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G-scan Brio is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, limbs, joints and spinal column. It is intended for imaging the head, 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 hip, imaging the temporomandibular joint and imaging the cervical, the lumbosacral sections as portions of the spinal column.

G-scan Brio 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 (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal and coronal and oblique cross-section images of the head, 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 foot, ankle, calf, knee, thigh and hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.

S-scan Brio 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 (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The change performed on the modified G-scan Brio, with respect to the cleared version - G-scan Brio K142421 - are due to the improvement of the system performance. This modification is for the introduction of the new Shoulder Coil 20 code 130000014 (already cleared with S-scan K161238), the Head Coil 16 code 13000100, and the head indication for use.

The change performed on the modified S-scan, with respect to the cleared version – S-scan K161238 – are due to the improvement of the system performance. This modification is the introduction of the new Head Coil 16 code 13000100 and the head indication for use.

The provided text describes a 510(k) premarket notification for the G-scan Brio and S-scan Magnetic Resonance (MR) systems. It confirms FDA clearance for these devices due to their substantial equivalence to legally marketed predicate devices.

However, the document does not contain information regarding acceptance criteria, reported device performance metrics (e.g., sensitivity, specificity), sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, details of multi-reader multi-case studies or standalone algorithm performance, or the specific type of ground truth used outside of general "diagnostically useful information."

The document primarily focuses on:

• Regulatory Clearance: Affirming that the devices are substantially equivalent to predicates.
• Device Description and Intended Use: Outlining what the MR systems image (head, limbs, joints, spinal column) and how they function.
• Technological Characteristics: Describing the changes made (new coils for shoulder and head imaging) and stating they do not alter the core technology.
• Non-Clinical Tests: Listing adherence to various safety and performance standards (e.g., IEC, ISO, NEMA).
• Clinical Tests (briefly mentioned): Stating that "sample clinical images and attestation from a U.S. Board-Certified Diagnostic Radiologist that the images are of good diagnostic quality were provided."

Therefore, it is not possible to provide the requested information in the format of acceptance criteria and proven device performance based on the provided document. The document states that the devices are "as safe, as effective, and performs as well as or better than the predicate" based on non-clinical testing and general attestations about image quality, but it does not quantify these claims or provide the specific details of a performance study as outlined in your request.

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S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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 hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column.

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 spinlatice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The change performed on the modified S-scan, with respect to the cleared version, S-scan K153039, is due to the improvement of the system performance. This modification, which does not affect the intended use or alter the fundamental scientific technology of the device, is the introduction of the Shoulder Coil 20 code 130000014. The Shoulder Coil N.20 is a three channels receiving coil. Its intended use is for shoulder examination on the S-scan. The Shoulder Coil is a wearable rigid coil equipped with an adaptor for fast placement in the patient table. The same adaptor matches for patient laterality (left /right shoulder).

This document, K161238, is a Special 510(k) submission for the ESAOTE S.p.A. S-scan Magnetic Resonance (MR) system, specifically regarding the addition of a new Shoulder Coil 20. The submission states that no clinical tests were performed to prove the device meets acceptance criteria. Instead, the submission relies on the concept of substantial equivalence to a previously cleared device (S-scan K153039) and non-clinical testing.

Therefore, many of the requested details related to acceptance criteria, device performance, and clinical study specifics are not available in this document.

However, based on the provided text, here's what can be extracted and inferred regarding the "study" that proves the device meets "acceptance criteria" through non-clinical means:

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

The document does not provide a table of acceptance criteria with specific performance metrics for the device itself or the new shoulder coil. Instead, the "acceptance criteria" are implied to be adherence to recognized safety and performance standards and demonstrating improved image quality/performance of the new coil compared to the previous one.

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

This information is not applicable as no clinical tests were performed with human subjects. The "test set" here refers to non-clinical evaluations against engineering standards and specifications within the manufacturer's testing environment.

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)

This information is not applicable as no clinical data or expert consensus was used for ground truth in this non-clinical submission. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.

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

This information is not applicable as no clinical data requiring expert adjudication was involved.

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, a multi-reader, multi-case comparative effectiveness study was not done. This submission is for an MR system, not an AI-powered diagnostic tool.

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

This information is not applicable. The S-scan is a diagnostic imaging system, not an algorithm. Its performance is evaluated based on its ability to produce diagnostically useful images when interpreted by a medical expert. The "standalone" performance here refers to the engineering validation of the system and its components.

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

For the non-clinical tests, the "ground truth" was based on established engineering and safety standards and specifications. For example, the Signal-to-Noise Ratio (SNR) was determined according to NEMA MS-1, and image uniformity according to NEMA MS-3. These standards define the acceptable performance characteristics for MR devices.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of this submission, as it does not involve machine learning or artificial intelligence.

