(128 days)
QuantaFlo is intended to aid clinicians in the diagnosis and monitoring of Peripheral Arterial Disease. It provides bilateral, non-invasive physiologic studies of the upper and lower extremity arteries, using volume plethysmography of the posterior tibial and anterior tibial/dorsalis pedis arterial distributions. Additionally, QuantaFlo may be used to perform bilateral, non-invasive physiologic studies of the upper and lower extremity arteries with provocative functional maneuvers.
The device is for adult use and not for pediatric or fetal use.
QuantaFlo aids clinicians in the diagnosis of vascular disease by measuring blood volume changes using volume plethysmography in the Brachial, Posterior Tibial, and Anterior Tibial/Dorsal Pedis arterial distributions. From these signals it calculates a result that is predictive of Peripheral Arterial Disease (PAD). In addition. QuantaFlo provides hard-copy waveforms as part of the report, which may be viewed on the system display, printed, and/or saved.
The clinician places a sensor and makes a measurement on each upper extremity and each lower extremity. The sensor includes a transducer, which detects changes in arterial blood volume. This signal is digitized and sent to a computer, which runs a specifically-designed software application. The application calculates the result via a proprietary algorithm, which is based on the features of the volume plethysmography signals from the Brachial. Anterior Tibial / Dorsalis Pedis, and Posterior Tibial arterial distributions.
Here's a breakdown of the acceptance criteria and study information for the QuantaFlo device, based on the provided text:
Acceptance Criteria and Device Performance
The document states that "Product testing was completed and met all of the acceptance criteria," but it does not explicitly list the acceptance criteria in a table format with specific thresholds. Instead, it broadly states that "clinical accuracy in determining the presence of PAD" was the focus for clinical performance.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Clinical Accuracy for PAD Detection | QuantaFlo was 80.2% accurate in detecting PAD. |
| Biocompatibility | Met ISO-10993 standards (Cytotoxicity, Sensitization, Irritation). |
| Electrical Safety & EMC | Complies with IEC 60601-1-2 standard for EMC. Safe low-voltage interface with adequate dielectric strength. |
| Software Verification & Validation | Application stability, USB sensor connection cycle, standard use-case, and automated use/"stress" testing completed. Validation confirmed moderate level of concern. |
| Design Verification & Product Validation | Dimensional verification, signal quality, temperature stability, accelerated life, cable tensile testing, and electrical EMC testing completed. |
Study Details
2. Sample size used for the test set and the data provenance:
* Sample Size: 333 limbs for QuantaFlo and 328 limbs for Doppler ABI.
* Data Provenance: The document does not explicitly state the country of origin. It does not mention if the data was retrospective or prospective, but the phrasing "Among six clinical sites, QuantaFlo was 80.2% accurate (n=333 limbs)" suggests a prospective collection for the purpose of the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* The document does not specify the number of experts used to establish ground truth.
* Qualifications of Experts: Not specified.
4. Adjudication method for the test set:
* The document does not explicitly describe an adjudication method for the test set in terms of expert consensus. It states that "Duplex ultrasound and/or angiography" were used as the "reference standard" (ground truth).
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:
* No, an MRMC comparative effectiveness study was not performed as described. The study compares the device's performance (QuantaFlo) against another accepted method (Doppler ABI) in detecting PAD, using a reference standard. It does not evaluate human readers' performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, a standalone performance assessment was done. The stated accuracy of 80.2% for QuantaFlo is a direct measure of the device's (algorithm's) ability to detect PAD compared to the reference standard, without human interpretation of the device's output. The device "calculates a result that is predictive of Peripheral Arterial Disease (PAD)." It's intended to "aid clinicians," implying the clinician uses the device's output.
7. The type of ground truth used:
* The ground truth used was Duplex ultrasound and/or angiography. These are considered reference diagnostic standards for Peripheral Arterial Disease (PAD).
8. The sample size for the training set:
* The document does not state the sample size used for the training set. It only provides details about the clinical performance study (test set).
9. How the ground truth for the training set was established:
* Since the training set sample size is not mentioned, how its ground truth was established is also not specified.
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).