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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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