(145 days)
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.
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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:
| Acceptance Criteria Category | Specific Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Safety | No new hazards identified | "No new hazards were identified with the ALOKA ARIETTA 850." The device conforms to applicable medical device safety standards (e.g., AAMI ANSI ES60601-1, IEC 60601-2-37, IEC 60601-1-2, ISO 10993 series). |
| Effectiveness/Functionality | Performance characteristics are comparable to predicate devices | "The analysis confirms the performance characteristics of the ALOKA ARIETTA 850 are comparable to the predicate device and support our conclusion that the subject system is substantially equivalent." |
| Technological Characteristics | No significant differences in core technological characteristics compared to predicate devices, or differences do not raise new questions of safety or effectiveness. | Differences (e.g., appearance, specific new probes, added software functions like Body Motion Tracking, Needle Tracking, Volume Data Extension, 3D Sim-Navigator, E-field Simulator, Automated FHR Measurement) are described, and the manufacturer judges them not to pose additional issues with safety and effectiveness given their previous clearances or known functionalities. |
| Intended Use | Intended use is equivalent to or within the scope of predicate devices. | The stated Indications for Use align with those of previously cleared predicate devices (K134016, K160559, K153421, K162583). |
| Compliance with Standards | Conformance to relevant national and international medical device standards. | The device conforms to several listed standards for electrical safety, EMC, acoustic output, and biocompatibility. |
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.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.