Search Results

Indications For Use of GE LightSpeed™ ACT FP16 when configured as a CT System:

The GE LightSpeed™ ACT FP16 is indicated for head and whole body X-ray computed tomography applications.

Indications For Use of GE LightSpeed™ ACT FP16 when configured as a Fluoroscopic System: .

GE LightSpeed™ ACT FP16 is indicated for use in generating fluoroscopic images of SE Elghtopeda. nonedures, and optionally, rotational imaging procedures. It is intended to replace procedures, and optionally, rethnology image intensifier technology and is not intended for mammography applications.

The GE LightSpeed ACT FP16 is a modified CT system intended to be located in close proximity to a GE Innova 4100 Single Plane Digital Fluoroscopic Imaging system utilizing a single patient table which can be configured for interventional x-ray or CT imaging procedures. This modification allows the patient to remain on the x-ray table which can be quickly configured for CT scanning via a movable gantry. Both the CT and X-ray systems are used separately, one at a time, in accordance with their respective indications for use.

This submission describes a modification to an existing CT system (GE LightSpeed ACT FP16) and asserts its substantial equivalence to a predicate device (GE HiSpeed X/i Smart Gantry Option). The information provided largely focuses on demonstrating safety and effectiveness for a 510(k) clearance, which is typically achieved through non-clinical testing for modifications of this nature, rather than extensive clinical studies with specific performance metrics against a ground truth as would be common for novel AI/software devices.

Here's the breakdown of the requested information based on the provided text:

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

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable in the context of clinical studies with patient data. The evaluation was done using "bench testing and imaging phantoms". The number of phantoms used is not specified.
• Data Provenance: Not applicable, as no human subject data was used for testing. The testing involved hardware and phantom evaluations, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not explicitly stated as "experts for ground truth" in a clinical sense. However, the evaluation was performed by "employees of the manufacturer and by an independent test agency" for safety and conformance, and "test personnel familiar with clinical practice and procedures" for equipment movement, controls, and display.
• Qualifications of Experts: Employees of the manufacturer, independent test agency personnel, and test personnel familiar with clinical practice and procedures. Specific degrees or years of experience are not provided.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. The evaluation was primarily engineering and performance testing against specifications and safety standards, rather than diagnostic interpretation requiring adjudication of results from multiple readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Tests: None required." and focuses on non-clinical testing and substantial equivalence to a predicate device.

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

• Standalone Performance: Not applicable. This device is a CT system, not an AI algorithm. The performance evaluated was the physical system's functionality and image quality (via phantoms), which inherently operates as a "standalone" system in terms of generating images, but not in the context of an AI algorithm making diagnostic decisions.

7. The type of ground truth used

• Type of Ground Truth: For the non-clinical tests, the ground truth was defined by engineering specifications, applicable medical device safety standards, and the expected performance of physical equipment movements, user controls, and status displays. For imaging performance, imaging phantoms were used as a controlled and known standard for evaluation.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a hardware modification, not an AI/machine learning device that requires a training set of data.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Ask a specific question about this device

The GE LightSpeed RT16 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT16/ LightSpeed Xtra) is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated acquisitions for all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. Further the images can be post processed to produce additional imaging planes or analysis results.

The GE LightSpeed RT18 / LightSpeed Xtra V2 Computed Tomography System (aka GE LightSpeed RT18/ LightSpeed Xtra) is indicated for head, whole body, and vascular X-ray Computed Tomography applications.

The device output is a valuable medical tool for the diagnosis of disease, trauma, or abnormality and for planning, guiding, and monitoring therapy.

The system is capable of assisting with minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of Bariatrics patients, up to and including the morbidly obese population (BMI > 40).

When used in the LightSpeed RT16 configuration, the system can acquire CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.

The GE LightSpeed RT16 / LightSpeed Xtra V2 (aka LightSpeed RT16 /LightSpeed Xtra CT) CT Scanner System is composed of a gantry, patient table, operator console, power distribution unit (PDU), and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software, and associated accessories.

The system generates images through the computer reconstruction of data acquired at different angles and planes of the rotating gantry. The gantry can rotate at up to 0.5 seconds (at full) per rotation, and can acquire up to 16 slices of data per rotation with a maximum total coverage of 20mm in the axial direction. The system can be operated in Axial, Cine, Helical, Fluoro and Gated acquisition modes.

