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510(k) Data Aggregation
(90 days)
The CT-Guide is a stereotactic accessory for Computed Tomography ("CT") systems. The CT-Guide displays an interventional instrument on a computer monitor that also displays a CT-based model of the target organ(s).
The CT-Guide is intended to be used in clinical interventions in the lung, where CT is currently used for visualizing such procedures.
The CT-Guide System is comprised of four main components: (1) the ActiSensor, a disposable video camera that is mounted onto a holder, which is clipped to a needle; (2) the ActiSticker, a disposable pad, which provides visual and radio-opaque reference markers; (3) a workstation that contains a dedicated computer; and (4) accompanying computer software.
The provided text describes the ActiViews Ltd.'s CT-Guide Needle Guidance System (K110812). Here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predefined specifications for performance and accuracy | "All results were satisfactory and met the predefined specifications." (bench tests on a custom phantom setup) |
| Software validation and testing | "The CT-Guide software was validated and tested." |
| Biocompatibility of skin-contacting materials | "Skin contacting materials were tested for biocompatibility per ISO 10933-1... All results were satisfactory." |
| Electromagnetic compatibility (EMC) | "The CT-Guide system was tested for electromagnetic compatibility per IEC 60601-1-2... All results were satisfactory." |
| Electrical safety | "The CT-Guide system was tested for... electrical safety per IEC 60601-1... All results were satisfactory." |
| Safety and effectiveness for intended use (clinical) | "A prospective, multi-center clinical study was conducted with CT-Guide system. The results established that the system is safe and effective for its intended use." |
| Functionality | "In all instances, the CT-Guide functioned as intended and the testing results observed were as expected." |
Study Details
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Sample size used for the test set and the data provenance:
The document states a "prospective, multi-center clinical study was conducted," but it does not specify the sample size for the test set (number of patients or procedures). The data provenance is prospective and multi-center, but the specific countries of origin are not mentioned. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the given text. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given text. -
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:
An MRMC comparative effectiveness study is not explicitly mentioned. The clinical study aimed to establish safety and effectiveness of the system rather than compare human readers with and without AI assistance. Therefore, no effect size for human reader improvement with AI assistance is provided. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is described as a "Needle Guidance System" and an "accessory for Computed Tomography ("CT") systems" that "displays an interventional instrument on a computer monitor." This implies a human-in-the-loop system, as the human operator (clinician) uses the guidance for the interventional procedure. Therefore, a standalone (algorithm-only) performance study would not be applicable or described for this type of device, and is not mentioned. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the clinical study, the text states, "The results established that the system is safe and effective for its intended use." While "safety and effectiveness" are outcomes, the specific type of ground truth used to measure these outcomes (e.g., successful lesion targeting confirmed by follow-up imaging, biopsy results, lack of complications) is not detailed. For the bench tests, predefined specifications were met, implying a ground truth based on engineering or performance metrics. -
The sample size for the training set:
The document does not specify a training set sample size. It mentions "software was validated and tested," but no details on training data. -
How the ground truth for the training set was established:
This information is not provided in the given text.
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(79 days)
The device is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data.
Electromagnetic tracking tool kit works in conjunction with images gathered by OEM imaging devices to provide physicians with a tool for image registration and/or tracking of instruments. This is accomplished by utilizing attachment brackets, needle guides, adhesive skin markers or fiducial markers, needles and other housings that are specially configured to contain an electromagnetic sensor. The electromagnetic sensor in the tracked instrument is used within an EM field introduced by OEM equipment. The position and orientation can be thus detected and combined with the acquired imaging to assist with navigating a tracked instrument. The system also utilizes accessories in conjunction with the system to allow the users additional options for protecting the equipment from contamination, needle guidance, and image registration.
The provided text describes a 510(k) summary for an Electromagnetic Tracking System. However, it does not contain any information regarding specific acceptance criteria, a study that proves the device meets those criteria, or performance data.
The document primarily focuses on:
- Intended Use: Electromagnetic tracking of instruments with respect to image data.
- Device Description: EM sensor within tracked instruments, used with OEM imaging devices, and various accessories (EMT sensor covers, EMT slot guide, skin markers).
- Predicate Devices: A list of previously cleared devices to which the current device claims substantial equivalence.
- Substantial Equivalence Claim: Based on equivalent intended uses, manufacturing materials, operating principles, and physical/operational specifications compared to predicate devices, with the only noted difference being qualification with the GE Logiq E9 system.
- FDA Clearance Letter: Confirming the 510(k) clearance and regulatory details.
- Indications for Use: Reiterating the intended use.
Therefore, I cannot provide the requested table and study details as they are not present in the input text. The document states that "There are no significant differences between the proposed and predicate devices except that they have now been qualified with the GE Logiq E9 system," which implies that the substantial equivalence argument, rather than a new performance study against specific acceptance criteria, was the primary basis for clearance.
