Search Results

These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skill, 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.

Sedecal Digital Mobiles (various models) are mobile x-ray units that covers, with a range of models, all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. These cordless units combine stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging. Two different brands of digital image acquisition panels are offered: Trixell and Varian. Integrated software for Dicom compatibility is also included.

The provided text describes a 510(k) premarket notification for "Sedecal Mobile Digital Diagnostic X-Ray Systems (various models)". This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria for performance metrics like sensitivity or specificity.

Therefore, many of the requested elements for a study that proves a device meets acceptance criteria cannot be extracted from this document, as it is not the type of study described.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device.

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

• Sample size: Not explicitly stated. The document mentions "bench, test laboratory results, and clinical image comparisons," but does not provide details on the number of images or subjects included in these comparisons.
• Data provenance: Not explicitly stated. It's implied that the clinical image comparisons would involve human subjects, but specifics regarding country of origin or whether the data was retrospective or prospective are not provided.

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

• Not specified. The document mentions "clinical image comparisons" but does not detail how ground truth was established or if experts were involved in a formal review process for comparing the new device's images to the predicate's images.

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

• Not specified.

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. This document describes an X-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not conducted.

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

• No. This is a medical imaging device, not a standalone algorithm. The performance evaluation focuses on the safety and effectiveness of the hardware and integrated software for image acquisition, not on an algorithm's diagnostic performance in isolation.

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

• Not explicitly stated. Given the context of "clinical image comparisons" for an X-ray system, the "ground truth" would likely be derived from the diagnostic interpretations of the images by qualified medical professionals using the predicate device, against which the images from the new device would be compared for qualitative assessment.

8. The sample size for the training set:

• Not applicable. This is not a machine learning device that requires a "training set."

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

• Not applicable. This is not a machine learning device that requires a "training set."

Summary of Study:

The "study" described in the 510(k) summary is a substantial equivalence comparison against a predicate device (Sedecal Easy Moving Digital K090322 and K091364, DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL I.4, GEHM UND REHBEIN GMBH). The primary method used to demonstrate equivalence was:

• Bench testing: Laboratory tests to verify technical specifications and performance.
• Test laboratory results: Further laboratory-based evaluations.
• Clinical image comparisons: Qualitative assessment presumably comparing images acquired by the new device to those acquired by the predicate device to ensure comparable diagnostic quality.

The conclusion is that "bench, test laboratory results, and clinical image comparisons indicate that the new devices are as safe and effective as the predicate devices," with "few technological differences" and "no new indications for use." The focus is on demonstrating that the new device performs equivalently to the predicate in terms of safety and imaging capabilities, rather than achieving specific quantitative performance metrics against a defined ground truth.

Ask a specific question about this device

This Portable Diagnostic 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, 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 Sedecal SPL-HF-4.0 portable x-ray generator consists of: X-ray Unit with: Control Panel with controls and displays for radiographic operations; Power Module containing control and power components; HV Tank that comprises the High Voltage Transformer, the Filament Transformer and the X-ray Tube; and a Collimator with controls to limit the X-ray beam; a Handswitch and a Mobile Column with an Articulated Arm and a Cassette Basket.

This 510(k) submission describes a new mobile X-ray system, the Sedecal SPL-HF-4.0 (and SPL-HF-2.0), which is intended for diagnostic radiographic exposures. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, the Sedecal Models SP-HF-2.8 and SP-HF-4.0 (K020436).

Based on the provided information, the focus is on demonstrating safety and effectiveness through non-clinical testing rather than a clinical study involving human subjects and diagnostic performance metrics. Therefore, many of the requested elements pertaining to clinical study design, such as sample size, ground truth establishment for a test set, expert qualifications, and comparative effectiveness, are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

Not applicable. The submission describes non-clinical testing (electrical safety, EMC, software, and radiation safety standards) rather than a clinical study with a test set of patient data.

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

Not applicable. No ground truth for image interpretation or diagnostic accuracy was established as this was not a clinical performance study.

4. Adjudication method for the test set

Not applicable. No clinical test set requiring adjudication was used.

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 applicable. No MRMC study was performed as this is a new X-ray generator, not an AI-based interpretation device.

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

Not applicable. This is a medical device (X-ray generator), not an algorithm or AI system.

