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The Cios Select is a mobile X-ray system intended for use in Operating room, Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

The Cios Select can operate in four different modes, Digital Radiography, Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of an intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

Theis 510(k) submission, Cios Select (VA21C) with Imagine Intensifier is a Mobile Carm X-ray System, which is a modification of the Cios Select (VA21) Image Intensifier originally cleared under Premarket Notification K210307 on March 04, 2021.

The Cios Select consists of two major units:

One is the acquisition unit with the C-arm and movable base containing the generator, power unit, system control, and tube housing assembly on one side of the C-arm and the image intensifier on the opposite side.

The second unit is the image display station with a moveable trolley for the image processing and storage system, image display, and documentation. Both units are connected to each other with a cable. The main unit is connected to the main power outlet and the trolley is connected to a data network.

The provided text describes a 510(k) premarket notification for a medical device called "Cios Select (VA21) Image Intensifier." This is a special 510(k) submission, meaning it concerns minor modifications to an already cleared predicate device (K210307). As such, the focus of the documentation is on demonstrating that the modified device remains substantially equivalent to the predicate, rather than proving novel performance.

Therefore, the document does not contain a typical "study" proving the device meets acceptance criteria in the sense of a clinical trial or performance study against specific, quantified metrics with a defined ground truth and expert review. Instead, the "acceptance criteria" are implied by compliance with safety and performance standards for an image-intensified fluoroscopic x-ray system, and the "study" is a series of verification and validation (V&V) tests to confirm that the modifications do not introduce new safety or effectiveness issues.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a special 510(k) for modifications, the "acceptance criteria" are primarily related to maintaining safety and performance equivalence to the predicate device and adhering to recognized standards. Specific quantitative performance metrics are not explicitly listed in a table format for the device's image quality or diagnostic accuracy in this submission narrative.

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

• Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of diagnostic performance involving patient data. The "tests" mentioned are non-clinical (bench testing, verification, and validation).
• Data Provenance: The study described is primarily non-clinical validation and verification. There is no indication of patient data being used for the performance evaluation in this specific 510(k) submission, as it relates to system modifications and demonstrating substantial equivalence. The predicate device's prior clearance would have relied on such data. Since clinical testing was deemed "not necessary" for this special 510(k), no patient data (retrospective or prospective, or country of origin) is specified for the current submission's performance evaluation.

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

• Not applicable as this submission describes non-clinical testing for substantial equivalence, not a diagnostic performance study requiring expert ground truth for patient data.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Not applicable for the same reason as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• No, an MRMC study was not performed. This device is an image intensifier system (mobile C-arm X-ray), not an AI-based diagnostic algorithm that assists human readers.

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

• No, this is a medical imaging hardware system with integrated software, not a standalone AI algorithm. The performance evaluation focuses on the safety and functionality of the modified system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• For the non-clinical tests described, the "ground truth" is defined by established engineering specifications, performance standards (e.g., IEC, AAMI, CFR), and functional requirements rather than medical ground truth like pathology or expert consensus on clinical cases. The tests verify that the device performs according to these engineering and regulatory specifications.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI model that underwent a separate and distinct training phase using a specific dataset. The "software" updates mentioned are for system control and image processing, not for a trainable machine learning model.

9. How the Ground Truth for the Training Set was Established:

• Not applicable for the same reason as above.

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The Garion is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

GARION is mobile fluoroscopy system is designed to provdie fluoroscopic and spot-film images of thepatient during diagnostic, surgical procedures. This device is a digital X-ray radiographic equipment that consists of high voltage generator, X-ray control unit, X-ray tube unit, Collimator, image processing unit. The image processing unit consists of medical image detector, power supply, medical image collecting unit and relevant software.

The provided text describes a 510(k) premarket notification for a medical device called "Garion", an image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device, "Zenition 70".

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to a predicate device rather than defining specific performance acceptance criteria for the Garion device against a set of quantitative metrics. The "performance" is implicitly assessed through a comparison of technical characteristics to the predicate.

The acceptance criterion, in this context, is that the Garion device's technological characteristics are substantially equivalent to the predicate device, implying similar safety and effectiveness. The reported performance is the direct comparison of these characteristics.

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

The document explicitly states: "9. Summary of clinical testing: Not required for a finding of substantial equivalene." This indicates that no clinical test set was used to evaluate the device's performance against specific acceptance criteria. The evaluation relies on comparing the technical specifications of the new device to the predicate device and adherence to relevant IEC standards.

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

Since no clinical test set was used, there were no experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document states that clinical testing was not required for substantial equivalence.

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

The "Garion" is an X-ray system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the same way as it would be for a pure software device. The evaluation is of the hardware and integrated software for image acquisition and display.

