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The ddrCruze™ 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, 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 represents the combination of the two of the predicate devices: K101517, Sedecal Mobile Digital Diagnostic X-Ray Systems (various models), manufactured by Sedecal SA (Spain), Software: PrestoDR Portable, K100400, CMT Medical Technologies LTD. (Used UNMODIFIED ). ddRCruze™ features a fully motorized mobile DR system, wireless connectivity, diagnostic image quality, viewing monitor for image review and system setup which can be positioned on any side of the system for added convenience. The system has a front-view camera for safe maneuverability.

Here's an analysis of the acceptance criteria and study information for the ddRCruze™ device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

This 510(k) summary does not delineate specific, quantifiable acceptance criteria in the traditional sense, such as specific sensitivity or specificity targets. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through a comparison of technical characteristics and intended use. The device's performance is reported by stating its characteristics alongside those of the predicate devices.

Table of Acceptance Criteria (Implicit) and Reported Device Performance

Study Information

Based on the provided 510(k) summary, the following information can be extracted regarding the studies conducted:

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

   • Not Applicable. The submission explicitly states "Description of clinical tests: Not applicable." This indicates that no new clinical test set with patient data was used to demonstrate the device's performance. The basis for clearance is substantial equivalence to previously cleared devices.

2. 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 test set was used, no ground truth needed to be established by experts for this specific device clearance.

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

   • Not Applicable. No clinical test set was used.

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 study was not conducted as this is a traditional X-ray system, not an AI-assisted diagnostic tool. The submission is for a mobile digital X-ray system comprising hardware (mobile unit, digital panel) and software, all of which had prior clearances or are components of previously cleared systems.

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

   • No. This device is an imaging system, not a standalone AI algorithm. It requires a human operator and interpretation.

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

   • Not Applicable. No new ground truth was established for this device's clearance. The clearance relies on the established safety and effectiveness of its predicate components and the equivalence of its technical characteristics.

7. The sample size for the training set:

   • Not Applicable. This submission is for a conventional medical imaging device (X-ray system), not an AI algorithm that requires a training set. The "software" mentioned (PrestoDR Portable) was used unmodified and had prior clearance.

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

   • Not Applicable. No training set was used for this device's clearance.

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The ddR Versa™ Motion System is intended for use by a qualified/trained doctor or technician on subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, 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)

ddRVersa™ Motion uses the same core technology as our ddRElement but is modified in that: The supplier for the digital x-ray receptor panel has changed. The system can now accommodate two digital x-ray receptor panels instead of just one. A Wi-Fi digital x-ray receptor panel may be chosen as the second panel. The tubestand is changed from a C-arm configuration to an overhead plus wall stand configuration. The table is changed from non-motorized to motorized. The generator supplier has been changed. The collimator has been changed.

The provided text describes a 510(k) summary for the ddRVersa™ Motion Digital Diagnostic X-Ray System (K123005), which is a modification of a predicate device. The information focuses on demonstrating substantial equivalence to the predicate device, rather than proving performance against specific acceptance criteria for a novel AI/software component.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are mentioned in the provided text for device performance. The submission aims to show "substantial equivalence" to a predicate device, meaning it performs "as well as or better than" the legally marketed predicate.

Instead, the "acceptance criteria" are implied by the comparative nature of the 510(k) process, which focuses on demonstrating equivalence to the predicate device in terms of safety and effectiveness.

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

• Sample Size for Test Set: The document states that "Clinical images were obtained." However, it does not specify the sample size (i.e., number of images or patients) used for the clinical evaluation.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

• Number of Experts: The document states images were "evaluated by professional radiologists." It does not specify the exact number of radiologists involved.
• Qualifications of Experts: The experts are described as "professional radiologists." No further specific qualifications like years of experience or subspecialty are provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for resolving discrepancies among expert readers or for establishing a definitive ground truth from the radiologists' evaluations. It simply states they "evaluated" the images.

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

• Was a MRMC study done? No. The document does not mention a MRMC comparative effectiveness study to assess how much human readers improve with AI vs without AI assistance. This device is an X-ray system, not an AI-powered diagnostic aide.

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

• Was a standalone study done? No. The device is a digital X-ray system that produces images for human interpretation, not an algorithm designed for standalone diagnostic performance.

7. Type of Ground Truth Used

The ground truth for the clinical evaluation was established by "professional radiologists" who found the images to be of "good diagnostic quality." This implies an expert consensus/opinion on image diagnosticity, rather than pathology, outcomes data, or a pre-defined reference standard.

8. Sample Size for the Training Set

The document does not refer to a "training set" as this device is a hardware system undergoing modifications and demonstrating substantial equivalence, not a machine learning model requiring a training phase.

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

Not applicable, as there is no mention of a training set for an algorithm in this submission.

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The ddRElement is a Digital Radiography system developed to be used for Medical General Radiography examinations on standing, seated and supine patients.

The ddRElement is a Digital Radiography system.

The provided text is a dated FDA clearance letter and an "Indications for Use Form" for a device called "ddR Element," a Digital Radiography system. It does not contain specific information about acceptance criteria for a study, reported device performance metrics, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes and data provenance for the test set.
• Number and qualifications of experts for ground truth.
• Adjudication method for the test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• A standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is solely an FDA letter granting substantial equivalence for a medical device based on its indications for use, without detailing specific performance studies or their methodologies.

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The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRFormula is a further development of the Addon Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRFormula is configured with a fiet panel (a-Si) X-ray detector (FP5000) and is intended for use on patients stocked in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.

The Swissray Medical AG direct digital X-ray Radiography diagnostic system class II (stationary) ddRFormula is a further development of the Addon Multi System. This system can be used in a hospital or doctor practice X-ray room. The ddRFormula is configured with a fiet panel (a-Si) X-ray detector (FP5000) and is intended for use on patients stocked in a supine, seated or standing position. The exposures can be readout on a high resolution viewing station, printout on a film printer or stored in a PACS system.

The provided document is a 510(k) clearance letter for the Swissray Medical AG ddRFormula, indicating substantial equivalence to legally marketed predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's diagnostic accuracy or effectiveness.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document primarily focuses on the regulatory clearance process rather than specific performance data.

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