The GE LightSpeed RT16 / LightSpeed Xtra V2 CT Scanner System is designed to be a head and whole body CT scanner incorporating the same basic fundamental operating principles and similar Indications for Use. Materials and construction are equivalent to our existing marketed products, which are compliant with UL 60601-1, IEC 60601-1 and associated collateral and particular standards, and 21CFR Subchapter J.

This 510(k) summary describes a GE LightSpeed RT16 / LightSpeed Xtra V2 CT Scanner System. The submission focuses on substantial equivalence to a predicate device and safety considerations rather than demonstrating performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not present in the provided text.

Specifically:

• No detailed acceptance criteria with performance metrics are provided. The document outlines the device's technical specifications and intended use but does not list specific quantitative performance criteria (e.g., sensitivity, specificity, accuracy for a diagnostic task) that a study would then prove the device meets.
• No specific study is described that tests the device's diagnostic performance against established acceptance criteria. The document mentions "System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements" and "Adherence and certification to industry and international standards." However, these refer to engineering and regulatory compliance, not a clinical study demonstrating diagnostic effectiveness.

Therefore, the following points will indicate that the information is "Not Available in the provided text" where the document does not contain the answer.

1. Table of acceptance criteria and the reported device performance:

Explanation: The document does not specify quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or report specific performance metrics for the device against such criteria. It emphasizes substantial equivalence to a predicate device and compliance with safety and regulatory standards.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not Available in the provided text
• Data Provenance: Not Available in the provided text

Explanation: As no study demonstrating diagnostic performance is described, information on sample size and data provenance for a test set is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not Available in the provided text
• Qualifications of Experts: Not Available in the provided text

Explanation: Without a described study involving ground truth establishment, this information is not available.

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

• Adjudication Method: Not Available in the provided text

Explanation: This information is not available as no study involving expert adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC Study Done: No.
• Effect Size: Not Applicable.

Explanation: The document describes a CT scanner system, not an AI-powered diagnostic device or a system designed to assist human readers in a diagnostic task that would typically involve an MRMC study assessing AI assistance.

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

• Standalone Performance Study Done: No.

Explanation: This device is a CT scanner, an imaging modality, not an algorithm, so a standalone algorithm performance study is not applicable in the context described.

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

• Type of Ground Truth: Not Available in the provided text

Explanation: No study requiring the establishment of diagnostic ground truth is described.

8. The sample size for the training set:

• Sample Size: Not Available in the provided text

Explanation: As this is primarily a hardware submission for a CT scanner system, and not an AI/algorithm-focused submission, there is no mention of a training set.

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

• Ground Truth Establishment: Not Available in the provided text

Explanation: No training set is mentioned in the document.

Summary of the Document's Approach:

The 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (GE LightSpeed Xtra CT Scanner System K060052) and compliance with regulatory and safety standards for the manufacturing and operation of the CT scanner. It highlights:

• The new device is an "evolutionary modification" to an existing platform.
• It shares "virtually the same materials and identical operating principle" as the predicate.
• It has "similar indications for use."
• It complies with X-ray requirements (21CFR1020.30 and 1020.33) and safety standards (UL 60601-1, IEC 60601-1).
• Risk management and verification/validation ensure performance to specifications and user requirements.

This type of submission typically does not involve new clinical studies to establish diagnostic accuracy against specific human-interpretable acceptance criteria, but rather demonstrates that the updated device performs equivalently and safely to its predicate.

Ask a specific question about this device

Ask a specific question about this device

The two Digital Fluoroscopic Imaging Systems are indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. These devices are not intended for mammography applications. The Bolus Chasing option submitted here is intended to perform subtracted angiography in real time of the lower limbs for diagnostic purpose.

The new Bolus Chasing is offered as an option for Innova 4100 and 3100, already cleared under K033244 and K031637.

The provided text contains information about a 510(k) submission for a Digital Fluoroscopic Imaging System with an optional Bolus Chasing feature. However, it does not include specific details about acceptance criteria, a dedicated study proving performance against defined criteria, sample sizes for test or training sets, data provenance, expert qualifications, or adjudication methods for establishing ground truth.