7. The Type of Ground Truth Used:

The "ground truth" for the substantial equivalence claim is effectively the established safety and effectiveness of the legally marketed predicate device (Zenition 70), supported by the device's compliance with applicable performance standards (IEC and FDA Radiation Safety Performance Standard). The comparison of technical specifications aims to show that the Garion device is sufficiently similar to the predicate to assume similar safety and effectiveness.

8. The Sample Size for the Training Set:

The concept of a "training set" is typically associated with machine learning or AI algorithms. Since this submission is for an X-ray system and does not mention any AI components requiring supervised learning, there is no training set in the conventional sense.

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

Not applicable, as there is no mention of a training set or AI algorithms requiring ground truth establishment.

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The Cios Select is a mobile X-ray system intended for use in Operating room. Traumatology, Endoscopy, Intensive Care Station, Pediatrics, Ambulatory patient care and in Veterinary Medicine.

The Cios Select can operate in four different modes, Digital Radiography, and Pulsed Fluoroscopy and Cassette exposure which are necessary in performing wide variety of clinical procedures, such as intraoperative bile duct display, fluoroscopic display of a intra-medullary nail implants in various positions, low dose fluoroscopy in pediatrics, fluoroscopic techniques utilized in pain therapy and positioning of catheters and probes.

This 510(k) submission, Cios Select (VA21) is a Mobile C-arm X-ray System. The Cios Select (VA21) is a modification of the Cios Select originally cleared under Premarket Notification K153232 on February 10, 2016.

The Cios Select consists of two major units:

One is the acquisition unit with the C-arm and movable base containing the generator, power unit, system control, and tube housing assembly on one side of the C-arm and the image intensifier on the opposite side.

The second unit is the image display station with a moveable trolley for the image processing and storage system, image display and documentation. Both units are connected to each other with a cable. The main unit is connected to the main power outlet and the trolley is connected to a data network.

The provided text is a 510(k) summary for the Cios Select (VA21) Image Intensifier, which describes modifications to an existing mobile X-ray system. The document focuses on demonstrating substantial equivalence to predicate devices through verification and validation of these modifications. It primarily references non-clinical performance testing and compliance with various standards.

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

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

The document does not provide a specific table of quantitative acceptance criteria and corresponding reported device performance values in the way one might expect for a diagnostic AI device. Instead, it details that the device underwent non-clinical performance testing to ensure compliance with several industry standards and regulations.

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 primarily discusses non-clinical performance testing and mentions "Bench test Summaries and System Verification and Validation testing." There is no mention of a "test set" in the context of clinical images or data provenance (country of origin, retrospective/prospective). The evaluations were primarily conducted in a laboratory or manufacturing setting.

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. This submission relies on engineering and regulatory compliance testing rather than clinical expert review of images for ground truth establishment.

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

Not applicable. As noted above, this submission does not involve a test set requiring expert adjudication for ground truth.

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 mentioned. The device is an image intensifier system, not an AI-powered diagnostic aid that assists human readers.

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

This refers to an X-ray imaging system, not an algorithm. The "standalone" performance refers to the system's ability to operate according to its specifications and regulatory standards. The documentation indicates that "Performance tests were conducted to test the functionality of Cios Select (VA21) System," implying standalone performance evaluation of the device itself.

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

For the non-clinical testing, the "ground truth" is defined by the technical specifications outlined in the various industry standards (e.g., IEC, AAMI) and regulatory requirements (e.g., 21 CFR sections) to which the device was tested for compliance.

8. The sample size for the training set

Not applicable. The document describes an X-ray imaging device and its software modifications, not a machine learning or AI algorithm that requires a "training set."

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

Not applicable, as no training set for a machine learning algorithm is discussed in the provided text.

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The Intensif Applicator is intended for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

EndyMed's Intensif Applicator is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (K08346) (EndyMed Pro). The Intensif Applicator has a custom grid array of micro electrodes that is used to deliver the energy into the tissue. The Intensif Applicator tip emits bipolar RF energy that flows between electrodes to create thermal heating of the tissue for hemostasis and coagulation. The Intensif Applicator consists of: . Disposable treatment element (tip) . RF electrodes on a disposable tip . Operation trigger.

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

1. Table of Acceptance Criteria and Reported Device Performance

Study Information

This device did not involve a clinical study with human subjects. The supporting studies are entirely preclinical and ex vivo.

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

• Test Set Sample Size: Not specified. The document mentions "a few Ex Vivo laboratory studies and Ex Vivo animal studies tests" but does not quantify the number of samples or animals used.
• Data Provenance: The studies were "Ex Vivo laboratory studies and Ex Vivo animal studies tests." The location where these studies were performed is not explicitly stated, but the company is based in Israel. This is a preclinical type of data.

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

• This information is not applicable as the studies were preclinical (ex vivo laboratory and animal) and did not involve human interpretation or expert evaluation to establish ground truth in the context of clinical outcomes. The "ground truth" was based on measurable physical and biological effects in the lab.

