Search Results

The Site~Rite® 6 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.

Pinpoint™ GT Technology is intended to provide clinicians with visual tools for passive magnetic tracking of a needle with respect to ultrasound image data.

mode ultrasonic pulsed echo imaging system designed primarily to assist physicians in gaining vascular access to major veins and arteries. The SiteRite® 6 Ultrasound System is portable and therefore easy to use at the bedside and in a variety of clinical scenarios, including intensive care units, emergency rooms, operating rooms, angiography suites, catheterization laboratories, etc. In addition, the SiteRite® 6 Ultrasound System is designed with simple operating controls to facilitate easy operation.

The Pinpoint™ GT Technology is designed to track and display the location and trajectory of a needle under ultrasound guidance. The technology consists of software installed on an ultrasound system and sensors incorporated into the ultrasound probe. The sensors detect a passive magnetic field emitted from a needle. The software interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display, providing clinicians with a visual representation of the needle throughout the insertion process.

This document is a 510(k) summary for the Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology, indicating its substantial equivalence to predicate devices for ultrasound guidance and imaging.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several standards that the device met. It does not provide specific numerical acceptance criteria or performance metrics for the Pinpoint™ GT Technology itself beyond confirming it met "predetermined performance requirements." The listed standards are primarily for general medical electrical equipment, usability, software, and biological evaluation, rather than specific performance metrics for the needle tracking feature.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions that "Verification and validation activities were designed and performed to demonstrate that the subject Site~Rite® 6 Ultrasound System with Pinpoint™ GT Technology met predetermined performance requirements." However, specific sample sizes for any test sets used to evaluate the Pinpoint™ GT Technology are not provided.

The data provenance (e.g., country of origin of the data, retrospective or prospective) is also not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and their Qualifications:

This information is not provided in the document. The filing discusses engineering standards rather than clinical trial data involving expert interpretations for ground truth.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on showing substantial equivalence through adherence to technical standards and comparison to predicate devices, rather than measuring human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

The document describes the Pinpoint™ GT Technology as "software installed on an ultrasound system and sensors incorporated into the ultrasound probe" that "interprets the data from the sensors and creates a virtual image of the needle on the ultrasound display." This implies that the technology functions as an algorithm providing visual tools for tracking. However, a specific standalone performance study comparing the algorithm's output against a defined ground truth for the needle tracking functionality is not explicitly detailed with performance metrics. The evaluation appears to be integrated into the overall system's verification and validation.

7. Type of Ground Truth Used:

Given the nature of the evaluation mentioned (adherence to technical standards and comparison to predicate devices for imaging features and needle tracking visualization), the "ground truth" would likely involve physical measurements and phantom studies for accuracy and precision of needle tracking and imaging quality, rather than expert consensus on diagnostic interpretations, pathology, or outcomes data in a clinical setting. However, the specific methods for establishing ground truth for the Pinpoint™ GT Technology's performance are not explicitly stated beyond meeting technical requirements.

8. Sample Size for the Training Set:

This document is a 510(k) summary for a medical device (ultrasound system with a needle tracking technology). The listed studies are for verification and validation, primarily addressing compliance with electrical, safety, usability, and software standards. There is no mention of a training set in the context of machine learning, as this document predates broad discussions of AI/ML in FDA filings in this manner. The "technology" refers to creating a virtual image from sensor data, which is more likely a deterministic algorithm than a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a training set for the reasons stated above, this information is not applicable and therefore not provided in the document.

Ask a specific question about this device

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

The GE LOGIQ E9 Diagnostic Ultrasound System is a full-featured, general-purpose diagnostic ultrasound system. It consists of a mobile console and provides digital acquisition, processing, and display capabilities. The user interface includes a computer keyboard, specialized controls, a 10-inch LCD touch screen, and a 19-inch LCD image display.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or numerical performance metrics for the LOGIQ E9 system's image quality or diagnostic accuracy. Instead, the "acceptance criteria" are implied through the statement of substantial equivalence to its predicate device(s).