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

This information is not applicable as there is no training set.

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S-scan is a Magnetic Resonance (MR) system that produces transversal, sagittal, 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 hip, imaging the temporomandibular joint and imaging the cervical, the thoracic and the lumbosacral sections as portions of the spinal column. 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 spinlattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in use of MR equipment, the images can provide diagnostically useful information.

The changes performed to S-scan, with respect to the cleared version – S-scan K131996 – are due to the improvement of the system performance. These modifications, which do not alter the fundamental scientific technology of the device, are the following and all have been cleared with G-scan Brio via K142421:

• 1. A new Bilateral TMJ Coil
• 2. Introduction of the thoracic spine section examination
• 3. A new software version including the following features:
  • Customization of Image Enhancement ●
  • Overlay sending to PACS
  • Isotropic 3D acquisition ●

This document describes a 510(k) submission for the Esaote S-Scan Magnetic Resonance (MR) system. The submission, K151668, pertains to improvements made to the S-Scan, specifically the introduction of a new Bilateral TMJ Coil, thoracic spine section examination, and new software features (Customization of Image Enhancement, Overlay sending to PACS, Isotropic 3D acquisition).

However, the provided text explicitly states that no clinical tests were performed to prove that the device meets acceptance criteria. Instead, the submission relies on the substantial equivalence to a previously cleared device, the G-Scan Brio (K142421), which already incorporated these changes.

Therefore, many of the requested details regarding acceptance criteria and a study proving their fulfillment cannot be extracted directly from this document.

Here's the information that can be gleaned and a table summarizing the explicitly requested points, with "N/A" where the information is not provided because no specific clinical study was conducted for this submission:

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

Since no new clinical tests were performed for this 510(k) submission, specific acceptance criteria and performance metrics for the S-Scan (K151668) are not detailed in the provided text. The submission argues that the changes do not alter the fundamental scientific technology and that the image quality performance has already been cleared via K142421 (G-Scan Brio).

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

N/A - No clinical tests were performed for this submission.

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)

N/A - No clinical tests were performed for this submission.

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

N/A - No clinical tests were performed for this submission.

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 document describes an MR system, not an AI-assisted device. No MRMC study was mentioned.

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

N/A - This document describes an MR system, not an algorithm, and no standalone performance study was mentioned.

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

N/A - No clinical tests were performed for this submission.

8. The sample size for the training set

N/A - No clinical tests or machine learning training were described for this submission.

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

N/A - No clinical tests or machine learning training were described for this submission.

Summary Table:

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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 hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.

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 (T1), 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.

The changes performed on the modified S-scan device, with respect to the cleared version - Sscan K121650 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. Upgrading of the electronics
• 2. Patient bed unlocking function
• 3. A new software version

This document is a 510(k) summary for the S-scan Magnetic Resonance (MR) system from Esaote S.p.A. It describes a modified version of the S-scan device compared to its cleared predicate (K121650).

Here's an analysis of the provided text regarding acceptance criteria and the study:

Important Note: The provided 510(k) summary is for a modified device, and the changes are described as "improvement of the system performance" due to "Upgrading of the electronics," "Patient bed unlocking function," and "A new software version." Crucially, it states that these modifications "do not affect the intended use or alter the fundamental scientific technology of the device." As a result, this 510(k) relies on the substantial equivalence to the predicate device (K121650) and does not describe a new study with explicit acceptance criteria for a novel AI/software feature with reported device performance results.

Therefore, I cannot directly extract "acceptance criteria and the study that proves the device meets the acceptance criteria" in the typical sense of a new AI algorithm's performance study from this particular document. The document essentially states that because the fundamental scientific technology and intended use are unchanged, a new major performance study against specific acceptance criteria for the new components is not required to demonstrate substantial equivalence for the overall device.

However, I can still extract information related to the device and its intended function, which would implicitly encompass its performance requirements.

1. Table of acceptance criteria and the reported device performance

Based on the provided text, there are no explicit acceptance criteria or reported device performance metrics stated for the modified S-scan's new software/electronics within this 510(k) summary. This is because the submission is a "Special 510(k)" relying on the fundamental equivalence to the predicate, K121650, where performance was presumably established. The modifications are described as improvements that do not alter the fundamental scientific technology or intended use.

The intended function of the device is to produce diagnostic MR images. Therefore, the implicit acceptance criterion is that the modified device must continue to produce diagnostically useful images of equivalent or improved quality compared to the predicate device, as determined by a medical expert.

Regarding the study proving the device meets acceptance criteria:

The document doesn't describe a specific clinical study for the modified S-scan to prove it meets new or modified acceptance criteria as if it were a novel AI algorithm. Instead, the "proof" is based on the argument of substantial equivalence to the predicate device (K121650). The modifications are considered "improvements" that do not alter the fundamental scientific technology. This type of submission (a Special 510(k)) typically relies on verification and validation of the engineering changes to ensure the device continues to meet its established performance specifications, rather than a full-scale clinical trial to re-establish diagnostic accuracy.