7. The type of ground truth used

Not applicable for a clinical performance study. For the non-clinical testing, the "ground truth" would be the specifications and requirements defined by the referenced IEC standards and internal design specifications.

8. The sample size for the training set

Not applicable. No training set for an algorithm was used.

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

Not applicable. No training set for an algorithm was used.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria is primarily a series of non-clinical tests mandated by international standards for medical electrical equipment and X-ray devices. These include:

• Electrical Safety Testing (IEC 60601-1): This standard ensures the device does not pose electrical hazards to patients or operators.
• Electromagnetic Compatibility (EMC) Testing (IEC 60601-1-2): This verifies that the device functions correctly in its electromagnetic environment and does not interfere with other equipment.
• Software Validation Testing: Ensures the software controlling the device functions as intended and is reliable.
• Radiation Safety/Performance Testing (IEC 60601-1-3 and IEC 60601-2-7): IEC 60601-1-3 specifies general requirements for radiation protection in diagnostic X-ray equipment, ensuring appropriate X-ray emission and safety features. As mentioned, IEC 60601-2-7's relevance here is somewhat ambiguous; it typically applies to medical electron accelerators. However, its inclusion suggests a comprehensive approach to safety standards where applicable.

The submission asserts that based on the results of these non-clinical tests, the device is "as safe, as effective, and performs as well as or better than the legally marketed devices" (specifically, the predicate device K020436). The core argument for acceptance and substantial equivalence relies on the fact that the new device shares "nearly identical" technological characteristics, design, materials, chemical composition, and energy source with the predicate device, with this submission representing an "updated design" of the previous model. The conclusion is that because the updated model passes the relevant safety and performance standards, and its technical characteristics are so similar to an already cleared device, it is substantially equivalent.

Ask a specific question about this device

These Digital Radiographic Systems are 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.

Easy Moving Plus is a mobile x-ray unit that covers, with a wide range of models, all the specific needs of any radiographic examination at the patient's bed, first aid, and emergency, orthopedics, pediatric, and operating theater. The cordless Easy Moving "B" (battery powered version) combines stand alone feature for exposures with battery assisted motor drive for the greatest ease in imaging.

The provided text is a 510(k) summary for the Sedecal Easy Moving Plus Mobile X-Ray System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, many of the requested categories about specific performance metrics, ground truth, and expert studies are not applicable or explicitly stated in this type of submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence to predicate devices, there isn't a table of specific acceptance criteria in the sense of quantitative performance targets for a new therapeutic or diagnostic algorithm. Instead, the "acceptance criteria" are implied by demonstrating that the new device's characteristics are either identical to or non-inferior to the predicate devices, particularly regarding safety and effectiveness.

The document directly compares the Sedecal Easy Moving Plus to its predicate devices, K012663 (Easy Moving film) and K043002 (Easy Moving Digital). The performance is effectively assessed by establishing that the new device shares the same intended use, configuration, relevant performance standards, and similar technical specifications (e.g., generator type, collimator, electrical safety).

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

This is not a study involving a "test set" in the context of an AI algorithm or a diagnostic test with patient data. The submission relies on bench and external laboratory testing to applicable standards, as stated in Section 5 and 7. The data provenance is not specified beyond "bench and external laboratory results," implying controlled engineering and electrical testing rather than clinical data from specific countries or patients.

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

Not applicable. The study is not assessing a diagnostic or predictive device requiring expert-established ground truth from clinical cases. It's about the safety and performance of an X-ray system itself.

4. Adjudication Method for the Test Set

Not applicable, as there is no clinical "test set" requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size

Not applicable. This is a medical device clearance for an X-ray system, not a clinical study evaluating the effectiveness of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is an X-ray system, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the applicable performance standards (e.g., 21 CFR 1020.30 for performance standards for diagnostic X-ray systems and their major components; IEC-60601 for electrical safety). The device's compliance with these standards (through bench and laboratory testing) serves as the "ground truth" for its safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as there is no training set.

Ask a specific question about this device

These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skall, 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.

These digital diagnostic x-ray systems consist of a tubehead and collimator assembly mounted on a U-Arm, along with a generator, generator control, and an xray 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. This device represents a new combination of already cleared Sedecal and Canon products.

The provided document is a 510(k) summary for the Sedecal Millennium Plus Digital Diagnostic X-Ray System. It states that the new device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement in a study as requested.

