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The dS Breast Coil 7ch 1.5T is intended to be used in conjunction with a Philips Prodiva 1.5T CX and a MR 5300 1.5T Magnetic Resonance Scanner to produce diagnostic images of the breast, chest wall, and axillary tissues that can be interpreted by a trained physician.

The dS Breast Coil 7ch 1.5T is a 7-element phased array receive only coil to be used on a 70cm bore Philips 1.5T MR Systems. The coil is designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei. The subject coil is designed to be used in conjunction with Philips Prodiva 1.5T CS and 1.5T CX MR System (K173507) and with Philips MR 5300 System (K212673) with dStream interfaces. The subject coil is designed for optimum coverage and high-resolution visualization of detailed cartilage structures of the breast anatomy. The coil is used independently and cannot be combined with any other coils. The coil is only available in 1.5T version. The open coil housing design of the dS Breast Coil 7ch 1.5T allows for lateral-medial and cranial-caudal access to the breast for both diagnostic breast imaging and interventional exams.

The device in question is the dS Breast Coil 7ch 1.5T.

Based on the provided text, the acceptance criteria and the study that proves the device meets them are outlined as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated in terms of the number of patient images or specific cases. The clinical performance testing mentions "images produced on the subject coil."
• Data Provenance: Not explicitly stated as retrospective or prospective, nor the country of origin. However, the clinicians involved were "U.S. Board Certified radiologists."

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

• Number of Experts: Two.
• Qualifications of Experts: U.S. Board Certified radiologists. No specific years of experience are mentioned.

4. Adjudication Method for the Test Set:

• The text states, "Acquired Image quality was assessed by two U.S. Board Certified radiologists to confirm images produced on the subject coil are sufficient quality for diagnostic use." This implies a consensus or agreement was reached between the two readers, but the explicit adjudication method (e.g., 2+1, 3+1, majority vote, etc.) is not detailed.

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

• No, a MRMC comparative effectiveness study was not done. The study focuses on confirming the diagnostic quality of images produced by the new coil, rather than comparing human reader performance with and without AI assistance, or comparing human readers with another device. This is a breast coil, not an AI diagnostic software.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. The dS Breast Coil 7ch 1.5T is a hardware device for image acquisition, not an algorithm or AI software for interpretation. Its performance is evaluated on the quality of the images it produces for human interpretation.

7. Type of Ground Truth Used:

• For the clinical performance assessment, the "ground truth" was established by expert consensus (assessment by two U.S. Board Certified radiologists) on the "sufficient quality for diagnostic use" of the images produced by the coil. This is effectively expert opinion regarding image quality for diagnostic purposes.

8. Sample Size for the Training Set:

• Not applicable. The dS Breast Coil 7ch 1.5T is a passive hardware device (receive-only coil) and does not involve AI or machine learning algorithms that require a "training set" in the conventional sense. The "training" for the device would be its engineering design and manufacturing process.

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

• Not applicable, as there is no training set for this type of device.

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The 8ch Wrist Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance scanner to produce diagnostic images of the wrist anatomy that can be interpreted by a trained physician.

The 8ch Wrist Coil magnetic resonance (MR) coil is a receive only phased array coil with 8 channels for wrist imaging. This Wrist Coil is designed for use with the SIGNA Prime (K211980). The 8ch Wrist Coil is designed to be used vertically at the patient's side or horizontally overhead. The wrist array comes with two rigid base plates (for flat or curved tabletops) for fixation to reduce patient motion. The coil receives magnetic resonance signals generated in hydrogen nuclei (protons) in the wrist while blocking the high-frequency B1 field applied by the MRI scanner at specified timing. The 8ch Wrist Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. Images are typically generated as axial, sagittal, coronal oblique slices and include coverage of the wrist anatomy.

The provided document is a 510(k) summary for the Philips 8ch Wrist Coil, a magnetic resonance (MR) coil. It describes the device, its intended use, and the testing conducted to demonstrate its safety and effectiveness.

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 does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it lists the types of performance testing conducted and generally states that the device "meets predefined performance criteria."

However, based on the non-clinical and clinical performance data summary, we can infer the areas of acceptance:

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

• Sample Size for Test Set: The document does not specify a numerical sample size for the clinical test set. It mentions "clinical images" were reviewed by a radiologist. It does not indicate the number of images or cases.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It simply refers to "clinical images reviewed by a radiologist provided in this submission."

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

• Number of Experts: One expert was used.
• Qualifications of Expert: "US Board Certified radiologist." No specific information on years of experience is provided.

4. Adjudication Method for the Test Set

The document states that a "US Board Certified radiologist's review of clinical images" was conducted. This suggests that a single expert provided the assessment, implying no formal adjudication method (like 2+1 or 3+1 consensus) was used for establishing ground truth from multiple readers.

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 described. The study focused on the performance of the device itself, rather than comparing human reader performance with and without AI assistance. The device is an MRI coil, not an AI diagnostic tool.

