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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.

The Paragon 2 is a mobile x-ray unit that covers all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These battery or line operated units combine stand-alone feature for exposures with battery assisted motor drive. Any of the following digital x-ray acquisition panels are available: Toshiba's FDX4343RPW, FDX 3543RPW, or FDX2520RPW. Integration of the panels and the software with the mobile system was straightforward since the panels and software have already been cleared. (K130883) The device complies with the US Federal Safety Performance Standard and is UL listed. The Paragon 2 has a telescoping tubestand which enhances visibility while transporting the unit. The Paragon 2 employs the digital x-ray panels and software employed in our premarket notification K143232.

This document describes a 510(k) premarket notification for the Paragon 2, a mobile x-ray system, and states that no clinical study was required for its clearance. Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be fully addressed in the typical manner of a clinical trial.

Instead, the submission relies on bench and laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices. The key aspects of the device's performance are evaluated against established safety and performance standards for x-ray equipment.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since no specific numerical clinical acceptance criteria are defined in this document (due to the nature of the 510(k) submission for substantial equivalence based on bench testing), the "acceptance criteria" are implied by compliance with safety and performance standards, and the "reported device performance" is its demonstrated adherence to these standards and equivalence to predicate devices.

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The UDI 2W system is a direct digital radiographic upgrade unit used to directly capture and convert conventinal projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, it can be printed and/or stored electronically. The Meridian UDI 2W unit provides digital radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The UDI 2W system can be used with a fixed, portable, or wireless 17"X17" or 14"x17" sensor plate. The UDI 2W can not be used for Mammography applications.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for the Universal Digital Interface 2W (UDI2W) and primarily discusses its regulatory classification, indications for use, and compliance requirements. It does not include details on specific performance metrics, study designs, sample sizes, or expert qualifications.

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The UDI 2 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on connomar monitor, without the time and costs involved with the film or cassette handling. The image can has further manipulated on a the computer monitor via imaging software, can be printed and/or e-mailed. The DI 2 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" x 14" x 17" sensor plate captures large patient imaging and areas.

Universal Digital Interface 2 (UDI 2)

This document is a 510(k) clearance letter for the Universal Digital Interface 2 (UDI 2) and does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. The letter primarily states that the FDA has reviewed the premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices.

Therefore, many of the requested details are not present in the provided text.

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

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

This information is not present in the document. The FDA letter is a regulatory clearance based on substantial equivalence, not a performance report.

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 present in the document. The letter does not detail the testing methodology or data sets used for demonstrating substantial equivalence.

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 present in the document.

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

This information is not present in the document.

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:

This information is not present in the document. The UDI 2 is described as a "Direct Digital Radiography Upgrade unit" that converts X-ray images to digital; there is no indication that it includes AI or that an MRMC study related to AI assistance was performed.

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

This information is not present in the document. The device description does not suggest an "algorithm-only" performance evaluation as it is an imaging system.

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

This information is not present in the document.

8. The sample size for the training set:

This information is not present in the document.

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

This information is not present in the document.

Summary of what the document does provide:

• Device Name: Universal Digital Interface 2 (UDI 2)
• 510(k) Number: K140251
• Primary Function: A Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images.
• Output: Diagnostic images viewable on a monitor, which can be manipulated, printed, and/or e-mailed.
• Application: Provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics, and imaging centers.
• Sensor Plate Size: 17" x 17" or 14" x 17".
• Regulatory Status: Substantially equivalent to legally marketed predicate devices, Regulatory Class II.
• Type of Use: Prescription Use.

To obtain the detailed information regarding acceptance criteria and study results, one would typically need to refer to the full 510(k) submission documentation, which is not included in this FDA clearance letter.

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The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" sensor plate capture large patient imaging and areas.

For the review of parts of the anatomy (legs, spine, etc.) that exceed the panel's dimensions, several Images can also be "stitched" together to allow the review of this part of the anatomy as one single image.

The UDI 1717 cannot be used for Mammography applications.

The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" sensor plate capture large patient imaging and areas.

For the review of parts of the anatomy (legs, spine, etc.) that exceed the panel's dimensions, several Images can also be "stitched" together to allow the review of this part of the anatomy as one single image.