4. Adjudication Method for the Test Set

• Not applicable. There was no human expert adjudication of a test set as the studies were preclinical.

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 (MRMC) comparative effectiveness study was not performed. This device is not an AI-assisted diagnostic tool; it's an electrosurgical applicator.

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

• While the device itself operates without human intervention post-activation, this question is typically relevant for diagnostic algorithms or AI. For this medical device, the "standalone" performance refers to its ability to achieve its intended physical effect (electrocoagulation and hemostasis) as demonstrated in the ex vivo studies. It is not an "algorithm only" type of device.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance was established through measurable physical and biological effects in ex vivo laboratory settings and animal tissues. This included:
  • Evaluating thermal and biological effects.
  • Measuring power control and accuracy.
  • Testing safety features functionality.
  • Validating needle depth.

8. The Sample Size for the Training Set

• Not applicable. This device is a medical device for electrocoagulation and hemostasis, not an AI/machine learning algorithm requiring a "training set" of data in the conventional sense. Its design and performance are based on engineering principles and physical testing.

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

• Not applicable, as there was no "training set" in the context of AI/machine learning for this device.

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The Toshiba J-Advanced I.I. is designed to capture x-ray images on a phosphor, and convert the xray pattern into a corresponding light image of a higher energy density. The intended use of this product is commensurate with other products currently in the marketplace.

The J-Advanced I.I., Model RTP9211J-G11 is a modification to a previously cleared device, 6' I.I. system [K771298].

This 510(k) submission describes the Toshiba J-Advanced I.I., Model RTP9211J-G11, which is a modification to a previously cleared X-ray image intensifier system. The submission does not contain a detailed study with acceptance criteria and device performance as typically seen for novel AI/software devices. Instead, it relies on substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "A comparison of the performance characteristics of the new intensifier to the previous models shows nominally improved resolution and contrast specifications. There are no new claims of effectiveness and no new intended uses offered with this new intensifier."

Since this is an image intensifier, common performance specifications would revolve around image quality. However, specific numerical acceptance criteria and reported values are not explicitly stated in this summary. Instead, a qualitative "nominally improved" is provided.

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

This submission does not describe a clinical study in the form typically seen for new AI/software devices with a specific "test set" in the context of diagnostic accuracy. The device is a hardware component (an image intensifier), and its performance assessment is likely based on engineering specifications, bench testing, and potentially laboratory comparisons rather than a clinical trial with patient data. Therefore, this information is not applicable/not provided in the document.

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

As there is no clinical "test set" described for diagnostic accuracy, this information is not applicable/not provided.

4. Adjudication Method for the Test Set

As there is no clinical "test set" described for diagnostic accuracy, this information is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

The device described is an X-ray image intensifier, a hardware component for image acquisition, not an Artificial Intelligence (AI) or software-based diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable.

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

This is an X-ray image intensifier, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The type of Ground Truth Used

Given the nature of the device as an image intensifier, "ground truth" would likely refer to objective physical performance characteristics measured through engineering and quality control tests (e.g., MTF for resolution, contrast-to-noise ratio). The specific methods for establishing ground truth for resolution and contrast are not detailed in this summary but would be based on instrument-based measurements.

8. The Sample Size for the Training Set

This device is not an AI/machine learning model, so there is no training set in the typical sense. Performance is based on the physical characteristics and design of the intensifier.

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

As there is no training set, this information is not applicable.

Summary of the Study (as described in the 510(k) submission):

The submission for the Toshiba J-Advanced I.I., Model RTP9211J-G11, is based on demonstrating substantial equivalence to a previously cleared predicate device (Toshiba 6" I.I. System [K771298]). The "study" here is not a typical clinical trial but rather a comparison of technological characteristics and compliance with regulatory standards.

• Rationale for Equivalence: The document states, "This device employs the same technological characteristics as the predicate device. The changes to the device are a result of continuing technological development towards the goals of increasing efficiency and reducing cost."
• Performance Comparison: "A comparison of the performance characteristics of the new intensifier to the previous models shows nominally improved resolution and contrast specifications." This suggests direct comparison of technical specifications and possibly bench testing rather than clinical trials.
• Safety and Effectiveness Concerns: The device's safety and effectiveness are supported by its design and manufacture under Quality System Regulations (21 CFR § 820) and compliance with the Federal Diagnostic Equipment Standard (21 CFR § 1020.30 and 1020.33) and applicable parts of IEC-60601 Medical Device Safety standards.

In essence, the submission relies on the fundamental similarity of the technology, documented nominal improvements in key image quality metrics (resolution and contrast), and adherence to established regulatory and quality standards, rather than a specific clinical study with patient data and statistical endpoints.

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