phosphor afterglow: less than 3 µs (Matches predicate) | ||
| Image read-out mechanism: CCD TDI (Matches predicate) | ||
| Method of detector cooling: Air/Fan (Matches predicate) | ||
| Power source: 220 VAC (Matches predicate) | ||
| X-Ray Parameters | Should have comparable X-Ray tube model, focal spot size (0.3 mm), inherent filtration (0.76 mm Be), target material (Rhenium-tungsten facing on molybdenum), heat capacity (600 KHU), additional equivalent filtration (0.5 mm Al normal, 2.0 mm Al calibration), collimator operation (fixed front/sides, motorized rear), and projected X-Ray beam (around 1x22cm) to the predicate. | X-Ray tube model name: Varian RAD70 or IAE XM 1016T (Predicate Varian RAD73) |
| Focal Spot Size: 0.3 mm (Matches predicate) | ||
| Inherent filtration: 0.76 mm Be or 0.5 mm Be (Predicate 0.76 mm Be) | ||
| Target material: Rhenium-tungsten (Predicate Rhenium-tungsten facing on molybdenum) | ||
| Heat capacity: 600 kHU or 300 kHU (Predicate 600 KHU) | ||
| Additional Equivalent Filtration: 0.5 mm Al in normal operation, 2.0 mm Al for calibration (Matches predicate) | ||
| Collimator operation: Fixed at front and sides, motorized rear blade (Matches predicate) | ||
| Projected X-Ray beam: 0.7x22 cm (Predicate 1x22cm) | ||
| Generator Information | Should have comparable generator type (High frequency), maximum power (12 kW), output voltage range (20-45 kV), output current range (80-200 mA), and backup timer (Yes) to the predicate. | Type: High frequency, Model name: Sedecal SHF-1030-M (Predicate High frequency) |
| Maximum power: 10 kW (Predicate 12 kW) | ||
| Output voltage range: 20-50 kV with 0.1 kV step, maximum ripple 1% (Predicate 20-45 kV with 1 kV step, maximum ripple 3%) | ||
| Output current range: 5-250 mA (Predicate 80-200 mA) | ||
| Output mAs range: 0.1 to 1200 mAs (Predicate "-") | ||
| Operation of AEC: AEC is implemented using pre-scan (not on generator level) (Predicate "-") | ||
| Backup timer: Yes (Matches predicate) | ||
| Image Quality | Images should be of sufficiently acceptable quality for clinical mammographic usage, comparable to the predicate device in aspects like Sensitometric response, Spatial resolution, Noise analysis, Signal-to-noise - DQE, Dynamic range, Automatic exposure control performance, Phantom testing, Patient radiation dose, and Image erasure/fading/repeated exposure. | "Image attribute evaluation... concluded that the images were of sufficiently acceptable quality for clinical mammographic usage." "This comparison showed that the Adani MammoScan device performed as well as or better than the predicate devices in all relevant areas." |
| Biocompatibility | Patient contact materials should meet ISO 10993 for cytotoxicity, irritation, and sensitization. | "Biocompatibility testing according to ISO 10993 was performed for the patient contact material, the compression plate: cytotoxicity, irritation, sensitization." (Meets standard) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions an "Image attribute evaluation" and that "Performance data from non-clinical testing... was compared with data from the PMA Summary of Safety and effectiveness of the predicate device." However, the specific sample size for images used in the clinical image attribute evaluation, data provenance (country of origin), and whether it was retrospective or prospective are not explicitly stated in the provided text.
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)
The document mentions an "Image attribute evaluation," but it does not specify the number of experts who participated in this evaluation or their specific qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for the image attribute evaluation.
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
The document describes a comparison of the Adani MammoScan to a predicate device, the Fischer SenoScan. It states: "Performance data from non-clinical testing of the Adani MammoScan ... was compared with data from the PMA Summary of Safety and effectiveness of the predicate device. This comparison showed that the Adani MammoScan device performed as well as or better than the predicate devices in all relevant areas."
However, this is not an MRMC comparative effectiveness study involving human readers with and without AI assistance. The Adani MammoScan is a Full-Field Digital Mammography system itself, not an AI software intended to assist human readers. Therefore, an effect size of human readers improving with AI vs without AI assistance is not applicable in this context. The study aims to show the device's inherent equivalence to a predicate system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance assessment was done for the device itself. The non-clinical (bench) testing evaluated various technical parameters of the Adani MammoScan, such as:
- Sensitometric response
- Spatial resolution
- Noise analysis
- Signal-to-noise - DQE
- Dynamic range
- Automatic exposure control performance
- Phantom testing
- Patient radiation dose
- Image erasure, fading and repeated exposure
This testing represents the "algorithm only" or device-only performance without a human in the loop for interpretation evaluation. The "Image attribute evaluation" also assessed the inherent quality of the images produced by the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Image attribute evaluation," the ground truth was expert assessment or consensus on the "sufficiently acceptable quality for clinical mammographic usage." The non-clinical (bench) testing used physical measurements and phantom images as ground truth against established technical performance standards and predicate device data. There is no mention of pathology or outcomes data being used for this specific 510(k) submission.
8. The sample size for the training set
This document describes a 510(k) submission for a physical medical imaging device (a full-field digital mammography system), not an AI algorithm that requires a training set. Therefore, the concept of a training set sample size is not applicable in this submission. The device's technical specifications and performance were evaluated, not a learning algorithm.
9. How the ground truth for the training set was established
As there is no training set for this device (as explained in point 8), the concept of establishing ground truth for a training set is not applicable.
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