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This ARETTA 65 is intended for use in a Healthcare facility (hospital, private medical office, etc.) by Healthcare trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Fetal, Abdominal, Intra-operative (Spec.), Intra-operative (Neuro.), Laparoscopic, Pediatric, Small Organ (Spec.), Neonatal Cephalic, Trans-rectal, Trans-vaginal, Trans-esoph. (non-Card.), Musculo-skel. (Convent.), Musculoskel. (Superfic.), Other (spec.) -Gynecological, Other (spec.) - Wound, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (card.), Peripheral vessel, clinical applications.

The Modes of Operation are B mode, PW mode (Pulsed Wave Doppler), CW mode (Continuous Wave Dopler), 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 imaqe 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.

The provided document describes the ARIETTA 65 ultrasound diagnostic system. It does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of diagnostic performance metrics like sensitivity or specificity.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ARIETTA 65 (K181376) and ALOKA ARIETTA 850 (K173739)) based on technological characteristics, safety standards, and intended use. The rationale is that since the new device has equivalent safety and effectiveness to a previously cleared device, it does not require new comprehensive clinical performance studies in the same way a novel device might.

Therefore, many of the requested details about acceptance criteria and clinical study specifics are not available in this regulatory submission.

Here's a breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria for diagnostic performance (e.g., specific sensitivity, specificity, or accuracy thresholds) or provide reported device performance metrics against such criteria. The "performance comparison" mentioned refers to demonstrating conformance with special controls or recognized standards and comparing technological characteristics to a predicate device, not clinical performance metrics.

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

Not applicable. The document states "Clinical testing was not required." The "Validation Testing - Bench" was conducted, but it's not described as a clinical performance test with a "test set" in the context of diagnostic accuracy.

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

Not applicable, as no clinical test set with ground truth establishment is described.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states "Clinical testing was not required."

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

Not applicable. This is an ultrasound system, not an AI algorithm intended for standalone diagnostic interpretation.

7. The Type of Ground Truth Used:

Not applicable, as no clinical study requiring ground truth is described.

8. The Sample Size for the Training Set:

Not applicable. This document describes a medical device (ultrasound system), not an AI algorithm that typically has a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable.

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The ZS3 and z.one pro Ultrasound Systems are intended for use by a qualified physician for ultrasound evaluation of Ophthalmic; Fetal; Abdominal (renal, GYN/Pelvic); Intra-operative (abdominal, thoracic(cardiac); Intraoperative (Neuro); Laparoscopic; Pediatic; Small organ (thyroid, breast, testes, etc); Neonatal cephalic/ Transcranial; Trans-rectal; Trans-vaginal; Trans-esoph.(non-Card); Musculoskeletal (Conventional); Musculoskeletal (Superficial);Cardiac Adult; Cardiac Pediatric; Trans-esoph. (Cardiac); Intra-cardiac; Peripheral vessel.

The ZS3 and z.one pro Ultrasound Systems are full-featured, general purpose, software controlled, diagnostic ultrasound systems used to acquire and display high-resolution, real-time ultrasound data through multiple imaging modes. The system utilizes zone technology which allows the system to collect more data at one time, thereby optimizing image quality.

The exam dependent default settings for the ZS3 and z.one pro allow the user to have minimum adjustment for imaging the patient, while the in depth soft-menu control enables the advanced user to set the system based on image appearance preference. The architecture of the ZS3 and z.one pro Ultrasound Systems support system integration to a variety of upgradable options and features. Up to three transducers can be connected to the multi-transducer port permitting easy transducer transition. The system can be operated on either battery or AC power.

This document describes the 510(k) premarket notification for the ZS3 and z.one pro Ultrasound Systems. This is a notification of intent to market a medical device, asserting its substantial equivalence to previously cleared devices. Therefore, the information provided focuses on demonstrating this equivalence through non-clinical testing and comparison to predicates, rather than extensive clinical studies or formal acceptance criteria for an AI/CADe device.

Based on the provided information, the device is an ultrasound system and not an AI/CADe device. As such, the typical acceptance criteria and study design for AI/CADe devices (multireader multi-case studies, ground truth establishment by multiple experts, defined performance metrics like sensitivity/specificity, etc.) are not applicable to this submission.

The acceptance criteria here pertain to the ultrasound system's performance and safety standards, and the "study" proving acceptance is a series of non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an ultrasound system and not an AI/CADe device, the acceptance criteria are based on compliance with recognized safety and performance standards for ultrasound equipment. The "reported device performance" is implicitly that the device conforms to these standards.

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

This document describes a 510(k) submission for an ultrasound imaging system. As such, it does not involve a "test set" or "data provenance" in the sense of a machine learning model's evaluation data. Instead, validation is based on non-clinical tests (electrical safety, acoustic output, biocompatibility, etc.) performed on the physical device and its components, in accordance with recognized industry standards. The data provenance would be the results from these engineering and biological safety tests. The specific "sample size" of devices or components tested is not detailed in this summary but is generally part of standard engineering verification and validation.

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

Not applicable. This is not an AI/CADe device, and therefore, an expert-established "ground truth" for a diagnostic test set is not relevant to its 510(k) submission. The "ground truth" for a device like this is its adherence to safety and performance standards.

4. Adjudication Method for the Test Set:

Not applicable, as there is no "test set" in the context of diagnostic interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This is an ultrasound imaging system, not an AI/CADe device designed to assist human readers, so such a study is not relevant.

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

Not applicable. This is not an AI/CADe device.

7. The Type of Ground Truth Used:

The "ground truth" for this device's acceptance is its compliance with established safety and performance standards for diagnostic ultrasound equipment, as detailed in section 7 ("Non-clinical Tests") of the 510(k) summary. This includes standards for electrical safety, acoustic output, biocompatibility, and software development, rather than clinical outcomes or expert consensus on image interpretation.

8. The Sample Size for the Training Set:

Not applicable. This is a hardware/software medical device (ultrasound system), not an AI/CADe system that undergoes machine learning training with a specific "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no "training set" for this type of device. The specifications and performance are established through engineering design, quality control, and adherence to regulatory standards.

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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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