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The PrestoDR Portable ™, is intended for use in general radiographic examinations, wherever conventional screen-film systems may be used, excluding fluoroscopy, angiography and mammography. PrestoDR Portable ™ allows imaging of the skull, chest, shoulders, spine, abdomen, and extremities.

The PrestoDR Portable is a Digital Radiography system, featuring an integrated portable flat panel digital detector (FPD) K090625 WIRELESS PORTABLE DETECTOR FD-W17, Philips Medical Systems North America CO (this is the 510(k) for the wireless portable flat panel detector) and CMT's proprietary technology, which incorporates state of the art object-oriented software and connectivity. The legally marketed SMARTRAD K003438 has been modified: To integrate the portable flat panel digital detector (FPD) K090625, improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.

The provided text is a 510(k) Summary and related FDA correspondence for the PrestoDR Portable, a Digital Radiography system. It focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study proving performance against specific acceptance criteria for AI or diagnostic accuracy.

The document indicates that the PrestoDR Portable is primarily a hardware and software system for general radiography, replacing conventional screen-film systems. The "Reason for 510(k) Submission" states it's a "Special 510(k) Submission" due to integration of a portable flat panel digital detector and redesign of "aging technologies and components (hardware and software)." It explicitly says, "The device major functions and principle of operation were not changed."

Therefore, the submission does not contain the detailed study results, acceptance criteria for device performance (especially in a diagnostic context), or specific data regarding AI-driven diagnostic improvements as requested in the prompt. The text focuses on regulatory compliance and substantial equivalence to a predicate device, as opposed to a clinical performance study with specific diagnostic accuracy metrics.

Here's a breakdown of why most of the requested information cannot be found in the provided text:

1. Table of acceptance criteria and the reported device performance

• Not found. The document states, "Tests data demonstrate that the PrestoDR Portable meets the required specifications." However, it does not specify what those specifications or acceptance criteria are, nor does it provide a table of reported device performance against them. The focus is on safety and effectiveness through substantial equivalence and compliance with 21CFR 820.30 regulations for design, verification, and validation, rather than specific clinical performance metrics.

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

• Not found. No information is provided about any specific test set, its sample size, or data provenance. The submission describes a device modification and asserts substantial equivalence, which typically relies on demonstrating that the modified device performs similarly to the predicate, rather than new clinical trials measuring diagnostic accuracy.

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 found. Since no specific test set or clinical performance study is described, there is no mention of experts establishing ground truth.

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

• Not found. No adjudication method is described because no specific test set or study requiring such a method is presented.

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 found. The document does not describe an MRMC study or any AI assistance. The device is a digital radiography system; while it uses "state of the art object-oriented software," this doesn't imply an AI-driven diagnostic aid that would require an MRMC study to show human reader improvement with AI.

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

• Not found. There is no mention of a standalone algorithm performance study.

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

• Not found. No ground truth type is specified, as no clinical performance study involving diagnostic accuracy is detailed.

8. The sample size for the training set

• Not found. There is no mention of a training set, as the document doesn't describe the development or validation of a diagnostic algorithm based on machine learning.

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

• Not found. Consequently, no information is provided on how ground truth for a training set was established.

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This digital radiographic system is 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, chest, abdomen, extremittes, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Excludes fluoroscopy, angiography, and mammography.

This digital diagnostic x-ray system consists of a tubehead/collimator assembly mounted on a ceiling suspension OR a U-Arm, along with a generator, generator control, and an elevating x-ray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. Models: Model DR3000 (U-arm single detector) and Model DR4000 (dual detector-ceiling suspension and table and upright bucky) and DR1000 single detector (standing bucky and ceiling suspension. The digital panel is the Pixium 3543pR (K090625) and the digital subsystem is the SmartRad, CMT Medical Technologies, K003438.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Viztek WL Series Digital Diagnostic Digital X-Ray Systems (K091752):

It is important to note that the provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data for new acceptance criteria. Therefore, much of the requested information regarding detailed study design, sample sizes, expert qualifications, and specific performance metrics tested against pre-defined acceptance criteria is not explicitly present in this type of document.

The "acceptance criteria" in this context are primarily tied to demonstrating the Viztek WL Series is as "safe and effective" and "substantially equivalent" to its predicate devices (K082604, K090625, and K003438). This usually involves showing that performance characteristics (like pixel size, software, safety standards) are comparable, and there are no new risks or concerns.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) summary for substantial equivalence, the "acceptance criteria" are implied by the characteristics of the predicate device. The "reported device performance" is essentially that it meets or is comparable to these characteristics.

Summary of "Acceptance": The device's performance is deemed "as safe and effective" and "substantially equivalent" to the predicate devices due to having "few technological differences" and "no new indications for use." The primary "acceptance" relies on meeting the same regulatory standards and having comparable technical specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document states, "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices," and "After analyzing bench and external laboratory testing to applicable standards..."

