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The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.

The Siemens 3.0T PROCURE™ Array Coil interfaces with a 3.0T 16-channel Siemens MRI scanner and provides high-quality images of the reproductive and urological anatomies in an easy-to-position, wearable, and very flexible design. This lightweight SemiFlex™ design facilitates effortless and accurate positioning similar to wearing a diaper and positions the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The enclosure for the antenna set is made of flexible liquid impermeable, biocompatible materials, and the coil is accompanied by disposable liners (USP Class 6 PET) easily changed between patients, should scanning without clothing be desired. The coil design and materials used for manufacture are identical to standard MRI coil technology that has existed for several years. The coil uses similar blocking networks and impedance matching circuits, and it does not transmit energy into the patient, neither predicate nor current submission.

This phased-array coil also accommodates popular biopsy systems, both delivered via an opening near the anus and/or vagina, neither included in the scope of this submission as they are independently operated and cleared by the FDA.

This document describes the Siemens 3.0T PROCURE Array Coil, an MRI accessory, and its substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving that a device meets those criteria in the way typically seen for AI/ML-based medical devices.

The document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than defining new performance acceptance criteria and proving them through a specific study for a novel device.

Therefore, many of the requested elements for an AI/ML-based device evaluation are not applicable or cannot be extracted from this document.

However, based on the provided text, I can infer some aspects related to the assessment performed for this device:

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

This document does not present explicit numerical acceptance criteria for diagnostic performance or reported performance results in a table. The evaluation focuses on demonstrating "substantial equivalence" to a predicate device, meaning it performs as safely and effectively as the predicate, rather than meeting specific quantifiable performance thresholds.

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

The document mentions "Analyses in all 3 planes (sagittal, coronal, and axial) were run on the Siemens 3.0T PROCURE™ Array Coil to show that the anatomies of the submitted and predicate coils have substantial equivalence." This implies a clinical evaluation, but:

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not specified. The document states images "when interpreted by a trained physician, may assist in medical diagnosis," but does not detail the process of expert review for establishing ground truth in a structured study.

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

Not specified.

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, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an MRI coil.

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

The document does not explicitly define how ground truth was established for "analyses". Given it's an imaging device, the "high-quality images" would likely be judged by expert clinical interpretation, but the specific standard for ground truth is not detailed.

8. The sample size for the training set:

Not applicable. This device is an MRI coil and does not use a training set in the context of machine learning.

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

Not applicable.

Summary of what is present in the document:

• Device Type: An MRI coil, an accessory to an MRI scanner.
• Purpose of Evaluation: To demonstrate "substantial equivalence" to a predicate device (1.5T and 3.0T GE PROCURE™ Array Coil, K140606).
• Non-Clinical Tests: Blocking network analysis, SNR and uniformity analysis, risk management (hazard analysis and FMEA), heat testing, compliance testing to IEC60601-1 3rd Edition.
• Clinical Tests: Analyses in all 3 planes (sagittal, coronal, and axial) to show substantial equivalence of anatomies imaged by the submitted and predicate coils.
• Intended Use/Indications for Use: To provide high-quality images of reproductive and urological anatomies to assist in medical diagnosis when interpreted by a trained physician.
• Key Argument for Equivalence: Identical scientific principles of operation, similar design (with minor modification for Siemens scanner compatibility), same materials, and successful biocompatibility track record for materials.

This information aligns with the typical process for 510(k) clearance of hardware devices where the emphasis is on safety, performance characteristics (like image quality assessed qualitatively), and comparability to an existing device, rather than explicit numerical performance metrics and detailed study designs for AI/ML algorithms.

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The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.

The Siemens 3.0T Blanket Array Coil embeds an MRI antenna set within a quilt-like enclosure providing high-quality images of general human anatomy. It is flexible enough to wrap snuggly around small bodies as well as large adult extremities so it can be used to image those challenging regions such as bilateral brachial plexus, bilateral lower extremities, and even heads. This lightweight SemiFlex™ design facilitates effortless and accurate positioning and ensures the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The Blanket Array Coil is an MRI coil contained within a water-resistant case, featuring a soft and cleanable cover. What the patient feels is a lightweight, warm and soothing blanket. What the radiologist sees is a flawless image without compromising comfort. The underlying technology and materials used for manufacture are identical to standard MRI coil technology that has existed for several years. The coil uses similar blocking networks and impedance matching circuits, and it does not transmit energy into the patient, neither predicate nor current submission.