The document primarily focuses on establishing substantial equivalence by comparing the new device's characteristics and intended use to those of its predicate devices (Sedecal Millennium Digital K042876 and Sedecal X Plus LP Plus K062335) and by stating that it passes bench and test laboratory evaluations to applicable standards (21 CFR 1020.30 and IEC 60601).

Therefore, I cannot provide the requested table and detailed information based on the content of this document. The document explicitly 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, it is the conclusion of Sedecal Inc that the Scdecal Millennium Plus Digital Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices."

This indicates that general safety and effectiveness testing was conducted, but the specific details of the acceptance criteria, study design, performance metrics, sample sizes, ground truth, or expert involvement are not disclosed in this 510(k) summary.

Ask a specific question about this device

These Digital Radiographic Systems are 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.

These digital diagnostic x-ray systems consist of a tubehead/collimator assembly mounted on a U-Arm, along with a generator, generator control, and an 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. This device represents a new combination of already cleared Sedecal and Canon products.

The provided 510(k) summary for the Sedecal X-Plus LP Plus Digital Diagnostic X-Ray System (K090238) does not contain the information requested regarding acceptance criteria and a specific study proving the device meets those criteria, as you would typically expect for performance data of AI/CADe devices.

This submission is for a traditional X-ray system, and the approval is based on substantial equivalence to predicate devices, rather than a performance study with defined acceptance criteria for diagnostic accuracy.

However, I can extract and infer some information based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: For this type of device, the acceptance criteria are generally related to demonstrating substantial equivalence to existing legally marketed devices, primarily focusing on safety and effectiveness through comparison of technical characteristics and adherence to relevant performance standards.
• Reported Device Performance: The document states, "The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."

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 in the document. The approval is based on "bench and test laboratory" results and comparison of specifications, not a clinical test set with patient data for diagnostic accuracy assessment.

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

• This information is not applicable/provided. No clinical reader study or ground truth establishment relevant to diagnostic accuracy is described.

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

• This information is not applicable/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:

• No, an MRMC comparative effectiveness study was not done. This device is a digital X-ray system, not an AI or CADe device designed to assist human readers or provide diagnostic interpretations.

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

• No, a standalone performance study was not done. This is an imaging acquisition device, not an algorithm.

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

• Not applicable. The "ground truth" for this submission revolves around engineering performance verified by "bench and external laboratory testing to applicable standards" (e.g., 21 CFR 1020.30, IEC-60601) to demonstrate the device functions as intended and is safe. It's not about diagnostic accuracy.

8. The sample size for the training set:

• Not applicable. This isn't an AI/machine learning device that requires a training set.

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

• Not applicable.

Ask a specific question about this device

The Definium™ 5000 X-Ray Systems are 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.

The Definium 5000 Digital Radiographic Imaging System provides state of the art image quality, image manipulation, operator control, dose reporting and system maintenance. These features make this system easy to use and reliable while providing high quality radiographic images in a digital environment. The Definium 5000 System is designed to handle radiographic applications using the digital table. The system configuration includes an elevating or non-clevating table, a floor column stand with rotating U-arm, and GE's patented Digital Detector that captures radiographic images in digital form, as well as an X-ray generator/power unit. An Acquisition and Review Workstation for image post-processing, short-term storage, and quick in-room viewing of images is included as part of the system. Images may be transferred manually or automatically via a DICOM network for printing, longterm storage archive, and detailed review.

The provided text is a 510(k) summary for the Definium™ 5000 X-Ray System (K063283). This document aims to demonstrate substantial equivalence to previously cleared devices rather than providing a detailed study proving performance against acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, and expert qualifications are not present in the provided text. The document focuses on comparing the new device's characteristics to its predicate devices to establish substantial equivalence.

Here's an attempt to answer the questions based only on the provided information:

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

The provided document does not explicitly state quantitative acceptance criteria for image quality or clinical performance as it would in a de novo submission or a detailed clinical study report. Instead, it attests to "state of the art image quality" and that "the new device is as safe and effective as the predicate devices" based on "bench, user, and standards testing."

The "Substantial Equivalence Chart" compares technical characteristics rather than performance metrics against acceptance criteria.

Note: The differences in "Digital Panel Size" and "Digital Resolution" are noted in the submission but are deemed not to raise new questions of safety or effectiveness, as the overall system is considered substantially equivalent. The performance "criteria" are implicitly met if the device is deemed substantially equivalent.

