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510(k) Data Aggregation
(43 days)
The PercuNav system is a stereotaxic accessory for computed tomography (CT), magnetic resonance (MR), ultrasound (US), and positron emission tomography (PET). CT, Ultrasound, PET, and MR may be fused in various combinations, such as CT with MR, MR with ultrasound, and so on. It may include instrumentation to display the simulated image of a tracked insertion tool such as a biopsy needle or probe on a computer monitor screen that shows images of the target organs and the current and the projected future path of the interventional instrument. The PercuNav system is intended for treatment planning and guidance for clinical, interventional, or diagnostic procedures. The PercuNav system also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.
The PercuNav system is intended to be used in interventional and diagnostic procedures in a clinical setting. The PercuNav system is also intended for use in clinical interventions to determine the proximity of one device relative to another.
Example procedures include, but are not limited to, the following:
- · Image fusion for diagnostic clinical examinations and procedures
- · Soft tissue biopsies (liver, lung, kidney, breast, pancreas, bladder, adrenal glands, lymph node, mesentery, and so on.)
- · Soft tissue ablation (liver, kidney, breast, pancreas, lung, and so on)
- Bone ablations
- Bone biopsies
- · Nerve blocks and pain management
- Drainage placements
- Tumor resections
The proposed PercuNav provides image-guided diagnostic and intervention that enables fusion of diagnostic images and guidance of tracked instruments to physician-defined targets. The target can be indicated either pre-procedurally or intra-procedurally, either using images or relative to an indicated position on the patient.
The proposed PercuNav provides real-time, three-dimensional visualization and navigation tools for all stages of diagnosis and intervention, including pre-procedure planning and procedure navigation. The system transforms two-dimensional patient images into dynamic representations that can be fused with live ultrasound or other previously acquired images. Those two-dimensional patient images, or scan sets, are derived from Ultrasound, CT, PET, PET/CT, and MRI. The resulting dynamic representation supports diagnostic review and instrument navigation.
The PercuNav system performs spatial mapping from one image space to another image space or from image space to physical space (registration), allowing the physician to correlate scan sets with each other and to the patient. The system facilitates minimally invasive diagnostic and interventional procedures.
Features include the following:
- Multiple Applications: The PercuNav system supports multiple applications and can be used for ablations, biopsies, and other diagnostic and guidance procedures.
- Multiple Modalities: The PercuNav system works with images from multiple modalities, including but not limited to CT, MR, PET, and ultrasound.
The Philips PercuNav Image Fusion and Interventional Navigation system, as described in the provided 510(k) summary, adds automatic MR/ultrasound registrations as a new technological characteristic compared to its predicate device. The performance data presented focuses on the accuracy of these new auto-registration features.
Here's a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Accuracy of auto registrations (liver vessel and liver surface) | The accuracy of auto registrations is "as good as that of the manual registration" (qualitative statement, no specific quantitative metric provided in the summary). |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "The accuracy test was done for the liver vessel and liver surface auto registrations." However, it does not specify the sample size used for this testing.
Regarding data provenance, the document does not explicitly state the country of origin of the data. Given Philips Ultrasound Inc. is in Bothell, WA, USA, and the FDA is a U.S. regulatory body, it's highly probable the data is primarily from the United States. The study is a non-clinical performance test, and it's implied to be retrospective as it's a test of the developed feature, not a prospective clinical trial.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth. The ground truth for the accuracy test is implicitly the "existing manual registration method available on the currently cleared PercuNav (K132087)." This suggests that the accuracy of the manual registration was used as the benchmark against which the auto-registrations were compared, rather than a separate expert-derived ground truth.
4. Adjudication Method for the Test Set
The document does not describe any explicit adjudication method. The comparison is between the automated process and an existing manual process, implying the manual process provided the reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "The proposed PercuNav did not require clinical study, since substantial equivalence to the currently marketed predicate devices... was demonstrated with the following attributes... Non-clinical performance testing." The testing described is a non-clinical accuracy test of the auto-registration feature itself, not a study of how human readers improve with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Yes, a standalone (algorithm only) performance study was done for the auto-registration features. The accuracy test directly assessed the performance of the auto-registration algorithm by comparing it to the manual registration method. This is an algorithm-only test, as there is no human decision-making loop described for the output of the auto-registration.
7. The Type of Ground Truth Used
The ground truth used for the accuracy test was the established accuracy of the "existing manual registration method available on the currently cleared PercuNav (K132087)." This implies that the accuracy of this manual method served as the reference against which the automated method was deemed "as good as." This is not expert consensus from independent readers, pathology, or outcomes data. It is a comparison to a previously validated manual system.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set for the auto-registration algorithms.
9. How the Ground Truth for the Training Set was Established
The document does not explicitly state how the ground truth for the training set was established. Given the nature of the device (image fusion and navigation), it is highly probable that the training data's "ground truth" for registration would involve:
- Careful manual registration performed by trained operators/engineers.
- Potentially, phantoms with known geometric properties.
