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The intended use of the iLoop Interventional Coil 0.55T is, in conjunction with a Magnetic Resonance Scanner, the MR examination of the human body. Used in a magnetic resonance tomograph, the iLoop Interventional Coil 0.55T is intended to produce transversal, sagittal, coronal and oblique images of the internal structures of the body. This device may be used for interventional procedures.

The iLoop Interventional Coil 0.55T is a 1-channel receiver coil that can be used for MR imaging before, during and after MR-guided interventions with a Siemens MRI System with field strength 0.55T. The iLoop Interventional Coil 0.55T can also be used as a standard diagnostic coil for diagnostic examination of the human body. The iLoop Interventional Coil 0.55T is a coil that can be used on many different regions of the body. Used in conjunction with a sterile, self-adhesive OP-drape, the coil enables the workflow for MR-guided interventions

The provided text is a 510(k) summary for the iLoop Interventional Coil 0.55T, a medical device. It does not describe a study involving an AI or algorithm for medical imaging analysis, nor does it detail acceptance criteria and performance of such a device in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, this document focuses on the substantial equivalence of a new MR coil to a legally marketed predicate device. The performance testing mentioned (e.g., Image Signal to Noise (SNR), Image Uniformity, Surface heating) is related to the physical and electrical characteristics of the coil itself, rather than the diagnostic interpretive performance of an AI system.

Therefore, I cannot extract the information required for the requested table and study description (e.g., sample size for test/training sets, expert qualifications, MRMC studies, standalone performance, ground truth methods) as they pertain to AI/algorithm-based diagnostic devices, because this document is about a different type of medical device (an MR coil).

The "SUMMARY OF PERFORMANCE TESTING" section (page 5 of the PDF, marked with {5} in your input) outlines engineering and safety tests for the physical coil, not a clinical study to evaluate an AI's diagnostic performance. It states: "J) CLINICAL TESTING: Not required." This explicitly confirms that clinical studies to evaluate diagnostic accuracy were not performed or required for this device's clearance.

Thus, I cannot fill out the requested table or describe such a study based on the provided text.

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The InVision 1.5 Surgical Theatre is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The InVision 1.5 Surgical Theatre may also be used for imaging during intraoperative and interventional procedures when performed with MR safe devices or MR conditional devices approved for use with the MR scanner.

The InVision 1.5 Surgical Theatre may also be used for imaging in a multi-room suite.

The proposed InVision™ 1.5 Surgical Theatre is a traditional Magnetic Resonance Imaging (MRI) scanner that is suspended on an overhead rail system. It is designed to operate inside a Radio Frequency (RF) shielded room to facilitate intraoperative and multi-room use. The InVision 1.5 Surgical Theatre uses a scanner, the Siemens MAGNETOM Sola (K203443, reference device), to produce images of the internal structures of the head as well as the whole body. The Siemens 1.5T MAGNETOM Sola MRI scanner is an actively shielded magnet with a magnetic field strength of 1.5 Tesla.

The InVision 1.5 Surgical Theatre provides surgeons with access to magnetic resonance (MR) images while in the surgical field without changing the surgical/clinical workflow. When images are requested in the operating room (OR), the magnet is moved from the diagnostic room (DR) to the OR on a pair of overhead rails while the patient remains stationary during the procedure. Imaging is performed and once complete the magnet is moved out of the OR to the DR. The magnet can be moved in and out of the surgical field multiple times, as required, throughout the course of the surgical procedure. When the Siemens MAGNETOM Sola MRI scanner is in the DR, the OR may be used as a standard OR, utilizing standard surgical instruments and equipment during surgery. When not required in the OR, the scanner is available for use in the DR as a standard diagnostic MRI.

This document primarily focuses on the substantial equivalence of a new medical device, the InVision™ 1.5 Surgical Theatre, to a previously cleared predicate device, the IMRIS iMRI 3T V. The information provided is characteristic of a 510(k) premarket notification to the FDA, which aims to demonstrate that a new device is as safe and effective as an already legally marketed device, and not a study proving the device meets specific acceptance criteria typical of an AI/ML software performance study.

