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The DUET MAGNA is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.

The device is a transportable Electromagnetic Extracorporeal Shock Wave Lithotripter incorporating a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and a Control subsystem. Also incorporated are interfaces for ECG synchronization, fluoroscopic imaging devices and sonographic imaging devices. The SWAG incorporates two stationary reflector-based electromagnetic transducers (Bottom and Top). Software control enables separate operation of the transducers in any one of three operating modes: "B" (Bottom only), "T" (Top only), "A" (B and T operate alternatively in a cyclic fashion, such that the time difference between the B and T pulses equals the time difference between the T and B pulses.

The provided text is a 510(k) summary for the DUET MAGNA Extracorporeal Shock Wave Lithotripter. It focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against those criteria as would be expected for an AI/ML device.

Therefore, many of the requested items related to AI/ML device performance studies (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment methods) are not applicable or available in this document.

However, I can extract the information relevant to the performance testing and substantial equivalence described, which serves as the basis for device acceptance in this context.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for devices like the DUET MAGNA in a 510(k) process are primarily based on demonstrating substantial equivalence to a legally marketed predicate device, ensuring the new device is as safe and effective. This typically involves meeting recognized standards for safety, performance, and functionality.

Study Information (as applicable for a non-AI/ML device)

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

   • Not Applicable / Not Provided: This device is a physical medical device (Extracorporeal Shock Wave Lithotripter), not an AI/ML software. The document describes compliance with performance and safety standards, but it does not involve a "test set" in the context of AI/ML performance evaluation. The testing would have involved engineering and functional tests on the device itself.

2. 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 / Not Provided: Ground truth and expert review are concepts relevant to AI/ML model validation, not typically for a physical medical device like a lithotripter being evaluated for substantial equivalence in this manner.

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

   • Not Applicable / Not Provided.

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

   • Not Applicable / Not Provided: This is not an AI-assisted diagnostic or interpretation device that would involve human readers.

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

   • Not Applicable / Not Provided: This is not an algorithm.

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

   • Not Applicable: For this device, "ground truth" would relate to the physical properties and functional performance measured against established engineering and medical device standards (e.g., shockwave pressure, localization accuracy, electrical safety, biocompatibility, etc.). These are assessed through physical testing, not expert consensus on diagnostic images or pathology.

7. The sample size for the training set

   • Not Applicable / Not Provided: No "training set" is mentioned as this is not an AI/ML device.

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

   • Not Applicable / Not Provided: No "training set" or corresponding ground truth establishment is described.

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Pronex is used to position a patient for prone breast radiation therapy.

The device comprise two rigid mechanical structures, each incorporating:

• A tabletop for supporting a patient's torso in the prone position such that a treated breast is able to hang down through a tabletop opening. The tabletops for each structure are identical.
• A selection of two application-oriented supporting structures. Each supporting structure is composed of a base for interfacing the device to a couch, and spacers that connect the tabletop to the base such that a space is provided for a treated breast. The applications are imaging and radiation treatment.

The imaging-oriented supporting structure is CT radiation transparent and is compatible with a 70cm bore and with a CT couch. The treatment-oriented supporting structure is treatment-radiation transparent and is compatible with the treatment couch. The supporting structures do not affect the patient's torso positioning on the tabletop, so as to allow imaging and treatment in the same position.

The respective couches provide positioning motion. The intended use, functionality, technological characteristics and materials of the device are similar to those of the predicate devices.

The provided text describes a medical device called "Pronex" and its 510(k) summary for FDA clearance. However, it does not contain the detailed information necessary to complete the requested table and study analysis.

Specifically, the document focuses on:

• The device's name, applicant, contact information, classification, and predicate devices.
• A general description of the device's components and intended use (positioning a patient for prone breast radiation therapy).
• The FDA's determination of substantial equivalence to predicate devices.
• The formal "Indications for Use Statement."

The document does not include any information regarding:

• Acceptance criteria for performance (e.g., specific measurements, thresholds).
• Reported device performance data.
• Details of a study conducted to prove the device meets acceptance criteria.
• Sample size for test or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study (AI vs. human readers).
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes, expert consensus).
• How ground truth for training data was established.

Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided input. The document establishes the device's regulatory clearance based on substantial equivalence to existing devices, inferring that safety and effectiveness are established by this comparison, rather than through a new performance study with explicit acceptance criteria.

