(37 days)
The Smartdop 45 detects arterial and venous blood flow in extremities as well as fetal heart rate. The Smartdop 45 displays and prints bi-directional velocity waveform, numerical data and fetal heart rate with heart beat indicator. The Smartdop 45 probe selection is 2, 4, 5, 8 and 10 MHz.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Peripheral Vascular.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Peripheral Vascular.
The Smartdop 45 is a hand held bi-directional Doppler is designed to obtain blood flow velocity. Ultrasound is transmitted from probe to patient and is reflected by the moving object (blood flow). The reflected ultrasound is received by the probe and is converted into electrical signals. The incoming Doppler Shifted signals are applied to the Velocity Circuity Circuits to remove unnecessary signals and to provide a bi-directional readout. This phase-shifting technique is a standard method employed in direction seeking Doppler, known for several decades. It continues in wide use.
The waveform data are applied to the CPU for all the digital processing on LCD Display. The waveform data are applied to the off for the routing to the routing to the speaker to operate the analogue signals before digital processing.
The LCD display can display combined bi-directionally separated waveforms. The printer can print out patient information and waveform.
Integrated speaker provide Doppler sounds. A headset can be used, when is used it will mute the speaker.
The following probes may be utilized with the Smartdop 45 Doppler:
- 2 MHz for fetal heart rate
- 4 MHz detections of arterial and venous blood flow velocity
- 5 MHz detections of arterial and venous blood flow velocity
- 8 MHz detections of arterial and venous blood flow velocity
- 10 MHz detections of arterial and venous blood flow velocity
The Smartdop 45 is intended for evaluation of the following:
- Fetal Heart rate
- ABI studies
- PEAK & MEAN blood velocity determinations
- Peripheral vascular procedures
- Blood pressure segmental studies
- Venous compressions
- Penile & digit systolic pressures
- Flow velocities in recovery room
The provided text is a 510(k) summary for the Koven Technology, Inc. Smartdop 45 Bi-Directional Doppler. It largely focuses on establishing substantial equivalence with a predicate device and safety information. There is no detailed study described that establishes explicit acceptance criteria with reported device performance in the way typically found in performance studies for AI/ML devices.
Here's an analysis of the provided information based on your request:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of metrics like sensitivity, specificity, accuracy, or similar performance measures for specific clinical tasks. Instead, it refers to "extensive safety, performance, and validation tests" and states the device "meets all of its functional requirements."
The closest the document comes to performance claims or criteria are the intended uses and the comparison to the predicate device. For example:
- "The Smartdop 45 detects arterial and venous blood flow in extremities as well as fetal heart rate."
- "The Smartdop 45 displays and prints bi-directional velocity waveform, numerical data and fetal heart rate with heart beat indicator."
- "The Smartdop 45 has the same device characteristics as the predicate device, except... a 2 MHz fetal heart rate 2 MHz probe capability."
- "The conclusion drawn from these tests is that the Smartdop 45 device is equivalent in safety and efficacy to its predicated device."
Since no specific performance metrics are given, a table of acceptance criteria and reported device performance cannot be created from the provided text.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set, nor does it provide information about data provenance. It mentions "extensive safety, performance, and validation tests" but offers no details on patients, samples, or data used.
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)
The document does not mention the use of experts to establish a ground truth for a test set. The testing appears to be functional and safety-focused, rather than a clinical performance study involving expert interpretation of results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Since no test set is described as being evaluated by experts, there is no mention of an adjudication method.
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
The document does not describe an MRMC comparative effectiveness study. This device is a standalone diagnostic tool (Doppler), not an AI-assisted diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Test Data" section states that "The Smartdop 45 device has been subjected to extensive safety, performance, and validation tests prior to release... Final testing for the system includes various performance and validations prior to release. It includes tests designed to ensure that the device meets all of its functional requirements and operational performance capabilities."
This implies "standalone" testing was performed to verify the device's functional and operational performance, independent of human interpretation. However, the details of these tests are not provided. The device itself is intrinsically "standalone" in its function as a Doppler, providing data (waveforms, numerical data, heart rate) for a clinician to interpret.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify a type of ground truth. Given the nature of a Doppler device, ground truth for measuring blood flow or fetal heart rate would typically involve comparison to established medical standards or other validated measurement devices. However, this is not explicitly stated.
8. The sample size for the training set
The document does not mention a training set, as it is not describing an AI/ML device.
9. How the ground truth for the training set was established
Since no training set is mentioned, this information is not applicable and not provided.
§ 870.2100 Cardiovascular blood flowmeter.
(a)
Identification. A cardiovascular blood flowmeter is a device that is connected to a flow transducer that energizes the transducer and processes and displays the blood flow signal.(b)
Classification. Class II (performance standards).