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

The document mentions "bench, user, and standards testing" but does not provide any details on sample sizes, whether the data was retrospective or prospective, or the country of origin.

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 in the document.

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

This information is not provided 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 device is an X-ray system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed. The document is about the physical X-ray system.

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

This refers to an AI algorithm's performance. As the device is an X-ray system and not an AI algorithm, this type of standalone performance study is not applicable and was not performed.

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

The document refers to "bench, user, and standards testing" leading to a conclusion of safety and effectiveness, but it does not specify the type of ground truth used. For an X-ray system, ground truth for image quality might involve physical phantoms, dose measurements, or qualitative expert assessment of image clarity, but these details are not provided.

8. The sample size for the training set

This refers to AI algorithm training. As the device is an X-ray system and not an AI algorithm, a "training set" as commonly referred to in AI/ML is not applicable.

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

Not applicable, as this is not an AI/ML device.

Ask a specific question about this device

The SEDECAL X PLUS LP PLUS Universal Radiographic Systems are 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.

SEDECAL X PLUS LP PLUS Universal Radiographic Systems are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device employs new controls, including a touch screen and an infrared remote.

This K062335 510(k) summary describes a submission for a modified medical device rather than a new device with novel performance claims directly tied to specific acceptance criteria and study results. Therefore, the standard format for presenting acceptance criteria, device performance, and detailed study information for AI/algorithm performance is not fully applicable or derivable from the provided text.

Here's why and what information can be extracted:

The submission is for the SEDECAL X PLUS LP PLUS Universal Radiographic Systems, which is a stationary X-ray system. The core of this 510(k) is to demonstrate substantial equivalence to a predicate device (Sedecal URS X-Ray Units K012546), focusing on changes to the user interface (touch screen and infrared remote) and ensuring the safety and effectiveness are maintained.

When a 510(k) relies on substantial equivalence for modified devices, the "study" often involves bench testing, user testing, and adherence to performance standards to show that the modifications do not introduce new safety or effectiveness concerns, and that the device performs as well as the predicate device. It doesn't typically involve a comparative effectiveness study with AI or a standalone algorithm performance study with specific metrics like sensitivity/specificity against a ground truth.

Therefore, many sections of your requested output will be marked as "Not Applicable" or "Not Provided in Document."

Acceptance Criteria and Study Overview for K062335

1. Table of Acceptance Criteria and Reported Device Performance

Notes on Acceptance Criteria:

• The primary "acceptance criteria" here are demonstrating substantial equivalence, meaning the modified device performs comparably to the predicate in terms of safety and effectiveness, especially given the "new controls, including a touch screen and an infrared remote."
• "Bench, user, and standards testing" are the methods used to meet these criteria, rather than a clinical study with calculated performance metrics.

2. Sample size used for the test set and the data provenance

• Sample Size: Not provided in the document. For device modifications like this, "user testing" might involve a small number of typical users to evaluate the new interface, but specifics are not disclosed. "Bench testing" refers to engineering and quality assurance tests. "Standards testing" refers to compliance with regulatory standards.
• Data Provenance: Not provided in the document.

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

• Not Applicable / Not Provided. This type of information is relevant for AI algorithms interpreting medical images or data, where expert consensus often establishes ground truth. For a stationary X-ray system, experts (engineers, quality control personnel) would evaluate the device's functionality, safety, and image quality (which is assumed to be equivalent to the predicate). There is no "ground truth" in the diagnostic sense being established in this submission.

4. Adjudication method for the test set

• Not Applicable / Not Provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where multiple human readers or algorithms are evaluating cases and their interpretations need to be reconciled to form a definitive "ground truth." This submission focuses on engineering and regulatory compliance, not diagnostic interpretation studies.

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, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI-assisted diagnostic devices to evaluate the impact of AI on human reader performance. The device described here is a basic X-ray system, not an AI diagnostic tool.

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

• No, a standalone algorithm performance study was not done. This device is an X-ray machine, not an algorithm.

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

• Not Applicable in the context of diagnostic performance. For this device, "ground truth" relates to functional specifications and safety standards being met, as per engineering and regulatory requirements. For example, voltage outputs measured during bench testing would be compared against engineering specifications, which themselves are the "ground truth" for those tests. Image quality being "equivalent" to the predicate would be the "ground truth," likely established through physical phantom tests and possibly expert review, but not in the detailed diagnostic sense.