Therefore, for aspects 2-9, the answer is largely that this information is not applicable to this specific 510(k) summary because it doesn't describe a new performance study to establish primary diagnostic performance of a new algorithm but rather an upgrade to an existing MR imaging system.

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

• Not applicable. This 510(k) does not describe a new performance study with a test set of images for diagnostic evaluation by a new algorithm. The "test set" for the system itself would be part of the predicate device's original clearance (K121650) and internal engineering verification and validation testing for the upgrades.

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. See point 2.

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

• Not applicable. See point 2.

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 510(k) is for a conventional MR imaging system, 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 510(k) is for an MR imaging system; it does not involve a standalone algorithm for diagnostic interpretation. The device's output (images) requires interpretation by a medical expert. ("When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.")

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

• Not applicable for this 510(k) submission. For the original predicate device (K121650), the ground truth for validating MR image quality would typically involve various phantoms, physical measurements, and potentially clinical correlation with other imaging modalities or pathologies if clinical validation was performed.

8. The sample size for the training set

• Not applicable. This device is an MR imaging system; it is not described as involving a machine learning algorithm with a "training set" in this context. The "new software version" likely refers to operational software for the MRI, not an AI diagnostic algorithm.

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

• Not applicable. See point 8.

Ask a specific question about this device

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 hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.

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 (T1), 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.

The changes performed on the modified S-scan device, with respect to the cleared version – S-scan K110802 - are due to the improvement of the system performance. These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

1. A new step for patient positioning.
2. A kit for patient positioning during hip examination using 4-channels lumbar spine coil 17 and 18.
3. Geometric distortion correction.
4. FSE parameters optimization
5. FSE acceleration and improving.
6. FSE sampling frequency management.
7. Streaming acquisition performance increasing.
8. Configurable send and export of XBONE echoes.
9. Environment for the management of the virtual film.
10. Data matching for patient coming from a worklist server.
11. SpeedUp technique introduction, cleared via K120748.
12. A new software version.

This 510(k) submission (K121650) for the S-Scan MR system describes modifications to an already cleared device (K110802), rather than a new device that requires extensive clinical validation to demonstrate its performance against acceptance criteria. Therefore, the information typically associated with acceptance criteria and a detailed study proving performance (e.g., specific metrics, ground truth establishment, sample sizes for training/testing datasets, expert qualifications, adjudication methods, or MRMC studies) is not explicitly provided in the document.

The submission focuses on demonstrating that the modifications to the S-Scan device do not affect its intended use or alter its fundamental scientific technology, and thus the device remains substantially equivalent to its predicate. The "acceptance criteria" here are implied to be that the improved system performance from the modifications does not negatively impact image quality or diagnostic utility against the baseline established by the predicate device.

However, based on the provided text, we can infer some aspects related to the device performance implicitly.

Here's an analysis based on the document, addressing as many of your points as possible:

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

Since this is a Special 510(k) for device modifications, explicit "acceptance criteria" for a new device's performance are not detailed in the provided text. The implicit acceptance criterion is that the modified device's performance is at least equivalent to, or improved compared to, the predicate device (K110802), specifically in areas where modifications were made, without compromising the overall diagnostic utility.

• Geometric distortion correction.
• FSE parameters optimization.
• FSE acceleration and improving.
• FSE sampling frequency management.
• Streaming acquisition performance increasing.
• SpeedUp technique introduction.
  These modifications aim to enhance image quality and acquisition efficiency. |
  | Maintenance of intended use and
  fundamental scientific technology. | Stated: "These modifications, which do not affect the intended use or alter the fundamental scientific technology of the device."
  The images "can provide diagnostically useful information" when interpreted by a medical expert. |
  | Compliance with general controls
  and relevant regulations. | Reviewed by FDA for substantial equivalence and allowed to market. |

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

The document does not specify a separate "test set" sample size or data provenance for a performance study. Since the modifications are for an already cleared device, it's likely that internal verification and validation activities were performed by the manufacturer, rather than a new clinical study with a distinct test set described in the 510(k). No information is provided regarding the country of origin or whether 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

This information is not provided. Given the nature of a Special 510(k) for modifications to an established MR system, it's improbable that a new, extensive ground truth establishment process for a clinical test set was required and detailed in this submission. The "ground truth" for the diagnostic utility of MR images, in general, is implicitly established by the experience and training of "a medical expert trained in the use of MR equipment."

4. Adjudication method for the test set

Not specified in the document.

