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The MAGNETOM Systems with the Numaris 4 VA15A are indicated for use as magnetic resonance diagnostic devices (MRDD's) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, based upon 'H and "P metabolites, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM systems with the new Numaris 4VA15A is substantially equivalent to the predicate MAGNETOM Systems with Numaris 4VA12A. The MAGNETOM Systems which will be affected will be: The MAGNETOM 1.5 Tesla Sonata system, The MAGNETOM 1.5 Tesla Symphony system, The MAGNETOM 1.0 Tesla Harmony system, The MAGNETOM 0.2 Tesla Concerto system. This includes Siemens upgrades of currently used MAGNETOM Impact/Expert, Vision, and Open (Viva) systems to systems described above. Siemens Medical Systems is adding an upgrade in software and hardware to the currently available MAGNETOM Systems. The MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Numaris 4VA15A:

This document is a 510(k) summary for a software and hardware upgrade to existing Magnetic Resonance Diagnostic Devices (MRDDs) manufactured by Siemens. The core premise of the submission is that the upgrade, Numaris 4VA15A, does not significantly alter the safety or performance of the existing predicate devices. Therefore, the provided text does not contain a study specifically designed to establish new acceptance criteria or prove device performance through a clinical trial or a detailed bench test against new, specific metrics for the Numaris 4VA15A itself.

Instead, the submission argues for substantial equivalence by stating that the safety and performance parameters remain unchanged from the already cleared predicate devices.

Let's break down the information based on your requested points:

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

   There are no new acceptance criteria or reported device performance metrics specifically for the Numaris 4VA15A upgrade. The submission states that the safety and performance parameters are exactly the same as those described and cleared in the 510(k)s for the predicate devices.

   The document lists the following parameters as having no significant effect due to the Numaris 4VA15A upgrade:

   Category	Parameter	Reported Performance (for Numaris 4VA15A)	Acceptance Criteria (for Numaris 4VA15A)	Note
   Safety	Maximum Static Field	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)	These values are stated to be "exactly the same as described in the 510(k)s for these systems."
   	Rate of Change of Magnetic Field	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
   	RF Power Deposition	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
   	Acoustic Noise Level	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
   Performance	Specification Volume	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
   	Signal to Noise	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
   	Image Uniformity	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
   	Geometric Distortion	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
   	Slice Profile, Thickness and Gap	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)
   	High Contrast Spatial Resolution	(Implicitly unchanged from predicate)	(Implicitly unchanged from predicate)

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

   No specific test set or data provenance is detailed for the Numaris 4VA15A as a new device requiring performance validation. The submission relies on the existing clearance of predicate devices, stating that "the MRI systems are exactly the same as what was described and cleared in the predicate premarket notifications." "Laboratory testing were performed to support this claim of substantial equivalence and to show that the technological differences do not raise any new questions pertaining to safety and effectiveness," but no details on these lab tests (sample size, data provenance) are provided.

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 new ground truth establishment for a test set is described for the Numaris 4VA15A.

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

   Not applicable. No new test set is described.

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

   Not applicable. This is not an AI-assisted device, and no MRMC study is mentioned.

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

   Not applicable. This device is an MRI system upgrade, not a standalone algorithm.

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

   Not applicable for new ground truth establishment by this submission. The devices, when interpreted by a "trained physician," yield information that may assist in diagnosis, implying that clinical diagnosis (likely based on various inputs, including expert interpretation, potentially pathology, and patient outcomes) would form the ultimate ground truth for the predicate devices' diagnostic capabilities.

8. The sample size for the training set

   Not applicable. This document describes an upgrade to existing hardware/software, not a new algorithm that requires a training set.

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

   Not applicable. No training set is mentioned.

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The SIOS product is intended to optimize procedures in the operating room by providing consistent preoperative, intra-operative and post-operative equipment control, image and data handling, and networking capabilities.

The SIOS product is limited to use with the following products:

• (1) Wolf Endocam 3CCD Endocam 5507,
• (2) Wolf Light Source Auto-CP 5131,
• (3) Wolf Insufflator Laparo CO2 Pacu 2332, and
• (4) Maquet OR Table ALPHAMAQUET 1150.

The Siemens Integrated Operating System (SIOS) is a system capable of networking select medical and non-medical equipment in the operating room (OR) and allowing trained medical personnel direct control of the equipment using remote control (i.e. voice command, touch screen console). The device combines a number of individual functional units through a standard interface to a centralized computer control station.

The provided text is a 510(k) summary for the Siemens Integrated Operating System (SIOS), which is an older document (dated December 15, 1999, with a corrected letter on July 27, 2015). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed standalone performance studies with acceptance criteria as would be expected for a novel AI/ML-driven device today.

Therefore, the document does not contain the detailed information required to populate a table of acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment methods, or information about expert adjudication, MRMC studies, or standalone performance. The SIOS is described as a system for controlling existing medical and non-medical equipment in an operating room and networking capabilities, not a diagnostic or AI-driven interpretative device that would typically undergo such performance evaluations.

Here’s a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. The document does not define specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) for the SIOS. Its purpose is to control other devices and handle data.

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

• Cannot be provided. The document does not describe any specific test set or data used for performance evaluation in the context of a clinical study or diagnostic accuracy assessment. The submission focuses on the functionality and safety of the control system itself.

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)

• Cannot be provided. Since no specific test set requiring expert ground truth is mentioned, this information is not available.

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

• Cannot be provided. This information is not relevant or present in the document given the nature of the device and the 510(k) submission type.

