Search Results
Found 4 results
510(k) Data Aggregation
(86 days)
Voluson P6, Voluson P8
Voluson P6 / Voluson P8 are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional 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 P6 / Voluson P8 clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including UrologyProstate) (TV),
Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, HD-Flow, Harmonic Imaging, 3D/4D Imaging mode, Contrast and Combined modes: B/M, B/Color, B/Pwwer/ PWD. The Voluson P6 / Voluson P8 are intended to be used in a hospital or medical clinic.
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD display, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three- dimensional imaging supporting all standard acquisition modes.
This document is an FDA 510(k) summary for the GE Healthcare Voluson P6 and Voluson P8 diagnostic ultrasound systems. It declares the device to be substantially equivalent to a predicate device and states that clinical studies were not required to support substantial equivalence.
Therefore, there is no information in this document regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only without human-in-the-loop) performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on non-clinical tests and compliance with safety standards to demonstrate substantial equivalence to existing devices.
Ask a specific question about this device
(90 days)
Voluson P6, Voluson P8
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obsternes); Abdominal (including renal and GYN/pelvic); Pediatic; Small Organ (breast, testes, thyroid, salivary gland, Jymph nodes, pediatic and neonatal patients); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-sketal Conventional and Superficial; Transrectal (Including Urology and Prostate) (TR); Transvaginal (TV).
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal, Transvaginal.
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD display, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate realtime three dimensional imaging supporting all standard acquisition modes.
The provided document is a 510(k) Premarket Notification for the GE Healthcare Voluson P6 / Voluson P8 Ultrasound Systems. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results with acceptance criteria in the same way an AI-powered diagnostic device might.
Based on the document, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a typical acceptance criteria table with corresponding device performance metrics for a diagnostic accuracy study. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices, and conformity to various electrical, safety, and performance standards.
The document discusses various operating modes and clinical applications for which the device and its transducers are indicated. The "performance" is implicitly tied to being equivalent to previously cleared devices which are presumed safe and effective for these applications.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Same fundamental scientific technology as predicate devices | Voluson P6 / Voluson P8 employs the same fundamental scientific technology as its predicate devices. |
| Substantially equivalent intended use as predicate devices | The Voluson P6 / Voluson P8 and predicate Voluson P Series systems have the same clinical intended use. |
| Substantially equivalent imaging capabilities as predicate devices | The Voluson P6 / Voluson P8 and predicate Voluson P Series systems have the same imaging modes. |
| Substantially equivalent technological characteristics as predicate devices | Transducers are identical or similar, with additions and removals noted for specific models; beam former changed to STB MLA4 (previously cleared). |
| Safety and effectiveness equivalent to predicate devices | Systems are manufactured with materials evaluated and found safe; acoustic power levels are below FDA limits; complies with approved electrical and physical safety standards and voluntary standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA PS 3.1 - 3.20). |
| Biocompatibility of patient contact materials | Transducer materials and other patient contact materials are biocompatible. |
| Similar capability in performing measurements, capturing digital images, reviewing and reporting studies | The Voluson P6 / Voluson P8 and predicate Voluson P Series systems have similar capability. |
| Added features (SIM card, GYN measurement tool) are previously cleared | SIM card (K142472) and IOTA LR2 model (K142472) were previously cleared. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The subject of this premarket submission, Voluson P6 / Voluson P8, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set sample size and no data provenance as defined for clinical performance evaluation. The evaluation was primarily based on non-clinical testing and comparison to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical studies were required or performed for this specific submission, no experts were used to establish ground truth for a test set.
4. Adjudication Method for the Test Set
As no clinical study was performed, no adjudication method was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No MRMC comparative effectiveness study was done. The submission did not involve evaluating human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
No standalone algorithm performance study was done. This device is a general-purpose ultrasound system, not an AI-powered diagnostic algorithm.
7. The Type of Ground Truth Used
No ground truth was established in the context of a diagnostic performance study. The "truth" for this submission is based on demonstration of compliance with safety standards and equivalence to predicate devices.
8. The Sample Size for the Training Set
This device is not an AI/ML algorithm that is trained on a dataset. Therefore, there is no training set sample size.
9. How the Ground Truth for the Training Set was Established
As this is not an AI/ML device, no ground truth was established for a training set.
In summary, the provided document describes a 510(k) submission for an ultrasound system focusing on demonstrating substantial equivalence to predicate devices and adherence to safety and performance standards, rather than presenting a performance study with acceptance criteria and ground truth for an AI/ML powered device.
Ask a specific question about this device
(30 days)
VOLUSON P6, VOLUSON P8
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric: Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
The medical device in question, the GE Voluson P6, Voluson P8 Ultrasound System, is a general-purpose ultrasound system. The provided information does not detail a study that defines specific acceptance criteria for a new AI feature or algorithm. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (K132913 Voluson E Series and K122387 Voluson P6/P8).
