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The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 1.5T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work with Siemens 1.5T MRI scanners for body MR imaging examinations. The coil is comprised of 24 total channels, with two individual flexible pads, each containing 12 individual elements. The elements are flexible to conform to patients' anatomies.

The provided text does not describe a study involving a device that uses AI or machine learning, nor does it provide a comparative effectiveness study with human readers. Instead, it describes a Magnetic Resonance (MR) Receive-only Coil and its substantial equivalence to a predicate device.

Therefore, many of the requested elements about acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment are not applicable based on the provided document.

However, I can extract information related to the device's performance testing from the document:

Device: InkSpace Imaging Small Body Array (a receive-only coil for MRI systems)

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

The document refers to performance testing in accordance with the "Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway" guidance document. It lists the tests performed, implying these tests are the acceptance criteria. The performance results are stated to have met established specifications.

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

• Sample Size: The document does not specify exact sample sizes (e.g., number of coils tested, number of images reviewed) for the nonclinical tests. It refers to "sample clinical images" for the acquired image quality analysis.
• Data Provenance: Not specified in terms of country of origin. The test data are generated from nonclinical bench testing and analysis of sample clinical images. The data is retrospective in the sense that the images are existing data used for evaluation.

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

• Number of Experts: "a board-certified radiologist" (implies one, though it could be a general statement about the type of expert).
• Qualifications: "board-certified radiologist."

4. Adjudication method for the test set:

• The document mentions a "review of their clinical quality by a board-certified radiologist." This implies a single expert review, not an adjudication process involving multiple experts for consensus.

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

• No. An MRMC study was not performed. This device is a passive component (MRI coil), not an AI/ML algorithm that assists human readers.

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

• N/A. This is not an algorithm; it's hardware. Its performance is assessed through its physical and electromagnetic properties, with the final output (images) being subject to human interpretation.

7. The type of ground truth used:

• For "Acquired Image Quality," the ground truth was established by the subjective "clinical quality" assessment by a "board-certified radiologist." Other tests (SNR, Uniformity, etc.) likely relied on objective measurements against engineering specifications.

8. The sample size for the training set:

• N/A. This device does not involve a training set as it's a hardware component, not an AI/ML model.

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

• N/A. (See point 8)

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The InkSpace Imaging Small Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adult and pediatric patients such as cardiac, spine, shoulder, elbow, knee, foot, and prostate in Siemens 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The InkSpace Imaging Small Body Array is a phased array, receive-only coil intended to work with Siemens 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution body MR imaging examinations. The coil is comprised of 24 total channels, with two individual flexible pads, each containing 12 individual elements. The elements are optimized to be flexible to conform to patients' anatomies.

The provided text describes the regulatory submission for a medical device, the InkSpace Imaging Small Body Array, and the FDA's "Substantially Equivalent" determination. However, it does not contain a detailed study proving the device meets specific acceptance criteria in the manner described in the prompt (e.g., sample size for test set, expert qualifications, multi-reader multi-case studies, or AI specific details).

The document focuses on demonstrating substantial equivalence to a predicate device (InkSpace Imaging Body Array, K223487) through non-clinical testing and a comparison of technological characteristics. It explicitly states that clinical testing was not required.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain the detailed study information for acceptance criteria related to a performance study on a test set (e.g., a study demonstrating a specific diagnostic accuracy or improvement in human reader performance). The information primarily pertains to device characterization and safety.

Here is what can be extracted and inferred from the text regarding acceptance criteria and performance data, acknowledging the limitations:

Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Testing):

Study Details (Inapplicable or Not Provided for a "Performance Study"):

