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Intended for use by a qualified/trained doctor or technologist on both and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography

This device is a medical x-ray image acquisition device. X-rays generated by X-ray generator/ tube that penetrate patient's body are converted to a digital file by the detector. After that the detector sends this digital file to a pc where the companion software has been installed. This software was cleared in our previous submission, K170202. A monitor displays this image. Images can then be transferred via the DICOM protocol. This device is nearly identical to the predicate but now the digital panels have Wi-Fi in addition to Ethernet interfaces. The Aquarius 8600 will be marketed in two possible configurations: Aquarius 8600 1717WCl (tethered or wireless), 17 x 17 inch flat panel as a retrofit package with Magellan software). Aquarius 8600 1417WCl (tethered or wireless), 14 x 17 inch flat panel as a retrofit package with Magellan software).

The provided text is a 510(k) premarket notification for a stationary x-ray system (Aquarius 8600 1417WCI; Aquarius 8600 1717WCI). It describes the device, its similarity to a predicate device, and the non-clinical tests conducted to establish substantial equivalence.

Based on the provided information, no specific acceptance criteria or a dedicated study proving the device meets those criteria are explicitly detailed in a format that would allow for a complete answer to all parts of your request.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Aquarius 8600 1417TC/1717TC, K170202) and references a cleared flat panel detector (K160810). The testing described is primarily non-clinical.

Here's an analysis of what information can be extracted and what is missing:

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

No explicit table of acceptance criteria is provided. The document states "Performance characteristics" are similar to the predicate and provides some technical specifications (MTF, DQE, Panel Resolution, Pixel Size) for both the predicate and the new device. It notes that the new panels have "slightly better MTF" and "slightly lower DQE," implying these performance characteristics were measured against the predicate's performance rather than predefined acceptance criteria.

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

The document mentions "Clinical images were provided," but explicitly states "these images were not necessary to establish substantial equivalence based on the modifications to the device... but they provide further evidence... that the complete system works as intended."

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not applicable, as the clinical images were not presented as part of a formal study with ground truth established by experts for performance evaluation against a specific clinical claim. They were "further evidence" of system functionality.

4. Adjudication method for the test set

Not applicable, as no formal clinical study with ground truth and expert adjudication is described for the purpose of establishing device performance against acceptance criteria.

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 an x-ray imagine acquisition device, not an AI-powered diagnostic tool. No AI component is mentioned.

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

Not applicable. This device is an x-ray imagine acquisition device, not an algorithm.

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

Not applicable, as no formal clinical study with ground truth for performance evaluation is described. For the non-clinical bench testing, the "ground truth" would be the physical properties and measurements of the device components themselves, following established engineering and physics principles.

8. The sample size for the training set

Not applicable. This is a hardware device (x-ray panel and system), not an AI algorithm requiring a training set.

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

Not applicable. This is a hardware device, not an AI algorithm.

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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, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

The Aquarius 8600 1717TG and Aquarius 8600 1417TG are digital flat panels, specifically termed solid state digital X-Ray detector. This technology couples a scintillator with an a-Si TFT sensor, and through integration with a radiographic imaging system, x-ray images can be captured and digitalized. The resulting RAW files are DICOM 3.0 compatible allowing image files to be processed by IDC Magellan software.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Information:

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

   • Sample Size: Not explicitly stated as a number of images or cases in the provided text for the DQE, MTF, NPS, or visual assessment tests. For the visual assessment, it mentions "laboratory images using phantoms were acquired." These are likely a set of standardized phantom images.
   • Data Provenance: The data for DQE, MTF, and NPS are from "measured" curves, implying direct testing of the device hardware. The visual assessment used "laboratory images using phantoms." This suggests the data is prospectively generated from controlled laboratory settings, not from patient data. The country of origin for the testing is not specified, but the applicant company is located in Canada.