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(113 days)
ABARIS is a stereotaxic accessory for Computed Tomography (CT), Magnetic Resonance, (MR), Ultrasound (US), Position Emission Tomography (PET), Single Photon Prosonan Computed Tomography (SPECT), Fluoroscopy, Endoscopy and other imaging systems. It displays the simulated image of a tracked insertion tool such as a biopsy needle, guidewire or probe on a computer monitor screen that shows images of the target psy noeans, guidewire and the projected future path of the interventional instrument taking into account movements of the patient. This is intended for treatment planning and intra-onerative guidant for surgical procedures. The device also supports an image-free mode in which the proximity of the interventional device is displayed relative to another device.
The device is intended to be used in clinical interventions and for anatomical structures where imaging is currently used for visualizing such procedures. The device is also intended for use in clinical interventions to determine the proximity of one device relative to ano inchier.
The ABARIS is a computer assisted, image guided surgery system. It guides a surgical instrument to a target that has been defined by the physician. The target can be indicated either preoperatively or intraoperatively using images or relative to an indicated position on the patient.
The ABARIS provides real-time, three-dimensional visualization and navigation tools for all stages of surgery including preoperative planning and intra-operative navigation. ABARIS transforms two-dimensional patient images (scan sets), derived from Computed Tomography (CT), Magnetic Resonance Imaging (MR), Position Emission Tomography (PET), Single Photon Emission Computed Tomography (SPECT), Ultrasound (US), Fluoroscopy etc. into dynamic representations on which a tool can be navigated. The system performs spatial mapping from one inage space to another image space or from image space to physical space ("vegistation") allowing the physician to correlate scan sets with each other and to the patient The system facilitates minimally invasive surgical procedures. Like other commercially available image guided surgery systems, the ABARIS also offers computer assisted image-free and registration free navigation using the same instrumentation.
Targeted use areas for ABARIS include hospital operating rooms, outpatient surgery centers and procedure rooms.
The K053610 submission for ABARIS describes a computer-assisted image-guided surgery system. The submission does not contain a study to prove acceptance criteria in the format requested. Instead, it relies on substantial equivalence to predicate devices. It states that "The technological characteristics of the ABARIS are the same or similar to those found in the predicate devices."
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
The submission is a 510(k) premarket notification, which often demonstrates substantial equivalence rather than presenting new clinical study data with explicit acceptance criteria. The FDA's letter (APR 19 2006) confirms this by stating, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...".
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(28 days)
The MR-Guide 2000 system is a frameless stereotactic guiding accessory for Magnetic Resonance (MR) systems. The system is MRI-compatible. It displays the simulated image of a rigid insertion instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the MR image of the target organs and the projected future path of the interventional instrument, compensating for respiratory movements of the patient.
The device is intended to be used in clinical interventions and for anatomical structures where magnetic resonance is currently used for visualizing such structures.
The MR-Guide 2000 provides visual guiding information of the interventional instrument by overlaying graphics depicting its relative position and its predicted future path on the MR image of the internal organs all displayed on the monitor of a personal computer.
This document describes the UltraGuide MR-Guide 2000, a guiding system for interventional instruments used with Magnetic Resonance (MR) imaging.
Here's an analysis of the provided text in relation to acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state specific numerical acceptance criteria for performance (e.g., accuracy thresholds, precision values, sensitivity, specificity). Instead, it relies on a claim of "equivalence to predicate devices in safety and efficacy."
However, it does mention "Accuracy tests were done in phantoms." While no specific accuracy values are reported in this summary, the success of the 510(k) suggests that the accuracy achieved in phantom testing was deemed acceptable by the FDA for demonstrating substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Accuracy (in phantoms) | Achieved acceptable accuracy |
| Safety and Efficacy substantially equivalent to predicate devices | Deemed substantially equivalent by FDA |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "Accuracy tests were done in phantoms." It does not specify the number of phantoms or the number of measurements taken within those tests.
- Data Provenance: The "Accuracy tests were done in phantoms" implies a synthetic/benchtop, experimental setting. The country of origin of this data is not specified, but the applicant is UltraGuide Ltd. located in Israel. The nature of the test is non-clinical/bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For phantom accuracy tests, the "ground truth" is typically established by the known physical properties and measurements of the phantom itself, often using highly precise measurement tools, not human experts.
4. Adjudication method for the test set
Not applicable. As noted above, the ground truth for phantom tests is not typically established by human experts requiring adjudication.
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 comparative effectiveness study was performed or reported. The device is a guiding system, not an AI-assisted diagnostic tool that would typically involve human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a form of standalone performance evaluation was done through the "Accuracy tests done in phantoms." This type of testing evaluates the device's inherent capability to track and display information accurately without direct human interaction influencing the measurement itself (though human operators would set up and execute the tests).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the accuracy tests mentioned, the ground truth would be the known physical dimensions and positions within the phantoms, established through precise measurements independent of the device being tested.
8. The sample size for the training set
Not applicable. This device is a "frameless stereotactic guiding accessory" that uses a magnetic tracking system for real-time guidance. It is not an AI/machine learning algorithm that typically undergoes distinct "training" with a dataset in the way a diagnostic image analysis algorithm would. Its function is based on physical principles of magnetic tracking and geometric calculations, not learned patterns from a training dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set or AI/machine learning model in the traditional sense outlined in the filing.
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