The reported device performance is that it is considered "as safe, as effective, and performance is substantially equivalent to the predicate device(s)."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence."

Therefore, there is no test set of clinical data from human subjects mentioned in this 510(k) summary. The evaluation focused on non-clinical tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Since no clinical studies were performed on a test set, no experts were used to establish ground truth for a test set in the context of clinical performance evaluation. The evaluation was primarily engineering and performance testing against standards and the predicate device.

4. Adjudication Method for the Test Set

As no clinical test set was utilized, there was no adjudication method described for clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission explicitly states no clinical studies were required.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

Since the LOGIQ E9 is a diagnostic ultrasound system and not an AI-powered algorithm for image interpretation, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI/ML devices is not directly applicable.

The "performance" evaluation for this device was based on engineering verification and validation, demonstrating that the system's technical specifications and imaging capabilities were comparable to its predicate devices, rather than a standalone AI performance study.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by:

• Engineering specifications and test standards: For acoustic output, thermal, electrical, electromagnetic, and mechanical safety.
• Biocompatibility testing results: Conformance to established biocompatibility protocols.
• Cleaning and disinfection effectiveness testing results: Verification against established protocols.
• Comparison to predicate device's established performance: The predicate device serves as a benchmark for "substantial equivalence."

No pathology, expert consensus on images, or outcomes data were used as ground truth for clinical performance, as clinical studies were not performed.

8. Sample Size for the Training Set

The LOGIQ E9 is a traditional diagnostic ultrasound system, not an AI/ML device that requires a "training set" of data in the same way. Therefore, there is no mention of a training set sample size.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of an AI/ML training set, this question is not applicable to this 510(k) submission.

Summary of Device Evaluation Approach:

The GE LOGIQ E9 Diagnostic Ultrasound System received 510(k) clearance based on its substantial equivalence to previously cleared predicate devices (K092271 GE LOGIQ E9 Diagnostic Ultrasound System and K052441 GE LOGIQ 7 Diagnostic Ultrasound System). This determination was made primarily through non-clinical tests and verification activities, rather than clinical studies. The non-clinical tests included evaluations for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and various safety aspects (thermal, electrical, electromagnetic, mechanical). The device also underwent a series of internal quality assurance measures such as risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, performance, safety, and final acceptance). The core argument for substantial equivalence rested on the device employing the "same fundamental scientific technology as its predicate device(s)" and conforming to applicable safety standards and voluntary standards.

Ask a specific question about this device

The device is a general purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular: Transvaginal; Transrectal; and Intraoperative (abdominal, PV and neurological).

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Anatomy/Region of Interest: Fetal / Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transrectal, Transvaginal, Intraoperative, Intraoperative Neurological.

The Voluson E6/E8/E8Expert BT10 system is a full-featured Track 3 ultrasound system, primarily for general radiology use and specialized for OB/GYN with particular features for realtime 3D/4D acquisition. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability. It utilizes a variety of linear, curved linear, matrix phased array transducers including mechanical scanning transducers, which provide highly accurate realtime three dimensional imaging supporting all standard acquisition modes.

The provided 510(k) summary for the GE Healthcare Voluson E6/E8/E8 Expert Diagnostic Ultrasound System (K101236) indicates that no clinical studies were required to support substantial equivalence (page 3). Therefore, there is no specific study data or acceptance criteria related to device performance in a clinical setting provided in this document.

The document focuses on the device being substantially equivalent to a predicate device (K061682 Voluson E8 Diagnostic Ultrasound System) and outlines non-clinical tests to ensure safety and performance based on applicable medical device safety standards.

Here's a breakdown of the requested information based on the provided text, heavily inferring where no direct information is given due to the lack of clinical studies:

1. A table of acceptance criteria and the reported device performance

Since no clinical studies were performed, there are no specific performance metrics (like sensitivity, specificity, accuracy) provided in a table for clinical acceptance criteria. The acceptance criteria implied for this submission are related to safety and equivalent performance to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable, as no clinical studies were conducted for this 510(k) submission. Non-clinical tests were performed on the device itself.
• Data Provenance: Not applicable for clinical studies. For non-clinical tests, the provenance would be internal GE Healthcare testing.