The UDI 1717 cannot be used for Mammography applications.

This document is a 510(k) premarket notification decision letter from the FDA for the Universal Digital Interface (UDI) 1717. It does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more extensive submission summary.

Therefore, I cannot extract the requested information (1-9) from the provided text. The document primarily focuses on the FDA's decision regarding substantial equivalence based on the device's indications for use.

To obtain the requested information, you would need to consult the actual 510(k) submission document (K112527) which would contain the technical specifications, testing protocols, and performance data used to demonstrate substantial equivalence to a predicate device.

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The UDI 1417W System is a Direct Digital Radiography Upgrade unit used to directly capture and conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The portable, Wireless 14" x 17" sensor plate captures large patient imaging and areas. The UDI 1417W cannot be used for Mammography applications.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a medical device called "Universal Digital Interface-Wireless (UDI 1417 W)". This document is a clearance letter, not a study report. It confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, this document does not contain the detailed information requested regarding:

• Acceptance criteria table and reported device performance
• Sample sizes used for test and training sets
• Data provenance
• Number of experts for ground truth and their qualifications
• Adjudication method
• MRMC comparative effectiveness study results or effect sizes
• Standalone algorithm performance
• Type of ground truth used
• How ground truth for training set was established

This type of information would typically be found in a separate Premarket Notification 510(k) Summary or the Design Validation Report submitted as part of the 510(k) application, not in the FDA's clearance letter itself.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This means the FDA compared the UDI 1417W to existing, legally marketed devices and found them to be similar enough in terms of safety and effectiveness, based on the data submitted by Meridian Medical Systems. The letter itself does not describe the specific studies and their results that led to this determination.

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The UDI 1717 System is a Direct Digital Radiography Upgrade unit used to directly capture and convert conventional projection images from an X-ray source to digital images. The result is a diagnostic image, viewable on a computer monitor, without the time and costs involved with film or cassette handling. The image can be further manipulated on the computer monitor via imaging software, can be printed and/ or e-mailed. The UDI 1717 unit provides Digital Radiographic (DR) images for every general radiographic application in hospitals, clinics and imaging centers. The 17" x 17" sensor plate capture large patient imaging and areas. The UDI 1717 cannot be used for Mammography applications.

Universal Digital Interface (UDI) 1717

This looks like an FDA 510(k) clearance letter and an "Indication for Use" statement, not a scientific study or clinical trial report. As such, it does not contain the detailed information required to answer your questions about acceptance criteria and study results.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The document is a regulatory approval letter. It confirms that the device (Universal Digital Interface (UDI) 1717) is substantially equivalent to a legally marketed predicate device. It does not specify any acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or present any device performance data from a specific study.
• No Study Details: This document does not describe any specific study conducted to prove the device meets acceptance criteria. It doesn't mention sample sizes, data provenance, expert qualifications, ground truth methods, MRMC studies, standalone performance, or training set details.

To answer your questions, you would need access to the actual 510(k) summary or the original submission documents, which contain the technical details and performance data that the FDA reviewed.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided text.

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The PTA (Progressive Tibial Alignment) external fixation system is a modular system with the components of: joints, bars, clamps or screws. Such components form a device indicated for reconstruction and corrections of bone segments of the human body.

The PTA is for progressive realignment of the knee.

The PTA has multiple components of metallic bone fixation appliances and accessories. It is designed for a progressive correction of the lower limb using tibial osteotomy. This device is composed of a main section of a bar and proximal distraction unit upon which are connected the clamps and grasping components. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316 LVM, ISO 5832-1.

The provided text is a 510(k) Summary for the PTA (Progressive Tibial Alignment) external fixation system. This document is for a medical device that realigns bone segments, primarily for progressive realignment of the knee, and it's seeking clearance based on substantial equivalence to a predicate device (FEP, K032427).

Crucially, the provided text DOES NOT contain the type of information requested about acceptance criteria, study details, performance metrics, ground truth establishment, or sample sizes related to an AI/algorithm-based device.