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

Yes, in a sense, a "standalone" performance evaluation of the device itself was conducted through the non-clinical and clinical image review. This device is an MRI coil, which is a component of an imaging system, not an AI algorithm. The performance being evaluated is its ability to acquire diagnostic-quality images. The "standalone" aspect here refers to the intrinsic performance of the coil (e.g., SNR, uniformity, safety) and the quality of the images it produces, which are then interpreted by a human.

7. The Type of Ground Truth Used

The ground truth for the clinical performance assessment was primarily based on expert assessment/consensus (from a single US Board Certified radiologist) of the diagnostic quality of the images produced by the device. Pathology or outcomes data are not mentioned as being used for ground truth in this context.

8. The Sample Size for the Training Set

The document does not mention a training set because the device is a physical MRI coil, not an AI algorithm that requires training data.

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

Not applicable, as the device is not an AI algorithm and therefore does not have a training set or associated ground truth for training purposes.

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The 1.5T T/R Quad Extremity Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the lower extremities that can be interpreted by a trained physician.

The 1.5T 8CH T/R Knee Coil is intended to be used in conjunction with a SIGNA Prime Magnetic Resonance Scanner to produce diagnostic images of the knee that can be interpreted by a trained physician.

The 1.5T T/R Quad Extremity Coil is quadrature Transmit and Receive coils. At 1.5T the coil can be used in 3 different operational modes: QuadKnee, QuadFoot and QuadAnkle. The coil is designed to image the Knee, Foot and Ankle, but can also be used for other parts of the lower extremities. The base of the coil is attached to a base plate and can be moved to scan either the Left or Right extremity. The coil is moved into position (Left to Right) and locked into place, the patient is then positioned in the base, the top section of the coil is placed over the patient and the latched closed. The fixed position of the coil and helps prevent the patient form moving, reducing artifact. This coil is used independently and can't be combined with any other coils. The 1.5T T/R Quad Extremity Coil is compatible with SIGNA Prime MRI Systems with P-Port Connector. It consists of a birdcage quadrature coil. During transmit phase, the coil is resonated by the RF power source of MR system, to excite hydrogen nuclei (protons) in the anatomy. The quadrature coil detects the magnetic resonance signals generated by hydrogen nuclei (protons) in the knee during the receive phase. The coil is tuned to transmit and receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation.

The 1.5T 8CH T/R Knee Coil is an 8 element phase array coil with a T/R quadrature birdcage shell, designed to image the knee. The base of the coil is attached to a base plate and can be moved to scan either the Left or Right Knee. The patient is positioned in the base, the top section of the coil is placed over the patient and the latched closed, which locks the position of the coil and helps prevent the patient form moving, reducing artifact. The transmit shell consist of a twist birdcage quadrature coil, resonated by the RF power source of MR system, to excite hydrogen nuclei (protons) in the anatomy. The coil receivers consist of 8 phased array elements that detect the magnetic resonance signals generated by hydrogen nuclei (protons) in the knee while blocking the high-frequency B1 field applied by the coil transmit shell at specified timings. The coil is tuned to transmit and receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. This coil is used independently and cannot be combined with any other coils.

The 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil are compatible with SIGNA Prime MRI systems with a P-Port connector.

Here's an analysis of the acceptance criteria and study information provided for the 1.5T T/R Quad Extremity Coil and 1.5T 8CH T/R Knee Coil:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to recognized standards. It doesn't explicitly list specific numerical acceptance criteria (e.g., minimum SNR values, specific image quality scores) prior to presenting performance results. Instead, the acceptance criterion for the clinical performance seems to be that the generated images are "of sufficient quality for diagnostic use."

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

• Test Set Sample Size: The document does not specify a numerical sample size for the clinical test set (i.e., how many patients or images were used). It only mentions "Sample clinical images" were provided.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. It only mentions the radiologist being "US Board Certified."

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

• Number of Experts: One "US Board Certified radiologist" was used.
• Qualifications of Experts: A "US Board Certified radiologist." No information is provided regarding their years of experience.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated. Since only one radiologist is mentioned as evaluating the images and providing a statement, an adjudication method like 2+1 or 3+1 was likely not used. It appears to be a single-reader assessment of diagnostic quality.

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

• No, an MRMC comparative effectiveness study was not done. The study's purpose was to demonstrate that the new coils produce diagnostic quality images, not to compare human reader performance with and without AI assistance (as this is a coil, not an AI device). Therefore, no effect size of human reader improvement with AI vs. without AI assistance is applicable or reported.

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

• Yes, in spirit, a form of standalone performance was assessed for the device's output. The devices are MRI coils, which produce images. The "performance testing" of NEMA standards (SNR, uniformity) assessed the intrinsic image quality generated by the coils themselves (the "algorithm only" equivalent for hardware). The clinical performance involved a radiologist interpreting "images produced," implying a standalone evaluation of the image quality delivered by the coil system.