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

   • Number of Experts: One (a single Radiological Technologist).
   • Qualifications: "A Radiological Technologist certified in the United States of America and Canada." Specific experience level (e.g., years) is not provided.

3. Adjudication method for the test set:

   • No adjudication method is described for the visual assessment. A single expert made the determination without mention of a consensus or tie-breaking process. For the DQE, MTF, and NPS, these are quantitative measurements that do not require expert adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done. The submission states: "No clinical testing was performed for this special 510(k) submission." The visual assessment mentioned was a comparison of phantom images by a single technologist, not a clinical study involving multiple readers assessing patient cases. Also, this device is an X-ray detector, not an AI-assisted diagnostic tool, so improvement with AI assistance is not applicable in this context.

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

   • This is not applicable as the device is a digital X-ray detector, not a standalone algorithm. Its performance is measured directly through physical parameters (DQE, MTF, NPS) and its ability to produce diagnostic images.

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

   • For the DQE, MTF, and NPS measurements, the "ground truth" is generally considered to be the intrinsic physical properties of the detector, measured against established standards and methodologies.
   • For the visual assessment, the "ground truth" was the subjective opinion of a single certified Radiological Technologist comparing images from the proposed device to the predicate device using phantoms.

7. The sample size for the training set:

   • Not applicable/Not provided. This device is a hardware component (digital flat panel detector) and associated software for image acquisition and processing. It does not employ machine learning or AI models that require specific "training sets." The IDC Magellan software underwent "full system level verification, validation and regression testing" as part of its development, but this is software testing, not ML model training.

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

   • Not applicable, as there is no specific "training set" in the context of machine learning model development for this device. The software validation relies on established software engineering principles and testing against specifications inherent to its function.

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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. Not intended for mammography.

The Aquarius 8600 1417WC is a digital flat panel (specifically termed solid state digital X-Ray detector), with the option for users to use the detector in either a tethered or wireless mode. This technology couples a scintillator with an a-Si TFT sensor, and through integration with a radiographic imaging system, x-ray images can be captured and digitalized. The resulting RAW files are DICOM 3.0 compatible allowing image files to be processed by IDC Magellan software.

This 510(k) submission describes the Aquarius 8600 1417WC, a digital flat panel X-ray detector. It is a modification of a previously cleared device (Aquarius 8600 1717TC) and integrates a 510(k)-cleared tethered/wireless flat panel detector with existing software and workstation components. The submission focuses on demonstrating substantial equivalence to the predicate device.

Here's an analysis of the provided text in the context of acceptance criteria and supporting studies:

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

The document doesn't explicitly define "acceptance criteria" in a quantitative manner for specific diagnostic tasks. Instead, it compares the technological characteristics and performance metrics of the proposed device (Aquarius 8600 1417WC) with those of the predicate device (Aquarius 8600 1717TC), aiming to demonstrate "similar" or "better" performance, thereby supporting substantial equivalence.

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

• Sample Size for DQE, MTF, NPS: Not explicitly stated as a numerical count of images or measurements. These are physical characteristics of the detector itself, typically measured under controlled laboratory conditions, not on a "test set" of patient images in the traditional sense.
• Sample Size for Diagnostic Similarity: "Laboratory images using phantoms were acquired with the proposed Aquarius 8600 1417WC detector and compared to images acquired with the Aquarius 1717TC predicate device." The number of phantoms or images is not specified.
• Data Provenance: The DQE, MTF, and NPS measurements are laboratory-derived data. The "laboratory images using phantoms" are also laboratory-derived. There is no indication of country of origin for the data; it would likely be from the manufacturer's testing facilities. The tests are non-clinical.

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

• Number of Experts: "A Radiological Technologist certified in the United States of America and Canada has reviewed the images (included in this submission)..." This indicates one radiological technologist was involved.
• Qualifications of Experts: "Radiological Technologist certified in the United States of America and Canada." (No mention of years of experience or specialization beyond general radiology).