The document focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing a detailed performance study against a set of acceptance criteria.

Therefore, many parts of your request cannot be answered from the provided text.

Here's what can be extracted based on the document:

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

• Acceptance Criteria: Not explicitly stated in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific quantifiable performance metrics.
• Reported Device Performance: Not explicitly stated as quantifiable performance metrics. The equivalence is based on the device's design, materials, and intended use being similar to the predicate.

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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 specific test set or ground truth establishment process is described in the context of a performance study.

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

• Not applicable.

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

• No MRMC study is mentioned. This device is an imaging system, not an AI-assisted diagnostic tool for interpretation by human readers.

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

• Not applicable. This is an imaging system, not an algorithm being evaluated in a standalone capacity. The "Bolus Chasing option" is a feature of the imaging system itself, controlling image acquisition.

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

• Not applicable as no specific performance study with ground truth is described. The basis for approval is substantial equivalence to a predicate device for its intended use.

8. The sample size for the training set

• Not applicable. This document describes a medical device, not a machine learning algorithm that requires a training set.

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

• Not applicable.

Summary of available information regarding the "study" (equivalence demonstration):

The "study" presented here is a Substantial Equivalence (SE) demonstration for the GE Healthcare Innova 4100 and Innova 3100 (with the new Bolus Chasing option).

• Predicate Device: GE Advantx LCV+ Bolus Chasing (K960575)
• Basis of Equivalence: Comparison table and product data sheets (details not provided in the text). The opinion is based on technical and functional similarity to the predicate device.
• Risk Management: The manufacturer states that potential hazards related to the new Bolus Chasing option are controlled by a risk management plan, including:
  • Hazard identification
  • Risk evaluation
  • Software Development and Validation Process
• Testing: Materials are compliant with UL 2601 and IEC 60601-1 standards. Design controls prevent useless X-ray/contrast agent exposure during a Bolus Chasing sequence in case of failure. This implies some form of engineering testing and verification, but not a clinical performance study as typically understood for diagnostic accuracy.

In essence, the document serves as a 510(k) summary demonstrating that the new device is as safe and effective as a previously cleared device, rather than providing a new clinical performance study with defined acceptance criteria.

Ask a specific question about this device

Senographe Stereo is an optional accessory for the Senographe DS full field digital system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from steroetactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices).

Senographe Stereo is an option of Senographe DS composed of the following elements:

• A stereotactic positioner .
• Display and stereo positioning software of the Senographe DS .
• A lateral arm for the lateral approach procedures .
• A vertical adapter for vertical approach procedures using a vacuum assisted . device

The Senographe Stereo is an optional accessory for the Senographe DS full field digital system, designed to accurately locate breast lesions in three dimensions using stereotactic pairs of 2D images. It provides guidance for interventional purposes like biopsy and presurgical localization.

1. Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state numerical acceptance criteria with corresponding reported device performance values. It mentions that "Three kinds of tests have been performed to verify the Senographe Stereo: Functional test, Application accuracy test, IQ Stereo test results." and that "These tests prove the safety and effectiveness of Senographe Stereo." However, the specific metrics or thresholds used for acceptance are not detailed.

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

The document does not specify the sample size used for the test sets (Functional test, Application accuracy test, IQ Stereo test results) nor the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any of the mentioned tests.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method used for the test set.

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

The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human reader improvement with AI assistance. The device is a stereotactic localization system, not an AI-powered diagnostic tool in the sense of image interpretation assistance.

6. Standalone Performance Study:

The information primarily describes the device's functional and accuracy tests, which inherently measure the standalone performance of the algorithm and system in a technical sense (e.g., coordinates calculation, needle positioning). However, it does not explicitly label a study as a "standalone performance study" with specific diagnostic metrics (e.g., sensitivity, specificity) against a human interpreter.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for the mentioned tests. For an "Application accuracy test" and "IQ Stereo test results," it's highly likely that a phantom with known, precisely defined target locations would be used as ground truth for evaluating the system's ability to accurately determine X, Y, and Z coordinates. Functional tests would likely involve verifying proper operation of mechanical and software components.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. This type of device (stereotactic localization) relies on geometric principles and precise engineering, rather than machine learning models that require extensive training data.

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

As no training set is mentioned or implied for this type of device, there is no information on how its ground truth might have been established.