7. The Type of Ground Truth Used

• Expert Consensus (single expert): For clinical performance, the ground truth was established by the statement of a single "US Board Certified radiologist" who confirmed the images were of "sufficient quality for diagnostic use."
• Physical/Technical Standards: For non-clinical performance, the ground truth was adherence to recognized consensus standards (e.g., ANSI/AAMI ES 60601-1, IEC 60601-1-2, NEMA MS-1).

8. The Sample Size for the Training Set

• Not Applicable. The devices are physical MRI coils, not an AI algorithm that undergoes a "training set." Therefore, there is no training set sample size to report.

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

• Not Applicable. As these are physical medical devices (MRI coils), there is no training set or ground truth establishment relevant to an AI/machine learning model. The devices are engineered and tested against established physical and safety standards.

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The dS Sentinelle Breast 16ch 3T Coil are intended to be used in conjunction with Philips 3.0T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.

The dS Sentinelle Breast 16 Ch 3.0T MR Coils is a receive only coil to be used on a 70cm bore Philips Ingenia 3.0T MR System. The coil arrays are designed to correspond with the scanner strength.

The dS Sentinelle Breast 16Ch 3T coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels):

1. 16Ch for diagnostic imaging: performed in 16Ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil.

2. 10Ch for bilateral interventional procedures requiring lateral access: performed in 10Ch configuration that consists of the dS Sentinelle Medical 8Ch coil and two dS Sentinelle Lateral 1Ch coils (right and left).

3. 2Ch for unilateral interventional procedures allowing both lateral and medial access: performed in 2Ch configuration that consists of two dS Sentinelle Lateral 1Ch coils (right and left).

The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings.

The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Ch right and left lateral biopsy coils.

Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy.

The dS Sentinelle Breast 16Ch 3T Coil is tuned to receive RF frequency corresponding to the proton precession in a 3.0 tesla magnetic field (respectively), which is governed by the Larmor equation.

The Variable Coil Geometry design of the dS Sentinelle Breast 16Ch 3T Coil allows each imaging element to be independently positioned and configured for each patient. Patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning.

The subject dS Sentinelle Breast Coil system also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). The intent of this is to reduce motion artifacts and ensure the imaging elements are positioned as close to the breast(s) as possible to optimize signal-to-noise ratio and image quality.

Based on the provided text, the device in question is the dS Sentinelle Breast 16ch 3.0T Coil, which is a receive-only MR coil. The acceptance criteria and the study proving the device meets them are described in the "Summary of Non-Clinical and Clinical Performance Data" section.

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document references "FDA guidance Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020" for the acceptance criteria. While the specific numerical thresholds for these criteria are not explicitly detailed in the provided text, the document states that these requirements were met. It lists the types of performance tests conducted.

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

• Test Set Sample Size: The document does not specify a numerical sample size for the clinical performance testing.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions that images were "Acquired." Given the context of FDA clearance for a medical device, it's generally expected to be prospective data collected for regulatory submission, but this is not explicitly stated.

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

• Number of Experts: The document states "a U.S. Board Certified radiologist." This implies only one expert was used for the clinical image quality assessment.
• Qualifications of Experts: The expert was a "U.S. Board Certified radiologist." No information about their years of experience is provided.

4. Adjudication Method for the Test Set

• Adjudication Method: There was no explicit adjudication method described. With only one radiologist assessing image quality, there's no need for an adjudication process.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported or conducted. The clinical performance testing focused on assessing image quality by a single radiologist, not on comparing reader performance with or without AI assistance. The device is an MRI coil, not an AI software.

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

• This question is not applicable to the device described. The dS Sentinelle Breast 16ch 3.0T Coil is a hardware device (an MR coil), not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product. The testing focused on the image quality produced by the coil.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the clinical performance assessment was the subjective interpretation of "sufficient quality for diagnostic use" by a U.S. Board Certified radiologist. This is expert consensus (albeit from a single expert). It is not based on pathology, outcomes data, or a complex consensus process.

8. The Sample Size for the Training Set

• This question is not applicable to the device described. The dS Sentinelle Breast 16ch 3.0T Coil is a hardware device (an MR coil). Hardware devices typically do not have "training sets" in the context of machine learning or AI models. Their performance is validated through engineering tests and clinical image quality assessment.

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

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

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The dS Sentinelle Breast 16ch 1.5T Coil is intended to be used in conjunction with Philips 1.5T Magnetic Resonance Scanners to produce diagnostic images of the breast anatomy that can be interpreted by a trained physician. When used with a disposable biopsy grid, the device permits access to breast anatomy for biopsy and localization procedures.

