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510(k) Data Aggregation
(280 days)
The ULTIMUS Series Ultrasound Diagnostic System is a general-purpose ultrasound system. It is intended for use by, or under the direction of a qualified and trained physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospitals or clinics environment.
The systems support the following clinical applications:
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology; Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and child); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); interventional(nerve block and vascular access); Adult Cephalic diagnostic Ultrasound applications.
Modes of operation include: 3D/4D Imaging mode, B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Combined modes: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
The ULTIMUS Series consists of a mobile console with a height-adjustable control panel, color LCD touch panel, LCD display monitor device. It includes a variety of electronic array transducers operating in linear, curved, sector/phase array, endocavity, and real time 3D transducer.
The ULTIMUS series is a Track 3 diagnostic ultrasound system. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for image storage.
The provided text describes the ULTIMUS Series Ultrasound Diagnostic System (K240676) and its substantial equivalence to a predicate device (GE LOGIQ E10 Ultrasound Diagnostic System, K231966). However, the document does not contain information about specific acceptance criteria related to device performance in terms of diagnostic accuracy or effect size with AI assistance. Instead, the acceptance criteria are focused on the device's adherence to regulatory standards, safety, and functional equivalence to the predicate device.
Here's an analysis based on the provided text, highlighting what is present and what is missing concerning your request:
Acceptance Criteria and Reported Device Performance
The document does not provide a table of performance acceptance criteria (e.g., sensitivity, specificity, accuracy for a specific clinical task) and reported device performance. The "acceptance criteria" discussed are largely regulatory and safety compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with relevant medical device safety standards | The ULTIMUS Series were evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety, and have been found to comply with applicable medical device safety standards. (A list of 16 standards is provided). |
| Substantial equivalence in intended use, indications for use, image capabilities, technological characteristics, image mode, and safety effectiveness to predicate device (GE LOGIQ E10) | The Proposed ULTIMUS Series system are substantially equivalent to the predicate GE LOGIQ E10 Ultrasound Diagnostic System (K231966) with regards to intended use, indication for use, image capabilities, technological characteristics, image mode, and safety effectiveness. (Detailed comparison tables are provided, highlighting similarities). |
| Patient contact materials meet ISO 10993-1 and FDA guidance | Material meet ISO 10993-1 and FDA guidance. |
| Acoustic output within specified limits (Track 3) | Ispta.3 ≤ 720 mW/cm2, MI ≤ 1.9, TI ≤ 6.0 (same as predicate). |
| Labeling conforms to 21 CFR Part 801 | Conforms to 21 CFR Part 801 (same as predicate). |
Missing Information Based on Your Request:
The document explicitly states: "The subject of this premarket submission, did not require clinical studies to support substantial equivalence."
Therefore, the following information, which would typically come from clinical studies or performance validation studies, is not available in the provided text:
- Sample size used for the test set and the data provenance: Not applicable as no clinical studies were performed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 mention AI assistance as a feature of the device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is an ultrasound system, not an AI algorithm for standalone diagnostic performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission relies on demonstrating substantial equivalence to a legally marketed predicate device through engineering, safety, and functional comparisons, rather than clinical performance studies.
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(170 days)
The device is a general purpose diagnostic ultrasound system intended for use by appropriately trained healthcare professionals in a hospital setting. The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
This device is indicated for Abdominal; Fetal/Obstetrics; Gynecology;Transvaginal; Urology(including prostate); Transrectal; Cardiac(adult and pediatric); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle, Musculo-skeletal Conventional and Superficial); Pediatrics(including neonatal cephalic); and Adult Cephalic diagnostic Ultrasound applications.
The operating modes supported by the device are B mode, Harmonic mode, M mode, Color Flow mode, Power-Doppler mode, Pulsed Wave Doppler mode, Continuous Wave Doppler, 3D mode, 4D mode, Spatio Temporal Image Correlation mode, Tissue Doppler mode, Tissue Velocity Imaging mode, Elastography mode and Contrast Agent Imaging mode.