• Sample Size for Test Set: Not specified. The document does not detail specific sample sizes for any testing (e.g., number of images, number of patients).
• Data Provenance: The testing is referred to as "bench and external laboratory testing." The country of origin for this data is not specified, nor is whether it was retrospective or prospective. It's typical for bench testing to not involve patient data in the same way clinical trials do.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable/Not specified. This type of 510(k) summary for an X-ray system, especially one establishing substantial equivalence based on technical specifications and safety standards, does not typically involve expert review for "ground truth" derived from patient images in the way AI/CAD devices do. The "ground truth" here is compliance with technical specifications and safety standards.

4. Adjudication Method for the Test Set

Not applicable/Not specified. As no expert review for "ground truth" is mentioned, no adjudication method would be detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. This document is for a digital X-ray system, not an AI or CAD system designed to aid human readers. Therefore, there's no discussion of human reader improvement with or without AI assistance.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

Not applicable/Not specified. This is a digital X-ray system, not an AI algorithm. Its performance is measured by its ability to acquire diagnostic images according to established standards and technical specifications, not as a standalone diagnostic algorithm.

7. Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Bench and external laboratory testing to applicable standards: This implies objective measurements of physical characteristics, adherence to electrical safety standards (IEC-60601), and performance standards (21 CFR 1020.30).
• Comparison of technical specifications: Matching or demonstrating acceptable differences in parameters like pixel size and other hardware components against the predicate device.

It does not rely on expert consensus, pathology, or outcomes data, as it's not evaluating diagnostic accuracy of a finding but rather the system's ability to produce images safely and effectively.

8. Sample Size for the Training Set

Not applicable/Not specified. This document does not describe the development of an AI algorithm with a training set. The software component mentioned (SmartRad) is an existing, previously cleared device (K003438), which would have had its own validation.

9. How the Ground Truth for the Training Set Was Established

Not applicable/Not specified. As there is no AI algorithm being developed by Viztek for this submission that would require a dedicated training set, this information is not available in the document.

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The CPI RAD VISION is a full featured Radiographic Flat Panel Digital Imaging System for X-ray Generator and Acquisition of digital radiography. The CPI RAD VISION is configurable to any high resolution (3K x 3K) Solid State X-Ray Imager (SSXI) presently in the market. It is intended to replace conventional film screen systems.

The CPI RAD VISION allows a qualified operator to perform digital radiographic examinations of various anatomic regions on both adult and pediatric patients. Anatomic regions of interest for diagnostic radiographic exposure include: skull, spinal column, chest, shoulder girdle, abdomen, pelvic girdle and extremities.

The CPI RAD VISION enables a qualified operator to acquire, process, and display images with for the benefit of obtaining an optimal diagnostic product. The CPI RAD VISION system enables the qualified operator to store, hardcopy images with a laser printer or send images over a network. This device is not intended for mammographic, fluoroscopic and or angiographic applications. The CPI RAD VISION will not include the X-Ray system itself.

The CPI RAD VISION is a component of a complete radiographic x-ray system. The CPI RAD VISION provides a single user interface for control of the x-ray generator and all digital imaging functions required by a radiographic acquisition modality (acquisition, processing, storage, display, and distribution of images).

The CPI RAD VISION consists of Flat Panel Detector, ISO-BOX (Medical Grade Isolation Transformer), LCD Monitor, and a workstation (computer) with x-ray generator interface, image receptor interface, and network port for communications with supported DICOM devices.

This document is a 510(k) summary for the CPI RAD VISION, a digital radiography system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria based on performance metrics. Therefore, many of the requested details about a study and acceptance criteria are not present in the provided text.

Based on the provided text, here's what can be extracted and what is missing:

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

This information is not provided in the document. The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria. The "Conclusion drawn from comparison" section merely states that the CPI RAD VISION can be considered substantially equivalent to the CMT MEDICAL TECHNOLOGIES LTD. SMART RAD. There are no performance metrics or acceptance criteria reported.

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

This information is not provided. As explained above, the document does not detail a study with a test set.

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)

This information is not provided.

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

This information is not provided.

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

There is no indication that an MRMC comparative effectiveness study was done. The device is described as a "Digital Radiography" system, primarily involving image acquisition, processing, storage, and display, and not an AI-assisted diagnostic tool that would typically involve human reader improvement metrics.

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

This information is not provided. The device is an imaging system, not an algorithm being tested in isolation.

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

This information is not provided.

8. The sample size for the training set

This information is not provided.

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

This information is not provided.

Summary of available information:

The document serves as a 510(k) premarket notification for the CPI RAD VISION, a digital radiography system. Its primary purpose is to establish substantial equivalence to a
predicate device (CMT MEDICAL TECHNOLOGIES LTD. SMART RAD 510(k) - K003438) based on its intended use and technological characteristics. The document does not contain specific acceptance criteria, detailed study designs, performance metrics, or information regarding ground truth establishment or expert involvement, as it is structured to fulfill the requirements of a 510(k) submission for substantial equivalence rather than a detailed clinical performance study.

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