Search Results

The X3C 2200 is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients can be performed with patient sitting, standing or lying in the prone or supine positions.

The X3C 2200 (510k submission device) is not intended for mammography.

The X3C 2200 is a modification to Xplorer 2200 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 2200 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 2200 system is manufactured by Imaging Dynamics.

This 510(k) submission, K071401, for the X3C 2200 Digital Radiographic System, explicitly states: "No clinical tests conducted." This means that there is no study described in the provided text that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Xplorer 2200, K063039) through non-clinical tests. The acceptance criteria and "device performance" in this context refer to the device's ability to meet safety, effectiveness, and performance requirements comparable to the predicate device through non-clinical evaluations.

Therefore, the requested information elements related to clinical studies, such as sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details, are not applicable or not available from the provided text for this specific submission because no clinical studies were performed.

Here's an attempt to answer the questions based on the available information regarding substantial equivalence and non-clinical testing:

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

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 test set or patient data was used as "No clinical tests conducted." The evaluation was based on non-clinical performance, safety, and effectiveness testing of the device itself, likely comparing its specifications and outputs to the predicate device.

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. As no clinical tests were conducted, there was no "test set" requiring ground truth established by medical experts in this submission. The "ground truth" for substantial equivalence was based on meeting engineering and safety standards, and performance specifications benchmarked against the predicate device.

4. Adjudication method (e.g., 2+1, 3+1, none) 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. This device is a digital radiographic system, not an AI-assisted diagnostic tool. Furthermore, no clinical studies (including MRMC) were conducted.

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

• Not applicable. This submission is for a digital radiographic system hardware, not a standalone algorithm. Also, no clinical studies were performed.

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

• The "ground truth" for evaluating this device's substantial equivalence in non-clinical testing would have been based on engineering specifications, performance metrics (e.g., image quality parameters, dose measurements), safety standards (electrical, thermal, mechanical), and biocompatibility testing results, all compared against the established characteristics of the predicate device. It represents verification against technical and regulatory benchmarks, not clinical disease states.

8. The sample size for the training set

• Not applicable. As this device is a hardware system and "No clinical tests conducted," there was no "training set" of data in the context of an AI/ML algorithm being developed or assessed.

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

• Not applicable. There was no training set for this device.

Ask a specific question about this device

The X3C 1100 motorized patient table with digital radiographic detector (510k submission device) is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, lying in the prone or supine positions.

The X3C 1100 (510k submission device) is not intended for mammography.

The X3C 1100 is a modification to Xplorer 1100 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1100 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1100 system is manufactured by Imaging Dynamics.

This submission (K071408) is for a X3C 1100 motorized patient table with digital radiographic detector. This device is a modification of an existing device, where the digital radiographic detector component has been updated.

The key takeaway is that no clinical studies were conducted for this 510(k) submission. The manufacturer relied on non-clinical tests and demonstrating substantial equivalence to a predicate device (Xplorer 1100, K062417) to meet acceptance criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. No clinical test set was used for this submission. The evaluation was based on non-clinical tests and comparison to a predicate device.
• Data Provenance: Not applicable for clinical data. Non-clinical test data provenance is not specified beyond being generated by Imaging Dynamics Company Ltd.

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

• Not applicable. No clinical test set requiring expert ground truth establishment was conducted for this submission.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication was conducted for this submission.

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

• No MRMC comparative effectiveness study was done. The submission explicitly states: "Clinical tests: No clinical tests conducted."

6. Standalone (Algorithm Only) Performance Study

• Not applicable. This device is a digital radiographic detector integrated into an X-ray system, not a standalone algorithm. Also, no clinical studies were performed.

7. Type of Ground Truth Used

• Not applicable for clinical studies. For the non-clinical tests, the "ground truth" would be established by engineering specifications, regulatory standards, and performance against the predicate device through direct comparison testing.

8. Sample Size for the Training Set

• Not applicable. This device does not appear to involve AI/ML requiring a training set in the context of this submission. The evaluation was primarily engineering-based and comparison to a predicate device.

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

• Not applicable, as no training set was used.

Ask a specific question about this device

The X3C 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pediatic patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatri patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1600 (510k submission device) is not intended for mammography.

The X3C 1600 is a modification to Xplorer 1600 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1600 system is replaced with X3C digital radiographic detector, previously marketed device under 1000 The X3C 1600 system is manufactured by Imaging Dynamics.

The provided text describes a 510(k) submission for the X3C 1600 Digital Radiographic System. This is a submission for a modification to an existing device (Xplorer 1600), where the detector is replaced. The key takeaway from the provided information is that no clinical tests were conducted for this device. Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the submission relies on the concept of "substantial equivalence" to a predicate device (Xplorer 1600, K042041). This means the manufacturer demonstrated that the new device (X3C 1600) is as safe and effective as a legally marketed device without needing to perform new clinical trials.