Ask a specific question about this device

The Digital Fluoroscopic Imaging System is indicated for use in diagnostic and interventional angiographic procedures of human anatomy. It is intended to replace image intensifier fluoroscopic systems in all diagnostic or interventionnal procedures. This device is not intended for mammography applications.

The new tilt table will support performing procedures like CO2 studies. Venography.

The new tilt table is offered as an option for Innova 4100, in place of the existing Omega V table, which is part of the Innova 4100 system already cleared under K023178.

The provided text describes a 510(k) summary for the GE Medical Systems Innova 4100 Digital Fluoroscopic Imaging System with an optional Tilt Table. It focuses on establishing substantial equivalence to a predicate device based on product characteristics and safety information, rather than performance against specific acceptance criteria derived from a clinical or technical study for the new tilt table option itself.

Therefore, many of the requested elements regarding acceptance criteria, device performance, and study details are not present in this document. The submission is primarily a declaration of equivalence based on design and safety standards.

Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The submission for K033244 is a 510(k) for a modification (new tilt table option) to an already cleared device (Innova 4100). The basis for clearance is substantial equivalence to a predicate device (Siemens Axiom Artis, K021021), not a performance study against specific acceptance criteria for the tilt table's diagnostic performance. The document states:

"The GE Medical System's Innova 4100, with a new Tilt table option for patient positioning, for diagnostic fluoroscopic imaging is substantially equivalent to Siemens Axiom Artis (K021021). This opinion is based on the information contained in the comparison table (Attachment 3), and the product data sheets (Attachment 4 & 5)."

This implies a comparison of specifications and features, not a clinical performance study with predefined acceptance criteria for the new option.

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

This information is not provided. As no such performance study is described, there is no test set, sample size, or data provenance.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not provided. As no such performance study is described, there's no ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided. As no such performance study is described, there's no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

This information is not provided. The document does not describe any MRMC study or any study comparing human readers with and without AI assistance. This device is a digital fluoroscopic imaging system, not an AI-powered diagnostic tool.

6. If a Standalone Performance Study Was Done

This information is not provided. No standalone performance study (algorithm only) is described, as the submission focuses on hardware equivalence and safety for a new option.

7. The Type of Ground Truth Used

This information is not provided. No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as there's no performance study described for the new tilt table option.

8. The Sample Size for the Training Set

This information is not provided. This document does not describe any machine learning or AI component requiring a training set.

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

This information is not provided. This document does not describe any machine learning or AI component for which ground truth would be established for a training set.

Ask a specific question about this device

The GE 1.5T 8 Channel Torso Coil is intended to be used in the abdomen, pelvis and chest regions for 2D and 3D Magnetic Resonance imaging and Parallel body imaging.

The GE 1.5T 8 Channel Torso Coil is a 12 element coil with integrated preamplifiers that provides optimized geometry for parallel imaging. The coil is designed to provide imaging of the abdomen, pelvis and chest regions. The device utilizes technology similar to the GE 8 Channel Cardiac Phased Array Coil (K022669), but is designed to image the torso, similar to the GE 3.0T Torso Phased Array Coil (K030495).

The provided text describes a 510(k) summary for a medical device, specifically the GE 1.5T 8 Channel Torso Coil. However, it does not contain the detailed information required to answer your prompt about acceptance criteria and a study proving the device meets those criteria for software or AI-driven systems.

This document is for a magnetic resonance coil, which is a hardware component, not a software or AI device. The "Summary of Studies" section only states: "Testing was performed to demonstrate that the design of the 1.5T 8 Channel Torso Coil meet predetermined acceptance criteria." It does not provide any specifics about:

• The acceptance criteria themselves.
• The reported device performance against those criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC/standalone study details.

These types of details are typically found in regulatory submissions for AI/ML-driven devices, which involve performance metrics like sensitivity, specificity, AUC, and their validation against clinical ground truth.

Therefore, based on the provided text, I cannot complete the table or answer the specific questions posed, as the information is not present for this type of device submission.

Below is a general template of how such an answer would be structured if the necessary information were available in the document:

1. Table of Acceptance Criteria and the Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: [Number of cases/patients]
• Data Provenance: [e.g., Retrospective or Prospective, Country(ies) of origin, e.g., "Multi-site retrospective study across 3 hospitals in the US and Germany."]

