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510(k) Data Aggregation
(137 days)
Venue Sprint is a general-purpose diagnostic ultrasound system for use by qualified and trained healthcare professionals or practitioners that are legally authorized or licensed by law in the country. state or other local municipality in which he or she practices, for ultrasound imaging, measurement. display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Users may also include medical students working under the supervision or authority of a physician during their education / training.
The Venue Sprint is intended to be used in a hospital, medical clinic, home environment and road/air ambulance.
Venue Sprint clinical applications include: abdominal (GYN and Urology), thoracic/pleural, ophthalmic, Fetal/OB, Small Organ (including breast, testes, thyroid), Vascular/Peripheral vascular, neonatal and adult cephalic, pediatric, musculoskeletal (conventional and superficial), cardiac (adults and pediatric, 40 kg and above) and interventional guidance (includes free hand tissue biopsy, fluid drainage, vascular access). Modes of operation include: B. M. PW Doppler, Color Doppler and Harmonic Imaging.
Venue Sprint is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals to evaluate the body by ultrasound imaging and fluid flow analysis. The Venue Sprint is used together with the Vscan Air probes and provides the user interface for control of the probes and the needed software functionality for analysis of the ultrasound images and saving/storage of the related images and videos.
This document describes the Venue Sprint diagnostic ultrasound system (K240206). Based on the provided text, the device is an ultrasound system and does not appear to have AI/ML functionality that requires specific performance metrics beyond general safety and effectiveness. The document explicitly states that clinical studies were not required to support substantial equivalence.
Therefore, most of the requested information regarding acceptance criteria, specific performance tables, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not present in this 510(k) summary for the Venue Sprint.
Here's an attempt to answer the questions based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain a specific table of acceptance criteria or performance metrics for an AI/ML component. The "acceptance criteria" for this device appear to be compliance with various safety and performance standards for diagnostic ultrasound systems.
| Acceptance Criteria Category | Reported Device Performance Summary (from document) |
|---|---|
| Acoustic Output | Complies with applicable medical device safety standards. |
| Biocompatibility | Complies with applicable medical device safety standards; Transducer material is biocompatible. |
| Cleaning and Disinfection Effectiveness | Complies with applicable medical device safety standards. |
| Thermal, Electrical, Electromagnetic, and Mechanical Safety | Complies with applicable medical device safety standards. |
| Voluntary Standards Compliance | Complies with: |
- Marketing Clearance of Diagnostic Ultrasound Systems and Transducers - Guidance
- AAMI/ANSI ES60601-1
- IEC 60601-1-2
- IEC 60601-2-37
- IEC 62359
- ISO 10993-1
- ISO 14971
- NEMA PS 3.1-3.20e (DICOM)
- AAMI TIR69
- IEC 60601-1-11
- IEC 60601-1-12 |
| Quality Assurance Measures | Risk Analysis, Requirements Reviews, Design Reviews, Testing (unit, integration, performance, safety) |
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 explicitly states: "The subject of this premarket submission, Venue Sprint, did not require clinical studies to support substantial equivalence." Therefore, there is no mention of a test set, its sample size, or data provenance from clinical studies within this submission.
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)
Not applicable, as no clinical studies requiring ground truth establishment for a test set were conducted or described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies requiring ground truth establishment for a test set were conducted or described.
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
Not applicable. The document does not describe any AI-assisted features or MRMC studies. The device is described as a "general-purpose diagnostic ultrasound system." The phrase "expanding cleared Auto Inferior Vena Cava (IVC), Auto B-Lines, Real Time ejection fraction (RT-EF) and cNerve" refers to features already cleared on other predicate devices and their expansion to new probes on this system; it does not constitute a new AI feature with its own performance study described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as no standalone algorithm performance study is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies requiring ground truth were conducted or described.
8. The sample size for the training set
Not applicable, as no machine learning model training is described in this submission.
9. How the ground truth for the training set was established
Not applicable, as no machine learning model training is described in this submission.
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