1. Sample sized used for the test set and the data provenance: Not applicable in the context of clinical performance testing. The "sample clinical images" used for review of acquired image quality are mentioned but no specific "test set" size is provided, nor is their provenance (country of origin, retrospective/prospective) detailed. The review was part of non-clinical data, not a formal clinical trial with a defined test set size.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For "acquired image quality," a "board-certified radiologist" reviewed the images. The exact number of radiologists is not specified, but the use of "a board-certified radiologist" (singular) is mentioned. No other ground truth establishment or expert panel for a "test set" is described as it was not a clinical efficacy study.
3. Adjudication method: Not applicable/provided, as it was not a study requiring adjudication of diagnostic outcomes.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is about an MRI receive-only coil, not an AI-powered diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm, but a hardware device.
6. The type of ground truth used: For the "Acquired Image Quality," the ground truth was expert review by a board-certified radiologist of sample clinical images. This is qualitative assessment for suitability, not a quantitative ground truth for diagnostic accuracy (e.g., pathology report).
7. The sample size for the training set: Not applicable. This is a hardware device, not an AI model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Summary of Device and Regulatory Context:

• Device: InkSpace Imaging Small Body Array - a receive-only MR coil.
• Purpose: To obtain diagnostic images of general human anatomy (cardiac, spine, shoulder, elbow, knee, foot, and prostate) in adult and pediatric patients using Siemens 3.0T MRI systems.
• Regulatory Path: 510(k) premarket notification, seeking substantial equivalence to a predicate device (InkSpace Imaging Body Array, K223487).
• Key Change from Predicate: Compatibility with Siemens 3.0T MRI Systems (predicate was for GE 3.0T MRI systems).
• Performance Data: Primarily non-clinical bench testing (SNR, uniformity, heating, etc.) and a qualitative review of sample clinical images by a radiologist. Clinical testing was explicitly stated as not required. The rationale for substantial equivalence is that the changes are minimal and do not raise new questions of safety or effectiveness.

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Pediatric Population: The InkSpace Imaging Body Array is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in GE 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis. Adult Population: The InkSpace Imaging Body Array is a receive-only coil, used for obtaining diagnostic images of general human anatomy in adults, such as spine, shoulder, elbow, knee, foot, and prostate resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The InkSpace Imaging Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Body Array were designed to fit the pediatric and adult populations for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to pediatric and adult patients' anatomies.

The document provided is a 510(k) premarket notification for a medical device called the "InkSpace Imaging Body Array," which is a receive-only coil for Magnetic Resonance Imaging (MRI) systems. The document focuses on demonstrating substantial equivalence to a predicate device (InkSpace Imaging Pediatric Body Array, K213397) rather than establishing novel acceptance criteria for a new device's performance.

Therefore, the acceptance criteria and study detailed in this document are primarily concerned with demonstrating that the modified device (InkSpace Imaging Body Array) functions as safely and effectively as its predicate device (InkSpace Imaging Pediatric Body Array). The "acceptance criteria" here are implicitly related to the performance characteristics of an MRI coil, and the "study" is a set of non-clinical tests and an assessment of acquired image quality.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the InkSpace Imaging Body Array as if it were a new device needing to meet predefined thresholds. Instead, it states that the device had to demonstrate substantial equivalence to the predicate. The "performance criteria" referenced in the guidance document are general for MR receive-only coils, and the testing was done to ensure the modified device meets established specifications and does not raise different questions of safety or effectiveness compared to the predicate.

The table below summarizes the characteristics that were assessed for "performance" in the context of substantial equivalence:

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

• Sample Size for Acquired Image Quality: Not explicitly stated as a number. The document refers to "sample clinical images from adult patients" and an "analysis of acquired image quality... based on sample clinical images from adult patients." This implies a qualitative assessment on a subset of images rather than a large-scale, quantitatively defined test set.
• Data Provenance: Not specified for the "sample clinical images from adult patients." It does not mention country of origin, nor whether the data was retrospective or prospective.

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

• Number of Experts: "a board-certified radiologist." This indicates one expert.
• Qualifications of Experts: "board-certified radiologist." No specific experience level (e.g., "10 years of experience") is provided, but board certification implies a high level of qualification in the field.

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

• Adjudication Method: Not applicable or "none" in the typical sense of multiple readers adjudicating cases. The review of clinical quality was performed by "a board-certified radiologist" (singular), suggesting a single-reader assessment for clinical quality.

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

• MRMC Study: No. The device is a receive-only MRI coil, not an AI-assisted diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this device and was not conducted. The study was to establish substantial equivalence for the coil itself.