Therefore, many of the specific details requested in the prompt, such as acceptance criteria in terms of AI model performance metrics (e.g., sensitivity, specificity, AUC), sample size for test sets directly related to AI performance, expert adjudication methods for ground truth, MRMC studies, or standalone algorithm performance, are not applicable or present in this document. This submission is for a physical medical device (an MRI scanner system with a moving gantry), not an AI/ML software.

However, I can extract information related to the device's validation and comparison to its predicate:

Acceptance Criteria and Device Performance (as per 510(k) for a physical device):

The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The performance is assessed through non-clinical testing to ensure it meets safety and functional standards, and maintains clinically acceptable imaging performance.

1. Table of acceptance criteria and the reported device performance:

Since this is a physical device and not an AI/ML software, the "acceptance criteria" are not reported as specific performance metrics like sensitivity/specificity for an algorithm. Instead, they relate to regulatory and functional compliance.

Differences and Rationale:

• Siemens MRI System: Proposed uses Siemens 1.5T MAGNETOM Sola (K203443) vs. Predicate's Siemens 3T MAGNETOM Vida (K192924).
• Static Field Strength: Proposed 1.5 Tesla vs. Predicate 3 Tesla.
• IMRIS Intraoperative Imaging Coils: HC150 Coil and InSitu Coil 1.5T vs. HC300 Coil and InSitu Coil 3T.
  These differences are assessed through non-clinical testing (functional, imaging performance, integration, software verification, acoustic energy analysis, heating verification) to ensure equivalent safety and performance. |
  | Compliance with Recognized Consensus Standards | All listed FDA recognized consensus standards (Table 2 on page 10-11) were conformed to. This includes standards for medical electrical equipment (safety, EMC), risk management, usability engineering, software life cycle processes, acoustic noise measurement, characterization of phased array coils, SNR/image uniformity, biocompatibility, and sterilization. |
  | Clinically Acceptable MR Imaging Performance | "Successful completion of the standard Siemens OA tests and expert review of sample clinical images demonstrates that the InVision 1.5 Surgical Theatre maintains clinically acceptable MR imaging performance within both the DR and OR(s)." |
  | Safety and Performance Profile Equivalent to Predicate | "The verification and validation testing of the InVision 1.5 Surgical Theatre support a determination of substantial equivalence." "The InVision 1.5 Surgical Theatre technological characteristics do not raise different questions of safety and effectiveness." |

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

• Test Set (Non-Clinical): The document refers to "Performance Testing" on the "InVision 1.5 Surgical Theatre (finished device) and applicable components and hardware" (Table 3, page 12). This indicates the testing was performed on the actual device hardware.
• Sample Clinical Images: "Sample Clinical Images in DR and OR" were assessed, as required by the guidance for Magnetic Resonance Diagnostic Devices. The number of images or patient cases is not specified.
• Data Provenance: Not explicitly stated, but given it's a medical device for US market clearance, typically such testing involves internal data or data collected under controlled conditions to demonstrate device functionality and safety. It's safe to assume it's retrospective, as it involves "sample clinical images" for assessment rather than a prospective clinical trial. Country of origin is not specified.

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

• The document mentions "expert review of sample clinical images." The number of experts and their specific qualifications (e.g., years of experience) are not specified.

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

• No specific adjudication method is described for the "expert review of sample clinical images."

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, an MRMC study was not done. This submission is for a physical MRI device, not an AI-assisted diagnostic software.

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

• Not applicable. This isn't an AI algorithm. The performance being assessed is the image acquisition capability of the MRI system, which a human clinician interprets.

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

• For the "sample clinical images" assessed, the "ground truth" for image quality and clinical acceptability was based on expert review. This is typical for demonstrating image quality of a diagnostic device. Since it's an MRI system, the "truth" is whether the images accurately represent the internal structure and/or function for diagnosis, as interpreted by a trained physician. It's not about diagnosing specific diseases with a "pathology" ground truth, but rather about the diagnostic quality of the images produced.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model that requires a "training set."