I'm sorry, but the provided text does not contain the detailed information necessary to fully answer the request regarding acceptance criteria and the study proving a device meets them. The document is primarily a 510(k) summary for a Siemens 3.0T Blanket Array Coil, focusing on its substantial equivalence to a predicate device, rather than a clinical study report with specific acceptance criteria and detailed performance metrics.

Here's what can be extracted and why other parts of your request cannot be answered:

Device Information:

• Trade/Device Name: Siemens 3.0T Blanket Array Coil (Model 516SI3001)
• Regulation Number/Name: 21 CFR 892.1000, Magnetic resonance diagnostic device
• Product Code: MOS
• Intended Use: "The coil is indicated for use by the order of a physician to be used as an accessory to a Siemens 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis."

Missing Information:

The document describes non-clinical tests and a mention of "clinical tests" but does not provide specific acceptance criteria, reported device performance metrics against such criteria, sample sizes, provenance of data, details about expert involvement in ground truth establishment or adjudication, MRMC studies, or standalone algorithm performance.

Explanation for Missing Information:

1. Acceptance Criteria and Reported Device Performance: While the document mentions "SNR and uniformity analysis" as a non-clinical test, it does not state specific numerical acceptance criteria (e.g., "SNR must be >X dB") nor does it present the quantitative results of these analyses as "reported device performance." The substantial equivalence decision relies on the similarity of the performance to the predicate, not on meeting predefined numerical targets that would typically be seen in a clinical trial with specific endpoints.

2. Sample Size for Test Set and Data Provenance: The document states that "Analyses in all 3 planes (sagittal, coronal, and axial) were run on the Siemens 3.0T Blanket Array Coil to show that the anatomies of the submitted and predicate coils have substantial equivalence." This statement is extremely vague and does not provide any information about the number of cases (sample size), patient demographics, or whether the data was retrospective or prospective, or its country of origin.

3. Number/Qualifications of Experts for Ground Truth: No information is provided regarding the use of experts to establish a "ground truth" for the test set. The study described seems to be more about demonstrating technical equivalence in imaging quality rather than diagnostic accuracy against a definitive ground truth. The indication for use mentions images being interpreted by a "trained physician," but this is a general statement, not a detail of the validation study.

4. Adjudication Method: Not applicable, as there's no mention of a formal expert review or ground truth establishment process involving multiple experts and adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No MRMC study is mentioned. The focus is on comparing the technical characteristics and imaging capabilities of the new coil to a predicate device, not on how human readers perform with or without the device's assistance.

6. Standalone Performance: The device is an MRI coil, an accessory to an MRI scanner, and does not operate as a standalone algorithm or device in a diagnostic sense. Its performance is intrinsically linked to the overall MRI system and the interpretation by a physician.

7. Type of Ground Truth Used: Based on the description, the "ground truth" appears to be the visual quality and anatomical depiction in the images, compared to the predicate device. It's not pathology, outcomes data, or expert consensus on diagnosis.

8. Sample Size for Training Set: This device is hardware (an MRI coil), not a software or AI algorithm that requires a "training set."

9. How Ground Truth for Training Set was Established: Not applicable, as it's not an AI/ML device.

In summary, the provided document is a 510(k) summary for a medical device (an MRI coil) seeking substantial equivalence based on technical characteristics and imaging capabilities, not a clinical trial report for an AI/ML diagnostic device that would typically include the requested details about acceptance criteria, ground truth, and reader studies.

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The intended use of this PROCURE Array coil family is to provide high-quality images of the reproductive and urological anatomies in an easy-to-position, wearable, and very flexible design.

The coil is indicated for use by the order of a physician to be used as an accessory to a General Electric 1.5T or 3.0T magnetic resonance scanner for general human anatomy imaging as supported by the scanner. These images, when interpreted by a trained physician, may assist in medical diagnosis.

