(14 days)
Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The CV70 system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current product that is already proprietary boxware, under the following 510(k) Premarket Notification number: K032111 (July 18, 2003) cleared as ACUSON CV70™ Cardiovascular System. The CV70 functions in the same manner as other diagnostic ultrasound systems, in that they transmit ultrasonic energy into the body via a transducer. In the body, acoustic impedance of different tissues reflect different amounts of ultrasound energy back to the transducer, where post processing of received echoes is performed to generate two-dimensional images of structures and fluid flow within the body. Doppler principles are used to process reflected ultrasound energy to display moving blood as a spectrum, or as color-coded two-dimensional images. The predicate device provides specialized measurements of structures and flow, and provide various calculations functions.
This document is a 510(k) submission for the ACUSON CV70™ Cardiovascular System, an ultrasound device. It primarily focuses on demonstrating substantial equivalence to a previously cleared device (K032111) and detailing its intended uses and compliance with safety standards.
Based on the provided text, there is NO information about acceptance criteria, study design, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) comparative effectiveness studies regarding the device's performance.
The document is not a study report demonstrating the device meets performance criteria in the way described in your request (i.e., evaluation of AI/algorithm performance against a defined ground truth). Instead, it's a regulatory submission affirming that the updated model of an existing device is substantially equivalent to its predicate.
However, I can extract the intended uses of the device and its various transducers as a proxy for what the device is designed to do, which effectively serves as the "acceptance criteria" for its functionality as an ultrasound system in a regulatory context when demonstrating substantial equivalence.
Summary of Acceptance Criteria and Reported Device Performance (as demonstrated by intended uses and substantial equivalence):
The "acceptance criteria" in this context are the previously cleared intended uses and performance of the predicate device (ACUSON CV70™ Cardiovascular System, K032111). The reported device performance is that the new ACUSON CV70™ Cardiovascular System is substantially equivalent and performs in the same manner as the predicate, transmitting and processing ultrasonic energy to display real-time images and perform measurements.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission for a diagnostic ultrasound system, the "acceptance criteria" are defined by the cleared Intended Uses and modes of operation for each transducer, which are considered substantially equivalent to the predicate device. The "reported device performance" is implicitly that the device successfully performs these functions as intended and is as safe and effective as the predicate.
Below is a combined table summarizing the overarching intended uses and modes of operation for the ACUSON CV70™ Cardiovascular System across its various transducers. "P" indicates previously cleared indications, and "E" indicates new indications added under Appendix E for a specific transducer. "N" indicates new indications for a specific transducer. "BMDC" stands for B-mode, M-mode, Doppler (PWD-Pulsed Wave, CWD-Continuous Wave), and Color Doppler.
| Clinical Application | Mode of Operation (P/N/E) | Other Features (P/N/E) |
|---|---|---|
| Fetal | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Abdominal | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Intraoperative (Abdominal, Neurological) | B, M, PWD, Color, Amplitude Doppler | 3D Imaging |
| Pediatric | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Small Organ | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Neonatal Cephalic | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Adult Cephalic | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging |
| Cardiac | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, Contrast Agent Imaging, B&W SieScape, Power SieScape |
| Transesophageal | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging |
| Peripheral Vessel | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
| Laparoscopic | B, M, PWD, Color, Amplitude Doppler | 3D Imaging, B&W SieScape, Power SieScape |
| Musculo-skeletal (Conventional & Superficial) | B, M, PWD, CWD, Color, Amplitude Doppler | Ensemble Tissue Harmonic Imaging, 3D Imaging, B&W SieScape, Power SieScape |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. This document does not describe a clinical study with a "test set" in the context of an algorithm or AI performance evaluation. The submission demonstrates substantial equivalence to a predicate device, relying on technical comparison, safety standards compliance, and previous clearances.
- Data Provenance: Not applicable. There is no mention of specific clinical data or patient data used for performance testing in this 510(k) summary. The comparison is primarily against the established performance of the legally marketed predicate device (K032111) and compliance with recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No specific "ground truth" establishment by experts for a test set is described in this regulatory submission.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable. No test set requiring expert adjudication is described.
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:
- MRMC Study: No. This document does not present any MRMC comparative effectiveness studies. The device is a diagnostic ultrasound system, not an AI-assisted interpretation tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Study: No. This document does not describe a standalone algorithm performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable. The submission for substantial equivalence relies on the established performance and safety profile of the predicate device, not on a new ground truth established for a specific clinical outcome or diagnostic accuracy study.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document does not describe the development or training of an AI algorithm; therefore, there is no training set.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable.
§ 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.