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

• Not applicable. As stated above, there is no AI/ML training set in this context.

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Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal, and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.

The subject devices, MAGNETOM Vida with software syngo MR XA31A, and MAGNETOM Vida with syngo MR XA20A, with the new pulse sequence MR Fingerprinting (MRF) consists of slightly modified software that are similar to what is currently offered in the predicate devices, MAGNETOM Vida with syngo MR XA31A (K203443) and MAGNETOM Vida with syngo MR XA20A (K192924) respectively.

The subject devices MAGNETOM Vida with software syngo MR XA31A, and MAGNETOM Vida with synqo MR XA20A includes features that were cleared under K203443 and K192924 respectively. In addition to these features, the subject devices include a new pulse sequence type called MR Fingerprinting (MRF), a method that permits the simultaneous non-invasive quantification mapping of MRF-derived T1 and T2 relaxation times of brain tissue. The MRF is not intended to yield the ground truth T1 and T2 relaxation times of brain tissue.

The document describes the Siemens MAGNETOM Vida MRI system with a new pulse sequence called MR Fingerprinting (MRF). The acceptance criteria for this device and the study proving it meets these criteria are outlined as follows:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: 3 healthy volunteers were scanned multiple times using multiple systems. Additionally, several clinical patient cases demonstrating a longitudinal use case scenario (repeated scans from the same subject over time) were provided.
• Data Provenance: The document does not explicitly state the country of origin. The study appears to be prospective, as it involved actively scanning volunteers and collecting clinical patient cases for demonstration.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the provided clinical patient cases or for interpreting the volunteer scans. It states that the device provides "information that may assist in diagnosis" when interpreted by a trained physician, but this is in the general "Indications for Use" and not directly about the ground truth establishment for the performance study.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned as being done to compare human readers with and without AI assistance. The study focuses on the technical performance of the MRF sequence itself.

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

Yes, a standalone performance evaluation of the MRF sequence was performed. The "Performance bench test" and "Software verification and validation" involved quantitative evaluation of MRF-derived T1 and T2 values in phantoms and volunteers, and testing to confirm stable and reproducible parametric values across systems. This assessment of the algorithm's output without human interpretation is a standalone evaluation.

7. The Type of Ground Truth Used

The ground truth used for the quantitative evaluation of T1 and T2 values came from:

• Quantitative Phantom: For confirming stability and reproducibility of parametric values.
• Healthy Volunteers: For evaluating quantitative performance in terms of precision (repeatability and reproducibility) for T1 and T2 maps.
• The document implies that for the "Sample clinical images" and "clinical patient cases," the assessment was based on whether the sequence executed successfully and produced images free of artifacts, rather than comparing against an external, independent "ground truth" for diagnosis. The MRF itself is described as "not intended to yield the ground truth T1 and T2 relaxation times of brain tissue."

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for the MRF pulse sequence.

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

The document does not provide information on how the ground truth for the training set was established, as details about a training set are not included.

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Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These inages and/ or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

MAGNETOM Avanto Fit with software syngo MR XA50A includes new and modified hardware and software compared to the predicate device. MAGNETOM Sola with software syngo MR XA31A. A high level summary of the new and modified hardware and software is provided below:

Hardware
Modified Hardware

• Cover: The cover has been modified to bring the system up to the Siemens Healthineers Design incl. all BioMatrix components and interfaces.
• EPC (Electronic Cabinet and Measurement Control / Electronic Power Cabinet): upgrade of components to upgrade the EPC to the newest electronic cabinet series

Software
New Features and Applications

• TSE MoCo: TSE MoCo is an image-based motion correction in the averagedimension for the TSE pulse sequence type.
• Automatic fiducial detection: MR Breast Biopsy is improved with an automatic fiducial detection.
• AbsoluteShim: The AbsoluteShim mode is a shimming procedure based on a 3-echo gradient echo protocol.

