(272 days)
Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms.
With respect to its ultrasound imaging capability, Kosmos is a general-purpose diagnostic ultrasound system used in the following clinical applications and modes of operation:
Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal, and interventional guidance (includes free hand needle / catheter placement fluid drainage, and nerve block) Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging
Kosmos is intended to be used in clinical care and medical education settings on adult and pediations. Kosmos includes the Al-assisted automated ejection fraction software, known as Auto EF, which is used to process previously acquired transthoracic cardiac ultrages, to store images, and to manipulate and make measurements on images using the Kosmos. Auto EF provides automated estimation of left ventricular ejection fraction. This measurement can be used to assist the clinician in a cardiac evaluation. Auto EF is indicated for use on adult patients only in healthcare facilities.
The Kosmos includes the Auto Anatomical Structure Labeling and View Identification, also referred to as AI FAST, software, which is intended for use only by qualified and trained medical professionals for automatic real-lime detection and labeling of anatomical structures during image acquisition during cardiac, thoracic/lung, or abdominal ultrasound imaging. This feature is only indicated for use on adult patients in healthcare facilities.
The device is non-invasive, reusable, and intended to be used on one patient at a time.
Kosmos is a general-purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular, Musculoskeletal, and interventional guidance (includes free hand needle / catheter placement fluid drainage, and nerve block) Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging. Kosmos also includes Al-assisted automated ejection fraction software (Auto EF) and Auto Anatomical Structure Labeling and View Identification software (AI FAST).
The provided text does not contain detailed information about the acceptance criteria or a study proving the device meets those criteria. However, based on the information provided regarding the "Kosmos" device and its AI-assisted features (Auto EF and AI FAST), we can infer the types of acceptance criteria that would typically be required for such a device and construct a hypothetical study design to demonstrate performance.
Inferred Acceptance Criteria and Hypothetical Study Performance for Kosmos (Based on typical FDA requirements for similar AI/ML medical devices):
The Kosmos device has two primary AI-assisted features:
- Auto EF (Automated Ejection Fraction Software): Provides automated estimation of left ventricular ejection fraction from transthoracic cardiac ultrasound images.
- AI FAST (Automated Anatomical Structure Labeling and View Identification): Automatically detects and labels anatomical structures in real-time during cardiac, thoracic/lung, or abdominal ultrasound imaging.
Given these functionalities, the acceptance criteria would likely focus on the accuracy, precision, and robustness of these AI features both in a standalone capacity and potentially in combination with human users.
Inferred Acceptance Criteria and Reported Device Performance
For Auto EF (Automated Ejection Fraction Software):
| Acceptance Criterion (Hypothetical) | Reported Device Performance (Hypothetical) |
|---|---|
| Accuracy of LV Ejection Fraction (EF) Estimation: Evaluation of the Mean Absolute Error (MAE) and 95% Limits of Agreement (LoA) compared to expert-derived ground truth EF values. | Mean Absolute Error (MAE): 3.5% ± 0.5% (Ejection Fraction units) |
95% Limits of Agreement (LoA) (Bland-Altman analysis): -7.0% to +7.0% EF units (showing good agreement with expert consensus, with 95% of differences falling within this range) |
| Bias in LV EF Estimation: The systematic difference between the AI-estimated EF and ground truth EF should be negligible. | Bias: -0.1% EF units (indicating a slight, non-significant underestimation by the AI, which is well within clinical acceptability). |
| Robustness Across EF Ranges: Performance should be maintained across various EF ranges (e.g., normal, mildly reduced, moderately reduced, severely reduced). | Performance across EF ranges: Similar MAE and LoA observed across all EF ranges (e.g., MAE ~3.0-4.0% for EF 45%), demonstrating consistent performance regardless of cardiac function. |
| Consistency/Reproducibility: Small intra-device and inter-device variability in EF estimation across repeated measures and different devices. Should show good intra-class correlation (ICC). | Intra-class Correlation (ICC) with ground truth: 0.92 (indicating excellent reproducibility). |
| Clinical Acceptability (for MRMC study, if performed): AI assistance should improve or at least not degrade the accuracy and efficiency of human readers in assessing EF. | Reader Performance Improvement (Hypothetical MRMC):
- Accuracy: Radiologists' average EF estimation MAE improved by 15% (e.g., from 5.0% to 4.25%) with AI assistance.
- Efficiency: Time to final EF reporting reduced by 25%. |
| Failure Rate: The percentage of cases where the AI cannot provide an EF estimate or provides an egregiously incorrect estimate (e.g., due to poor image quality). | Failure Rate (no EF provided): 2% of cases.
Egregiously incorrect (outlier, >3 SD from mean difference): 0.85 (indicating high overlap with ground truth segmentation).
Per-structure labeling accuracy: 97% for major structures, 90% for smaller/more variable structures. |
| Real-time Performance: The latency of the labeling and identification should be imperceptible or clinically acceptable during live scanning. | Average Latency:
§ 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.