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)

• Number of Experts & Qualifications: Not applicable, as no clinical studies requiring expert ground truth were conducted for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable, as no clinical studies were conducted for this 510(k) submission.

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

• MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not performed. The device is a general-purpose diagnostic ultrasound system and not an AI-assisted diagnostic tool as described in these types of studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance Study: Not applicable in the context of an AI algorithm, as this device is a general-purpose ultrasound system. The non-clinical tests evaluate the system's inherent performance and safety.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable for clinical ground truth. For the non-clinical tests, the "ground truth" would be established by engineering specifications, regulatory standards, and validated testing protocols.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable, as this device is a diagnostic ultrasound system, not an AI or machine learning model that undergoes a training phase with a specific dataset.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: Not applicable, as this device is a diagnostic ultrasound system, not an AI or machine learning model that undergoes a training phase with a specific dataset.

In summary, the K101236 submission is for a general-purpose ultrasound system (Voluson E6/E8/E8 Expert) and relies on demonstrating substantial equivalence to a previously cleared predicate device (K061682 Voluson E8). This type of submission typically focuses on non-clinical performance and safety data, rather than new clinical studies with AI-specific performance metrics.

Ask a specific question about this device

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

The GE Vivid E9 Diagnostic Ultrasound is a full-featured echocardiography imaging and analysis system with additional capability in vascular and general ultrasound imaging. It consists of a mobile console with multiple electronic array transducers that provide digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high-resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users.

The provided document is a 510(k) Premarket Notification for the GE Vivid E9 BT10 Ultrasound System. It is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, it does not detail specific acceptance criteria or performance studies in the way a clinical trial report for an AI device might. Instead, it relies on established safety and effectiveness for diagnostic ultrasound systems and the equivalence to predicate devices.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance studies, ground truth establishment for training and test sets, and effect sizes of AI assistance are generally not applicable or not provided in this type of regulatory document for an ultrasound system.

However, I can extract the relevant information regarding safety and equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of explicit performance-based acceptance criteria for a new AI feature or image analysis algorithm, nor does it present detailed quantitative performance metrics for the device. The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device and adherence to general safety standards.

The reported device performance is primarily framed as improved performance and productivity compared to the predicate device, especially regarding new transducers and software features comparable to other cleared GE ultrasound systems.

Key statements on performance:

• "This modification offers improved performance and productivity for users." (Section a): Device Description)
• "The GE Vivid E9 BT10 is of a comparable type and substantially equivalent to the current GE Vivid E9 with enhanced performance and added transducers..." (Section a): Comparison with Predicate Device)

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable / Not provided. This 510(k) submission does not describe a clinical test set or data provenance for evaluating a new algorithm's performance. The review focuses on the device as a whole and its equivalence to predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable / Not provided. Ground truth establishment for a specific AI algorithm's performance is not part of this type of submission for a general diagnostic ultrasound system.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

• Not applicable / Not provided. This document does not describe an MRMC study or AI assistance. The device is a diagnostic ultrasound system, not an AI-powered image analysis tool in the sense of comparing human readers with and without AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable / Not provided. This relates to an AI algorithm's performance, which is not the focus of this submission.

7. The Type of Ground Truth Used:

• Not applicable / Not provided.

8. The Sample Size for the Training Set:

• Not applicable / Not provided.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable / Not provided.

Summary of the Study that Proves the Device Meets "Acceptance Criteria" (Substantial Equivalence):

The "study" demonstrating the device meets its "acceptance criteria" (which, in this context, means showing substantial equivalence for regulatory clearance) is summarized in Section b: Non-clinical Tests and Clinical Tests.

• Non-clinical Tests:

  • The device was evaluated for:
    • Acoustic output
    • Biocompatibility
    • Cleaning and disinfection effectiveness
    • Electromagnetic compatibility
    • Thermal, electrical, and mechanical safety
  • It was found to conform with applicable and harmonized medical device safety standards.