The PROCURE™ Coil Family interfaces with a 1.5T or 3.0T 8-channel GE MRI scanner and provides high-quality images of the reproductive and urological anatomies in an easy-to-position, wearable, and very flexible design. This lightweight SemiFlex™ design facilitates effortless and accurate positioning similar to wearing a diaper and positions the multiple antenna elements as close as possible to the target anatomies regardless of patient size. The enclosure for the antenna set is made of flexible liquid impermeable, biocompatible materials, and the coil is accompanied by disposable liners (USP Class 6 PET) easily changed between patients, should scanning without clothing be desired. The two coils in the product family are identical in design, construction, materials, and operation, with the exception of resonant frequency. The designs and materials used for manufacture of both coils are identical to standard MRI coil technology that has existed for several years. The coils use similar blocking networks and impedance matching circuits, and they do not transmit energy into the patient, neither predicate nor current submission.

This phased array coil also accommodates popular biopsy systems, both delivered via an opening near the anus and/or vagina, neither included in the scope of this submission as they are independently operated and cleared by the FDA

This device is an MRI coil, a non-AI medical device. The provided text is a 510(k) summary for a substantial equivalence determination, not a study evaluating acceptance criteria for an AI/ML powered device. As such, acceptance criteria, efficacy study, and information regarding ground truth and expert involvement are not applicable in the context of AI/ML evaluation.

The 510(k) summary details the "PROCURE™ Array Coil Family" and compares it to a predicate device (1.5T ScanMed® PV Array, K022395) to demonstrate substantial equivalence.

Here's an analysis based on the information provided, specifically addressing the non-AI nature:

1. Table of acceptance criteria and the reported device performance

For a non-AI device like an MRI coil, "acceptance criteria" for performance primarily revolve around meeting established safety standards and demonstrating image quality comparable to or better than a predicate device. The document does not present a formal table of quantitative acceptance criteria and reported device performance in the way one would for an AI/ML model's diagnostic accuracy. Instead, it relies on demonstrating equivalence through various engineering and scientific analyses.

The key performance metrics for an MRI coil typically involve Signal-to-Noise Ratio (SNR) and image uniformity.

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

The document mentions "Clinical Tests" were performed with "Analyses in all 3 planes (sagittal, coronal and transverse) were run on the PROCURE Array product." However, it does not specify the sample size of these clinical tests (i.e., number of patients or imaging studies). The data provenance (country of origin, retrospective/prospective) is also not stated.

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

Not applicable. For MRI coils, the "ground truth" is not established in the same way as for AI models requiring expert annotation. Image quality is assessed based on physical properties and visual interpretation by a "trained physician" for diagnosis, but there's no mention of a formal expert panel to establish ground truth for a test set in the context of an efficacy study as would be seen for an AI product.

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

Not applicable. As this is not an AI/ML product requiring diagnostic accuracy adjudication, no such method is described.

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

Not applicable. This is not an AI-assisted device, and no MRMC study or AI-related comparative effectiveness study was performed. The comparison is between two physical MRI coils.

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

Not applicable. This is a passive receive-only MRI coil, not an algorithm.

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

Not applicable in the AI/ML sense. The "ground truth" for an MRI coil's performance typically refers to its ability to produce clinically usable images, which is assessed by "trained physicians" for "medical diagnosis." However, this is not a formal ground truth as required for validating an AI diagnostic algorithm.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML model that requires training data.

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

Not applicable, as there is no training set for an MRI coil.

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The intended use for this 1.0T 8-channel Neurovascular Coil is to facilitate diagnostic targeting imaging of brain, neck and upper chest that may be interpreted by a trained physician.

• To collect image data throughout the region of the head, neck and chest region of the patient using a Philips vertical-field 1.0T MR scanner.
• Various regions of the Brain, including brainstem, pituitary, IAC, and orbits, intra cerebral vascular structure, soft tissue of the facial area, arteries between the aortic arch and the Circle of Willis, soft tissue in the anterior neck, pediatric head/neck, cervical spine, long top and brachial plexus, and with the ability to scan feet and ankles.