8. The sample size for the training set

• Not Applicable. This is an X-ray system, not a machine learning model that requires a training set.

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

• Not Applicable. As there is no training set for an AI/ML algorithm.

Ask a specific question about this device

The Sedecal URS LP/Millennium/RadPro Xray Units with Detector are 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.

URS LP/Millennium/RadPro X-ray Units with Detector are stationery units which operate from 120 or 220 V 50-60~ AC. The units utilize high frequency inverters. The usual safety precautions regarding the use of x-rays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G. The new units offer additional mounting options for the tube head and other components.

The provided text describes a 510(k) summary for the SEDECAL URS LP/Millennium/RadPro X-ray Units with Detector. This submission appears to be for a combination device, integrating two previously cleared devices.

Based on the provided information, the 510(k) summary does not contain details about specific acceptance criteria or a study designed to prove the device meets those criteria in terms of clinical performance or detection accuracy. Instead, the summary focuses on demonstrating substantial equivalence to existing predicate devices.

Here's an analysis based on the information available:

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

No specific acceptance criteria related to a performance study (e.g., sensitivity, specificity, accuracy) are mentioned. The "Performance Standard" in the Substantial Equivalence Chart refers to 21 CFR 1020.30, which is a regulatory performance standard for diagnostic X-ray systems and their major components, not a clinical performance metric. This standard typically covers aspects like radiation safety, image quality characteristics (e.g., resolution, contrast, noise), and operational parameters.

The reported device performance is implicitly covered by the "SAME" statements in the Substantial Equivalence Chart, indicating that the new device's characteristics are the same as the predicate devices in terms of energy source, digital resolution (160 x 160 microns pixel pitch, approximately 6 million pixels and 4,096 gray scale contrast), and relevant safety/performance standards.

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

Not applicable. No clinical or performance test set data is provided. The evaluation was based on "bench, user, and standards testing" and a comparison of technical characteristics to predicate devices.

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. No ground truth establishment by experts is mentioned, as there was no study involving medical image interpretation.

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

Not applicable. No adjudication method is mentioned.

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 such study was conducted or reported. This device is an X-ray unit, not an AI-powered diagnostic tool. The focus is on the hardware and its integration.

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

Not applicable. This is not an algorithmic diagnostic device.

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

Not applicable. No clinical ground truth was established, as the submission relies on demonstrating substantial equivalence of the hardware's technical characteristics and adherence to regulatory standards.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not a machine learning model.

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

Not applicable.

Summary of Acceptance Criteria and Performance (Based on provided text):

Since the submission is a 510(k) for a combination device based on substantial equivalence, the "acceptance criteria" are implied by the characteristics of the predicate devices and adherence to relevant regulatory standards.

In essence, the "study" demonstrating that the device meets acceptance criteria is the comparison to predicate devices and the assertion that "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." No specific details of these "bench, user, and standards testing" are provided in the 510(k) summary itself, but they would collectively serve to confirm that the combined device meets the functional and safety requirements established by regulatory standards and the performance of its cleared components.

Ask a specific question about this device

The Sedecal Mobile Radiographic Systems with Digital Detector are 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.

Sedecal Mobile X-ray Units with Digital Detector arc mobile units which operate from 120 or 220 V 50-60~ AC or batteries. The units utilize high frequency inverters. The usual safety precautions regarding the use of xrays must be observed by the operator. This modified device combines two FDA cleared devices by way of a common user interface, a color LCD touch panel. The X-Ray generator is controlled by a serial port on the CANON CXDI-50G.

The provided text describes a 510(k) summary for the Sedecal Mobile X-Ray Units with Digital Detector. This regulatory submission primarily focuses on demonstrating substantial equivalence to existing predicate devices, rather than an independent study to prove the device meets specific performance acceptance criteria in the same way a de novo or PMA submission might.

Therefore, the information typically requested in your prompt regarding acceptance criteria, study design, expert involvement, and ground truth for a performance claims study is largely not applicable in this context.

Here's an breakdown based on the provided text:

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

The submission does not present explicit acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting specific pathologies) because it's a substantial equivalence submission. Instead, the "acceptance criteria" are implied by demonstrating equivalence in technical specifications and intended use to existing, cleared devices.

The table provided is a comparison to predicate devices for various technical characteristics, not performance metrics against acceptance criteria.