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

• Standalone Performance: No. This device is an MRI coil, which is a hardware component that produces images. It is not an algorithm, and thus, "standalone" algorithmic performance without human-in-the-loop is not applicable. The performance is assessed on the quality of the images it produces for human interpretation.

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

• Type of Ground Truth: For the "acquired image quality" assessment, the ground truth was the expert opinion/review of a board-certified radiologist regarding the clinical quality of the images. For the more objective non-clinical tests (SNR, uniformity, heating, etc.), the "ground truth" would be engineering specifications and regulatory standards.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This document describes a medical device (MRI coil), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of algorithm development. The non-clinical testing and image review are for validation/verification, not training.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this hardware device.

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The InkSpace Imaging Pediatric Body Array is a receive-only coil, used for obtaining diagnostic images of pediatric cardiac and body in GE 3.0T magnetic resonance imaging systems. These images, when interpreted by a trained physician, yield information that may assist in diagnosis.

The InkSpace Imaging Pediatric Body Array is a phased array, receive-only coil intended to work with GE 3.0T MRI scanners to provide optimal signal-to-noise ratio and uniformity for high resolution pediatric body MR imaging examinations. The size and layout of individual channels of the InkSpace Imaging Pediatric Body Array were designed specifically to fit the pediatric population for body imaging. The coil is comprised of 24 total channels, with two individual flexible pads, intended to be placed anterior and posterior to the patient, containing 12 individual elements. The elements are optimized to be flexible to conform to a pediatric patient's anatomy.

The InkSpace Imaging Pediatric Body Array is a receive-only coil for pediatric cardiac and body imaging in GE 3.0T MRI systems. Its acceptance criteria and performance are based on non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Study Proving Acceptance Criteria:

The device's acceptance criteria were proven through a series of nonclinical tests conducted in accordance with the FDA Guidance Document entitled, "Magnetic Resonance (MR) Receive-only Coil – Performance Criteria for Safety and Performance Based Pathway," issued December 11, 2020.

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

• Sample Size for Test Set: The document does not specify a numerical sample size for "test sets" in the traditional sense of a clinical trial with patient data. The testing primarily involved bench testing and technical evaluations of the device itself. For "Acquired Image Quality," sample clinical images were analyzed.
• Data Provenance: Not explicitly stated as "country of origin" for patient data, since the primary testing was non-clinical. The "sample clinical images" used for image quality analysis would presumably be from a clinical setting, but no details on their origin (e.g., country, specific institution, retrospective/prospective collection) are provided.

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

• Number of Experts: One expert.
• Qualifications of Experts: "A board-certified radiologist."

4. Adjudication method for the test set:

• The document mentions "a review of their clinical quality by a board-certified radiologist" for the acquired image quality. This implies a single-reader adjudication for the image quality assessment. There is no mention of a multi-reader, consensus, or other adjudication methods.

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. This device is a hardware component (MRI coil), not an AI-assisted diagnostic tool.

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

• Yes, in essence, standalone performance was assessed through the nonclinical bench testing. The "device performance" metrics (SNR, uniformity, heating, electrical safety, etc.) were evaluated for the coil itself, independent of human interpretation or interaction beyond its operational use in an MRI system. The image quality analysis, while reviewed by a radiologist, evaluated the device's output (the images) when compared to clinical expectations, not the radiologist's performance with or without the device.

7. The type of ground truth used:

• For the technical performance aspects (SNR, uniformity, heating, electrical safety, biocompatibility, etc.), the "ground truth" was established by engineering specifications, recognized industry standards (e.g., ISO 10993), and regulatory guidance documents (FDA Guidance Document for MR Receive-only Coil).
• For "Acquired Image Quality," the ground truth was based on the clinical interpretation and judgment of a board-certified radiologist regarding the diagnostic utility of the sample images produced by the device.

8. The sample size for the training set:

• Not applicable. This device is a hardware component (MRI coil); it does not involve machine learning or an "algorithm" in the sense of requiring a training set for model development.

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

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

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