(227 days)
The Smartdop XT 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 and/or Doppler probe. The optional foot temperature provides skin temperature readings on the foot. Collected data is captured and stored with Smart-XT-Link 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.
The Smartdop XT with Smart-XT-Link is designed to provide both qualitative and quantitative 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-Link software for Windows OS with capabilities to print waveform data and export to electronic health record management systems.
Here's an analysis of the provided text regarding the Smartdop XT device, focusing on its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K131623) is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed performance metrics against specific acceptance criteria for a novel device. The document mostly outlines a series of standards and guidance the device was designed to meet and states that testing was completed with acceptance to these standards. It doesn't explicitly list quantitative acceptance criteria with corresponding performance results in a table format.
However, based on the document's content, we can infer some implied acceptance criteria and the general statement of compliance:
| Acceptance Criteria (Implied from Standards & Testing) | Reported Device Performance |
|---|---|
| Electrical Safety (IEC 60601-1) | "The Smartdop XT system have been subjected to... Electrical Safety... testing by certified laboratories." (Implied: Device met the safety requirements.) |
| Mechanical Safety (IEC 60601-1, etc.) | "The Smartdop XT system have been subjected to... Mechanical Safety... testing by certified laboratories." (Implied: Device met the safety requirements.) |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2) | "The Smartdop XT system have been subjected to... EMC emissions and immunity... testing by certified laboratories." (Implied: Device met the EMC requirements.) |
| Acoustic Output (IEC 60601-2-37) | "The Smartdop XT system have been subjected to... Acoustic Output... testing by certified laboratories." (Implied: Device met the acoustic output requirements for ultrasonic medical diagnostic equipment.) |
| Software Life Cycle Processes (IEC 62304) | "The Smartdop XT was designed to meet... IEC 62304 Medical device software Software life cycle processes (2006-05)." (Implied: Software development followed the standard processes, indicating reliability and safety.) |
| Risk Management (ISO 14971) | "The Smartdop XT was designed to meet... ISO 14971, Medical devices - Application of risk management to medical devices (2007-10-01)." (Implied: Risks were identified, evaluated, and controlled according to the standard.) |
| Non-invasive Sphygmomanometers (Automated) (ANSI/AAMI/IEC 80601-2-30) | "The Smartdop XT was designed to meet... ANSI/AAMI/IEC 80601-2-30:2009... Particular requirements for the basic safety and essential performance of automated noninvasive sphygmomanometers." (Implied: Device performance for automated blood pressure measurement complied with the standard.) The document doesn't provide specific numerical accuracy results for blood pressure measurements but implies compliance through adherence to this standard. |
| Non-invasive Sphygmomanometers (Non-automated) (ANSI/AAMI/ISO 81060-1) | "The Smartdop XT was designed to meet... ANSI/AAMI/ISO 81060-1:2007... Requirements and test methods for non-automated measurement type." (Implied: Device performance for non-automated blood pressure measurement complied with the standard.) Similar to the above, no specific numerical results are provided. |
| Functional Specifications (Device Master Record) | "Internally the Smartdop XT is subjected to unit testing, verification, performance testing, and validation to ensure that the device(s) meet all of their functional specifications listed in the Device Master Record." (Implied: All intended functions operate as designed.) |
| Equivalence to Predicate Device (Safety & Efficacy) | "The conclusion drawn from these tests is that the Smartdop XT non-invasive peripheral vascular diagnostic system is equivalent in safety and efficacy to the predicate device [Falcon/Pro, K111416]." (This is the overarching conclusion of the 510(k), implying performance is comparable to an already approved device.) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for any clinical test set. The testing described is primarily focused on compliance with engineering and safety standards rather than clinical validation with a patient cohort. The document mentions "performance testing by certified laboratories" and "unit testing, verification, performance testing, and validation" internally, but these refer to bench testing and engineering verification, not clinical studies on patient data.
Therefore, information on data provenance (country of origin, retrospective/prospective) is also not available.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. Since the testing described is not a clinical study involving diagnosis or interpretation of medical images/data by experts, the concept of "ground truth" as established by medical experts for a test set doesn't apply in the context presented.
4. Adjudication Method for the Test Set
This information is not provided. As there's no mention of a clinical test set requiring expert interpretation or diagnosis, there's no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and adherence to standards, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Given the nature of the device (an ultrasonic transducer for non-invasive peripheral vascular evaluation providing qualitative and quantitative information for examiner aid), it is likely designed for human-in-the-loop operation. The document describes it as aiding "the examiners in obtaining systolic segmental blood pressures."
No specific standalone algorithm performance study is described. The device is a diagnostic tool that provides data and waveforms, not an automated diagnostic algorithm meant to operate independently.
7. The Type of Ground Truth Used
Based on the described testing, the "ground truth" would be related to:
- Engineering and Safety Standards: Compliance with the numerous IEC, ISO, and ANSI/AAMI standards listed (e.g., electrical safety, acoustic output limits, EMI/EMC limits).
- Functional Specifications: The device's internal "functional specifications listed in the Device Master Record." This implies that the 'ground truth' for verification is defined by the manufacturer's own design requirements and expected performance parameters during bench testing.
There is no mention of ground truth established by expert consensus, pathology, or outcomes data in a clinical context within this document.
8. The Sample Size for the Training Set
The document does not mention or describe any training set for an algorithm. The Smartdop XT is an ultrasonic transducer and software system for data acquisition and display, not an AI/ML-based diagnostic algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set, this information is not applicable/not provided.
§ 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).