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: [e.g., 3]
• Qualifications of Experts: [e.g., "Board-certified radiologists, each with 10+ years of experience in abdominal imaging."]

4. Adjudication method for the test set:

• [e.g., "2+1 adjudication method: Initial consensus by two experts; in cases of disagreement, a third senior expert provided a final decision."]

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:

• [e.g., "Yes, a prospective MRMC study was conducted. Readers demonstrated a significant improvement in diagnostic accuracy (e.g., 15% increase in AUC) when using the AI-assisted workflow compared to reading without AI assistance."] (If not done, state "Not explicitly mentioned" or "No.")

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

• [e.g., "Yes, a standalone performance evaluation was conducted using the test set described above."] (If not done, state "Not explicitly mentioned" or "No.")

7. The type of ground truth used:

• [e.g., "Histopathological confirmation (biopsy results) as the gold standard." or "Expert consensus derived from a panel of radiologists reviewing all available clinical and imaging data." or "Long-term patient outcomes data."]

8. The sample size for the training set:

• [Number of cases/patients]

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

• [e.g., "Similar to the test set, ground truth for the training set was established via expert consensus by a separate panel of board-certified radiologists." or "Leveraged existing annotated datasets from public repositories combined with internal expert labeling."]

Ask a specific question about this device

CT Colonography is a CT image analysis software package which allows the visualization of 2D and 3D medical image data of the colon derived from DICOM 3.0 compliant CT scans for the purpose of screening of a colon to detect polyps, masses, cancers, and other lesions. It provides functionality for 2D/3D rendering, bookmarking of suspected lesions, synchronized viewing of supine & prone data sets, and an object oriented endoluminal display. In comparison to colonoscopy, this tool has an advantage of depth penetration due its 3D presentation capability. It is intended for use by Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print, and distribute colon image studies.

CT Colonography is an image analysis software package that includes all the required software that allows the user to study the inside, wall, and outside of the colon using CT-acquired helical images. The tool is laid out to facilitate the detection of colonic lesions. CT Colonography is an advanced visualization software option that provides endoluminal views of anatomical structures. The flexibility of this software allows the user to move interactively from air paths to inner vessels visualization and thus, it is not limited to inner navigation of structures as lungs and sinuses. Volume Analysis (includes both. CT/MR Windows Workstation, K913770 and 3D & Dentascan for Windows K923077) provides the base for Colonography, CTC/Nav2 and Nav2 alone, which allows an increase in the ease of use and productivity. Colonography, CTC/Nav2 and Nav2 alone, also use some options of Volume Rendering (AW Volume Render Option K972399), which allows the user to quickly isolate structure of interest and render volumetric data in three dimensions.

The provided text does not contain detailed information about specific acceptance criteria or a dedicated study proving that the device meets those criteria. Instead, it focuses on establishing substantial equivalence to previously cleared devices.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or provide a table of reported device performance metrics against such criteria. The "Conclusions" section in {1} states: "The CT Colonography option (K023943) does not result in any new potential safety risks and performs as well as devices currently on the market." This suggests that the performance standard is to be equivalent to the predicate devices, rather than meeting specific numerical thresholds.

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

The document does not mention a specific test set, its sample size, or its data provenance (e.g., country of origin, retrospective or prospective nature). The safety and effectiveness claim is based on substantial equivalence to predicate devices, implying that their established performance is sufficient.

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

This information is not provided. Since no specific test set or study validating device performance is described, the process of establishing ground truth for such a set is not detailed.

4. Adjudication Method for the Test Set:

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

The document does not indicate that an MRMC comparative effectiveness study was conducted. The focus is on demonstrating that the CT Colonography software provides similar functionality and safety as the predicate devices.

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

The document does not explicitly state whether a standalone algorithm performance study was done. The device is described as an "image analysis software package" intended for "Radiologists, Clinicians, and referring Physicians to process, render, review, archive, print, and distribute colon image studies," implying it is used with human interaction, not as a standalone diagnostic tool.

7. The Type of Ground Truth Used:

The document does not specify the type of ground truth used for any performance evaluation, as no such evaluation is detailed. Given the nature of CT Colonography for lesion detection, a typical ground truth would likely involve colonoscopy with biopsy/histopathology or surgical pathology.

