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The ARIETTA 65 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel clinical applications.

The Modes of Operation are B mode, M mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Power Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging.

The ARIETTA 65 is a multi-functional ultrasound diagnostic scanner in which Doppler, Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications.

The ARIETTA 65 can be used for individual or combined display in the image display model listed below.

• B mode is a display mode in which the tomographic image is formed with plural ● ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
• M mode is a display mode of ultrasound beams received sequentially and repeatedly on ● the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
• . There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
• Color Doppler mode receives ultrasound from the same direction and detects any ● changes that occur over time to identify three types of bloodstream information: its direction, its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode, Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.

The 4 methods of electronic scanning are as follows.

• Linear Scanning Method:
  By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject.

• Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject.

• . Sector Scanning Method:

By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject.

• . Trapezoidal Scanning Method:
  By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.

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The ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, Sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesoph. (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous/Non-Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, and gastro-intestinal (GI) endoscopic clinical applications.

The ALOKA ARIETTA 850 is a multi-functional ultrasound diagnostic scanner in which Doppler, Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications.

The ALOKA ARIETTA 850 can be used for individual or combined display in the image display model listed below.

• B mode is a display mode in which the tomographic image is formed with plural ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
• M mode is a display mode of ultrasound beams received sequentially and repeatedly on the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
• There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
• Color Doppler mode receives ultrasound from the same direction and detects any changes that occur over time to identify three types of bloodstream information: its direction. its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode. Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.

The 5 methods of electronic scanning are as follows.

• Linear Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject.
• Convex Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject.
• Sector Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject.
• Radial Scanning Method: By this method. the ultrasound beam emits a 360 degree (radial) ultrasound beam and draws a tomographic image of the test subject.
• Trapezoidal Scanning Method: By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.

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The ECHELON Oval MRI System is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The ECHELON OVAL is a Magnetic Resonance Imaging System that utilizes a 1.5 Tesla superconducting magnet in a gantry design. The design was based on the ECHELON MRI system. The ECHELON OVAL has been designed to enhance clinical utility as compared to the ECHELON by taking advantage of open architecture.

The provided text is a 510(k) summary for the ECHELON OVAL V6.0A MRI system, which is a software update to an existing MRI system. The document states that "The ECHELON OVAL V6.0A MRI System is only a software update with new and improved features." This implies that the core hardware and fundamental MRI functionalities (such as image acquisition, magnet strength, etc.) remain as per the predicate device (ECHELON OVAL V5.1 MRI System, K153547).

The performance evaluation primarily focuses on the new and improved software features rather than establishing a new acceptance criteria for the entire MRI system from scratch. The acceptance criteria essentially revolve around demonstrating that these new and improved features perform as intended and produce diagnostically acceptable images.

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

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

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 does not explicitly state the numerical sample size for the test set. It mentions "Clinical image examples are provided for each applicable new and improved feature." The provenance of the data (country of origin, retrospective or prospective) is not specified.

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)

Number of experts: Singular ("a radiologist").
Qualifications of experts: Only "a radiologist" is mentioned. No specific experience level (e.g., 10 years of experience) is provided.

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

No formal adjudication method (like 2+1 or 3+1) is described. The text states: "a radiologist validated that the clinical images have acceptable image quality for clinical use." This implies a single expert review for validation.

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 such study (MRMC comparative effectiveness study with AI assistance) is mentioned or implied. The device is purely an MRI system software update, not an AI-powered diagnostic aid that assists human readers.

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

This question is not applicable in the context of this device. The device is a Magnetic Resonance Imaging System, designed to produce images for interpretation by a trained physician. It's not an an algorithm performing a standalone diagnostic task without human intervention.

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

The ground truth for the test set, specifically for the clinical image quality, appears to be based on expert opinion/validation by a radiologist. The document doesn't mention pathology, outcomes data, or a formal expert consensus process.

8. The sample size for the training set

The document does not mention a "training set" or its sample size. This is consistent with a software update for an MRI system, where the focus is on verifying the performance of new/improved features rather than an AI/ML algorithm that undergoes a distinct training phase.

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

Not applicable, as no training set is mentioned in the context of this device's evaluation.

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The ALOKA ARIETTA 850 is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Pediatric, Small Organ (Spec.), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Trans-esophageal (non-Card.), Musculo-skel. (Convent.), Musculo-skel. (Superfic.), Wound (Cavernous), Gynecology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), and Peripheral vessel clinical applications.

The ALOKA ARIETTA 850 is a multi-functional ultrasound diagnostic scanner in which Doppler, Color Flow Mapping, etc. are provided and all circuits related to image quality are fully digitalized. This device can be utilized with linear, convex, radial and phased array scan type probes for usage with a variety of clinical applications.

The ALOKA ARIETTA 850 can be used for individual or combined display in the image display model listed below.

• B mode is a display mode in which the tomographic image is formed with plural ● ultrasound beams by the methods mentioned above. During the process of creating the tomographic image, adaptive filters (HI REZ) that modify the characteristics of each echo filter are used to produce a clear image.
• M mode is a display mode of ultrasound beams received sequentially and repeatedly on ● the screen from the same direction. It indicates these reflected echoes in one direction from the interior of the patient's body's on time-series scale.
• There are two types of D (Doppler) mode: PW Doppler mode and CW Doppler mode. ● PW Doppler mode displays bloodstream information consecutively at a sample point that is detected by pulsed Doppler sonography. CW Doppler mode displays bloodstream information continuously in the single-direction ultrasound beam that is detected by the CW Doppler method.
• Color Doppler mode receives ultrasound from the same direction and detects any ● changes that occur over time to identify three types of bloodstream information: its direction. its speed, and its inconsistency. The mode then colors that information and displays it as an overlay on B mode or M mode. Color Flow Mode. Power Doppler Mode, High-Resolution Power Doppler (eFlow) Mode can be used with this instrument according to need.