The dS Sentinelle Breast 16ch 1.5T Coil is a receive only coil to be used on a 70cm bore Philips Ingenia 1.5T MR System. The coil arrays are designed in a magnetic strength (1.5T) to correspond with the scanner strength. The dS Sentinelle Breast 16ch 1.5T Coil is a phased array design consisting of patient support with three different coil configurations (2, 10 or 16 channels): 1. 16Ch for diagnostic imaging: performed in 16ch configuration that consists of two dS Sentinelle Lateral 4Ch coils and the dS Sentinelle Medial 8Ch coil. 2. 10Ch for bilateral interventional procedures requiring lateral access: performed in 10Ch configuration that consists of the dS Sentinelle Medical 8ch coil and two dS Sentinelle Lateral 1ch coils (right and left). 3. 2Ch for unilateral interventional procedures allowing both lateral and medial access: performed in 2Ch configuration that consists of two dS Sentinelle Lateral 1Ch coils (right and left). The coils receive magnetic resonance signals generated in hydrogen nuclei (protons) in the Breast while blocking the high-frequency magnetic field applied by the MRI scanner at specified timings. The coil arrays include 4Ch right and left lateral coils, a medial coil and 1Ch right and left lateral biopsy coils. Images are typically generated as axial, sagittal, coronal and oblique slices and include full coverage of the breast anatomy. The dS Sentinelle Breast 16ch 1.5T Coil is tuned to receive RF frequency corresponding to the proton precession in a 1.5 tesla magnetic field, which is governed by the Larmor equation. The Variable Coil Geometry design of the dS Sentinelle Breast 16ch 1.5T Coil allows each imaging element to be independently positioned and configured for each patient. Patients can then be positioned quickly and effectively as the imaging elements can be positioned as close to the breast as possible optimizing the signal-to-noise ratio for each individual patient. For clinical imaging, coil housings are placed next to the tissue to help minimize motion artifacts due to patient motion during scanning. The subject dS Sentinelle Breast 16ch 1.5T Coil system also includes a tabletop compression system which facilitates immobilization of the breast for imaging and interventional procedures and serves to hold the individual imaging coils in proximity to the breast(s). The intent of this is to reduce motion artifacts and ensure the imaging elements are positioned as close to the breast(s) as possible to optimize signal-to-noise ratio and image quality.

The provided document is a 510(k) Pre-market Notification for the dS Sentinelle Breast 16ch 1.5T Coil, a medical device used with MRI scanners. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's diagnostic performance. Therefore, many of the requested details about acceptance criteria, study design, and performance metrics for an AI/CADe device are not applicable or not present in this regulatory submission.

However, I can extract and infer some information related to the device's performance assessment and acceptance as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the device meets safety and effectiveness requirements as outlined in FDA guidance: Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway, issued December 11, 2020. This guidance would contain specific performance criteria, but the document provided does not list them explicitly or provide a detailed table comparing them to the device's reported performance. Instead, it generally states that the criteria were met.

The performance testing mentioned includes:

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

The document does not specify a distinct "test set" in the context of an AI/CADe evaluation. For the "Performance Testing – Clinical" section, it only mentions that acquired image quality was assessed. It doesn't specify the number of patients/cases used for this assessment, nor does it provide information about the data provenance (e.g., country of origin, retrospective or prospective). This type of information is typically not included in a 510(k) for a basic hardware component like an MRI coil.

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

For the "Performance Testing – Clinical" section, it states: "Acquired Image quality was assessed by a U.S. Board Certified radiologist...". It indicates one expert (a U.S. Board Certified radiologist), but does not specify their years of experience or if more than one assessed the images. There is no "ground truth" to be established in the context of a diagnostic outcome for a coil itself, as the coil simply produces images. The expert's role was to confirm the diagnostic usability of the images.

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

Not applicable, as there isn't a "test set" and ground truth establishment in the traditional sense for a diagnostic algorithm. The assessment described is a qualitative review of image quality by a single radiologist.

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

Not applicable. This device is an MRI coil, a hardware component that produces images, not an AI or CADe device that assists human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

Not applicable. This device is an MRI coil and does not perform any diagnostic algorithm in a standalone manner.

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

Not applicable in the context of a diagnostic algorithm's performance. The "ground truth" for this device's performance is whether the images it produces are of sufficient quality for diagnostic use, which was determined by a radiologist's assessment. There is no disease outcome or pathology as a "ground truth" for the coil itself.

8. The sample size for the training set:

Not applicable. This device is an MRI coil, not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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The dS FootAnkle 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the foot and ankle anatomy that can be interpreted by a trained physician.

The dS HiRes Hand/Wrist 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the hand and wrist anatomy that can be interpreted by a trained physician.

The dS Small Extremity 16ch 1.5T and 3.0T MR Coils are intended to be used in conjunction with Philips 1.5T/3.0T Magnetic Resonance Scanners to produce diagnostic images of the small extremities anatomy on adult and pediatric patients that can be interpreted by a trained physician.

The Philips Orthopedic MR Coils are designed for use with Magnetic Resonance Imaging (MRI) systems. The coils are designed to work in unison with the Body Coil of the MRI system, which will transmit the radio frequency (RF) signals, so that the coil may receive the resultant RF signal from the excited nuclei.

The subject devices have 16-elements and are for use with Philips Ingenia 1.5T and 3.0T MR Systems with dStream interface (K193215). The devices are designed for optimum coverage and high-resolution visualization of detailed cartilage structures of the body anatomy (foot/ankle, hand/wrist, small extremity). The coil is used independently and cannot be combined with any other coils. The coils are available in both 1.5T and 3.0T magnetic strengths.