8. The Sample Size for the Training Set:

The document does not mention a training set or its sample size.

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

This information is not provided, as no training set is discussed.

Summary of Device Acceptance Rationale:

The core of the acceptance for the "CT Colonography" (K023943) device is its substantial equivalence to two predicate devices:

• CT Colonography/Navigator2 (K012313)
• V3D-Colon (K020658)

The manufacturer, GE Medical Systems, asserts that their CT Colonography option "does not result in any new potential safety risks and performs as well as devices currently on the market." This suggests that the acceptance criteria are met by demonstrating that the new device shares fundamental technological characteristics, intended use, and performance characteristics (as understood from the predicate devices) without raising new questions of safety and effectiveness. The "Conclusions" section acts as the primary statement on how the device meets "acceptance criteria" by equating its performance to already cleared devices.

The FDA's clearance letter (pages {2} and {3}) confirms this approach, stating they "have determined the device is substantially equivalent... to legally marketed predicate devices." This regulatory pathway does not typically require extensive new clinical studies to prove performance against novel acceptance criteria, but rather a demonstration of similarity to existing safe and effective devices.

Ask a specific question about this device

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: 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); Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

The GE LOGIQ 9 is a full featured general purpose diagnostic ultrasound system. It consists of a mobile console approximately 64 cm wide, 90 cm deep and 140-160 cm (adjustable) high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT and LCD display. This modification will provide users with additional probe options, improved user interface and image enhancement.

The GE LOGIQ 9 Diagnostic Ultrasound System (K030934) is a general-purpose ultrasound system. The provided document does not contain acceptance criteria or a study proving the device meets said criteria. Instead, it is a 510(k) premarket notification for a predicate device.

The document indicates that no clinical tests were required for this submission. The basis for clearance is substantial equivalence to a previously cleared device (GE LOGIQ 9 K011188). This means the device is considered safe and effective because its technological characteristics, safety features, physical design, construction, intended uses, and basic operating modes are comparable to a device already on the market.

Therefore, the following information outlines the lack of specific acceptance criteria or a dedicated study within this document, as per the 510(k) process for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Rationale: The 510(k) submission for the GE LOGIQ 9 BT03 is based on substantial equivalence to an already marketed device (GE LOGIQ 9, K011188) and not on meeting specific, pre-defined performance acceptance criteria through a clinical study. The submission states, "The GE LOGIQ 9 BT03 is of a comparable type and substantially equivalent to the current GE LOGIQ 9. It has the same technological characteristics, key safety and effectiveness features, physical design, construction, and has the same intended uses and basic operating modes as the predicate device."

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

• Sample Size: Not applicable. No dedicated clinical test set was used for this submission.
• Data Provenance: Not applicable. No clinical data was generated for this specific submission to prove effectiveness. The claim is based on the known performance and safety of the predicate device and the general understanding of diagnostic ultrasound.

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

• Number of Experts: Not applicable. No clinical test set requiring expert ground truth was established for this submission.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No clinical test set was used.

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

• MRMC Study Done: No.
• Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable, as this is an ultrasound system and not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation in this context.

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

• Standalone Study Done: No. This is not an algorithm-only device. Its performance is intrinsically tied to human operation and interpretation.

7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• Type of Ground Truth: Not applicable. The submission relies on the established safety and effectiveness of the predicate device and scientific literature regarding diagnostic ultrasound in general. The document explicitly states: "Diagnostic ultrasound has accumulated a long history of safe and effective performance."

8. Sample Size for the Training Set:

• Sample Size: Not applicable. As this device is not an AI/ML algorithm requiring a training set, this information is irrelevant.

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

• Ground Truth Establishment: Not applicable. No training set was used.

Summary of the Study (or lack thereof) that Proves the Device Meets Acceptance Criteria:

The GE LOGIQ 9 BT03 Diagnostic Ultrasound System's acceptance for marketing clearance (K030934) by the FDA was based on a premarket notification (510(k)) asserting substantial equivalence to a predicate device (GE LOGIQ 9, K011188).

The submission explicitly states: "Clinical Tests: None required."