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TrackPort is an online EPID intended to aid in target-to-beam relative positioning for administration of radiotherapy. It is indicated for all body procedures and operable in conjunction with TrackLeaf Micro Multi Leaf Collimating (MMLC) system

TrackPort

The provided text is a 510(k) premarket notification letter from the FDA to Direx Systems Corp. regarding their device, TrackPort. This document confirms substantial equivalence but does not contain information about the acceptance criteria or a study proving the device meets those criteria. It primarily focuses on the regulatory approval and indications for use.

Therefore, I cannot extract the requested information based on the provided text.

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TrackLeaf-10 is intended to assist the radiation oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

TrackLeaf-10 is a tertiary Micro Multi Leaf Collimating (MMLC) system. It performs the same functions as beam shaping blocks, circular or cut blocks collimators for Conformal and "step and shoot IMRT" treatments, and it also performs "dynamic arcs" and "dynamic IMRT" treatments.

TrackLeaf is a LINAC based Micro-Multi-Leaf-Collimator (MMLC), used in radiation treatment.

It enables shaping the Linac beam according to target geometrical and clinical requirements.

The device is composed of the MMLC modules the Linac interface modules the v Workstation (with TrackLeaf. Control. Software), and the Power Distribution module. »

The device operates in conjunction with a Linac, a treatment couch, a data file that contains the desired aperture parameters, and any additional equipment required in radiation treatment. In addition, means are provided to receive aperture offset data from an Image Guided Radiation Therapy (IGRT) system in order to perform leaves position adjustments.

MMLC apertures are generated by positioning the motor-driven leaves. TrackLeaf software operates as a sequential process of forming apertures.

TrackLeaf operation modes are: Step-and-Shoot, Dynamic Arc, and dynamic IMRT (DIMRT).

• Step-and-Shoot: TrackLeaf forms apertures while irradiation is off and gantry is stationary.
• Dynamic Arc: TrackLeaf forms apertures while irradiation is on and the gantry rotates.
• DIMRT: TrackLeaf forms apertures while irradiation is on and the gantry is stationary.

There is no information about acceptance criteria or a study proving the device meets acceptance criteria in the provided text.

The document is a 510(k) summary for a medical device (TrackLeaf-10, a Micro Multi-Leaf Collimator) that focuses on its substantial equivalence to predicate devices. It discusses the device's intended use, description, and classification, as well as regulatory compliance.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement.

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Accusoft-XL v.4.04 / CrossPlan is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radiation therapy.

CrossPlan / AccuSoft-XL v. 4.04 is an upgraded version of the Company's proprietary AccuSoft-XL. CrossPlan / AccuSoft-XL v. 4.04 is a radiation treatment planning system (RTPS), consisting of a collection of software modules that execute algorithms to produce estimates of beam radiation dose distribution in body tissues. It includes the image, delineation and beam planning techniques. CrossPlan / AccuSoft-XL v. 4.04 is designed to operate with Cones, Blocks and Wedges, as well as with a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular shape of the lesion. The ability to shape the radiation beam enables maximization of the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures. CrossPlan / AccuSoft-XL v. 4.04 is used for computation, display, evaluation, and output of dose estimations, including those for several modes of treatment, such as Conformal, Blocks and Wedges, Cones and Intensity Modulated Radiation Therapy (IMRT). There are several IMRT treatment modes: (1) Intensity Modulated Arc Therapy (IMAT) - in which an irradiating Linac rotates while leaves form a sequence of apertures (arcs), (2) Dynamic Intensity Modulated Radiation Therapy (DIMRT) – in which irradiating Linac is stationary while leaves form a sequence of apertures, as well as (3) Intensity Modulated Radiation Therapy (also called Step-and-Shoot), during which apertures are formed prior to irradiation As an option, some of the data can be imported via DICOM server that will include information of RT objects (RT Plan, RT Structure Set, RT Images) and CT Images. CrossPlan / AccuSoft-XL v. 4.04 is able to combine two registered images to create a fusion image. This is often used to combine two images acquired differently but from a single source to enhance the display of various materials or tissues.

The provided text describes a 510(k) premarket notification for a radiation treatment planning system (RTPS) called AccuSoft-XL v. 4.04 (also marketed as CrossPlan). However, it does not contain the specific information required to complete the detailed breakdown of acceptance criteria and a study proving device performance as requested.