The provided text outlines the performance testing for the Philips Orthopedic MR Coils, but it does not contain details on acceptance criteria or performance data as would be found in a study proving a device meets specific acceptance criteria in the context of an AI/ML diagnostic device regulatory submission. The document is a 510(k) summary for magnetic resonance coils, which are hardware components, not artificial intelligence software.

Therefore, I cannot fulfill your request for details regarding:

• A table of acceptance criteria and reported device performance (in the context of AI/ML diagnostic output).
• Sample sizes for test sets or data provenance (as there's no AI algorithm being tested).
• Number of experts or their qualifications, or adjudication methods (as this pertains to evaluating AI output against ground truth).
• MRMC comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set information.

The document focuses on the substantial equivalence of the MR coils to predicate devices based on:

• Physical characteristics (design, material, chemical composition, energy source).
• Adherence to recognized standards for MR coil performance (e.g., NEMA MS 1, 3, 9, IEC 62464-1 for image quality; ANSI/AAMI ES 60601-1, NEMA MS 14 for surface heating).
• General electrical/mechanical safety (IEC 60601-2-33, AAMI/ANSI ES 60601-1).
• Biocompatibility (ISO 10993 series).

The closest mention of "image quality assessment by a U.S. Board Certified radiologist" just confirms that the images produced were "sufficient quality for diagnostic use," but this is a general statement and not a quantitative performance metric against specific acceptance criteria for a diagnostic algorithm.

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The dS Head 32ch 3.0T MR Coil is intended to be used in conjunction with a Philips 3.0T Magnetic Resonance Scanner to produce diagnostic images of the head on adult and pediatric patients that can be interpreted by a trained physician.

The subject dS Head 32ch 3.0T Coil is a receive-only, phased-array radiofrequency (RF) coil designed for high-resolution head examinations on adult and pediatric patients. The coil is intended for use with Philips magnetic resonance (MR) scanners with a 3.0 tesla magnetic field strength.

The provided text describes the 510(k) summary for the Philips dS Head 32ch 3.0T MR Coil. This document focuses on the safety and performance criteria for the device itself (a medical imaging coil), not on the performance of an AI algorithm interpreting images produced by the device.

Therefore, the information typically requested for AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) is not applicable or not provided in this document as it's not a submission for an AI/ML powered device.

However, I can extract the relevant information regarding the device's acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The study proving the device meets the acceptance criteria is detailed under "Summary of Non-Clinical and Clinical Performance Data":

The subject dS Head 32ch 3.0T Coil met all safety and performance criteria outlined in the FDA guidance "Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway" issued December 11, 2020.

The specific tests performed include:

• Image Signal to Noise and Image Uniformity characterization (NEMA MS 1, 3, 9 and IEC 62464-1)
• Surface heating (ANSI/AAMI ES 60601-1 and NEMA MS 14)
• Acquired Image quality assessment by a U.S. Board Certified radiologist
• Confirmation of the presence of decoupling mechanisms
• EMC – Immunity, electrostatic discharge (IEC 60601-1-2)
• General electrical/mechanical safety (IEC 60601-2-33 and AAMI/ANSI ES 60601-1)
• Biocompatibility evaluation (ISO 10993 series)

Regarding the specific questions about an AI study (which are not directly applicable to this device submission as it's not an AI device):

2. Sample size used for the test set and the data provenance: Not applicable. This submission is for an MR coil and focuses on its physical and imaging performance, not an AI algorithm's diagnostic performance on a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI algorithm test set. For the device's image quality assessment, it states "Acquired Image quality was assessed by a U.S. Board Certified radiologist." It does not specify the number beyond "a" radiologist.

4. Adjudication method for the test set: Not applicable for an AI algorithm 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: Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used: For the device's performance, physical measurements and adherence to engineering standards (NEMA, IEC, ANSI/AAMI, ISO) served as ground truth for technical performance aspects. For diagnostic utility, the "U.S. Board Certified radiologist" assessment of image quality serves as the ground truth (expert opinion) that the images produced are suitable for diagnostic use.

8. The sample size for the training set: Not applicable. This device does not use an AI algorithm that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

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The MR Patient Care Portal 5000 is intended for use by healthcare professionals. The device is indicated for use to monitor vital signs of patients undergoing MRI procedures including ECG, pulse oximetry (SpO2), non-invasive blood pressure (NIBP), and optionally, invasive pressure (IP), carbon dioxide (CO2) and respiration rate, anesthetic agents, nitrous oxide (N2O), oxygen (O2), and/or temperature based on the configurations of the host patient monitor with which the MR Patient Care Portal 5000 is wirelessly communicating. The target patient population includes adult, pediatric, and neonatal patients that require monitoring during MRI procedures.

The Philips MR Patient Care Portal 5000 is an information portal that serves as a remote monitor and remote control with electronic medical records capabilities outside the MR Scanner room (i.e. Control Room, Induction Room, or Recovery Room). The Philips MR Patient Care Portal 5000 displays the vital signs of a single patient monitoring system with which the device is communicating with from the MR control room.