The 8 individual coils that comprise the ST SENSE NV 8 Array Coil (Neurovascular Array) interface with a 1.0 Tesla, 8-channel Panorama MRI scanner. Between the device and its predicate, there are slight variations in physical size of electrical and physical aspects (to accommodate focus of anatomies) The designs and materials used to manufacture the individual coils are nearly identical and are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing has been formed by utilizing a rigid housing that disconnects to facilitate both close coupling of the imaging coil's regionof-sensitivity to the anatomy of interest on a patient anatomy, and ease of entry to each patient. All employ similar blocking, impedance matching and integrated pre-amplifier circuitry.

The provided text describes a 510(k) summary for the ST SENSE NV 8 Array Coil, an MRI coil, and focuses on demonstrating its substantial equivalence to a predicate device. The information presented is primarily for a medical device regulatory submission and does not detail a study proving the device meets acceptance criteria in the format typically used for AI/algorithm performance.

Here's an analysis based on the provided text, structured to address your requested information points, but with the caveat that many points are not applicable (N/A) as the document is not about AI/algorithm performance.

Device: ST SENSE NV 8 Array Coil (MRI coil)

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable way for performance metrics that would be applicable to an AI device. Instead, it describes a "substantial equivalence" comparison to a predicate device based on design, materials, chemical composition, energy source, and non-clinical tests.

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

The document mentions "Analyses in all 3 planes (sagittal, coronal and transverse) were run" for "Clinical Tests," but it does not specify the sample size (number of patients or scans), data provenance, or whether the study was retrospective or prospective.

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

Not applicable. This device is an MRI coil, not an AI/algorithm that requires expert-established ground truth for its performance evaluation in the typical sense. The images are "interpreted by a trained physician," but this refers to the end-user clinical interpretation, not the establishment of ground truth for evaluating the device itself.

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

Not applicable. The clinical tests described involve comparing image quality of anatomical regions to a predicate device, not an adjudication process for diagnostic interpretations.

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 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 (expert consensus, pathology, outcomes data, etc.)

Not applicable in the typical sense for an AI/algorithm. The "ground truth" for this device's performance is essentially the ability to produce diagnostic quality images of specified anatomical regions, which is compared to a predicate device and assessed by evaluating sensitivity profiles, SNR, and image clarity across planes. This is a functional and safety evaluation, not a diagnostic accuracy evaluation against a ground truth diagnosis.

8. The sample size for the training set

Not applicable. This is a physical medical device (MRI coil), not an AI algorithm requiring a training set.

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

Not applicable.

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

The "study" described is a regulatory submission demonstrating substantial equivalence of the ST SENSE NV 8 Array Coil to a legally marketed predicate device (1.5T Pediatric Head/Spine Array Coil). This is a standard pathway for medical device clearance in the US, indicating that the new device is as safe and effective as the predicate.

The evidence presented includes:

• Comparison of Technological Characteristics:
  • Design: Both are receive-only coils for MRI systems, with the subject device being an 8-channel coil capable of imaging brain, neck, and upper chest, with angiography. The predicate covers "very similar anatomy" but for a different system and field strength.
  • Material: Both use biocompatible polycarbonate with enamel paint and Ultem latching parts, with proven insulating qualities and liquid ingress resistance.
  • Chemical Composition: Both are biocompatible.
  • Energy Source: Both are receive-only, stimulated by the MRI system.
• Non-Clinical Tests: The new device was compared using "similar risk management efforts" to the predicate, including Sensitivity profile, SNR Analysis, Hazard Analysis, FMEA, Blocking Analysis, and Heat Tests. These tests "determined to be substantially equivalent."
• Clinical Tests (Image Quality Comparison): "Analyses in all 3 planes (sagittal, coronal and transverse) were run to show that the anatomies of the submitted and predicate coils have substantial equivalence." The predicate images the complete brain and neck regions, while the new device images anatomies between the brain and lung tops. The "Final Discussion" reiterates that the device "is as safe, as effective, and performs as well or better than the legally-marketed device on the target anatomies."

In essence, the "study" is a comprehensive engineering and performance comparison against a predicate device, focusing on safety and efficacy markers relevant to an MRI coil's operation and imaging capabilities, rather than a clinical trial measuring diagnostic accuracy against a definitive ground truth.

