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SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the k-space, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

SpeedUp is a software option intended for use on G-scan and O-scan Esaote MRI svstems. SpeedUp is an imaging technique to increase scan speed reducing the acquisition time. The sparsity which is implicit in MR images is exploited to significantly undersample the kspace, resulting in incoherent artifacts (noise like). Time is decreased reducing the number of acquired k-space lines (i.e. undersampling) and the final image can be reconstructed accurately with an appropriate non-linear reconstruction method.

The provided text is a 510(k) summary for a medical device called "SpeedUp," which is a software option for MRI systems designed to increase scan speed. It states that the device is "substantially equivalent" to predicate devices, but it does not contain specific acceptance criteria or details of a study with performance metrics in a format that would allow for the direct creation of the requested table and detailed study information.

Here's a breakdown of what is and is not available in the provided text, and how it relates to your request:

1. Table of acceptance criteria and reported device performance:

• Not Available. The document states that "non-clinical verification and validation testing" and "clinical images... demonstrated that the systems met performance requirements and are as safe and effective as the predicate devices." However, it does not provide any specific quantitative (e.g., sensitivity, specificity, accuracy, dice score) or qualitative performance metrics, nor does it define what those "performance requirements" actually were.

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

• Not Available. The document mentions "clinical images" were used, but does not specify the number of cases or patients included in any test set, nor does it provide information about the country of origin or 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:

• Not Available. The document does not describe how ground truth was established, nor does it mention the number or qualifications of any experts involved in such a process.

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

• Not Available. There is no mention of any adjudication method.

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 Available. The document does not mention an MRMC study or any AI component. SpeedUp is described as an "imaging technique" and "software option" for MRI to reduce acquisition time through k-space undersampling and non-linear reconstruction, which is a signal processing technique, not necessarily an AI algorithm in the contemporary sense. It focuses on the image acquisition and reconstruction quality compared to standard methods, not on human interpretation improvement with or without AI assistance.

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

• Partially Available (Implied Standalone). SpeedUp is described as a "software option" that "reconstructs" images. The statement "Clinical images... demonstrated that the systems met performance requirements" implies a standalone assessment of the generated images, likely for image quality and diagnostic utility, but specific standalone performance metrics (e.g., SNR, contrast, resolution) are not provided. The function itself is image reconstruction, which is inherently "algorithm only" in its output.

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

• Not Available. The document refers to "clinical images" and meeting "performance requirements" but does not specify the ground truth used to evaluate these images or the output of the SpeedUp software.

8. The sample size for the training set:

• Not Applicable/Not Available. Given that SpeedUp is described as exploiting "sparsity" and using a "non-linear reconstruction method" rather than a deep learning AI model requiring a training set in the modern sense, a "training set" as typically understood for AI algorithms may not be relevant. Even if there were parameters optimized, the document does not mention any specific training data or its size.

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

• Not Applicable/Not Available. (See point 8).

In summary, the provided 510(k) summary for SpeedUp attests to substantial equivalence based on meeting performance requirements through non-clinical and clinical testing, but it does not disclose the specific criteria, study designs, sample sizes, expert involvement, or quantitative results that would fulfill your request for detailed acceptance criteria and study proving device performance. The document is high-level and focused on regulatory compliance through substantial equivalence, not detailed technical performance disclosure.

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S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and imaging portions of the spinal column, including the cervical and lumbo-sacral sections.

S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (Ti), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.

S-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.

This 510(k) is to add the DPA cervical coil. This is a dual phased array receiving coil, shaped for suitability to the areas under examination and designed to the patient's cervical vertebrae.

This 510(k) summary is for the addition of a DPA cervical coil to the Esaote S-Scan MR System, not for a new device requiring a comprehensive study to prove its acceptance criteria. Therefore, the document primarily focuses on demonstrating substantial equivalence to a predicate device (K080968) rather than providing extensive details about a performance study with acceptance criteria in the manner requested.

Based on the provided text, a detailed table of acceptance criteria and reported device performance, or a standalone study as typically seen for new AI/CADe devices, is not present. The submission focuses on demonstrating that the addition of a new coil does not alter the fundamental scientific technology or intended use of the already cleared S-Scan system.

Here's an attempt to address your requests based only on the provided text, acknowledging that many points cannot be fully answered due to the nature of this particular 510(k):

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table detailing "acceptance criteria" for the device's diagnostic performance and "reported device performance" against those criteria. This 510(k) submission is for an accessory (DPA cervical coil) to an already cleared MR system (S-Scan, K080968). The primary "acceptance" is demonstrating that the new coil does not materially change the safety and effectiveness of the existing device.

The "performance" described is in the context of the overall S-Scan MR system, which "produces transverse, sagittal and oblique cross-section images of the limbs, joints and spinal column." The images "can provide diagnostically useful information when interpreted by a medical expert trained in the use of MR equipment." This implies that the image quality with the new coil is expected to be sufficient for expert interpretation, consistent with the predicate device.

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

Not applicable/Not provided. The document does not describe a clinical performance study with a distinct "test set" in the context of diagnostic accuracy for the addition of the DPA cervical coil. This 510(k) focuses on the technological characteristics and substantial equivalence to an existing device.

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

Not applicable/Not provided. No test set requiring expert ground truth establishment is described for this 510(k) submission.

4. Adjudication method for the test set

Not applicable/Not provided. 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

Not applicable. This device is a Magnetic Resonance (MR) system with an added coil, not an AI or CADe device. Therefore, no MRMC study or AI-related comparative effectiveness is mentioned.

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

Not applicable. This is an MR imaging system, not an algorithm.

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

Not applicable/Not provided. As no specific clinical performance study with ground truth is described, this information is not available in the document. The general implication for the S-Scan system is that "diagnostically useful information" comes from images "interpreted by a medical expert trained in the use of MR equipment," suggesting clinical diagnosis as the ultimate truth.

8. The sample size for the training set

Not applicable/Not provided. This submission does not describe an algorithm requiring a training set.

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

Not applicable/Not provided.

Summary of the Study (or lack thereof) Proving Acceptance Criteria:

The document states: "The addition of the DPA Cervical Spine Coil to the S-scan system... does not alter the fundamental scientific technology of the S-scan system, the predicate device, cleared via K080968."

This statement is the core of the "proof" for this particular 510(k). The regulatory acceptance criteria for this submission are primarily met by demonstrating:

• Substantial Equivalence: The new DPA cervical coil, when added to the S-Scan system, is substantially equivalent to the predicate S-Scan system (K080968) in terms of its technological characteristics and intended use.
• No new questions of safety or effectiveness: The addition of the coil does not raise new questions of safety or effectiveness that were not addressed by the predicate device.

The study proving this involved a comparison of "Technological Characteristics" between the modified device (S-Scan with DPA cervical coil) and its predicate. This is typically achieved through engineering design verification and validation, ensuring that the new component integrates safely and produces images of comparable quality and diagnostic utility to what the original system was cleared for. No specific clinical trial or performance study with detailed metrics against acceptance criteria is described in this summary because the change is limited to an accessory and its impact on the fundamental technology.

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