4. Adjudication method for the test set:

• No formal adjudication method (e.g., 2+1, 3+1) is described for the image review to establish diagnostic similarity. It appears to be a single reviewer's assessment.

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. The device is a digital X-ray detector, not an AI-assisted diagnostic tool. The comparison is between the performance of the proposed detector and a predicate detector, not between human readers with and without AI assistance.

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

• Yes, in spirit, for the detector's physical performance. The DQE, MTF, and NPS measurements represent the standalone performance of the detector hardware. While a human is involved in analyzing the output (e.g., in phantom image review), the core metrics (DQE, MTF, NPS) characterize the intrinsic performance of the detector itself, independent of a diagnostic interpretation by a human.

7. The type of ground truth used:

• For DQE, MTF, NPS: These are objective physical performance metrics measured under controlled laboratory conditions using established methodologies. The "ground truth" is the accurately measured physical response of the detector.
• For Diagnostic Similarity: The "ground truth" is essentially the predicate device's image quality, which is already considered diagnostically acceptable. The expert's role was to confirm that the proposed device's images (of phantoms) were "diagnostically similar" to those of the predicate device. This is a form of expert consensus/comparison against an established benchmark rather than an independent "ground truth" for disease detection.

8. The sample size for the training set:

• Not applicable. This submission is for a digital X-ray detector, which captures images. It does not describe an AI/machine learning model that would require a "training set" of images to learn from. The software (Magellan 3) processes and displays images but is not an AI algorithm in the context of typical training sets.

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

• Not applicable. As no training set for an AI/ML model is described, there's no mention of how ground truth for such a set would be established.

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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 and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography.

The Aquarius 8600 1717TC are digital flat panels, specifically termed solid state digital X-Ray detector. This technology couples a scintillator with an a-Si TFT sensor, and through integration with a radiographic imaging system, x-ray images can be captured and digitalized. The resulting RAW files are DICOM 3.0 compatible allowing image files to be processed by IDC Magellan software.

The Aquarius 8600 1717TC and 1417TC represents a modification of our own predicate device cleared under K070079, X3C Digital Radiographic Detector.

The Aquarius 8600 1717TC and 1417TC integrates the 510(k) cleared flat panel detectors (K122173 and K122919) with IDC Magellan software and workstation. There were no changes made to the cleared panels, workstation or software. All components were integrated and tested to make the Aquarius 8600 1717TC and 1417TC medical devices.

The Aquarius 8600 will be marketed in two possible configurations:
Aquarius 8600 1717TC (tethered, 17 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1717TC" throughout the rest of this document
Aquarius 8600 1417TC (tethered. 14 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1417TC" throughout the rest of this document.

The provided text describes a 510(k) submission for the Aquarius 8600, a digital flat panel X-ray detector. However, it does not include information about a study that proves a device meets acceptance criteria related to AI/Machine Learning device performance, as there is no AI component mentioned in this submission. The submission is for a radiographic imaging system and focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (DQE, MTF, NPS), safety testing, and software lifecycle documentation.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, ground truth establishment, expert adjudication, MRMC study, standalone performance against ground truth, training set details) are not applicable to this specific submission, as they relate to the validation of an AI/ML algorithm rather than a traditional medical imaging hardware component.

I will fill in the relevant information that is present in the document and explicitly state where information is not applicable or not provided.

Acceptance Criteria and Device Performance (Aquarius 8600)

The acceptance criteria here are implicitly defined by demonstrating "substantial equivalence" to a predicate device (IDC X3C Digital Radiographic Detector) through comparable performance metrics and safety standards. The study primarily relies on non-clinical (bench) testing.

1. Table of Acceptance Criteria (based on predicate equivalence) and Reported Device Performance

Note: The increase in NPS values for the Aquarius 8600 at lower spatial frequencies compared to the X3C detector is noted in the table but the document states they have "a similar noise performance profile". This suggests that while raw values may differ, the overall expected noise characteristics for diagnostic purposes were deemed acceptable for substantial equivalence.