The "acceptance criteria" presented here are inferred from the declaration of substantial equivalence, which implies that the device must perform equivalently to its predicates across various clinical applications and imaging modes. The "reported device performance" is the statement that the device IS substantially equivalent.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| General System Performance: | |
| - Safety: Conformance to applicable medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971, NEMA DICOM Set). | - The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. Voluson P6/P8 and its applications comply with listed voluntary standards. |
| - Effectiveness: Equivalent imaging capabilities, technological characteristics, and safety as predicate devices. | - The Voluson P6/P8 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness. |
| - Intended Use: Support diagnostic ultrasound imaging and fluid flow analysis for specified clinical applications (Fetal/Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional and Superficial, Transrectal, Transvaginal). | - The Voluson P6/P8 and predicate Voluson P6/P8 systems have the same clinical intended use. |
- The device supports the intended uses and modes of operation as detailed in the Indications for Use forms (Pages 7-14), with 'P' indicating applications previously cleared by FDA for the predicate devices. |
| - Acoustic Power Levels: Below applicable FDA limits. | - The systems have acoustic power levels which are below the applicable FDA limits. |
| - Transducers: Identical to predicate Voluson P6/P8 systems. | - The Voluson P6/P8 and predicate Voluson P6/P8 systems transducers are identical. The submission lists the following transducers: RAB2-6-RS, 4C-RS, E8C-RS, 12L-RS, RICS-9W-RS, RAB2-5-RS, 3S-RS. |
| - Digital Imaging & Reporting: Similar capability in performing measurements, capturing digital images, reviewing and reporting studies as predicate devices. | - The Voluson P6/P8 and predicate Voluson P6/P8 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. |
| - New Software Features (HDLive, Sono IT, SonoBiometry, Sono L&D): Same features cleared on predicate Voluson E Series (K132913). | - New software features added to Voluson P6/P8: HDLive, Sono IT, SonoBiometry and Sono L&D are the same features cleared on predicate Voluson E Series (K132913). |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document indicates that no clinical studies were required to support the substantial equivalence claim for the Voluson P6, Voluson P8. Therefore, there is no specific test set sample size and no data provenance (country of origin, retrospective/prospective) related to clinical performance testing for this submission. The evaluation was based on non-clinical tests and comparison to predicate device specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical studies were performed, there was no ground truth established by experts for a test set in the context of this 510(k) submission.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
As no clinical studies were performed, there was no adjudication method used for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No MRMC comparative effectiveness study was performed as indicated by the statement: "The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence." Therefore, no effect size of human readers improving with AI vs. without AI assistance is reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The submission does not describe a standalone algorithm performance study. The "new software features" (HDLive, Sono IT, SonoBiometry, Sono L&D) are stated as being "the same features cleared on predicate Voluson E Series (K132913)," implying their performance was already established, likely as part of the predicate device's clearance.
7. The Type of Ground Truth Used
For this 510(k) submission, the "ground truth" used for demonstrating substantial equivalence was effectively the established safety and performance of the predicate devices. The device's compliance was evaluated against established medical device safety standards and the known characteristics of the predicate systems. There was no de novo clinical ground truth establishment in this submission.
8. The Sample Size for the Training Set
Since no new AI algorithms requiring a training set are explicitly detailed as being newly developed and tested for this submission (rather, the new features are already cleared on a predicate), no training set sample size is mentioned.
9. How the Ground Truth for the Training Set Was Established
As no new training set is described, no information on how ground truth was established for a training set is provided. The substantial equivalence argument relies on the prior clearance of features on predicate devices.
Ask a specific question about this device
(36 days)
VOLUSON P6, VOLUSON P8
The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application / Anatomy/Region of Interest: Ophthalmic; Fetal / Obstetrics; Abdominal; Pediatric; Small Organ; Neonatal Cephalic; Adult Cephalic; Cardiac; Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Other.
Exam Type, Means of Access: Transesophageal; Transrectal; Transvaginal; Transuretheral; Intraoperative; Intraoperative Neurological; Intravascular; Laparoscopic.
The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronic-array transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 general-purpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.
The provided 510(k) summary for the GE Healthcare Voluson P6, Voluson P8 Ultrasound System states explicitly:
"The subject of this premarket submission, Voluson P6, Voluson P8, did not require clinical studies to support substantial equivalence."
Therefore, no acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study results are detailed in this document. The submission relies on non-clinical tests and substantial equivalence to predicate devices (K120741 Voluson S6, Voluson S8 Diagnostic Ultrasound System and K113758 Voluson E6E8E8ExpertE10) to demonstrate safety and effectiveness.
The document lists conformity to applicable medical device safety standards for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. It also mentions quality assurance measures during development, such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, and safety).
Therefore, I cannot provide the requested information regarding acceptance criteria and clinical study results as this device did not require clinical studies for its 510(k) submission.
Ask a specific question about this device
Page 1 of 1