The manufacturer, GE Medical Systems, argued that the GE LOGIQ 9 BT03 is substantially equivalent to the current GE LOGIQ 9 because it has:

• The same technological characteristics.
• The same key safety and effectiveness features.
• The same physical design and construction.
• The same intended uses and basic operating modes.

In lieu of specific clinical performance data, the submission emphasizes that:

• The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety, conforming to applicable medical device safety standards.
• Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines.
• The manufacturer's design and development process conforms with 21 CFR 820, ISO 9001:2000, and ISO 13485 quality systems.
• Diagnostic ultrasound, as a modality, has a long history of safe and effective performance.

Therefore, the "study" that proves this device meets "acceptance criteria" (in the context of a 510(k)) is the demonstration of its substantial equivalence to a legally marketed predicate device, rather than a clinical trial with specific performance endpoints. The FDA's clearance indicates their agreement that the new device does not raise new questions of safety or effectiveness compared to the predicate.

Ask a specific question about this device

The GE 3.0T General Purpose Flex Coil is designed to facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh. The GE 3.0T General Purpose Flex Coil will facilitate dynamic MR imaging of the joints of lower extremity (Knee and Ankle). This coil consists of two 5" x 6.5" surface coils coupled as a Helmholtz pair in a flexible package that can be wrapped around the anatomy of interest. This flexibility allows for the coil to be applied to a wider range of patients when compared to a similar coil in a rigid package. The coil is an option to the GE Signa® 3.0T whole body MR System.

The GE 3.0T General Purpose Flex Coil is a modification of the existing 1.5T GP Flex Coil (K923264), to increase the field strength from 1.5T to 3.0T. In addition, two passive blocking networks are added to improve reliability and patient safety.

This GE 3.0T General Purpose Flex Coil is a magnetic resonance coil, not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or ground truth establishment relevant to AI/ML device evaluation. Instead, the document discusses the substantial equivalence of the new 3.0T coil to an existing 1.5T coil.

Here's an analysis of what is provided and why the requested information is absent:

The document states: "Testing was performed to demonstrate that the design modifications to the 1.5T general Purpose Flex coil meet predetermined acceptance criteria." However, it does not detail what those "predetermined acceptance criteria" were or the specific results of that testing quantitatively.

The core of this submission is a claim of substantial equivalence to an existing cleared device (GE Medical Systems 1.5T GP Flex coil M1085GP (K923264)). This means the device is being marketed as essentially the same in terms of safety and effectiveness as a predicate device, rather than a novel device requiring extensive performance studies as would be the case for many AI/ML technologies.

Therefore, I cannot populate the requested table or answer most of the questions as they pertain to the evaluation of an AI/ML diagnostic device, which this product is not.

However, I can provide what information is available based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This is not an AI/ML device study, so the concept of a "test set" and "data provenance" in this context is not applicable. The "testing" mentioned would likely involve engineering verification and validation (e.g., electrical safety, mechanical integrity, SAR compliance, image quality comparisons) rather than clinical performance on a dataset of patients.

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 this is not an AI/ML diagnostic device.

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

• Not applicable.

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; this is a medical device (MR coil), not an AI/ML software.

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

• Not applicable; this is a hardware device.

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

• Not applicable. For a device like this, "ground truth" would relate to its physical and functional specifications (e.g., signal-to-noise ratio, uniformity, SAR values) compared to engineering design requirements and the performance of the predicate device.

8. The sample size for the training set:

• Not applicable; this is a hardware device, not an AI/ML algorithm.

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

• Not applicable.

Summary of available information from the document:

• Device Type: Magnetic Resonance Coil (hardware)
• Purpose: To facilitate MR imaging of the Brachial Plexus, Unilateral Hip and Thigh, and dynamic MR imaging of the joints of the lower extremity (Knee and Ankle) at 3.0T field strength.
• Key Modification: Retuning from 1.5T to 3.0T and addition of two passive blocking networks for reliability and patient safety.
• Justification for Market: Substantial equivalence to an existing 1.5T GP Flex Coil (K923264).
• Type of Study Performed: "Testing was performed to demonstrate that the design modifications to the 1.5T general Purpose Flex coil meet predetermined acceptance criteria." (Specific criteria and results are not detailed in this summary).
• Conclusion: The device is substantially equivalent, and its usage "does not result in any new potential hazards."

Ask a specific question about this device