(147 days)
The Smartdop XT6 is intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. It detects systolic pressures for ankle-brachial index (ABI), toe-brachial index (TBI), and arterial and venous blood flow in extremities. Measurements are provided utilizing cuffs, photoplethysmography (PPG) and/or Doppler probe. The optional foot temperature probe provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link6 software that includes capabilities to print waveforms and export to into the facility's electronic health records.
It is not intended to be used in fetal applications or used inside the sterile field. It is intended to be used by licensed healthcare practitioners on adults and pediatrics only.
The Smartdop XT6 with Smart-XT-Link6 is designed to provide both qualitative information. The qualitative information mainly includes visual display of waveform's shapes, including qualitative analysis of Pulse Volume Recordings (PVR), Photoplethysmography (PPG) and Doppler waveforms. The quantitative information is focused primarily on aiding the examiners in obtaining systolic segmental blood pressures, including the ABI (ankle-brachial index) and TBI (toe-brachial index). Additional quantitative measurements relate to the Doppler blood flow velocity waveforms. Foot skin temperature readings are done with optional temperature probe and can be displayed in either Fahrenheit or Celsius. All tests controlled and stored by computer with Smart-XT-Link6 software for Windows OS with capabilities to print waveform data and export to electronic health record management systems.
The Koven Technology, Inc. Smartdop XT6 (K153762) is a non-invasive device for evaluating peripheral vascular pathology. It detects systolic pressures for ankle-brachial index (ABI), toe-brachial index (TBI), and arterial and venous blood flow in extremities.
Here's an analysis of the acceptance criteria and supporting study details based on the provided document:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics for the device's diagnostic capabilities (e.g., accuracy, sensitivity, specificity for ABI/TBI measurements). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device and adherence to various medical device standards.
The primary "performance" reported is the demonstration of compliance with relevant standards and functional specifications that ensure the device operates as intended and safely.
| Acceptance Criteria Category | Reported Device Performance / Assessment |
|---|---|
| Substantial Equivalence | The Smartdop XT6 is deemed substantially equivalent in safety and efficacy to the predicate device, Smartdop XT (K131623), despite having fewer pressure ports (6 vs. 14). |
| Functional Specifications | The device meets all of its functional specifications listed in the Device Master Record, as verified by internal unit testing, verification, performance testing, and validation. |
| Safety and EMC Standards | Compliance with: |
- IEC 60601-1 (Medical electrical equipment)
- IEC 60601-1-2 (EMC)
- IEC 60601-2-37 (Ultrasonic medical diagnostic and monitoring equipment)
- ANSI/AAMI/IEC 80601-2-30 (Automated noninvasive sphygmomanometers)
- ANSI/AAMI/ISO 81060-1 (Non-invasive sphygmomanometers) |
| Software Safety | Compliance with IEC 62304 (Medical device software) |
| Risk Management | Compliance with ISO 14971 (Application of risk management to medical devices) |
| Bio-Compatibility | Passed bio-compatibility testing by certified laboratories. |
| Electrical Safety | Passed electrical safety testing by certified laboratories. |
| Mechanical Safety | Passed mechanical safety testing by certified laboratories. |
| Acoustic Output | Passed acoustic output testing by certified laboratories.
(Specific for 8MHz probe: 390 mW/cm² or less) |
| Labeling | Labeling includes instructions for safe and effective use, warnings, cautions, and guidance for use. |
Study Details for Acceptance
The document describes a series of tests and assessments performed, primarily focused on regulatory compliance and functional testing rather than a traditional clinical study with a test set of patient data and expert ground truth.
1. Sample sized used for the test set and the data provenance:
- Test Set Size: Not explicitly stated as a number of patient cases or samples in the context of diagnostic performance. The "testing" sections refer to compliance testing (e.g., electrical, mechanical, EMC) and internal verification/validation, not a clinical test set for diagnostic accuracy.
- Data Provenance: Not applicable for a traditional clinical test set. The compliance testing was likely conducted in a laboratory setting, and internal validation would use test data generated or simulated by the manufacturer.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a test set requiring expert ground truth for diagnostic accuracy evaluation in this submission. The "ground truth" for the compliance and functional tests would be the established performance limits and specifications defined by the relevant standards and the device's design.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical test set requiring expert adjudication.
4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an ultrasonic transducer/Doppler system for physical measurements, not an AI-assisted diagnostic imaging interpretation tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device performs measurements (systolic pressures, blood flow, temperature) which can be considered "standalone" in the sense that the device itself generates these quantitative outputs. However, there's no "algorithm only" performance reported in the context of, for example, classifying disease or interpreting complex images without human input, as might be found in an AI/CADx device. The device provides "information" (qualitative waveforms, quantitative measurements) that is then used by a "licensed healthcare practitioner."
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical and safety testing, the "ground truth" would be the established requirements and specifications of the referenced standards (e.g., IEC, ISO, ANSI/AAMI). For internal performance validation, the ground truth would be the defined functional specifications from the Device Master Record. There is no indication of clinical ground truth (e.g., pathology, outcomes) being used for performance evaluation in this submission.
7. The sample size for the training set:
- Not applicable. This document describes a traditional medical device (ultrasonic transducer) and does not refer to machine learning or AI components that would require a "training set."
8. How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this device.
§ 870.2880 Ultrasonic transducer.
(a)
Identification. An ultrasonic transducer is a device applied to the skin to transmit and receive ultrasonic energy that is used in conjunction with an echocardiograph to provide imaging of cardiovascular structures. This device includes phased arrays and two-dimensional scanning transducers.(b)
Classification. Class II (performance standards).