Here's why and what information is missing:

• Acceptance Criteria and Reported Performance Table (Item 1): The document lists voluntary standards that the device complies with (IEC 60601-1-4, FDA guidances), but these are general guidelines for software in medical devices, not specific performance acceptance criteria for dose computation or a comparative table of measured performance against those criteria.
• Study Details (Items 2-7): The text mentions "performance validation" and "performance testing" but provides no details on any specific study, including sample size, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or the type of ground truth used.
• Training Set Details (Items 8-9): Information about the training set size or how its ground truth was established is completely absent.

Conclusion:

Based on the provided text, it is not possible to fill in the requested table and answer the questions about the study that proves the device meets acceptance criteria. The document focuses on regulatory compliance through substantial equivalence to predicate devices and adherence to general software standards, rather than detailing a specific performance validation study with quantitative acceptance criteria.

To answer your request, such a study would typically be detailed in a separate section of the 510(k) submission, often under "Performance Data" or "Clinical Performance," which is not present in the provided "510(k) Summary."

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Integra SL is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and upper ureter.

Integra SL is a transportable Electromagnetic (EM) Extracorporeal Shock Wave Lithotripter (ESWL) used for urinary stones treatment. The device consists of a Shock Wave Generator (SWAG), a Urological Table (UT) and the remote controls. Integra SL also contains the necessary interfaces for fluoroscopic and (or) ultrasonic imaging devices. The device has no Software control.

Integra SL includes the following features:

• EM Shockwave generator with parabolic reflector for focusing mechanism
• Swinging reflector (i.e. shockwaves are produced by angularly moving the shockwave while keeping the Therapeutic focus (F2) at the stone such that the shockwaves converge on the stone from multiple orientations).
• A stand alone UT unit
• Modular construction

Here's a summary 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 Data Provenance

• Sample Size: Not applicable. The document states "No clinical tests were performed." Performance testing was based on compliance with engineering and safety standards.
• Data Provenance: Not applicable, as no clinical tests were performed.

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

• Not applicable. No clinical tests were performed, and thus no expert-established ground truth for a test set was required.

4. Adjudication Method for the Test Set

• Not applicable. No clinical tests were performed.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states "No clinical tests were performed."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This device is an Extracorporeal Shock Wave Lithotripter (ESWL), a physical medical device, not an algorithm or software requiring standalone performance evaluation in the context of AI. The device has "no Software control."

7. Type of Ground Truth Used

• Not applicable. No clinical tests were performed. The "ground truth" for this submission refers to compliance with safety and performance standards for a physical device.

8. Sample Size for the Training Set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable. This is not an AI/ML device requiring a training set.

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

The Direx Systems Corporation Integra SL device's acceptance criteria are primarily based on its compliance with a series of recognized international and national standards for medical devices, specifically those pertaining to Extracorporeal Shock Wave Lithotripters (ESWLs). The document lists several IEC, ANSI/AAMI/ISO standards, and FDA guidance documents.

The study proving the device meets these criteria is described as "Performance Testing" within the 510(k) submission. This does not involve clinical trials or studies with human subjects. Instead, it refers to in-house engineering and laboratory testing to ensure the device's design and functionality align with the safety, electrical, mechanical, and performance specifications outlined in the referenced standards. The submission asserts that the Integra SL "was tested according to the following standards:" and implicitly states that by meeting these standards, it fulfills the performance requirements.

The submission also leverages a "special 510(k)" pathway, stating that the Integra SL "meets the requirements for a special 510(k) by the virtue of being a minor modification, which does not change the fundamental technology or reduce safety and effectiveness, of the Company's predicate device, Integra." This implies that the safety and effectiveness are largely established through the predicate device's prior clearance and the current device's adherence to the same core technology and performance standards, without new clinical data being necessary for this specific modification.

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AccuSoft-XL is to be used for the computation, display, evaluation and output of radiation dose estimations to be submitted for independent clinical review and judgment prior to use in radia fon therapy.