The Philips MR Patient Care Portal 5000 is intended to replace the substantially equivalent device, the Expression Information Portal (Model IP5), cleared under 510(k) K121424 as a remote display and remote control for host patient monitoring systems, the Expression Model MR400 MRI Patient Monitoring System and Expression MR200 MRI Patient Monitoring System.

The Philips MR Patient Care Portal 5000 is not designed to be used in the MR Scanner room, does not perform any data collection or processing of data as stand-alone patient monitoring system, and it is not a central station.

The Philips MR Patient Care Portal 5000 system consists of the following primary components:

• Desktop unit;
• Radio Kit, USB;
• . Radio Cradle:
• Display, 18.5 inch;

The provided document is a 510(k) summary for the Philips MR Patient Care Portal 5000. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily on proving novel clinical effectiveness or "improvement" with quantifiable effect sizes from clinical studies. The device in question is a remote display and control unit for vital signs monitors during MRI procedures, not a diagnostic AI device.

Therefore, the acceptance criteria and supporting studies are focused on safety, performance, and functional equivalence, rather than clinical diagnostic accuracy or reader improvement. The document does not contain the kind of detailed information about acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC), nor clinical study results (like MRMC studies for diagnostic accuracy, sample sizes for test sets in that context, ground truth establishment by expert consensus for diagnostic tasks) that your request implies.

Based on the provided document, here's an attempt to extract relevant information according to your template, acknowledging the differences in device type and regulatory pathway:

Device Name: Philips MR Patient Care Portal 5000
Device Type: Remote display and control for vital signs monitors (Cardiac Monitor)
Regulatory Pathway: 510(k) (Substantial Equivalence)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI diagnostic device, the acceptance criteria are related to safety, functional performance, and equivalence to a predicate, not diagnostic metrics like sensitivity/specificity. The document states that the device "met performance, usability, and safety test acceptance criteria." Specific quantitative thresholds for these tests are not provided in this summary.

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

• Test Set Sample Size: Not applicable in the context of diagnostic performance testing. The "test set" here refers to units of the device itself undergoing various non-clinical performance and safety tests. The document doesn't specify the number of physical devices or components tested for each non-clinical assessment (e.g., how many units were subjected to accelerated cleaning, or how many were involved in human factors testing).
• Data Provenance: The data described is from non-clinical performance testing (bench, safety, EMC, software V&V, human factors, cleaning/disinfecting, lifetime) of the device itself. There is no mention of patient data or clinical images. The testing would have been conducted by Invivo Corporation (a division of Philips Medical Systems) or their designated testing facilities.
• Retrospective/Prospective: All testing described is prospective as it's part of the development and verification/validation of the new device.

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

• Not applicable. This device is a monitor/display, not a diagnostic AI. There is no concept of "ground truth" (e.g., disease presence/absence in imaging) established by experts for a test set in the way you would for an AI diagnostic algorithm. The "truth" for functional tests is simply whether the device operates according to its specifications and regulatory standards.

4. Adjudication Method for the Test Set

• Not applicable. This relates to diagnostic image interpretations, which is not what this device does or what this submission is about.

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 is not relevant for this type of device (a patient vital signs display) and was not conducted or required for this 510(k) submission. This type of study would be for evaluating diagnostic AI's impact on human reader performance.

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

• No, not applicable in the requested context. The device itself is a component in a human-in-the-loop system (healthcare professionals monitoring patients). There is no "standalone algorithm" in the diagnostic sense. The device's "performance" is its ability to accurately display information and meet safety standards.

7. The Type of Ground Truth Used

• Not applicable in the requested context. The "ground truth" for this device's evaluation is primarily its adherence to engineering specifications, recognized safety and performance standards (e.g., IEC 60601 series, FCC), and functional equivalence to its predicate device. This is defined by technical standards and engineering verification, not by expert consensus on clinical cases, pathology, or outcomes data from patients the device is used on.

8. The Sample Size for the Training Set

• Not applicable in the AI sense. This document does not describe an AI/machine learning model that requires a "training set" of data. The device is hardware and software designed to perform a specific data display and control function.

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

• Not applicable. As there is no AI training set, there is no ground truth establishment for such a set described.

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DynaCAD is a MR image analysis software medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: • MR Analysis Server post-processing software application facilitates the analysis of dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. · Viewer application facilitates the analysis and presentation of datasets generated by the MR Analysis Server. · Interventional Planning image-guidance application for diagnostic and interventional procedure planning for biopsy and/ or soft tissue ablation. DynaCAD is indicated for medical conditions that require interventional and/or diagnostic procedures of the prostate gland or breast tissue.