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

• Cannot be provided. An MRMC study is not mentioned. The SIOS is an integrated operating system for control and data handling, not a device that assists human readers in interpreting medical images or data.

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

• Cannot be provided. The SIOS is a system for controlling other devices; it doesn't have an "algorithm-only" performance that would be evaluated in this context. Its function is to facilitate human operators' control of other equipment.

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

• Cannot be provided. No ground truth is established as the device is not making diagnostic or interpretative claims.

8. The sample size for the training set

• Cannot be provided. Training sets are typically associated with machine learning or AI models, which are not described for the SIOS in this document.

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

• Cannot be provided. As no training set is mentioned, this is not applicable.

Summary from the provided document:

The Siemens Integrated Operating System (SIOS) is a control and networking system for operating rooms. The 510(k) submission (K994231) demonstrates its substantial equivalence to predicate devices (HERMES™ Operating Room Control Center and Accessories by Computer Motion, and EndoALPHA™ Integrated Endosurgery System by Olympus). The "study" referenced in this context is the general comparison to these predicate devices, focusing on the technological characteristics and intended use rather than
quantitative performance metrics of a diagnostic or AI algorithm. The core functionality and safety were deemed equivalent by the FDA based on the comparison of features and intended use.

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The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner. The MAGNETOM Open Viva with the Permanent magnet is indicated for use as diagnostic imaging device to produce transversal, sagittal, coronal and oblique images of the internal structures of the head or body. The images produced by the MAGNETOM OPEN with the permanent magnet reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin lattice relaxation time (T1), spin-spin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

The MAGNETOM OPEN viva with the Permanent magnet is an open, whole body scanner.

This 510(k) submission describes a Magnetic Resonance Imaging (MRI) device, the Magnetom Open Viva with Permanent Magnet, and does not involve AI or algorithms. Therefore, many of the requested criteria, such as those related to AI algorithm performance, training sets, and expert adjudication, are not applicable.

Here's the relevant information based on the provided text:

Acceptance Criteria and Device Performance

The device is a medical imaging device (MRI) and its "performance" is assessed against established safety and technical specifications for MRI systems. The submission states that the modifications to this new model (a new permanent magnet) do not affect these critical safety and performance parameters.

Study Description for Substantial Equivalence

The study conducted was a laboratory testing to demonstrate "substantial equivalence" to a predicate device, the currently available MAGNETOM OPEN viva System. The purpose was to show that the technological differences (the new permanent magnet) do not raise any new questions pertaining to safety and effectiveness.

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

• Sample Size: Not specified in the provided text. The testing was laboratory-based, implying physical device measurements rather than patient data.
• Data Provenance: Not specified, but given it's laboratory testing of a device, it would be internal to the manufacturer's testing facilities. It's prospective testing of the manufactured device.

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

• Number of Experts: Not applicable. This is not a study involving human interpretation of images for diagnosis or ground truth establishment. It's about direct measurement of the device's physical and imaging characteristics.
• Qualifications of Experts: Not applicable.

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

• Not applicable. No human interpretation or adjudication of diagnostic findings was involved in this assessment for substantial equivalence.

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. This study is for a standalone MRI device, not an AI-assisted interpretation tool. Therefore, MRMC studies and effect sizes related to AI assistance are not applicable.

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

• No. This is not an algorithm. It's a medical imaging device. The "standalone" performance here refers to the device's physical and imaging capabilities.

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

• Ground Truth: The "ground truth" for this type of device evaluation is adherence to pre-defined engineering specifications, safety standards (e.g., those from the FDA guidance document for MR Diagnostic Devices), and performance metrics (e.g., Signal to Noise, Image Uniformity). These are objective, measurable parameters of the device itself.

7. The sample size for the training set:

• Not applicable. This is not an AI algorithm requiring a training set.

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

• Not applicable.

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The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format. The 3D-Angio package is intended to assist the physician in diagnosis and treatment of vessel malformations (i.e. aneurysms, AVMs, stenoses), particularly neuro-angiographic cases.

The 3D-Angio package is a x-ray imaging software option which allows the reconstruction of two-dimensional images acquired with a standard angiographic C-arm device into a three-dimensional image format.

This 510(k) summary for the 3D-Angio software option provides very limited information regarding acceptance criteria and performance studies. The document primarily focuses on establishing substantial equivalence to a predicate device based on its technological characteristics and intended use. Therefore, much of the requested information cannot be extracted from the provided text.

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

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

No explicit acceptance criteria are mentioned in the provided text. The document states that the 3D-Angio software is "substantially equivalent" to the GE Advantage 3D XR, implying that its performance is comparable to that device. However, no specific performance metrics or acceptance criteria for the 3D-Angio itself are presented.

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

Not mentioned in the document.

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

Not mentioned in the document.

4. Adjudication method for the test set

Not mentioned 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

Not mentioned in the document. This submission predates the commonality of "AI" as understood today, and the focus is on a software option for 3D reconstruction, not an AI-powered diagnostic tool in the modern sense.

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

The entire device is a "software option," which inherently means it's an algorithm. However, the performance is described in terms of its ability to "assist the physician" implying human interpretation remains central. No specific standalone performance study without human interaction is detailed as an independent evaluation. The performance is implied through its intended use and comparison to a predicate device.

7. The type of ground truth used

Not mentioned in the document. Given the nature of a 3D reconstruction tool, the "ground truth" would likely relate to the accuracy of the 3D model relative to the actual anatomical structures, but no details are provided on how this was assessed.

8. The sample size for the training set

Not mentioned in the document.

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

Not mentioned in the document.

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