AccuSoft-XL is a radiation treatment planning system (RTPS), consisting of a collection of software modules that execute algorithms to produce estimates of beam radiation dose distribution in body tissues. It includes the image, delineation and beam planning techniques. AccuSoft-XL is an upgraded version of the Company's proprietary AccuSoft v3.14. It is designed to operate with Cones, Blocks and Wedges, as well as with a Micro-Multi-Leaf Collimator (MMLC), such that the shape of the radiation beam conforms to the irregular, shape of the lesion. The ability to shape the radiation beam enables maximization of the radiation dose to the lesion, while minimizing the radiation dose to the surrounding normal tissue and critical structures. AccuSoft-XL is used for computation, display, evaluation, and output of dose estimations, including those for several modes of treatment, such as Conformal, Blocks and Wedges, Cones and Intensity Modulated Radiation Therapy (IMRT). There are several IMRT treatment modes: (1) Intensity Modulated Arc Therapy (IMAT) – in which an irradiating Linac rotates while leaves form a sequence of apertures (arcs), (2) Dynamic Intensity Modulated Radiation Therapy (DIMRT) – in which irradiating Linac is stationary while leaves form a sequence of apertures, as well as (3) Intensity Modulated Radiation Therapy (also called Step-and-Shoot), during which apertures are formed prior to irradiation The Linac and Cones / MMLC configuration parameters shall be written to a file to be sent to both the Linac and the Company's proprietary Cone Changer / MMLC devices. In the AccuFusion module, AccuSoft-XL combines two different types of axial images. This enables to enhance the display of various materials or tissues and to perform target delineation on fused images. Thus, CT images and Secondary Images (CT, MRI, PET, etc.) in DIOOM format from the same patient can be combined, resulting in an improved single image.

The provided document (K062032) is a 510(k) summary for the AccuSoft-XL radiation treatment planning system. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain acceptance criteria or detailed study results proving the device meets acceptance criteria.

The document states:

• "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act."
• "Based on validations and performance testing results, Direx Systems Corp. believes that AccuSoft-XL is substantially equivalent to the above predicate devices without raising new safety and/or effective use issues." (This implies that testing was done, but the results are not detailed here).

Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically does not include the detailed testing protocols and results that would be found in the full 510(k) submission.

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Vert-X is a mobile apparatus used for fluoroscopic examination of a patient.

Vert-X is a compact, mobile fluoroscopic system designed for general fluoroscopic imaging. Vert-X acquires, processes, displays, and stores x-ray images, for image diagnosis.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI or clinical effectiveness.

Here's a breakdown of why and what information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not found. The document states "No clinical tests were performed" and describes "Performance Testing" only in terms of compliance with various IEC and ISO standards for electrical safety, electromagnetic compatibility, and risk management. These are regulatory compliance standards, not clinical performance metrics or specific device-performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task).

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

• Not applicable/Not found. Since no clinical tests were performed, there is no "test set" in the context of evaluating diagnostic or prognostic performance. The document refers to "Vert-X was tested according to the following standards," but this refers to compliance testing, not a study involving patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable/Not found. No clinical study was performed, so there was no need for experts to establish ground truth for a test set.

4. Adjudication Method for the Test Set:

• Not applicable/Not found. No clinical test set was used.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical tests were performed." Therefore, there is no effect size related to human reader improvement with AI.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

• No, a standalone algorithm performance study was not done. The device, Vert-X, is a mobile fluoroscopic system, a hardware device for imaging, not an AI algorithm. The document states "No clinical tests were performed."

7. The Type of Ground Truth Used:

• Not applicable/Not found. No clinical study was conducted that would require a "ground truth" to evaluate diagnostic performance. The ground truth for the "Performance Testing" refers to the requirements of the listed standards.

8. The Sample Size for the Training Set:

• Not applicable/Not found. This device is a hardware imaging system, not an AI model that requires a training set of data.

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

• Not applicable/Not found. As it's not an AI model, there's no training set or associated ground truth.

Summary of Device and Approval:

The Vert-X device is a mobile fluoroscopic x-ray system. Its 510(k) approval (K061873) in 2006 was based on substantial equivalence to a predicate device (Direx 3Dscope, K053640). This was a "special 510(k)" because it was considered a "minor modification, which does not change the intended use, fundamental technology or reduce safety and effectiveness" of the predicate device. The performance testing mentioned specifically related to compliance with recognized electrical, safety, and risk management standards (IEC, ISO, FDA CDRH regulations), not clinical efficacy or diagnostic accuracy studies involving patient data or AI.