The 5 methods of electronic scanning are as follows.

• Linear Scanning Method: ●
  By this method, the ultrasound beam from the ultrasound probe is emitted in a straight line (linearly) and draws a tomographic image of the test subject.

• Convex Scanning Method: ●
  By this method, the ultrasound beam from the ultrasound probe is emitted radially and draws a tomographic image of the test subject.

• Sector Scanning Method:
  By this method, the ultrasound beam from the ultrasound probe is emitted in a fan shape (sector) and draws a tomographic image of the test subject.

• . Radial Scanning Method:
  By this method, the ultrasound beam emits a 360 degree (radial) ultrasound beam and draws a tomographic image of the test subject.

• . Trapezoidal Scanning Method:
  By this method, the ultrasound beam from the ultrasound probe is emitted radially without regard to the form of the probe head and draws a tomographic image of the patient.

Here's a breakdown of the acceptance criteria and study information for the ALOKA ARIETTA 850, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative metrics in the provided document. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "reported device performance" is the assertion of comparable safety, effectiveness, and functionality.

Based on the document, the acceptance criteria implicitly boil down to the following:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. The document explicitly states, "Performance Testing - Clinical: None required." This indicates that no separate clinical "test set" in the traditional sense (i.e., a dataset of patient cases used to evaluate the device's diagnostic performance against a ground truth) was used in this submission. The evaluation was primarily based on non-clinical bench testing and comparison to predicate devices.
• Data Provenance: Not applicable, as no clinical test set was used for this specific submission's performance evaluation. The predicate devices themselves would have had their own data associated with their original clearances, but that information is not provided here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not applicable. No clinical test set with associated ground truth was used for performance testing (as clinical testing was not required).
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No clinical test set with associated ground truth requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. The document states "Performance Testing - Clinical: None required" and focuses on substantial equivalence to predicate devices through non-clinical means. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted or reported in this submission.
• Effect Size of AI Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: No. The device is a diagnostic ultrasound system intended for use by "trained personnel (doctor, sonographer, etc.)" (human-in-the-loop). While new software features are mentioned (e.g., Body Motion Tracking, Needle Tracking, Automated FHR Measurement), their performance is not evaluated as a standalone algorithm in this document, but rather as part of the overall system's substantial equivalence to predicates.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for performance testing in this submission. The evaluation relies on the established safety and effectiveness of the predicate devices and demonstrating that the new device is comparable in its technical characteristics and intended use.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a 510(k) premarket notification for a diagnostic ultrasound system, not an AI/ML algorithm that would undergo explicit "training." The device itself is the diagnostic tool, and its "performance" is evaluated against established physical and performance characteristics, and comparison to existing cleared devices.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Establishment: Not applicable, as there is no mention of an algorithm training set in this submission.

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The Supria True64 system is indicated for head, whole body, and vascular X-ray Computed Tomography applications in patients of all ages. The images can be acquired in either axial, helical, or dynamic modes.

The volume datasets acquired by the Supria can be post processed by the system to provide additional information. Post processing capabilities included in the Supria software include CT angiography (CTA), Multi-planar reconstruction (MPR) and volume rendering.

Volume datasets acquired by the Supria can be transferred to external devices via a DICOM standard interface.

The guideShot Option adds a remote in-room display and controls to support interventional imaging. The device output can provide an aid to diagnosis when used by a qualified physician.

The Supria True64 is a multi-slice computed tomography system designed to perform multi-slice CT scanning supported by 64-detector technology. The system allows optimum clinical applications ranging from routine exams in response to the diversified circumstances in imaging whole body regions.

The Supria True64 system uses 64-slice CT technology, where the X-ray tube and detector assemblies are mounted on a frame that rotates continuously around the patient using slip ring technology. The solid-state detector assembly design collects up to 64 slices of data simultaneously. The X-ray sub-system features a high frequency generator. X-ray tube, and collimation system that produces a fan beam X-ray output. The system can operate in a helical (spiral) scan mode where the patient table moves during scanning. As the X-ray tube/detector assembly rotates around the patient, data is collected at multiple angles.

The collected data is then reconstructed into cross-sectional images by a high-speed reconstruction sub-system. The images are displayed on a Computer Workstation, stored, printed, and archived as required. The workstation is based on current PC technology using the Windows™ operating system.

The Supria True64 system consists of a Gantry, Operator's Workstation, Patient Table, High-Frequency X-ray Generator, and accessories.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Important Note: This submission is a 510(k) premarket notification for a new version of an existing device (Supria True64 CT system). The primary goal of a 510(k) is to demonstrate substantial equivalence to a previously legally marketed device (predicate device), not necessarily to establish novel clinical efficacy or new performance benchmarks against a specific disease. Therefore, the "acceptance criteria" here are largely focused on maintaining equivalent performance to the predicate and adhering to relevant standards for CT systems. The studies are primarily to confirm this equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or target-based fashion for all parameters. Instead, it relies heavily on demonstrating that the Supria True64's performance is "similar to" or "comparable to" the predicate device (HITACHI SUPRIA Whole-body X-ray CT System Phase 3, K163528) and complies with relevant industry standards.

Here's a table summarizing the implicit acceptance criteria and reported performance, derived from the "Performance Comparison" and "Technological Characteristic Differences" sections:

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