Given that no clinical study was conducted, I cannot provide information on acceptance criteria related to device performance in a clinical setting, sample sizes, expert ground truth, MRMC studies, or standalone performance.

However, I can extract the information provided regarding the non-clinical tests and the basis for substantial equivalence.

Based on the provided text, here is what can be inferred about the acceptance criteria and the "study" (non-clinical evaluations) proving the device meets them:

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

Since no clinical study was performed, there are no reported clinical performance metrics in terms of sensitivity, specificity, accuracy, etc. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence through non-clinical evaluations.

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

• No clinical test set was used. The evaluation was based on non-clinical tests for an engineering modification and comparison to a predicate device.
• Data provenance: Not applicable as no clinical data was generated for this specific 510(k) submission.

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 clinical test set requiring expert ground truth was used.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

• No MRMC study was done. This is not an AI-assisted device, and no clinical studies were performed.

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

• Not applicable. This device is a digital radiographic system, not an algorithm, and no standalone clinical performance was assessed for this 510(k) submission. The evaluation was non-clinical.

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

• Not applicable. No clinical ground truth was established as no clinical study was conducted. The "ground truth" for the non-clinical evaluations would be established engineering and quality standards for device performance, safety, and effectiveness.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, and no training set was used in the context of this 510(k) submission.

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

• Not applicable. No training set was used.

Ask a specific question about this device

The X3C 1600 PLUS is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1600 Plus (510k submission device) is not intended for mammography.

The X3C 1600 Plus is a modification to Xplorer 1600 Plus where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1600 Plus system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1600 Plus system is manufactured by Imaging Dynamics.

The provided text describes a 510(k) submission for the X3C 1600 Plus Digital Radiographic System. However, it explicitly states that no clinical tests were conducted for this device, and its substantial equivalence was determined based on non-clinical tests comparing it to a predicate device. Therefore, it is not possible to provide information on acceptance criteria and a study proving the device meets them, as no such study focusing on clinical performance was performed or referenced in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Xplorer 1600 Plus) by replacing a detector, and relies on non-clinical tests (performance, biocompatibility, safety) to support this claim.

To address the specific points of your request based on the absence of clinical data in this submission:

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

• Acceptance Criteria: Not specified for clinical performance as no clinical study was conducted. Non-clinical acceptance criteria would likely relate to technical specifications, safety standards, and performance against the predicate device in areas like image quality metrics (e.g., DQE, MTF), and electrical/mechanical safety (e.g., IEC 60601). These specific criteria and their reported performance are not detailed in the provided text.
• Reported Device Performance: In terms of clinical performance, none reported as no clinical tests were conducted. The submission states, "The device has been evaluated for performance, biocompatibility and effectiveness as well as thermal, electrical and mechanical safety and has been found to substantially equivalent to predicate device." However, specific quantitative performance metrics are not given.

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

• Sample Size: Not applicable for clinical tests as none were performed.
• Data Provenance: Not applicable for clinical tests.

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

• Not applicable as no clinical study with a test set requiring ground truth establishment by experts was conducted.

4. Adjudication method for the test set

• Not applicable as no clinical study with a test set requiring adjudication was conducted.

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 performed. This is a digital radiographic system, not an AI or CAD device. The submission explicitly states "No clinical tests conducted."

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

• Not applicable. This is a medical imaging hardware system, not an algorithm being tested for standalone performance.

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

• Not applicable as no clinical study requiring ground truth was conducted.

8. The sample size for the training set

• Not applicable as no clinical training set was used for an AI/CAD algorithm.

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

• Not applicable as no clinical training set was used for an AI/CAD algorithm.

Ask a specific question about this device

The X3C 1590 is intended for use by a qualified/trained doctor or lechnologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1590 (510k submission device) is not intended for mammography.

The 1590 Digital Radiographic System is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained day or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with the patient sitting, standing or lying in the prone or supine positions.

The X3C 1590 is a modification to Xplorer 1590 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1590 system is replaced with X3C digital radiographic detector, previously marketed device under K070079. The X3C 1590 system is manufactured by Imaging Dynamics.

The provided text is a 510(k) summary for the X3C 1590 Digital Radiographic System. It details a special 510(k) submission where a component (digital radiographic detector) of an existing device (Xplorer 1590) is replaced with a previously marketed device (X3C digital radiographic detector).

Based on the provided information, the device does not have specific acceptance criteria or a study demonstrating performance against those criteria in the typical sense of an AI/ML device or a device requiring new clinical performance data.

