(410 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transcranial (Adult Cephalic) and Peripheral Vascular Diagnostic Device
The Pioneer TC8080 applies ultrasound probes of 1.6 MHz Pulsed Wave (PW), 2 MHz PW, 4 MHz PW and Continuous Wave (CW), 8 MHz, PW/CW, 16 MHz PW and 20 MHz PW to support Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation.
This document is primarily a 510(k) cleared device notification letter, which indicates the device, Pioneer TC8080, is substantially equivalent to legally marketed predicate devices. It also lists the intended uses and associated transducers.
Crucially, this document does NOT describe specific acceptance criteria or an analytical study with performance metrics. The tables provided are "Diagnostic Ultrasound Indications for Use Forms," which specify the clinical applications and modes of operation for various transducers. They do not contain any quantitative performance data, sample sizes, expert qualifications, or details about ground truth establishment.
Therefore, many of the requested items cannot be answered from the provided text.
Here's an attempt to answer what can be gleaned from the document, with explicit indications of missing information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The tables are "Indications for Use" forms, not performance results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. The device is an ultrasound system with transducers, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a hardware ultrasound system with transducers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document.
8. The sample size for the training set
This information is not provided in the document.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of what the document does provide:
The document is a 510(k) clearance letter from the FDA for the Pioneer TC8080 Ultrasonic pulsed doppler imaging system and associated diagnostic ultrasonic transducers.
-
Device Name: Pioneer TC8080
-
Device Type: Ultrasonic pulsed doppler imaging system and diagnostic ultrasonic transducers
-
Intended Uses (as per the "Diagnostic Ultrasound Indications for Use Form"):
- Diagnostic ultrasound imaging or fluid flow analysis of the human body.
- Specific clinical applications and modes of operation (PWD = Pulsed Wave Doppler, CWD = Continuous Wave Doppler) are indicated by 'N' (new indication), 'P' (previously cleared by FDA), or 'E' (added under Appendix E).
Here's a summary of the indicated uses for various transducers:
For the Pioneer TC8080 system generally (implied for various transducers due to overall statement):
- Adult Cephalic: PWD (N)
- Peripheral Vascular: PWD (N), CWD (N)
Specific Transducer Applications:
- 1.6 MHz Pulsed Wave (PW): Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (Indicated as "E" for Adult Cephalic PWD in one form).
- 2 MHz PW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (Not explicitly shown as an 'N', 'P', or 'E' in the provided tables for specific clinical applications, but mentioned in the general comments).
- 4 MHz PW and Continuous Wave (CW): Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "P" for Adult Cephalic PWD, referring to previous clearance K993939).
- 8 MHz PW/CW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "P" for Peripheral Vascular PWD and CWD, referring to previous clearance K993939).
- 16 MHz PW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "N" for Peripheral Vascular PWD, for a microvascular transducer with 1.5mm and 2.0mm crystal diameters).
- 20 MHz PW: Supports Transcranial Doppler (TCD) Adult Cephalic and Peripheral Vascular blood flow evaluation. (One form indicates "N" for Peripheral Vascular PWD, for a microvascular transducer with 1.5mm and 2.0mm crystal diameters).
-
Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices. This typically means the device has the same intended use and technological characteristics as a predicate, or if there are differences, they do not raise different questions of safety and effectiveness. The specifics of the comparison to predicate devices are not 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.