DynaCAD is a MR image analysis software only medical device used during clinical diagnosis, reporting, and interventional pre-planning and is intended to assist the physician through a series of sequential tasks. DynaCAD consists of: - . MR Analysis Server post-processing software application, which facilitates the analysis of dynamic and non-dynamic MR datasets to provide study review, lesion characterization, and additional mathematical and/or statistical analysis. It includes the following software modules: DynaCAD Breast, DynaCAD Prostate, DynaLOC Breast, DynaLOC Prostate, and PK MRI Analysis. - . Viewer application, which facilitates the analysis and presentation of datasets generated by the MR Analysis Server. It includes the following functions: Region of Interest (ROI) curve, Pixel of Interest (POI) curve, Report Card, Volume Calculation, Statistical Analysis, 3-D visualization of image series, and DICOM reporting, among other capabilities. - Interventional Planning image-guidance application, i.e. Ablation Planning, which facilitates diagnostic and interventional procedure planning for biopsy and/or soft tissue ablation. It helps the user to prepare for ablation procedures by presenting the target regions along with critical structures identified in MR, and previously acquired biopsy data. It provides information about the ablation devices and applicators for automatic ablation plan computation, which the user can adjust as necessary. DynaCAD is used in both the radiology, i.e. DynaCAD Radiology, and urology domain, i.e. DynaCAD Urology.

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria. It is a 510(k) summary for DynaCAD, a medical image analysis software, asserting its substantial equivalence to a predicate device.

The document focuses on:

• Description of the Device: DynaCAD, its components (MR Analysis Server, Viewer application, Interventional Planning application), and its use in radiology and urology for breast and prostate tissue.
• Intended Use/Indications for Use: Confirms similarity to the predicate device, emphasizing assistance to physicians for diagnosis, reporting, and interventional pre-planning.
• Technological Characteristics: Details the similarities and minor differences (e.g., urology workflow, ablation planning) between the subject and predicate devices, stating that these differences do not raise new safety or effectiveness questions.
• Non-Clinical Performance Data: Mentions compliance with international and FDA-recognized consensus standards (IEC 62304, IEC 62366-1, ISO 14971, ISO 15223-1, NEMA PS 3.1-3.20 DICOM). It states that software verification and validation testing (including usability and in-house simulated use) were performed, and all tests "passed." These tests demonstrated that DynaCAD meets "acceptance criteria of the device requirements" and is adequate for its intended use.
• Clinical Performance Data: Explicitly states, "The subject DynaCAD did not require clinical performance data to demonstrate safe and effective use."

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details because they are not present in the provided text. The text asserts that non-clinical tests were performed and that "all executed verification test passed" and "all executed validation protocols were passed," indicating the device "Meets the acceptance criteria of the device requirements," but it does not list what those specific acceptance criteria are or the quantitative results of those tests.

The document makes a claim of substantial equivalence based on the device's technological characteristics and non-clinical performance (software verification and validation), rather than a comparative effectiveness study with human readers or a standalone performance study with specific metrics.

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UroNav is a stereotaxic accessory for image-guided interventional and diagnostic procedures of the prostate gland. It provides 2D and 3D visualization of Ultrasound (U/S) images and register these images with those from other imaging modalities such as Magnetic Resonance (MR). It also provides the ability to display a simulated image of a tracked insertion tool such as a biopsy needle, guidewire, grid plate or probe on a computer monitor screen that shows images of the target organ and the current and the projected future path of the interventional instrument taking into account patient movement. Other software features include patient data management, multiplanar reconstruction. segmentation, image measurements and 2D/3D image registration.

UroNav is intended for treatment planning and guidance for clinical, interventional and/or diagnostic procedures. The device is intended to be used in interventional and diagnostic procedures in a clinical setting. Example procedures include, but are not limited to image fusion for diagnostic clinical examinations and procedures, soft tissue ablations and placement of fiducial markers.

UroNav System is a medical image processing system that provides image-guided intervention and diagnostic information, which guides interventional instrumentation to targets that have been defined by the physician. The target can be indicated either pre-procedurally or intraprocedurally using images or relative to an indicated position on the patient. As a diagnostic system, it combines pre-procedural and intraprocedural imaging to assist in locating areas of interest detected on one set of images on the other. The system provides fusion between Ultrasound (US) and different imaging modalities such as Magnetic Resonance Imaging (MR). When used as a navigation aid, it also transforms two and three-dimensional patient images (scan sets) into dynamic representations on which a medical instrument can be navigated. The system performs spatial mapping from one image space to another image space or from image space to physical space ("registration") allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive interventional procedures. Images used by UroNav can include archived image data from a CD, PACS, etc., and live images from an ultrasound system.

The UroNav system consists of an Electromagnetic Measurement System (EMMS) (including a Field Generator, System Control Unit and System Interface Unit(s)), a System Unit (including a CPU/monitor, medical-grade power supply and mobile cart), Field Generator stand, UroNav software and various instrumentation devices. The UroNav System Unit and the UroNav software utilize the keyboard, mouse and visual display to interact with the image data from a connected Ultrasound System. This interaction includes the selection of targets and associated navigation on the UroNav monitor. Targeted use areas for UroNav include hospital operating rooms, outpatient surgery centers, ultrasound suites, and procedure rooms.