The VINNO G50、VINNO G55、VINNO M50、VINNO E30、VINNO X5、VINNO X6、VINNO X7、VINNO M55、VINNO E35、VINNO X65、VINNO X55、VINNO X35、VINNO G55E、 VINNO G55P、VINNO M55E、VINNO M55P、VINNO E35E、VINNO E35P ultrasound devices are professional digital color ultrasonic diagnostic apparatus. It transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow accordingly.
The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets them in the context of AI performance or clinical efficacy. Instead, it describes a 510(k) premarket notification for a general-purpose diagnostic ultrasound system (VINNO G50, etc.) and focuses on demonstrating substantial equivalence to a predicate device (HS40 Diagnostic Ultrasound System).
The "Performance Data" section (VIII) refers to non-clinical testing to support the substantial equivalence determination, rather than clinical performance or AI-specific criteria.
Therefore, I cannot provide the requested information from the given text regarding:
- A table of acceptance criteria and reported device performance (for clinical/AI performance)
- Sample size and provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method for the test set
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used (for clinical/AI performance)
- Sample size for the training set
- How ground truth for the training set was established
The document primarily addresses electrical safety, EMC, software verification/validation (general to medical device software, not AI-specific), biocompatibility, and acoustic output, comparing these aspects to the predicate device and relevant standards. It concludes that the device is substantially equivalent, implying it is "as safe, as effective and performs as well as the legally marketed device" based on these non-clinical comparisons.
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(170 days)
The device is intended for ultrasound imaging, measurement, display and analysis of the human body and fluid.
The operating modes supported by the device are B, M.PWD CWD, Tissue Doppler, Color Doppler, Power Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, Combine modes.
This device is indicated for Abdominal; Fetal; Obstetrics; gynecology;Trans-vagmal; Urology(including prostate); Transrectal; Cardiac(adult and pediatic); Peripheral Vascular; Small Organs/Parts(thyroid, breast, testicle); Musculoskeletal(Conventional and Superficial); Pediatrics(including neonatal cephalic diagnostic Ultrasound applications.
This device is intended to use by, or by the order of, and under the supervision of an appropriately-trained healtheare professional qualified to direct the use of the device in hospitals or clinics.
VINNO E20, VINNO E10, VINNO E10E, VINNO X1, VINNOX1E, VINNOX1E, VINNO X2, VINNO X2E, VINNO X2E ultrasound devices are professional digital color ultrasonic apparatus. It transmits ultrasound waves into the body tissues and displays the echo images of the tissues and blood flow accordingly.
This document is a 510(k) Premarket Notification summary for VINNO E20, VINNO E10, VINNO E10P, VINNO E10E, VINNO X1, VINNO X1E, VINNO X1P, VINNO X2, VINNO X2E, VINNO X2P ultrasound devices. It establishes substantial equivalence to an existing predicate device rather than presenting comprehensive clinical study data with detailed acceptance criteria for an AI-powered device.
Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving an AI device meets those criteria. The document focuses on showing the VINNO ultrasound systems are similar to a previously cleared ultrasound system, referencing general performance data for basic functions such as biocompatibility, electrical safety, software verification, and acoustic output.
It does not describe a clinical study for an AI algorithm, nor does it provide details such as:
- A table of acceptance criteria and reported device performance for an AI feature.
- Sample sizes for AI test sets.
- Number of experts, their qualifications, or adjudication methods for establishing ground truth for AI.
- MRMC comparative effectiveness studies for AI assistance.
- Standalone performance data for an AI algorithm.
- Specific types of ground truth (e.g., pathology, outcomes data) for AI.
- Training set sample sizes or how ground truth was established for an AI training set.
The document generally states that the device "performs as well as the legally marketed device" based on non-clinical testing, which is the standard for a 510(k) submission seeking substantial equivalence for a medical device that doesn't contain a novel AI component requiring extensive clinical validation.
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(174 days)
The device is general purpose diagnostic ultrasound system for use by qualified healthcare professionals. It is applicable for adults, pregnant women, pediatric patients and neonates.