Modified Features and Applications

• Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
  Other Modifications and / or Minor Changes
• The MAGNETOM Avanto Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Avanto

This document describes the regulatory clearance for the Siemens MAGNETOM Avanto Fit, a Magnetic Resonance Diagnostic Device (MRDD). The submission is a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device. This type of submission generally does not require extensive clinical studies or acceptance criteria tables with numerical thresholds, as the focus is on demonstrating that the new device is as safe and effective as an existing one, not necessarily proving novel clinical performance beyond the predicate.

Therefore, the requested information on "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size," "number of experts," "adjudication method," "MRMC study," "standalone performance," and "ground truth" (as typically defined for AI/CADe device submissions) is not applicable to this 510(k) submission for a conventional MRDD.

This submission focuses on demonstrating that modifications and new features (TSE MoCo, Automatic fiducial detection, AbsoluteShim, Fast GRE RefScan) on the MAGNETOM Avanto Fit do not change its fundamental safety or effectiveness compared to the predicate MAGNETOM Sola.

Here's an explanation based on the provided text, addressing why most of the requested points are not present:

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

• Not applicable in this context. For a 510(k) of a conventional MRDD, "acceptance criteria" are generally met by demonstrating compliance with recognized standards and showing that changes do not introduce new safety concerns or degrade performance compared to the predicate. There isn't a specific performance metric table with numerical targets as would be seen for, say, an AI-driven diagnostic algorithm with a quantifiable output like sensitivity/specificity for a particular disease.
• The performance demonstration implicitly relies on:
  • Image quality assessments: "Image quality assessments by sample clinical images. In some cases a comparison of the image quality / quantitative data was made."
  • Performance bench tests: For new/modified hardware.
  • Software verification and validation: Ensuring new software features function as intended and meet design specifications.
  • Safety tests: Electrical, mechanical, structural, and related system safety tests (compliance with AAMI / ANSI ES60601-1, IEC 60601-2-33).

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

• Not explicitly stated for a dedicated "test set" in the context of clinical performance evaluation. The document mentions "sample clinical images" were used for image quality assessments. These are likely images acquired during internal testing or from a small cohort, but not a large, controlled, prospective dataset for a formal clinical trial of diagnostic accuracy.
• Data Provenance: Not specified, but generally, such internal testing images would be from Siemens' development or internal research facilities.

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

• Not applicable/specified. As no formal clinical trial with an established "ground truth" (e.g., pathology-confirmed diagnosis for a specific disease) was conducted or needed, expert reads for ground truth establishment are not detailed. Image quality assessments would be done by qualified internal personnel, but this isn't the same as clinical ground truth.

4. Adjudication method for the test set:

• Not applicable/specified. No formal adjudication process is described because a clinical diagnostic performance study requiring expert consensus for ground truth was not performed.

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 Magnetic Resonance Diagnostic Device (MRDD), not an AI-assisted diagnostic software. It produces images and spectra that are then interpreted by a trained physician. The new features mentioned (TSE MoCo, Automatic fiducial detection, AbsoluteShim, Fast GRE RefScan) are technical improvements to image acquisition and processing, not AI algorithms intended to directly assist or influence human reader performance in a diagnostic task that would typically be evaluated with an MRMC study.

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

• Not applicable. This refers to a medical imaging device itself, not a separate standalone algorithm.

7. The type of ground truth used:

• Not explicitly defined as a "ground truth" dataset in the clinical sense. For MRDDs, performance is often assessed against engineering specifications, phantom measurements, and the visual quality of clinical images, rather than against a disease-specific "ground truth" (like biopsy results for a target lesion). The "ground truth" for showing substantial equivalence relies on demonstrating that the output (MR images) remains clinically acceptable and safe.

8. The sample size for the training set:

• Not applicable. This device is an MR scanner with modified hardware and software for image acquisition and reconstruction, not an AI algorithm that requires a "training set."

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

• Not applicable. See point 8.

Summary of Device Performance (Based on the document):

The document states:

• "The results from each set of tests demonstrate that the subject device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared."
• "While there are some differences in technical features compared to the predicate device, the differences have been tested and the conclusions from all verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate device and reference devices."