The UroNav System is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image. The system has been designed to work with the clinicians' existing ultrasound machine, transrectal ultrasound (TRUS) probe, commercially available needle guides and needle gun combinations. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurement and 3D image registration. UroNav utilizes an electromagnetic measurement system (EMMS) for identifying and tracking the location of the TRUS probe (and associated needle guides, instruments, etc.) relative to the 2D and 3D images. The EMMS Field Generator is positioned near the patient and provides an electromagnetic (EM) field for detection by a proprietary electromagnetic (EM) Sensor, which is attached to the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject prostate. The Field Generator and EM Sensor are connected to the UroNav System Control Unit and the PC running the UroNav software. Control of the ultrasound probe and ultrasound system is done manually by the physician, just as it would be in the absence of UroNav System. However, by tracking the position and orientation of the ultrasound probe while capturing the video image, UroNav System is able to reconstruct and display a 3D image and 3D rendered surface model of the prostate.

The reconstructed 3D image can be further processed to perform various measurements including volume estimation and can be examined for abnormalities by the physician. Patient information, notes and images may be stored for future retrieval.

Locations for biopsies, needles, markers, and other devices may be selected by the physician, displayed in the 3D image and 3D rendered surface model, and stored. Previously created 3D models may be recalled and may be aligned or registered to the current live display of the prostate. The 3D model used for co-registration may be based on another series of ultrasound images or DICOM images.

The physician may also attach a commercially available biopsy needle guide to the TRUS probe and use the probe and biopsy needle to perform tissue biopsy. Whenever the ultrasound machine is turned on by the physician, the live 2D ultrasound image is displayed on the UroNav display during the biopsy. As the TRUS probe with attached needle guide is maneuvered by the physician, the position and orientation of the probe is tracked. UroNav System is able to add, display and edit plans for target locations (e.g., biopsy sites) as well as an estimate of the probe position and needle trajectory relative to the 3D image and 3D rendered surface model of the prostate and the planned target locations. UroNav System offers the physician additional 3D information for assessing prostate abnormalities, planning and implementing biopsy procedures. The additional image processing features are generated with minimal changes to previous TRUS probe based procedures, and the physician always has access to the live 2D ultrasound image during prostate assessment or biopsy procedure.

In addition to standard transrectal procedures, UroNav System also supports transperineal access and commercially available gridplates normally used for performing such procedures. When using transperineal mode, the UroNav EM Sensors are attached to both the TRUS probe and the transperineal gridplate within a mechanical stepper assembly. Procedure planning, segmentation, registration and navigation are performed the same as the standard transrectal procedure except that a computer rendering of the transperineal gridplate is displayed on the UroNav System display. UroNav System provides an indication of the gridplate coordinates that correspond to the identified target location.

The provided text describes the UroNav System and its substantial equivalence to a predicate device but does not contain a detailed study report that proves the device meets specific acceptance criteria with quantifiable metrics. Instead, it states that "Non-Clinical verification and or validation test results demonstrate that the UroNav System: Complies with the aforementioned international and FDA-recognized consensus standards and Meets the acceptance criteria and is adequate for its intended use."

The document focuses on establishing substantial equivalence to a predicate device (UroNav Version 3.0, K182561) rather than presenting a standalone study with specific performance outcomes.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the text. The text explicitly states: "The UroNav System did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes... Non-clinical performance testing..."

However, I can extract the information that is present regarding the non-clinical verification and validation:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size for test set: Not specified. The document refers to "Non-Clinical verification and or validation tests" but does not detail the methodology or sample sizes used for these tests.
• Data provenance: Not explicitly stated as retrospective or prospective clinical data, as it was a "non-clinical" study. The intent was to demonstrate substantial equivalence through technical testing rather than patient data.

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

• Not applicable as this was a non-clinical verification and validation study, not a study involving expert-established ground truth on medical images or patient data.

4. Adjudication method for the test set:

• Not applicable for a non-clinical verification and validation study focused on technical performance and compliance with standards.

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 comparative effectiveness study was not done. The document explicitly states: "The UroNav System did not require clinical study since substantial equivalence to the primary currently marketed and predicate device was demonstrated with the following attributes: ... Non-clinical performance testing..."

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

• The document implies that non-clinical verification and validation tests were performed on the system's functionality, which would include algorithm-only performance for various features like image processing, segmentation, registration, and EM navigation. However, the exact details of such standalone testing (e.g., specific metrics, test cases) are not provided. The UroNav system itself is described as a medical image processing system that assists in procedures, implying a human-in-the-loop context for its intended use, even if components were tested in a standalone manner.

7. The type of ground truth used:

• For the non-clinical verification and validation tests, the ground truth would typically be established through engineering specifications, simulated data with known parameters, or phantom studies with measurable outcomes, in accordance with the mentioned consensus standards. The document does not specify the exact nature of this "ground truth" but implies it was based on functional requirements and technical accuracy.

8. The sample size for the training set:

• Not applicable. The document describes a "non-clinical verification and validation" study to demonstrate substantial equivalence, not a study involving machine learning model training.

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

• Not applicable, as there was no mention of a training set for a machine learning model.

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