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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 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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