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The family is to be used in conjunction with a GE 1.5T and GE 3.0T Magnetic Resonance Scanner, to produce diagnostic images of the orbits and surrounding anatomy, as well as mandible regions that can be interpreted by a trained physician.
The intended use for the device family is to provide MRI antenna sets to facilitate targeting imaging of the orbit region and mandible region.
Tissue of the brain and face with emphasis on the orbits, and of the mandible joint of the head.

The devices are a 1.5T Orbit and Mandible Array and a 3.0T Orbit and Mandible Array. The designs and materials used to manufacture each coil are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing is formed by an EVA foam cover around a flexible circuit board. The two devices in this family are identical except for the tuned frequency.

The provided text is a 510(k) summary for the "Orbit and Mandible Array Family" MRI coils. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, many of the requested sections about clinical studies, reader studies, and ground truth establishment are not applicable or cannot be extracted from this document.

Here's an analysis based on the information provided:

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

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it argues for substantial equivalence to a predicate device based on design, materials, chemical composition, energy source, and non-clinical tests. The "performance" is implicitly deemed acceptable if it's "as safe, as effective, and performs as well or better than the legally-marketed device on the target anatomies."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes non-clinical tests and comparisons to a predicate device, rather than a clinical study with a "test set" in the context of an AI/algorithm validation. The "analyses in all 3-planes" mentioned under clinical tests refer to showing substantial equivalence in imaging capabilities, not a study involving patient data with a defined sample size for performance evaluation. No sample size for a test set is provided, and thus, data provenance cannot be determined.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document discusses device characteristics and equivalence, not an AI/algorithm where ground truth would be established by experts for a test set. The images are intended to be "interpreted by a trained physician," but this refers to the end-user clinical interpretation, not ground truth establishment for a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no test set requiring ground truth adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for MRI coils, not an AI-assisted diagnostic tool. No MRMC study was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (MRI coil), not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is the ability of the coil to produce diagnostic images, which is assessed through non-clinical performance characteristics and comparison to a predicate device's established performance.

8. The sample size for the training set
Not applicable. This is not an AI/algorithm device requiring 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 intended use for the device family is to provide form fitting MRI antenna sets to facilitate targeting imaging of various musculoskeletal extremity regions using a GE 3.0T MRI scanner. The Indications for use are:

• Soft tissue and bone imaging of the extremities as allowed by the MRI system. .
• Magnetic resonance peripheral angiography.

The individual coils that comprise the Extremity Coil Family interface with a 3.0 Tesla, 8channel MRI scanner.
All coils included in the Extremity Set are extremely similar in design, construction, materials and operation. There are slight variations in physical size (to accommodate differing patient sizes), and slight physical housing variations (required to optimize the image quality depending on the extremity anatomy). The designs and matcrials used to manufacture the individual coils are nearly identical and are no different from standard MRI coil technology that has existed for years. The geometry of each coil housing has been formed by utilizing a semi-rigid housing in conjunction with semi-flexible flaps and/or padding that facilitates close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest on a broad size variation of patient anatomy. All employ similar blocking, impedance matching and integrated pre-amplifier circuitry.

The provided text is a 510(k) summary for the Extremity Coil Family, which describes MRI coils. This type of document is for a medical device that serves as an accessory to an imaging system (MR scanner). It focuses on establishing substantial equivalence to a predicate device, rather than proving the performance of a diagnostic algorithm or AI.

Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness with AI is not applicable to this submission. These coils are hardware components whose performance is typically evaluated based on engineering specifications related to signal-to-noise ratio (SNR), image uniformity, and physical compatibility with the MRI scanner.

The document confirms that this device is a basic MRI coil, not an AI-driven diagnostic tool. It states: "The designs and materials used to manufacture the individual coils are nearly identical and are no different from standard MRI coil technology that has existed for years."

No study related to AI or diagnostic performance is mentioned in the provided text.

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i. Soft tissue and bone imaging of the spine and brain as allowed by the MRI system.
ii. Magnetic resonance angiography.

