(25 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal, Abdominal, Intraoperative (Transcranial and Intracranial Doppler Monitoring, Carotid Monitoring, Microvascular Blood Flow, Emboli Detection, Extracranial carotid monitoring), Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral Vascular, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
The modified Pioneer TC 8080 and Companion III are Doppler ultrasound systems. Both systems utilize the well-understood principle of Doppler shift to detect the flow of blood within the body. The ultrasound probe generates ultrasonic energy, which is coupled to the body. The ultrasonic energy, which is reflected from the moving blood in blood vessels and the returning signal, is detected as a frequency shifted signal. The amount of frequency shift is a function of the velocity of the flowing blood. These systems generate, transmit and receive an ultrasonic signal, then process and display the Doppler signal returning from the anatomy.
The Pioneer TC8080 can be used with up to four Doppler ultrasound probes simultaneously. The Companion III, applying the same software and hardware as the Pioneer TC8080, can be used with up to two Doppler ultrasound probes simultaneously.
Here's an analysis of acceptance criteria and supporting study details based on the provided text:
The provided text is a 510(k) Summary for a medical device (Pioneer TC8080 and Companion III Doppler Ultrasound Systems). A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a rigorous clinical study with novel data. The "study" here is essentially the demonstration of substantial equivalence by comparing the device to legally marketed predicate devices.
Therefore, many of the typical clinical study components (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance with ground truth for test/training sets, and the way ground truth was established for training) are not applicable in the context of this 510(k) submission. There isn't an independent clinical performance study described in the way a new, non-substantially equivalent device would require.
The "acceptance criteria" for a 510(k) submission largely revolve around demonstrating that the new device has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness, compared to the predicate device.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (as demonstrated in 510(k)) |
|---|---|
| Intended Use: Device indicates blood flow using Doppler ultrasound technology, with specific clinical applications. | The modified Pioneer TC8080 and Companion III are applied to indicate blood flow by application of Doppler ultrasound technology. The indications for use are identical or substantially similar to predicate devices (K020754, K864695, K011224) across various clinical applications (Adult Cephalic, Peripheral Vascular, Intraoperative: Transcranial/Intracranial Doppler Monitoring, Carotid Monitoring, Microvascular Blood Flow, Emboli Detection, Ophthalmic, Neonatal Cephalic, Pediatric, etc., depending on the specific probe). |
| Technological Characteristics: Utilizes Doppler shift principle to detect blood flow; generates, transmits, processes, and displays ultrasonic signals; compatible with various Doppler ultrasound probes (1.6 MHz, 2 MHz, 4 MHz, 8 MHz, 16 MHz, 20 MHz, unfocussed PW/CW modes). | Both systems utilize the well-understood principle of Doppler shift. They generate, transmit, receive an ultrasonic signal, then process and display the Doppler signal. The systems are compatible with the described range of probes and modes, which are consistent with the predicate device. |
| Safety and Effectiveness: Does not raise new questions of safety or effectiveness compared to predicate devices. | "The indications, intended use and technology of the modified Pioneer TC8080 and Companion III devices are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised." This is the concluding statement of the 510(k) summary. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable. This 510(k) likely did not involve a specific "test set" of patient data for performance evaluation in the way a de novo device would. The evaluation focused on comparing specifications and intended use to predicate devices.
- Data provenance: Not applicable for a traditional test set. The data provenance would be the technical specifications, design documents, and regulatory clearances of the predicate devices (K864695, K020754, K011224).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no "ground truth" derived from expert consensus on patient data described in this 510(k) for a standalone performance study. The ground truth for substantial equivalence is based on the legally marketed status and specifications of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication method for a test set 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
- Not applicable. This device is an ultrasonic pulsed Doppler imaging system, not an AI-assisted diagnostic tool for which an MRMC study comparing human readers with and without AI assistance would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a Doppler ultrasound system, not an algorithm, so a "standalone" algorithm performance study is not relevant in this context. Its performance is inherent in its physical and technological capabilities as a medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the conventional sense of a clinical study. The "ground truth" here is regulatory: the predicate devices are legally marketed and considered safe and effective for their intended uses. The new device demonstrates equivalence to these established predicate devices.
8. The sample size for the training set
- Not applicable. This device does not use an "algorithm" in the sense of machine learning that requires a training set. The development of the device is based on established engineering principles and medical physics.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an algorithm described.
§ 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.