Search Results

The AURA DR 43C-AG detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.

Device Description

AURA DR 43C-AG is a digital X-ray flat panel detector which has 43cm x 43cm imaging area and communicates with a wired communication feature, Giga-bit Ethernet communication method through connecting a tether cable. The device intercepts x-ray photons and the scintillator (Gadox:Tb) and emits visible spectrum photons that illuminate an array of photo (a-SI) detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and sharing of image information on network.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (AURA DR 43C-AG Digital Flat Panel X-ray Detector) and focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device meets a specific set of acceptance criteria in the way one might for an AI/ML clinical study.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be directly extracted from this document, as the submission takes a different approach to demonstrating safety and effectiveness.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't define explicit acceptance criteria in the typical "pass/fail" numerical sense for clinical performance. Instead, it demonstrates performance by showing the proposed device is equivalent or superior to a predicate device based on specific technical characteristics and non-clinical tests.

Acceptance Criteria Category	Reported Device Performance (AURA DR 43C-AG)	Comparison/Remark to Predicate (LLX240AB01)
Intended Use	Digital imaging solution for general radiographic system for human anatomy, intended to replace film/screen based systems. Not for mammography.	Same
Technological Characteristics	Amorphous Silicon, TFT detector, Gadox:Tb scintillator, 17x17 inch imaging area, 3072x3072 pixel matrix, 140 µm pixel pitch, 3.5 lp/mm resolution, 16 bit A/D conversion, 16384 (14bit) grayscale, RAW data output convertible to DICOM 3.0.	Similar/Same (e.g., pixel pitch and A/D conversion are similar, others are same).
Operating Principle	Intercepts x-ray photons, scintillator emits visible photons, photo detector creates electrical signals converted to digital values.	Same
Design Features	Digital X-ray flat panel detector, 43cm x 43cm imaging area, wired communication (Giga-bit Ethernet).	Similar
Performance (Non-clinical)	DQE and MTF NPS values are equivalent or performed better than the predicate. Offers better resolution performance at 0-3.5 lp/mm. More efficient in utilizing input image signal at same patient exposure.	Equivalent or Better
Electrical Safety & EMC	Complies with IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) and IEC 60601-1-2: 2007.	Complies with same standards
Software Validation	Performed software validation and verification testing.	Not explicitly compared but assumed compliance with standards
Risk Management	Analyzed with FMEA, specific risk controls implemented, determined all risks satisfactorily mitigated and accepted.	Not explicitly compared but assumed compliance with standards

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not mention a "test set" in the context of clinical images or patient data. The non-clinical performance testing involved measurements of physical values (DQE, MTF NPS) usually conducted on a device itself or phantoms, not a patient sample. No clinical studies were conducted for this 510(k) submission.
Data Provenance: Not applicable as no clinical data was used for testing.

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 as no clinical studies were performed, and thus no expert ground truth was established for a test set of images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical studies were performed.

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 MRMC study was done, as this is an X-ray detector, not an AI-powered diagnostic tool. The submission focuses on device characteristics and substantial equivalence to a predicate, not on human reader performance with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is an imaging hardware device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable as no clinical images or patient data requiring ground truth were used in the testing described in this 510(k) summary. The "ground truth" for the non-clinical performance relied on standardized measurement methods for DQE, MTF, and NPS.

8. The sample size for the training set

Not applicable, as this is an X-ray detector and not an AI/ML device that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Ask a Question

Ask a specific question about this device

Page 1 of 1