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MAGIS1 / MAGIS2 is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures

MAGIS1 and MAGIS21 are self-supported, added-on mobile imaging systems incorporating one or two X-ray channels respectively. MAGIS is mechanically coupled to the Linac Gantry and the couch, and is capable of rotating with both. MAGIS acquires and processes stereoscopic images for deriving localization data, in the form of discrepancy between planned and actual object position. Localization methods include markers trianqulation and DRR comparisons to acquired images.

MAGIS incorporates X-ray production and detection modules mounted on extension arms attached to a Ring. The ring has a bore large enough to accommodate a patient and is operable to rotate about a horizontal axis, whereas said axis is parallel to couch direction and intersecting the isocenter.

MAGIS also incorporates a Console for user interface and for accommodation of the image acquisition, processing, display and user interface equipment.

The provided text discusses the MAGIS1 and MAGIS2 devices for radiation therapy patient setup and their substantial equivalence to predicate devices, but it does not contain any performance testing results, acceptance criteria, or details of a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information from the given input.

The document only lists the following:

• Intended Use: Aid in patient target to radiation beam set-up for administration of radiation therapy, indicated for all body procedures.
• Device Description: Self-supported, added-on mobile imaging systems (one or two X-ray channels) that acquire and process stereoscopic images for deriving localization data (markers triangulation and DRR comparisons).
• Performance Testing List: A list of IEC and FDA standards the device was tested according to, but no results or specific acceptance criteria are provided. The standards listed are:
  • IEC 60601-1 (1988) + A1(1991) + A2 (1995)
  • IEC 60601-1-1 (2000)
  • IEC 60601-1-2 (2001)+A1(2004)
  • IEC 60601-1-3 (1994)
  • IEC 60601-2-7 (1998)
  • FDA CDRH 21CFR 1020.30
  • FDA CDRH 21CFR 1020.32
  • IEC 60601-1-4 (1996) + A1(1999)
• Substantial Equivalence: Claimed based on descriptive information and performance testing (without providing details of those tests).

To answer your request, a different document containing the actual performance study details would be needed.

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MIGUE is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures.

MIGUE is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. MIGUE uses x-ray registration as the method of locating the position of the patient. It is indicated for all body procedures.

The device consists of three units:

1. MIGUE Main Unit incorporates two angularly spaced identical Fluoroscopic Channels, mounted on a rigid ring, for acquisition of X-ray images.
2. Console Workstation PC with embedded software, used for control, display and image processing.
3. Electronics Cabinet.

Principle of operation:
a) Acquire two images, one from each channel.
b) Each channel displays an acquired image and a marker indicating the IsoCenter projection onto the fluoroscopic screen.

The provided text does not contain detailed information regarding the acceptance criteria, study design, or performance data for the MIGUE device. The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on the device's substantial equivalence to predicate devices and its indications for use.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can be inferred or stated from the provided text, and what cannot:

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

This information is not present in the provided text. The document states "The Substantial Equivalence table provides a comparison of MIGUE's technological characteristics to those of the predicate devices. The table is located in Section 8 of this submission." However, Section 8 is not included in the provided snippets. Without this section, specific acceptance criteria or performance metrics are unknown.

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

This information is not present in the provided text. The document does not describe any specific clinical or performance studies, test sets, or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the provided text. There is no mention of ground truth establishment or expert involvement in any testing.

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

This information is not present in the provided text. No adjudication method is described.

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

This information is not present in the provided text. The MIGUE device, as described, is an X-ray registration system for patient placement, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be applicable, and no such study is mentioned.

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

This information is not explicitly stated as a formal "standalone study." However, the description of MIGUE indicates its primary function is automated X-ray registration for patient positioning. Its "Principle of operation" describes acquiring images, displaying them, and indicating the isocenter projection. This implies an inherent standalone algorithmic function to perform its intended task, operating without direct human intervention in the core image analysis for positioning (though human oversight and control are certainly part of the workflow). The document doesn't detail a specific study proving this standalone performance, but the device's function implies it.

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

This information is not present in the provided text.

8. The sample size for the training set

This information is not present in the provided text. There is no mention of a "training set," implying that if machine learning is involved, it's not discussed in this summary, or the device relies on traditional image processing/registration algorithms rather than learned models requiring a training set.

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

This information is not present in the provided text, as no training set or ground truth for it is mentioned.

In summary, the provided document is a regulatory submission summary (510(k)) focusing on equivalence to predicate devices and indications for use, rather than a detailed technical or clinical study report. Therefore, most of the requested performance and study details are not available within the given text.

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