The device is intended for ultrasound imaging, measurement and analysis of human body and fluid for multiple clinical applications including: abdominal (GYN and Urology), Thoracic/Pleural, Fetal/Ob, small organ (including breast, thyroid, testes), peripheral vessel, neonatal cephalic, pediatric, musculo-skeletal (conventional, superficial), transrectal, trans-vaginal, cardiac pediatric, magnetic Needle guidance and imaging guidance of interventional procedures (e.g. biopsy).
This device is intended to use by, or by the order of, and under the supervision of a licensed physician qualified to direct the use of the device.
The device is used in hospital, clinical point-of-care for diagnosis of patients. The operating modes supported by the device are B, M,PWD CWD, Tissue Doppler, Color M Doppler, Power Doppler, Tissue Velocity Imaging, Harmonic Imaging, 3D/4D, CBI, EI, Combine modes.
The VINNO 6EXP, VINNO 6PRO, VINNO 5EXP, VINNO 5PRO, VINNO 3, VINNO 3EXP, VINNO 3PRO ultrasound devices are laptop digital color ultrasonic diagnostic devices which transmit ultrasound waves into the body tissues and display the echo images of the tissues and blood flow accordingly. The devices are capable of digital acquisition, processing and display and operate from an integrated battery or separate power supply/charger.
The provided 510(k) summary does not contain performance criteria or a study proving that the device meets specific acceptance criteria in the manner typically requested for AI/ML devices. This submission focuses on establishing substantial equivalence to a predicate ultrasound device through technical comparisons and compliance with general safety and performance standards, rather than evaluating a specific AI algorithm's diagnostic performance against established criteria.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device with specific diagnostic performance metrics (like sensitivity, specificity, AUC) for a particular medical condition, the "acceptance criteria" revolve around demonstrating comparable safety and effectiveness to the predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met by Predicate Equivalence) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1:2009 standards for probes. | All evaluation acceptance criteria were met. |
| Electrical Safety | Comply with IEC 60601-1 standards. | The system complies with IEC 60601-1. |
| EMC (Electromagnetic Compatibility) | Comply with IEC 60601-1-2 standards. | The system complies with IEC 60601-1-2. |
| Software Verification & Validation | Follow FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for "moderate" level of concern software. | Software verification and validation testing were conducted, and documentation was provided as recommended. |
| Acoustic Output | Comply with Track 3 limits (Ispta.3 ≤ 720mW/cm², MI ≤ 1.9) according to NEMA UD2 and IEC 60601-2-37. | Acoustic output testing was performed according to NEMA UD2 and IEC60601-2-37, and the device complies with Track 3 limits (explicitly stated). |
| General Performance | Perform as safely and effectively as the predicate device for its intended uses and technological characteristics. | Non-clinical testing demonstrates that the device is as safe, as effective, and performs as well as the legally marketed device (predicate). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable in the context of this 510(k) summary. This submission is for an ultrasound system, not an AI diagnostic algorithm. There is no "test set" of patient data used for diagnostic performance evaluation of an AI algorithm in this document. The performance data discussed are related to engineering and safety standards (biocompatibility, electrical safety, etc.), not a clinical performance study using patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. There is no "ground truth" to be established by experts for a test set in this kind of submission, as it doesn't involve the evaluation of an AI algorithm's diagnostic accuracy.
4. Adjudication Method
This information is not applicable for the same reasons as above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as this is not an AI-assisted diagnostic device being evaluated for its impact on human reader performance.
6. Standalone Performance Study
This information is not applicable as this is not an AI algorithm requiring standalone performance evaluation. The device itself is a standalone ultrasound system.
7. Type of Ground Truth Used
This information is not applicable as there is no diagnostic AI algorithm being evaluated. The "ground truth" for the device's claims are the established engineering standards and specifications (e.g., IEC 60601-1) and the performance characteristics of the predicate device.
8. Sample Size for the Training Set
This information is not applicable. There is no AI algorithm being trained.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no AI algorithm being trained.
In summary: The provided document is a 510(k) summary for a general-purpose diagnostic ultrasound system. Its "acceptance criteria" and "proof" primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device by showing that it meets relevant safety, electromagnetic compatibility, software validation, and acoustic output standards, and that its technical characteristics and indications for use are the same. It does not involve the type of AI/ML performance study described in the prompt.
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