Key tests performed (Nonclinical Tests Section 9):

• Sample clinical images (for image quality assessments)
• Performance bench tests (for new/modified hardware)
• Software verification and validation (for new/modified software features)
• Electrical, mechanical, structural, and related system safety tests (compliance with AAMI / ANSI ES60601-1, IEC 60601-2-33)

In conclusion, this 510(k) submission for a conventional Magnetic Resonance Diagnostic Device (MRDD) primarily relies on non-clinical engineering, software, and image quality testing to demonstrate substantial equivalence, rather than extensive clinical performance studies with specific patient "ground truth" evaluations as would be required for novel AI/CADe devices.

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The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.

MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR include modified hardware compared to the predicate device, MAGNETOM Vida with software syngo MR XA31A (K203443). A high-level summary of the modified hardware is provided below:

Hardware

Modified Hardware

• The Nexaris Dockable Table is a variant of the MR patient table which is used for intraoperative or interventional imaging. It enables the patient transfer between OR/ARTIS tables and the MR system without repositioning on the MR patient table and vice versa during interventional procedures and surgeries. Additionally, it can be used for diagnostic imaging.

The provided text is a 510(k) Summary for a medical device (MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies for novel claims.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not directly available in this document. The submission relies on demonstrating that the modified hardware of the new device maintains the safety and performance profile of the predicate device.

Here's an analysis based on the information provided, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported device performance metrics for a novel diagnostic claim. Instead, the "acceptance criteria" are implied by compliance with recognized standards and successful verification and validation of modified hardware, demonstrating equivalent safety and performance to the predicate device.

The reported "performance" is that the device "perform[s] as intended" and "bear[s] an equivalent safety and performance profile to that of the predicate device."

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

• Sample Size: Not applicable/not provided. The submission focuses on hardware modifications and compliance with standards, not on a clinical test set for diagnostic performance.
• Data Provenance: Not applicable/not provided for a clinical test set. The data provenance described is related to non-clinical performance testing of modified hardware against engineering and safety standards.

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

Not applicable. As there was no clinical diagnostic test set evaluated for novel claims, there was no need for experts to establish ground truth in this context. The "truth" evaluated was compliance with engineering and safety standards.

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

Not applicable. No adjudications were performed related to a diagnostic test set.

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 comparative effectiveness study was done, as this submission is for a Magnetic Resonance Diagnostic Device (MRDD) and not an AI-assisted diagnostic tool or software. The document explicitly states: "No additional clinical tests were conducted to support substantial equivalence for the subject devices."

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

No standalone performance study of an algorithm was done. This submission is for an MRDD system with modified hardware, not a standalone algorithm.

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

The "ground truth" for the nonclinical tests was based on engineering specifications, recognized safety standards (e.g., AAMI / ANSI ES60601-1, 21 CFR §820.30), and risk management principles (ISO 14971).

8. The Sample Size for the Training Set

Not applicable. This submission does not involve an AI algorithm that would require a training set.

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

Not applicable. This submission does not involve an AI algorithm or a training set.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (which in this context are interpreted as demonstrating safe and equivalent performance to the predicate device) was a series of nonclinical performance tests focused on the modified hardware.

• Study Type: Nonclinical performance testing (verification and validation against established standards and engineering requirements).
• Focus: Evaluation of "modified hardware" (Nexaris Dockable Table) to ensure it performs as intended and maintains the safety and performance profile of the predicate device.
• Tests Conducted:
  • Electrical, mechanical, structural, and related system safety tests (utilizing AAMI / ANSI ES60601-1).
  • Verification and validation (in accordance with 21 CFR §820.30).
• Conclusion: The results of these nonclinical tests demonstrated that the modified features "bear an equivalent safety and performance profile to that of the predicate device." The device also conforms to various recognized standards including IEC 62304, ISO 14971, IEC 60601-1 series, and others listed in the document.

In essence, the "study" was a comprehensive engineering and regulatory compliance assessment of the hardware changes, leveraging industry standards and internal verification processes instead of clinical performance studies with diagnostic endpoints.

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