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

The text states: "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." and "After analyzing bench, user, and standards testing data...".

• Sample Size for Test Set: Not specified. This typically refers to a clinical dataset for performance evaluation, which wasn't the primary focus of this 510(k). The "user testing" likely refers to functional testing, not a clinical study with a defined patient sample.
• Data Provenance: Not specified.
• Retrospective or Prospective: Not specified. Given the nature of a 510(k) for device combination, clinical studies are often not required if substantial equivalence can be demonstrated through technical comparison and bench 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. The submission does not detail any clinical study where ground truth for diagnostic features would need to be established by experts.

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

Not Applicable. No clinical study with adjudicated ground truth is described.

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 Applicable. This is an X-ray imaging system, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant for this type of 510(k) submission.

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

Not Applicable. This is an X-ray imaging system, not an algorithm, so standalone performance is not relevant in this context.

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

Not Applicable. As no clinical diagnostic performance study is described, the concept of "ground truth" for diagnostic findings is not addressed in this submission. The "ground truth" for the technical specifications (e.g., power output, exposure times) would be established by direct measurement during bench testing.

8. The sample size for the training set

Not Applicable. This is an X-ray imaging system, not a machine learning algorithm that requires a training set.

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

Not Applicable. As there is no training set mentioned.

Ask a specific question about this device

Models SP-HF-2.8 and SP-HF-4.0 are 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.

Models SP-HF-2.8 and SP-HF-4.0 are a portable units which operate from 120 V 50-60~ AC. The unit utilizes a newly designed high frequency inverter and can be either mounted to a tripod or support arm or can be hand held.

The provided document describes the safety and effectiveness summary for two portable X-ray units, Models SP-HF-2.8 and SP-HF-4.0. The study's acceptance criteria are implicitly defined by demonstrating substantial equivalence to a predicate device, the MinXray HF100H.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally understood to be that the new devices (Models SP-HF-2.8 and SP-HF-4.0) perform as safely and effectively as the predicate device (MinXray HF100H) and present no new indications for use or significant technological differences that would raise new questions of safety or effectiveness. The document achieves this by comparing technical specifications and intended use.

Note: For the physical and operational characteristics (Size, Weight, Energy Source, User Interface, Exposure times, Ma., KvP), the acceptance criteria are not explicitly stated as strict numerical equivalence. Instead, "substantial equivalence" is being claimed, meaning the differences are not considered to raise new questions of safety or effectiveness. The new devices often show improvements (e.g., wider range of mAs/kVp, lower weight) or minor variations that are deemed acceptable and within the scope of the predicate device's intended use.

2. Sample size used for the test set and the data provenance

The document states that "bench and user testing" was performed. However, there is no specific sample size provided for the test set. The data provenance (country of origin, retrospective/prospective) is also not specified.

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

The document mentions "user testing" but does not specify the number or qualifications of experts used to establish ground truth. Given the nature of the device (portable X-ray unit) and the era of the submission, "user testing" likely refers to evaluations by technicians or qualified medical personnel regarding the device's operational aspects and image acquisition capabilities rather than diagnostic interpretation.

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

The document does not describe any adjudication method for establishing ground truth from the "user testing."

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 comparative effectiveness study was done or reported. This device is a portable X-ray unit, not an AI-powered diagnostic tool. The comparison is between the new X-ray unit and a predicate X-ray unit, focusing on technical specifications and overall safety/effectiveness in producing images, not on human reader performance or AI assistance.

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

No standalone algorithm performance study was done or reported. This is a hardware device for image acquisition, not a software algorithm.

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

The concept of a "ground truth" as typically applied to diagnostic performance studies (e.g., pathology, expert consensus on disease presence) is not applicable or described in this 510(k) summary. The "ground truth" for this submission revolves around the technical performance metrics of the X-ray unit (e.g., kVp, mA, exposure times, safety standards) and whether it can produce diagnostic-quality images, implicitly judged during "user testing." The "ground truth" for substantial equivalence is the established safety and effectiveness of the predicate device based on its technical specifications and intended use.

8. The sample size for the training set

Not applicable. This submission is for a medical device (X-ray unit) that does not involve machine learning or AI algorithms requiring a training set in the typical sense.

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

Not applicable. As stated above, this device does not utilize a training set.

Ask a specific question about this device