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

An MRMC study is not mentioned. The device described is an MR system, not an AI-assisted diagnostic tool, so the concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.

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

Not applicable. The S-Scan is an MR imaging system, not a standalone algorithm. Its output, images, requires interpretation by a human expert.

7. The type of ground truth used

The ground truth is implied to be expert interpretation of MR images. The document states: "When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information." There is no mention of pathology or outcomes data as direct ground truth for this submission, as the submission focuses on system modifications.

8. The sample size for the training set

Not applicable. This document describes modifications to an MR imaging system. It is not an AI/algorithm-based device that would typically have a "training set" in the context of machine learning.

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

Not applicable, as there is no mention of a training set for an AI/algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device

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 hip 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 (T1), 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.

The indications for use of the S-scan system, as described in its labeling, are the same as those of the unmodified S-scan system cleared via K063207.

The changes performed on the modified S-scan device, with respect to the cleared version - S-scan K063207 -, are due to the improvement of the system performance. These modifications, that do not affect the intended use or alter the fundamental scientific technology of the device, are the following:

• 1. A device that locks the patient table in the current position, unless the user disconnects the coil cable.
• 2. A limb protection for patient table.
• 3. Modified pulse sequences.
• 4. A new software release.

The provided text is a 510(k) summary for the S-scan System, a Magnetic Resonance Imaging (MRI) device. It details modifications to an existing device (K063207) and compares its technological characteristics to several predicate devices.

However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, or any performance metrics from such a study.

The submission focuses on establishing substantial equivalence to previously cleared devices based on technological characteristics and intended use, rather than presenting new performance study data for approval. Therefore, I cannot complete the requested tables and information based on the input provided.

Here's a breakdown of what is present in the document, and what is not:

What is present:

• Device Name: S-scan System, Nuclear Magnetic Resonance Imaging
• Intended Use: Produces transversal, sagittal, coronal, and oblique cross-section images of limbs, joints, and the spinal column for diagnostic information when interpreted by a medical expert.
• Predicate Devices: S-scan (K063207), G-scan (K042236), Siemens Magnetom C! (K043030), Esaote Dynamic MRI Software (K061429), Siemens Syngo Multimodality Workstation (K010938).
• Modifications to the S-scan (K063207):
  • Device that locks the patient table.
  • Limb protection for the patient table.
  • Modified pulse sequences.
  • A new software release.
• Technological Characteristics Comparison: Detailed lists of pulse sequences and their parameters for the modified S-scan compared to the predicate S-scan (K063207), G-scan (K042236), and Siemens Magnetom C! (K043030). Also details image processing functions, networking functions, system access management, and accessories compared to predicate devices.

What is NOT present (and therefore cannot be provided in the requested format):

• Table of Acceptance Criteria and Reported Device Performance: No acceptance criteria or performance metrics are stated. The submission relies on demonstrating substantial equivalence to predicates, implying that if the technological characteristics and intended use are similar, the performance is also considered similar.
• Study details (Sample size, data provenance, number of experts, adjudication method, MRMC, standalone performance, ground truth type, training set size, ground truth for training set): The document does not describe any specific performance study conducted to assess the diagnostic accuracy or clinical effectiveness of the modified S-scan device. The "study" here is essentially a technical comparison for substantial equivalence.

In summary, the provided 510(k) summary focuses on demonstrating that the modified S-scan device is substantially equivalent to existing cleared devices based on its technological characteristics and intended use, rather than providing the results of a clinical performance study with specific acceptance criteria.

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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 hip 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 (T1), 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.

The system is composed of these main parts:

1. Patient positioning table.
2. Magnetic unit with the display panel.
3. Operating console that consists of the PC unit (including keyboard and mouse), the monitor and the operating table.
4. Electronics box with filter panel.

The provided text is a 510(k) summary for the S-scan MRI system. It describes the device, its intended use, and technological characteristics compared to predicate devices. However, it does not contain information about acceptance criteria, specific performance studies, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies (MRMC or standalone AI performance).

The document focuses on demonstrating substantial equivalence to existing MRI systems based on similar technology and intended use, rather than presenting a detailed performance evaluation with specific acceptance criteria as one might expect for a new diagnostic algorithm or AI-powered device.

Therefore, I cannot populate the requested tables and information based on the provided text. The document primarily highlights modifications to an existing G-scan MRI system (K042236) and its similarity to other predicate devices like the E-scan Opera (K060956) and Siemens Magnetom C! (K043030).

The "Comments" column in the "Technological Characteristics" table mentions that some S-scan features (like oversampling and gradient moment nulling) are already in place on other commercial scanners (e.g., MAGNETOM C! K043030). This suggests that the substantial equivalence argument relies on the established performance of similar technologies in predicate devices, rather than a new, independent performance study with defined acceptance criteria for the S-scan.

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