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The Digimamo D ® Full-Field Digital Mammography System is a device intended to produce planar digital x-ay images of the entire breast. The Digimamo D is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Digimamo D is intended to be used in the same clinical applications as traditional film/screen systems.

This is a mammography system available in only a digital version. The main characteristics are: Operation Panel/Console, X-ray tube information, Filter Selection, Window Material and thickness, Focal Spot Sizes, Operating principle, Radiological Characteristics, Column and Gantry, Flat Panel Detector, Workstation.

The provided text describes the Digimamo D Full-Field Digital Mammography System and its comparison to a predicate device (Adani MammoScan K172027) and a reference device (DRTECH RSM2430C K170930). The information primarily focuses on the device's technical specifications and a summary of non-clinical and clinical testing performed to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly listed in a table format with specific quantitative thresholds. Instead, the document states that the device was tested to establish "substantial equivalence" to a predicate device, meaning it is "as safe and effective." The performance is deemed acceptable if the images are of "sufficiently acceptable quality for mammographic usage."

However, we can infer some "acceptance" from the successful outcome of the comparison and the conclusion of substantial equivalence. The key is that the new device's performance aligns with the predicate device and that the images were found to be diagnostic quality by experts.

Study Details:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: "Sixty images" were evaluated. The document further clarifies "Totally, there are 12 sets of images presented in this review." Each set consists of four standard views (right CC, right MLO, left CC, left MLO), so 12 sets * 4 views/set = 48 images initially. However, it also states "If requested by the radiologist, additional image with magnification was taken." This suggests more than 48 images could have been evaluated, up to 60 total. It's not explicitly clear if all "sixty images" were unique patient cases or if "12 sets of images" corresponds to 12 patient cases, each with multiple views. The phrasing "Sixty images were evaluated" followed by "Totally, there are 12 sets of images" could be interpreted as 60 individual images selected from these 12 sets, or 60 total images including any additional magnification views for the 12 cases.
   • Data Provenance: Images were taken during the "standard screening procedure in Fundação Municipal de Saúde de Macaé, Rio de Janeiro, Brazil." This indicates the data is retrospective as it was already acquired.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: "Three Board Certified US based radiologists."
   • Qualifications of Experts: "US-based MQSA qualified radiologists." MQSA (Mammography Quality Standards Act) qualification ensures competence in mammography interpretation.

3. Adjudication method for the test set:

   • The document states, "Images were reviewed by US-based MQSA qualified radiologists. The results of clinical image evaluation determined that the clinical images reviewed by the expert radiologists were of sufficiently acceptable quality for mammographic usage."
   • There is no explicit description of an adjudication method (e.g., 2+1, 3+1 consensus). It sounds like a qualitative assessment by individual radiologists, and the collective outcome was that the images were acceptable. It doesn't describe a process for resolving disagreements or reaching a formal consensus for a specific ground truth label.

4. 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, an MRMC comparative effectiveness study was not done. The study described is a clinical image evaluation by human readers of images produced by the device to confirm diagnostic quality, not a study comparing human performance with vs. without AI assistance. The device itself is a full-field digital mammography system, not an AI-based reading aid.

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

   • Not explicitly described as a standalone algorithm study. The device is an imaging system (hardware + software for image acquisition and display). The "clinical testing" refers to human readers evaluating the image output of the system, not an algorithm's classification performance. The "digital panel software employed was already reviewed by FDA in the reference submission list," which implies its performance characteristics (e.g., image quality metrics) would have been assessed as part of its original clearance. This is an assessment of the entire system's output through human review.

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

   • The "ground truth" for the clinical image evaluation was the qualitative assessment by the three Board Certified US-based MQSA qualified radiologists that the images were of "sufficiently acceptable quality for mammographic usage." This is a form of expert opinion/consensus on image quality for diagnostic purposes. It is not described as being based on pathology or clinical outcomes.

7. The sample size for the training set:

   • The document does not mention a training set sample size as this device is a mammography imaging system (hardware and associated acquisition/processing software), not an AI algorithm requiring a training set in the conventional sense (e.g., for classification or detection). The software involved (digital panel software) was from a previously cleared device (DRTECH RSM2430C K170930), implying its development and validation were part of that prior submission.

8. How the ground truth for the training set was established:

   • As no "training set" for an AI algorithm is described for this device's new performance evaluation, the method for establishing ground truth for a training set is not applicable/not provided in this document.

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

This is a multifunctional fixed X-ray equipment consisting of Examination Table, Bucky Stand, Tube/Bucky Stand, X-ray Source Assembly (Tube/Collimator), High Voltage Generator plus Operating Panel, Conventional Image Receivers and, in specific version, Image System with Flat panel detector and Workstation for image acquisition, processing and visualization. The equipment was developed to perform radiographic examinations of patients in reclining, standing or sitting positions. Six possible tube head configurations are available: FLOOR TO CELLING TUBE STAND, FLOOR MOUNTED TUBE STAND, ROTARY U-ARM mount with integrated film/digital cassette mount, MANUAL CEILING-MOUNTED TELESCOPIC TUBE STAND, MOTORIZED CEILING-MOUNTED TELESCOPIC TUBE STAND, ROTARY STRAIGHT ARM mount with integrated film/digital cassette mount. The Apolo provides a complete x-ray system with generator, tube head, and collimator. The generator is made by us, VMI, whereas the tube head, collimator, and digital x-ray receptor panels/software are made by other manufacturers. Tube heads are typically Toshiba and collimators are typically Ralco. The Apolo D comes with digital x-ray receptor panels (see the comparison table below) while the Apolo S comes without digital x-ray receptor panels. This system employs without modification software Econsole cleared in K152172. This software has a Moderate level of concern. The reference detectors made by DRTECH can be used with anti-scatter grids.

This document is a 510(k) premarket notification for the Apolo D / Apolo S stationary x-ray system. It does not contain information about an AI/ML-based device or a study involving acceptance criteria for such a device. The device described is a traditional x-ray system, and the clearance is based on substantial equivalence to a predicate device, not on AI-driven performance metrics.

Therefore, I cannot extract the requested information (acceptance criteria, details of a study proving device meets acceptance criteria, sample sizes, expert involvement, adjudication, MRMC, standalone performance, ground truth, training set specifics) from the provided text because these elements are related to the evaluation of AI/ML devices, which is not applicable here.

The document explicitly states regarding clinical testing:
"Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance." This further confirms that no clinical performance study, particularly one measuring AI-driven diagnostic accuracy, was conducted for this submission.

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Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

Aquila 320-D Series: Small, light, easy handling. High Performance, High Power 320 mA, Leading Technology. Capacitive discharge technology, wireless image capture and transmission technology, smartphone image access. Wireless Detector and Workstation on touchscreen notebook or tablet. High frequency generator with micro-processor controls: Power 35.2 KW (The Aquila 320-S comes without the digital panels and workstation)

The provided text is a 510(k) summary for the AQUILA 320 D / AQUILA 320 S mobile x-ray system. It details the device, its intended use, and its substantial equivalence to a legally marketed predicate device. However, it does not describe an AI-powered device or a study where an AI device meets acceptance criteria.

The document explicitly states regarding clinical testing:
"Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets them based on the provided text, as this document pertains to a traditional medical imaging device (mobile x-ray system) and not an AI-powered one, and no clinical study was conducted or described.

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