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510(k) Data Aggregation
(85 days)
The Versana Premier/Versana Premier Lotus/LOGIQ F is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Versana Premier/Versana Premier Lotus/LOGIQ F clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Adult, Cardiac Pediatric, Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and nonvascular access).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD.
Versana Premier/Versana Premier Lotus/LOGIQ F is intended to be used in a hospital or medical clinic
The Versana Premier, Versana Premier Lotus and LOGIQ F is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers. The console provides digital acquisition, processing, and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source. The operator control panel includes function keys, trackball, and a touch panel with a digital keyboard (physical keyboard as an option) as input sources of the device. The variety of transducers include convex, linear, sector, Bi-plane probe and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal, transcranial and transesophageal. The Versana Premier, Versana Premier Lotus and LOGIQ F share a common software and hardware platform. There may be different configurations commercially offered, however they are all within the overall design of the product.
The provided text is a 510(k) Summary for a new medical device submission (K242005) for the GE Versana Premier, Versana Premier Lotus, and LOGIQ F ultrasound systems. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study proving that the device meets specific acceptance criteria for performance.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- A table of acceptance criteria and the reported device performance: Not provided. The document outlines a comparison to predicate devices, but no specific performance metrics with acceptance criteria are listed.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided, as no clinical study demonstrating performance against acceptance criteria was conducted.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
- 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 provided. The device is a diagnostic ultrasound system and not an AI-assisted diagnostic tool as described.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided.
Summary of what the document does state regarding meeting requirements:
The document states:
- "The subject of this premarket submission, Versana Premier/Versana Premier Lotus/LOGIO F did not require clinical studies to support substantial equivalence." (Page 8)
- It attests to the device's conformance with recognized performance standards and safety standards through non-clinical tests (acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety).
- It lists several voluntary standards the device complies with (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, ISO 10993-1, ISO 14971, NEMA PS 3.1 - 3.20, IEC 62359).
- It outlines quality assurance measures applied during development, including Risk Analysis, Requirements Reviews, Design Reviews, and various levels of testing (unit, integration, system, performance, safety).
In essence, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices and compliance with recognized safety and performance standards for ultrasound systems, rather than on a new clinical study with specific acceptance criteria met by the device's performance.
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(132 days)
The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals 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. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatio; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including UrologyProstate) (TR); Transvaginal (TV).
Mode of operation include: B, M, AMM (Anatonical M-Mode), PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, HD-Flow (High Definition-Flow), Harmonic Imaging, Coded Pulse, 3D/4D Inaging mode, Elastography, B-Flow and Combined modes: BM, B/ Color, B/PWD, B/Power/PWD. The Voluson SWIFT / Voluson SWIFT+ are intended to be used in a hospital or medical clinic.
The subject device is a Track 3 device, primarily intended for general-purpose radiology evaluation and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. The Voluson SWIFT, Voluson SWIFT+ provide digital acquisition, processing and display capability. Voluson SWIFT, Voluson SWIFT+ consist of a mobile console with control panel, full touch monitor, optional image storage and printing devices. It provides high-performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducer including mechanical and electronic scanning transducers which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Auto-Caliper:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Success rate of the AI feature (Auto-Caliper) for 2D caliper placement is 70% or higher. | The reported success rate is not explicitly stated as a single percentage, but the aggregate data on absolute difference between AI predicted diameter and ground truth diameter can be used to infer performance. The provided table shows that 85.4% of cases have an absolute difference less than or equal to 2.0 mm (5.3 + 32.8 + 22.1 + 25.2 = 85.4%), and 5.3% of cases have an absolute difference less than 0.1mm. The study's goal was to demonstrate performance, and while a direct "success rate" percentage isn't given in relation to the 70% criteria, the detailed error distribution provides a granular view of accuracy. If "success" is defined by a certain tolerance (e.g., within 2mm), then the performance is high. |
Study Details for Auto-Caliper Feature:
2. Sample Size Used for the Test Set and Data Provenance:
* Test Set Sample Size: 67 volumes, with a total of 134 follicles evaluated (2 follicles per volume).
* Data Provenance: Data collected across multiple geographical sites: Germany, India, Spain, United Kingdom, USA. The data was collected from women examined in regular clinical practice. It was de-identified by external clinical partners.
* Retrospective/Prospective: The data appears to be retrospective, as it was "collected from patients from regular clinical practice" and then "de-identified."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
* Number of Experts: Not explicitly stated as a single number. The verification for the Auto-Caliper AI feature was performed by "clinical experts" following a specific protocol. The "truthing process" for training data mentions "clinical experts" and a "senior sonographer" reviewing a random subset. It is reasonable to infer that experts with similar qualifications were used for the test set ground truth.
* Qualifications: "Clinical experts" and a "senior sonographer." Specific experience levels (e.g., "10 years of experience") are not provided.
4. Adjudication Method for the Test Set:
* Method: The outputs were evaluated by the clinical expert and the assessment was documented as Pass/No result/Fail. This suggests a qualitative assessment by individual experts rather than a specific multi-reader consensus method like 2+1 or 3+1 for resolving discrepancies. However, the quantitative evaluation involved calculating the deviation from manual measurements, which likely served as the definitive ground truth for performance metrics.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
* Was one done? No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was compared.
6. Standalone (Algorithm Only) Performance Study:
* Was one done? Yes. The provided data is a standalone performance evaluation of the Auto-Caliper AI feature, comparing its predictions against ground truth (manual measurements by experts). The evaluation directly reports the deviation of the AI predictions from the manual measurements.
7. Type of Ground Truth Used:
* Type: Expert consensus / Manual measurements. The ground truth was established by "clinical experts" who manually placed calipers following a specific protocol. The "deviation of the measurements predicted by the Auto-Caliper tool from the manual measurements" confirms that expert manual measurements served as the reference.
8. Sample Size for the Training Set:
* Sample Size: 223 volumes.
9. How the Ground Truth for the Training Set Was Established:
* Method: A "curation protocol has been developed by clinical experts to be followed by curators." Additionally, "during and after the data curation process, a senior sonographer reviewed a random subset of the curated dataset for clinical accuracy." This indicates a structured process involving clinical expert input and review to establish the ground truth for the training data.
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