The document describes a physical medical device (an external fixation system) and its components, materials, and intended use. It focuses on demonstrating substantial equivalence to a previously cleared device, not on evaluating the performance of a software algorithm.

Therefore, I cannot extract the requested information. The prompt specifically asks for details related to acceptance criteria and a study proving device meets these criteria, typically found in submissions for AI/ML-driven devices or diagnostic tools. This document is for a mechanical orthopedic device.

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The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.

The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest. The electrodes are screen-printed onto a clear plastic substrate. An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored.

The PRIME software also contains a diagnostic algorithm that may be used as an aid in diagnosing AMI. The algorithm provides an explanation of the measurements that were interpreted to reach the suggested diagnosis.

Acceptance Criteria and Study Details for PRIME ECG System with Diagnostic Algorithm

The provided 510(k) summary for the PRIME ECG System with Diagnostic Algorithm (K030104) offers limited details on specific acceptance criteria and the comprehensive study that proves the device meets them. However, it does state that a clinical study was performed to demonstrate the algorithm's utility in diagnosing AMI. Based on the available information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The 510(k) summary does not specify quantitative metrics for the "assistance in diagnosis of AMI" nor does it provide a specific performance target or range for this criterion. It merely states that the study "demonstrated" this capability.

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

The 510(k) summary does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the clinical study validating the diagnostic algorithm.

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

The 510(k) summary does not provide details on the number of experts used to establish ground truth or their qualifications for the clinical study.

4. Adjudication Method for the Test Set

The 510(k) summary does not provide details on the adjudication method used for the test set in the clinical study.

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

The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The study described appears to focus solely on the algorithm's ability to "provide information that may assist in the diagnosis of AMI," rather than a comparative study with human readers.

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

Yes, a standalone study appears to have been conducted. The description "a clinical study was performed that demonstrated that the PRIME ECG System diagnostic algorithm provides information that may assist in the diagnosis of acute myocardial infarction" suggests that the algorithm's performance in providing diagnostic information was evaluated. There is no mention of human-in-the-loop performance in the context of this specific clinical study for the diagnostic algorithm.

7. Type of Ground Truth Used

The 510(k) summary does not explicitly state the type of ground truth used for the clinical study demonstrating the diagnostic algorithm's utility for AMI. Given the nature of AMI diagnosis, it is highly probable that a combination of clinical assessment (symptoms, physical exam), biomarkers (cardiac enzymes), follow-up outcomes, and potentially expert consensus on other diagnostic tests (e.g., echocardiography, coronary angiography) would have been used to establish the ground truth for AMI. However, this is an inference and not explicitly stated in the document.

8. Sample Size for the Training Set

The 510(k) summary does not provide details on the sample size for the training set used for the diagnostic algorithm.

9. How Ground Truth for the Training Set Was Established

The 510(k) summary does not provide details on how the ground truth for the training set was established for the diagnostic algorithm.

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The PRIME ECG is indicated for the recording of electrocardiographic signals on the body surface.