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

• Test Set: Non-clinical (phantom) images were used. The document does not specify an exact number of phantom images or specific test scenarios beyond mentioning "Laboratory images using phantoms were acquired."
• Data Provenance: The testing was conducted by Imaging Dynamics Company, Ltd. (IDC) (Canada). The nature of the non-clinical testing (phantoms) means there's no patient data provenance to specify. The study is a pre-market submission for substantial equivalence, relying on bench tests, rather than a clinical trial with retrospective/prospective patient data.

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

• Number of Experts: One expert.
• Qualifications: A "Radiological Technologist certified in the United States of America and Canada." (Note: This is a technologist, not a radiologist, and their role was to review images for diagnostic similarity, not to establish a clinical "ground truth" from patient data.)

4. Adjudication method for the test set:

• Adjudication Method: None explicitly mentioned or applicable beyond the single radiologic technologist's review of phantom images. This was not a multi-reader clinical study requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted. The submission explicitly states: "No clinical testing was performed for this special 510(k) submission." The evaluation was primarily based on non-clinical performance parameters (DQE, MTF, NPS) and a subjective review of phantom images by one technologist.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study with human-in-the-loop AI assistance was conducted.

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

• Standalone Performance: Not applicable. This device is a digital X-ray detector, which is hardware, not an AI algorithm. Its "performance" is measured by physics-based parameters (DQE, MTF, NPS) derived from phantom images, not by an algorithm's diagnostic output against a clinical ground truth.

7. The type of ground truth used:

• Type of Ground Truth: For the quantitative performance metrics (DQE, MTF, NPS), the "ground truth" is established by the standardized measurement methodologies described in relevant international standards and best practices for X-ray detector characterization. For the qualitative image review, the "ground truth" was a subjective assessment by a certified technologist comparing images from the new device to the predicate using phantoms. No clinical "ground truth" (e.g., pathology, clinical outcomes) from patient data was used.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is a hardware device; there is no AI/ML algorithm that requires a "training set" in the context of this 510(k) submission.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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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. Not intended for mammography.

The innovaXion FP represents a modification of our own predicate K071402 X3C 1600 plus Digital Radiographic System. We now support the 510(k) cleared Samsung digital panel. The other radiographic equipment is identical to that supplied by Viztek in Ku 102123. We will market the product in four possible configurations:
. innovaXion FP 1600 Plus
innovaXion FP (flat panel as a retrofit package with Magellan FP software) .
. Magellan (software)

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The document mentions "Clinical images were acquired" but does not give a specific number.
• Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective in comparison, as "clinical images were acquired and compared to our predicate images," suggesting existing data from the predicate device was used for comparison.

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

• This information is not provided in the document. The abstract does not detail the process of establishing ground truth for the clinical images used in the comparison.

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

• No, a multi-reader, multi-case comparative effectiveness study of the device with human readers was not done or described. The study focuses on comparing the new device's images to the predicate device's images.
• This device is a digital X-ray system, not an AI-assisted diagnostic tool, so the concept of human readers improving with AI assistance is not applicable in this context.

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

• The study described is a standalone performance comparison of the device itself (new digital panel and software) against a predicate device, based on acquired clinical images. It assesses image quality and output, not an algorithm's diagnostic performance. Therefore, in a sense, it's a "standalone" evaluation of the imaging system.

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

• The document implies that the ground truth for the clinical images was established by the predicate images themselves serving as the reference. The new device's images were compared to these predicate images to determine if there were "no significant differences between them," implying the predicate images represented an acceptable standard. There's no mention of expert consensus, pathology, or outcomes data being used to establish a separate, independent ground truth.

8. The sample size for the training set

• This information is not applicable as the device is not an AI algorithm that requires a training set in the typical sense. It's a digital X-ray system.

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

• This information is not applicable for the same reason as point 8.

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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.

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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.

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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.

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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.

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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.

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