(139 days)
The RS80A Diagnostic Ultrasound System and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body.
The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Intra-operative, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-reginal, Trans-esoph. (non-Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Trans-esophageal (Cardiac) and Peripheral vessel.
The RS80A is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode, CW Spectral Doppler mode, Harmonic imaging, Tissue Doppler imaging, Tissue Doppler Wave, 3D imaging mode (real time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The RS80A also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The RS80A has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.
Here's a summary of the acceptance criteria and the studies that prove the device meets them, based on the provided text:
Device: RS80A Diagnostic Ultrasound System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the device's equivalence to predicate devices, rather than explicit acceptance criteria with numerical targets. The "acceptance criteria" are implied by demonstrating substantial equivalence to existing cleared devices in terms of safety, effectiveness, and functionality.
The performance is implicitly demonstrated by showing that the new features (E-Strain, S-3D Arterial Analysis, S-Detect for Thyroid) and improved features (S-Detect for Breast) perform comparably to their respective predicate features.
| Feature Assessed | Implied Acceptance Criterion (Substantial Equivalence) | Reported Device Performance |
|---|---|---|
| E-Strain | - Measuring two average strain values within two separate regions of interest (phantom test). |
- Comparable sensitivity and AUC values to the predicate (clinical data).
- Accuracy value within the scope of the predicate (clinical data). | - Successfully demonstrated measuring two average strain values within two separate regions of interest using a phantom.
- Clinical data showed comparable sensitivity and AUC values to the predicate.
- Accuracy value was within the statistical scope of the predicate, despite a slightly lower specificity rate. |
| S-3D Arterial Analysis | - Quantitative comparison of plaque volume value to the predicate (clinical data). - Similar segmentation method and user interface to the predicate. | - Successfully compared plaque volume value quantitatively to the predicate using clinical data, demonstrating substantial equivalence.
- Functionality and user interface were similar to the predicate. |
| S-Detect for Thyroid | - Measurement of lesion size using phantom as an essential and basic method. - Workflow similar to the predicate.
- Lexicon classification method allows user selection and printing, comparable to the predicate for diagnostic decisions. | - Demonstrated measurement of lesion size using a phantom.
- Workflow was the same as the predicate.
- Lexicon classification, while items differ, uses the same method for user selection and printing for diagnostic decisions, demonstrating substantial equivalence. |
| S-Detect for Breast | - Direct comparison of lesion size measurement to the predicate, showing substantial equivalence. | - Demonstrated substantial equivalent value in lesion size measurement through direct comparison to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- E-Strain:
- Test Set Sample Size: Not explicitly stated, but "clinical data" was used. For the mechanical test, a "phantom" was used.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
- S-3D Arterial Analysis:
- Test Set Sample Size: Not explicitly stated, but "clinical data" was used.
- Data Provenance: Not explicitly stated.
- S-Detect for Thyroid:
- Test Set Sample Size: Not explicitly stated. A "phantom" was used for lesion size measurement.
- Data Provenance: Not explicitly stated.
- S-Detect for Breast:
- Test Set Sample Size: Not explicitly stated, a "predicate" was used for direct comparison.
- Data Provenance: Not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not specify the number of experts used or their qualifications for establishing ground truth for the test sets of E-Strain, S-3D Arterial Analysis, S-Detect for Thyroid, or S-Detect for Breast.
4. Adjudication Method for the Test Set
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test sets.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- The document states, "Not applicable. The subject of this submission, RS80A, did not require clinical studies to support substantial equivalence."
- Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done and no effect size is reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The studies described for E-Strain, S-3D Arterial Analysis, S-Detect for Thyroid, and S-Detect for Breast appear to be evaluations of the software features themselves, not necessarily incorporating human-in-the-loop performance measurement.
- For E-Strain, it "Calculates the strain between the areas of the suspected lesion (ROI A) and reference tissue area (ROI B, reference) and displays the results." This sounds like an algorithmic output.
- For S-3D Arterial Analysis, it "display the highly comprehensible vessel structure through the 3D vessel and plaque analysis with the ultrasound equipment and help to diagnose cardiovascular by calculating clinically useful indicators." This also describes algorithmic functionality.
- For S-Detect for Thyroid, "It is a set of functionalities for conducting ultrasound thyroid exams. It assists the entire process of locating a lesion in an ultrasound image and making a diagnosis." This suggests the algorithm primarily assists or provides information, but the evaluation focuses on lesion measurement and lexicon classification, which are standalone functionalities.
- Therefore, the tests primarily focused on the standalone performance of specific software functionalities (e.g., measurement, analysis, classification display).
7. The Type of Ground Truth Used
- E-Strain: For the mechanical evaluation, a "phantom" was used. For quantitative comparison, "clinical data" was used, and the "accuracy value was within the scope of the predicate." This suggests the ground truth was derived from presumably established clinical assessments or measurements reflected in the predicate device's performance.
- S-3D Arterial Analysis: "Plaque volume value quantitatively to the predicate using clinical data." This implies the ground truth for plaque volume was established from clinical assessment, likely from the predicate device's output or other accepted clinical standards.
- S-Detect for Thyroid: "Measurement of lesion size using phantom" for essential measurement. "Lexicon classification is provided in the predicate [and] it is the same method for user to select item of best description to their diagnosis decision." This suggests ground truth for measurement comes from phantom characteristics, and for classification, it's aligned with established diagnostic lexicon criteria.
- S-Detect for Breast: "Direct comparison to the predicate" for lesion size measurement. Ground truth would be based on the established measurements from the predicate device that was already cleared.
8. The Sample Size for the Training Set
- The document does not provide information on the sample size used for the training set for any of the described software features. This filing is for substantial equivalence to existing cleared devices, and it focuses on the performance of the new features.
9. How the Ground Truth for the Training Set Was Established
- Since the sample size for the training set is not provided, the method for establishing its ground truth is also not elaborated upon in this document.
§ 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.