The 3.0T Pediatric Head and Spine Array, Catalog #808GE3000, interfaces with the G.E. 3.0 Tesla Excite® system. It has been designed and optimized to collect spine (cervical, thoracic, and lumbar) and brain image data from many overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inouts and utilizes standard coil configuration files available on the G.E. system. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) submission for a medical device (MRI accessory coil) and primarily details the device description, intended use, and substantial equivalence to a predicate device, leading to FDA clearance.

There is no information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Ground truth establishment, including the number and qualifications of experts.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance studies.
• Types of ground truth used (e.g., pathology, outcomes data).
• Training set sample size or how its ground truth was established.

The document states that the new device has "minor changes to the size and physical orientation of the individual elements" and "the materials, use, and safety features are equivalent." It also notes that "Both are receive-only MRI antennas so no energy is imparted to the patient." This suggests that the clearance was based on demonstrating substantial equivalence in design and function, rather than extensive performance testing against acceptance criteria as might be seen for devices with more complex diagnostic or algorithmic components.

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i. Soft tissue and bone imaging of the spine and brain as allowed by the MRI system.
ii. Magnetic resonance angiography.

The 1.5T Pediatric Head and Spine Array, Catalog #808GE1500, interfaces with the G.E. 1.5 Tesla Excite® system. It has been designed and optimized to collect spine (cervical, thoracic, and lumbar) and brain image data from many overlapping coil groups. The multi-channel design utilizes the G.E. Phased Array Coil inputs and utilizes standard coil configuration files available on the G.E. system. The coil form geometry has been formed to facilitate close coupling of the imaging coil's region-of-sensitivity to the anatomy of interest. The coil assembly comes with a comfort pad set to comfortably place the patient on the coil assembly.

This document describes a 510(k) submission for a new medical device, the "1.5T Pediatric Head and Spine Array," which is an MRI accessory coil. The submission aims to demonstrate that this new device is substantially equivalent to a legally marketed predicate device (1.5T Pediatric Array #801GE1500, K051640).

The key takeaway is that this submission does not contain a study proving the device meets specific acceptance criteria based on performance metrics (e.g., sensitivity, specificity, image quality scores). Instead, it demonstrates substantial equivalence by highlighting that the new device has the same technological characteristics as the unmodified device with only minor changes to size and physical orientation of coil elements, and that the materials, use, and safety features are equivalent. The intended use also remains virtually identical.

Therefore, for the information requested in your prompt, I can only provide what is available in the text.

Here's a breakdown of why many of your specific questions cannot be answered from the provided text:

• Acceptance Criteria & Device Performance: The document does not define specific performance-based acceptance criteria (e.g., image signal-to-noise ratio, image resolution, diagnostic accuracy) that would be typically found in a clinical study for a diagnostic AI device. The "performance" described is in terms of technological characteristics and intended use being equivalent to a predicate device, not in terms of achieving specific quantitative diagnostic metrics.
• Studies: The document is a 510(k) summary and the FDA's response letter. It does not include a detailed study report with methods, results, or statistical analysis of device performance. The "study" here is essentially the comparison of the new device's technical specifications and intended use against a predicate device. This is a common approach for Class II devices that are substantially equivalent, where extensive new clinical performance studies are not always required if equivalence can be demonstrated through other means (e.g., engineering analysis, bench testing, comparison to predicate).

Based on the provided text, here is the information that can be extracted, acknowledging the limitations mentioned above:

1. Table of Acceptance Criteria and Reported Device Performance

Since the submission focuses on demonstrating substantial equivalence through comparison of technical characteristics and intended use, rather than a clinical performance study with AI, the following points are not applicable (N/A) based on the provided text:

• 2. Sample size used for the test set and the data provenance: N/A (No specific test set for performance evaluation is described).
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No ground truth establishment for a diagnostic performance test is described).
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No test set requiring adjudication is described).
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (This is not an AI device, and no MRMC study or human-AI comparison is described).
• 6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: N/A (This is hardware, not an algorithm, and no standalone performance evaluation is described).
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (No diagnostic ground truth is established for performance evaluation).
• 8. The sample size for the training set: N/A (No AI training set is applicable).
• 9. How the ground truth for the training set was established: N/A (No AI training set is applicable).

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