- Utilizing the established accuracy of the predicate device's manual registration technology.
However, this is inferred, as the document provides no specific details on the training data or its ground truth establishment.
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(177 days)
The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It displays simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows an imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments.
The system supports the imaging-based model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy.
The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments.
The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures.
The IQQA-Guide System is a stereotactic accessory for Computed Tomography (CT). It utilizes electromagnetic tracking technology to locate and navigate instruments relative to an imaging-based model of the patient anatomy. IOOA-Guide displays the simulated image of interventional instruments (such as biopsy needle, ablation needle, probe) on a computer monitor that also shows the imaging-based 3D model of the patient anatomy, and the current and the projected future path of the interventional instruments.
IQQA-Guide supports the imaging-based 3D model derived from physician's confirmed segmentation results of patient's image scans, including intra-operative CT, pre-procedural CT, and CT or MR previously acquired before surgical procedures. The model of segmentation results may also be loaded from saved reports of the IQOA-BodyImaging software (K141745). Additionally, overlaying ultrasound images (when available) may be displayed with the model of patient anatomy. The system supports a workflow based on automated image registrations of spatial mapping from one image space to another image space, or from image space to physical space. Physician may interactively adjust and confirm registration results, and evaluate 3D visualization and quantitative information in terms of distance, size, and spatial location associated with patient anatomy and instruments.
The IQQA-Guide system consists of an EM tracking system, software, and a computer system. The system is intended for intra-operative guidance for surgical procedures. It is intended for use by trained physicians in clinical intervention and for structures where imaging is currently used for visualizing such procedures.
The acceptance criteria and study proving the device meets them are described below:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specification) | Reported Device Performance (IQQA-Guide) |
|---|---|
| System Registration Accuracy (phantom studies) | 2.35 ± 1.23 mm (Hospital Site 1) |
| 2.23 ± 0.82 mm (Hospital Site 2) | |
| System Registration Accuracy (patient studies) | 4.62 ± 3.07 mm (Hospital Site 1) |
| 4.9 ± 1.9 mm (Hospital Site 2) | |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2 standard |
| Electrical Safety | Complies with IEC 60601-1 standard |
| Software Functionality | Satisfies design intent |
| Major Functionalities in Clinical Intervention | Validated by physicians |
2. Sample Size and Data Provenance for Test Set
The provided text only mentions "experiments involving intervention on phantoms" and "experiments involving patient studies." It does not specify the exact sample size (number of phantoms or patients) used for the test set.
- Data Provenance: The testing was conducted at "two hospital sites". This suggests retrospective or prospective clinical data, though details are not provided. The country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth
The document mentions that "physicians use the IQQA-Guide during clinical interventional procedures" and "provide feedback along the line of the intended use of the system." It also states "Test results were reviewed by designated technical professionals." However, it does not specify the number of experts or their detailed qualifications (e.g., years of experience, subspecialty) used to establish the ground truth for the test set.
4. Adjudication Method for Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It only states that "physicians use the IQQA-Guide" and "provide feedback," and "Test results were reviewed by designated technical professionals."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance is mentioned in the provided text. The device is a "stereotactic accessory" for guidance, not an AI for image interpretation or diagnosis.
6. Standalone (Algorithm Only) Performance
The device, IQQA-Guide, is described as a "stereotactic accessory" that displays simulated images of interventional instruments and anatomical models. It relies on physician input for confirmed segmentation results and interactive adjustments. Therefore, it is not a standalone algorithm in the sense of making independent diagnostic or interventional decisions without human-in-the-loop. Its performance is evaluated in the context of aiding a physician.
7. Type of Ground Truth Used
The ground truth for the registration accuracy in phantom studies would likely be based on precisely known physical measurements of the phantom and instrument positions. For patient studies, the ground truth for accuracy would be based on "physician's confirmed segmentation results of patient's image scans" and potentially real-time imaging modalities, but the document does not explicitly state the definitive ground truth method for patient accuracy.
8. Sample Size for the Training Set
The document does not mention the sample size used for any training set. The device is described as an upgrade from already cleared software (IQQA-BodyImaging K141745), but information about its original development or training data is not provided in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, information on how its ground truth was established is not available in the provided text.
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(58 days)
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.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| IEC 60601-1:2005, CORR. 1(2006), CORR 2(2007) (Medical Electrical Equipment - Basic Safety and Essential Performance) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 60601-1-2:2007 (Medical Electrical Equipment - Electromagnetic Compatibility) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 60601-2-37:2007 (Particular Requirements for Ultrasonic Medical Diagnostic and Monitoring Equipment) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 60601-1-6:2010 (Medical Electrical Equipment – Usability) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 62304:2006 (Medical Device Software - Software Life Cycle Processes) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| IEC 62366:2007 (Medical Devices - Application of Usability Engineering) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
| ISO 10993-1:2009 (Biological Evaluation of Medical Devices) | Met all pre-determined acceptance criteria and demonstrated substantial equivalence. |
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.
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