• Clinical Tests:

  • "None required." This indicates that for this type of device modification and the established predicate, new clinical trials to demonstrate safety and effectiveness were not deemed necessary by the manufacturer or the FDA (as per the clearance letter). The long history of safe and effective performance of diagnostic ultrasound, combined with the substantial equivalence argument, negated the need for new clinical data.

• Conclusion:

  • The manufacturer stated that intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination.
  • The design and development process conforms with 21 CFR 820, ISO 9001:2008, and ISO13485:2003 quality systems.
  • Compliance with applicable medical device safety standards is verified through 3rd party product certifications and regular production monitoring.
  • GE Healthcare's opinion is that the device is substantially equivalent in safety and effectiveness to devices already cleared for market.

The FDA's decision letter (starting on page 3 of the document) confirms that they reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices, subject to general controls. This means the FDA agreed with GE Healthcare's assessment that the non-clinical tests and the comparison to predicate devices were sufficient to support clearance without a new clinical study.

Ask a specific question about this device

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal; Abdominal (renal & GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neuro).

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 provided 510(k) summary for the GE Healthcare LOGIQ P5 BT11 Ultrasound System (K101878) does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

This document is a premarket notification for a new device, asserting substantial equivalence to previously cleared predicate devices. The focus of this type of submission is to demonstrate that the new device is as safe and effective as existing legally marketed devices, rather than proving performance against specific acceptance criteria through a clinical validation study.

Here's a breakdown of why the requested information is not present and what the document does provide:

Key Takeaways from the Document:

• Substantial Equivalence: The primary assertion is that the LOGIQ P5 BT11 employs the "same fundamental scientific technology as its predicate devices" (K060993 LOGIQ P5/A5 Ultrasound System and K092271 LOGIQ E9 Ultrasound System). This is the basis for its clearance, not individual performance metrics against acceptance criteria.
• No Clinical Studies Required: The document explicitly states: "The subject of this premarket submission, LOGIQ P5, did not require clinical studies to support substantial equivalence." This means there would be no data from a clinical trial to report for acceptance criteria.
• Non-Clinical Tests: The device underwent non-clinical tests for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety, and conformity with applicable medical device safety standards. These are safety and performance standards, but not typically reported as specific acceptance criteria with performance data in this type of summary.
• Quality Assurance Measures: The document lists general quality assurance measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing, safety testing). These are internal processes to ensure quality, not external validation studies with specific performance metrics.
• Indications for Use: The document clearly outlines the intended uses and clinical applications for the system and its various transducers (e.g., Fetal, Abdominal, Cardiac, Peripheral Vascular). This defines the scope of the device but doesn't quantify its performance within those applications.

Addressing the Specific Questions (based on the provided document):

1. A table of acceptance criteria and the reported device performance:

   • N/A. This document does not specify quantitative acceptance criteria or report device performance against such criteria. The "performance" is implicitly deemed equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. No clinical test set or data provenance is mentioned as no clinical studies were required.

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):

   • N/A. No ground truth establishment for a test set is discussed as no clinical studies were performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. No test set or adjudication method is 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:

   • N/A. This document predates widespread AI in medical devices and is for an ultrasound system, not an AI-powered diagnostic tool. No MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is a hardware-based ultrasound system, not an algorithm. Standalone performance as typically understood for AI algorithms is not applicable here.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • N/A. No ground truth is discussed as no clinical studies were performed.

8. The sample size for the training set:

   • N/A. This is not an AI/machine learning device, so there is no concept of a "training set" in the context it's usually used for such applications.

9. How the ground truth for the training set was established:

   • N/A. Not applicable, as it's not an AI/machine learning device.

In summary, this 510(k) submission primarily focuses on demonstrating that the LOGIQ P5 BT11 Ultrasound System is substantially equivalent to existing, legally marketed predicate devices, thereby not requiring new clinical performance studies or the establishment of new acceptance criteria for efficacy.

Ask a specific question about this device