Here's a breakdown of why and what information is (or isn't) present:

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

• Acceptance Criteria: Not explicitly stated as pass/fail metrics. The submission focuses on substantial equivalence to a predicate device.
• Reported Device Performance: The document states that the device has been evaluated for "performance, biocompatibility and effectiveness as well as thermal, electrical and mechanical safety" and found to be "substantially equivalent to predicate device." No specific quantitative performance metrics are provided for the X3C 1590 system itself in this summary. The performance of the individual components (Xplorer 1590 system and X3C digital radiographic detector) must have been established in their respective prior 510(k) submissions (K062405 and K070079).

2. Sample sized 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 "Clinical tests: No clinical tests conducted." The evaluation relied on non-clinical tests and a comparison to a predicate device.

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 clinical studies were conducted, so no ground truth was established by experts for a test set in this submission.

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

• Not applicable. No clinical studies were conducted.

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 submission is for a digital radiographic system, not an AI/ML algorithm. No MRMC study was performed, nor is AI assistance mentioned.

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

• Not applicable. This is not an AI/ML algorithm.

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

• Not applicable. No clinical ground truth was established for this submission. The "ground truth" here is the established safety and effectiveness of the predicate device and the approved components.

8. The sample size for the training set

• Not applicable. This is not an AI/ML algorithm that requires a training set.

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

• Not applicable. This is not an AI/ML algorithm.

Summary of Acceptance:

The acceptance of the X3C 1590 Digital Radiographic System is based on demonstrating substantial equivalence to a legally marketed predicate device (Xplorer 1590 - K062405). The key "study" proving this is a non-clinical evaluation comparing the modified device to the predicate device, focusing on:

• Non-clinical tests: Performance, biocompatibility, effectiveness, thermal, electrical, and mechanical safety.
• Fundamental scientific technology: The submission asserts that replacing the detector does not alter the fundamental scientific technology.
• Intended Use: The intended use remains the same as the predicate device.
• Quality Systems: The manufacturer conforms to 21 CFR part 820, ISO 9001, and ISO 13485 quality systems.

The FDA's decision to grant 510(k) clearance (as evidenced by the letter in the document) indicates they agreed that the device is substantially equivalent and does not require new clinical data for market entry.

Ask a specific question about this device

The Xplorer 2200 is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediation patients and other, performed with patient sitting, standing or lying in the prone or supine positions.

The Xplorer 2200 (510k submission device) is not intended for mammography.

The Xplorer 2200 is a combination of two Xplorer 1000 CCD imagers, a previously marketed device covered by 510k K992955. One imager is in the Xplorer 1100 radiographic table, a previously marketed device covered by 510k K062417 and the other imager is on a vertical stand, a previously marketed device covered by 510k K062405. The system is operated in conjunction with a celling mounted X-ray tube/collimator assembly. The Xplorer 2200 system is manufactured by Imaging Dynamics. The CCD Imagers are unchanged from that which is marketed under K992955.

The provided text does not contain acceptance criteria or a study that proves the device meets specific performance criteria.

Instead, the document is a 510(k) summary for the Imaging Dynamics Xplorer 2200 Digital Radiographic System. This type of submission focuses on demonstrating substantial equivalence to a previously legally marketed device (the predicate device) rather than presenting new performance data against acceptance criteria.

The key points from the provided text are:

• Device Description: The Xplorer 2200 is a combination of existing components (two Xplorer 1000 CCD imagers, an Xplorer 1100 radiographic table, and a vertical stand) with a ceiling-mounted X-ray tube/collimator assembly. The core imager technology is unchanged from a previously cleared device (K992955).
• Predicate Device: The Xplorer 1600 Digital Radiographic System (K042041).
• Comparison with Predicate Device: The manufacturer states that "The Xplorer 2200 is substantially equivalent to the currently marketed Xplorer 1600. Xplorer 2200 device does not alter the fundamental scientific technology from Xplorer 1600 predicate device." The only modification is the integration of existing components.
• Non-clinical tests: Evaluated for performance, biocompatibility, thermal, electrical, and mechanical safety, and found substantially equivalent to the predicate device.
• Clinical tests: "No clinical tests conducted."
• Conclusion: The device was evaluated against the predicate device for all performance, safety & effectiveness requirements and found to be substantially equivalent.

Therefore, I cannot provide the requested information because the provided text explicitly states that no clinical tests were conducted to establish new performance data against specific acceptance criteria for the Xplorer 2200. The regulatory approval was based on the substantial equivalence to a predicate device, leveraging the performance data and established safety/effectiveness of its constituent components.

To answer your specific points:

1. A table of acceptance criteria and the reported device performance: Not available. The submission relies on the substantial equivalence to the predicate device's performance, not new performance data for this specific combined system.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set was used.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set 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. This device is a digital radiographic system, not an AI-powered diagnostic tool, and no clinical study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical study was performed.
8. The sample size for the training set: Not applicable. The device is not an AI algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document details a Special 510(k) submission based on substantial equivalence and the integration of previously cleared components. It explicitly states that no new clinical tests were conducted for this specific permutation of the device.

Ask a specific question about this device