The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest or harness. The electrodes are screen-printed onto a clear plastic substrate. The section of the vest applied to the anterior side of the patient (anterior harness, applied to chest area) contains channels 1 to 55 and 59 to 64. The section applied to the posterior side of the patient (posterior harness, applied to the patient's back) contains channels 65 to 80. Channels 56, 57 and 58 are applied to the right arm, left arm and left leg, respectively. Signals are conducted along pathways that are also printed, eliminating the need for conventional lead wires. The electrode array or " vest" features pre-applied gel to assure good conductivity and secure attachment. Anatomical markers provide for consistent location on different size patients. The vest can be applied in less than 5 minutes. An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored. The system measures the ECG recordings simultaneously for all 80 channels. For practical reasons only eight channels are displayed at one time, so the operator may scroll through 10 screens to visualize all active channels. The system contains an algorithm that identifies (with color, words and symbols) any individual electrode that may be suspect, allowing the operator to make adjustments before recording. Once satisfied, the operator activates the recording and the system retains 10.0 seconds of data. If the recording contains any poor signals, the algorithm alerts the operator who must determine whether to accept the recording. The number of poor quality leads may not exceed 6 on the anterior harness. If the signals from any 2 adjacent electrodes, or any posterior electrode, are bad, the maps are not accepted. It is possible for the operator to accept a recording which contains channels that have low quality, but resulting maps contain the legend "Unacceptable Quality" and each poor quality channel is marked in red. Because the electrode vest covers most of the torso, electrode locations include those for a standard 12-lead ECG. This means that among the 80 leads individual locations are consistent with required placement necessary to result in a conventional 12-lead recording and display. There is a user-selected option for displaying these leads, (e.g., the channels are automatically selected and displayed which correspond to a Lead II ECG), although the operator may designate specific electrodes to reflect preferred locations for display. Once the 80-lead recording is accepted, the system creates a series of isopotential and isointegral images (maps) for specific segments of a single beat. Measuring signal strength at a specific time interval of the beat creates Isopotential maps. The resulting strengths and locations of these signals are plotted against an "unwrapped" image of the torso. For example, the unwrapped torso image can be oriented with an x and y axis. At a given point in time, an voltage measurement in millivolts is collected at each location (x,y). This voltage can be plotted along the z axis. If lines are drawn on this plot to connect points with the same voltage z, isopotential contour maps are created. Isopotential maps can be created at any point in time during the cardiac cycle to reflect the cyclic polarization and repolarization of the heart. Isointegral maps are an attempt to provide a look at what is happening over the cycle, as a body surface distribution of the ventricular gradient. At each location (x,y) the potential z changes over the time of the cardiac cycle. Integrating the areas under the QRST of each lead gives the gradient at each point. The gradient at each point is then mapped. Joining points on the plot with the same calculated gradient produces the isointegral contour map. The isointegral map allows evaluation of repolarization properties.

This document describes the PRIME ECG™ System, an 80-lead electrocardiograph, and its FDA 510(k) submission. However, the provided text does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Specifically, the document states: "a clinical study was performed that demonstrated that the PRIME ECG System provides information enabling improved diagnosis of AMI upon presentation to the ER compared to standard 12 lead ECG systems." However, it does not provide the results, metrics, acceptance criteria, study design details (like sample size, ground truth, expert qualifications), or specific effect sizes from this clinical study.

Therefore, the following response will reflect the information that is present in the provided text.

Acceptance Criteria and Study for PRIME ECG™ System

Based on the provided 510(k) summary, the PRIME ECG™ System's acceptance criteria primarily revolve around its equivalence to a predicate device and its compliance with relevant industry standards. While a clinical study is mentioned for improved AMI diagnosis, the details of its acceptance criteria and results are not included.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size: The document mentions that "a clinical study was performed," but it does not specify the sample size for this study or any test set.
• Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective).

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

• The document does not specify the number of experts used or their qualifications for establishing ground truth in the "clinical study."

4. Adjudication Method for the Test Set

• The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the clinical study.

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

• The document mentions "a clinical study was performed that demonstrated that the PRIME ECG System provides information enabling improved diagnosis of AMI upon presentation to the ER compared to standard 12 lead ECG systems."
• However, it does not provide details on whether this was an MRMC study, nor does it specify an "effect size of how much human readers improve with AI vs. without AI assistance." The PRIME ECG is described as an ECG system itself, not necessarily an AI-assisted interpretation tool in the context of human reader improvement. It provides more data (80-leads) to aid diagnosis.

6. Standalone Performance Study (Algorithm Only)

• The document does not explicitly state if a standalone (algorithm only without human-in-the-loop performance) study was done for the "improved diagnosis of AMI" claim. The nature of an ECG system typically involves a clinician interpreting the output.

7. Type of Ground Truth Used

• The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the "clinical study" related to AMI diagnosis.

8. Sample Size for the Training Set

• The document does not mention any training set or its sample size. This suggests the primary demonstration of equivalence was based on predicate device comparison and standard compliance, with the clinical study serving as supportive evidence for improved diagnostic capabilities, rather than a deep learning model requiring a distinct training and test set in the modern sense.

9. How Ground Truth for the Training Set Was Established

• As no training set is mentioned (see point 8), the method for establishing its ground truth is not applicable based on the provided text.

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