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Found 4 results
510(k) Data Aggregation
(205 days)
Reprocessed AcuNav Diagnostic Ultrasound Catheter
The Reprocessed Acunav Diagnostic Ultrasound Catheter is intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients.
The reprocessed device is not indicated for use with pediatric patients.
The Reprocessed AcuNav Diagnostic Ultrasound Catheters distal end has an ultrasound transducer providing 2-D imaging. A steering mechanism controls the image plane orientation through four-way articulation of the tip.
The provided text describes a 510(k) premarket notification for a Reprocessed AcuNav Diagnostic Ultrasound Catheter. This document focuses on demonstrating the substantial equivalence of the reprocessed device to legally marketed predicate devices, rather than establishing acceptance criteria or proving performance of a novel AI/ML-driven device.
Therefore, the information required to answer your questions about acceptance criteria, device performance, sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not present in this document.
This document describes a medical device reprocessing process and the testing performed to ensure the reprocessed device's safety and effectiveness are equivalent to new devices. The "Functional and Safety Testing" section highlights the types of tests conducted, but it doesn't provide specific quantitative acceptance criteria or detailed results of those tests.
In summary, this document does not contain the information requested in your prompt regarding acceptance criteria and study results for an AI/ML-driven device.
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(139 days)
AcuNav Diagnostic Ultrasound Catheter 8F,10F
The catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediatric patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.
The AcuNav catheters are, disposable, and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization.
The provided document is a 510(k) summary for the Siemens AcuNav Diagnostic Ultrasound Catheter 8F, 10F. It states that the device is substantially equivalent to a previously cleared predicate device (AcuNav Diagnostic Ultrasound Catheter 8F, 10F, K071234) and therefore does not provide information on acceptance criteria or a study proving that the device meets those criteria through clinical data.
The summary explicitly states: "Because the AcuNav catheters in this submission uses the same technology, patient contact materials and principles as the predicate device, clinical data is not required to establish substantial equivalence."
Instead, the submission relies on the substantial equivalence to a predicate device and non-clinical tests to demonstrate safety and effectiveness.
Here is a breakdown of the information that can be extracted or deduced from the document, along with an explanation of why other requested information is not available:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study demonstrating performance against specific acceptance criteria was required or provided, this table cannot be populated from the given document. The document focuses on demonstrating that the new device shares the same "Features/Characteristic" of the predicate, implying that if the predicate performed acceptably, so will the new device.
| Feature/Characteristic | Acceptance Criteria (Not explicitly stated for new device performance) | Reported Device Performance (Implied by Substantial Equivalence to Predicate) |
|---|---|---|
| Indications for use: | Equivalent to predicate | Cardiac, Pediatric, Intra-luminal, Intra-cardiac visualization |
| - Cardiac | Equivalent to predicate | √ |
| - Pediatric | Equivalent to predicate | √ |
| - Intra-luminal | Equivalent to predicate | √ |
| - Intra-cardiac | Equivalent to predicate | √ |
| Mode of operation: | Equivalent to predicate | 2D, C, D, CW |
| - 2D | Equivalent to predicate | √ |
| - C | Equivalent to predicate | √ |
| - D | Equivalent to predicate | √ |
| - CW | Equivalent to predicate | √ |
| Patient contact materials | ISO 10993-1 compliance | ISO 10993-1 compliant |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. As no clinical study demonstrating performance of the new device was conducted, there are no test sets, data provenance, or sample sizes associated with such a study in this document. The submission relies on the established safety and effectiveness of the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No clinical test set data was provided for the new device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No clinical test set data was provided for the new device.
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 device is a diagnostic ultrasound catheter, not an AI-powered diagnostic tool. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm, but rather a medical hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No clinical test set data was provided for the new device.
8. The sample size for the training set:
Not applicable. No training set for an algorithm for the new device was mentioned. The device is a hardware component.
9. How the ground truth for the training set was established:
Not applicable. No training set for an algorithm for the new device was mentioned.
Summary of Non-Clinical Tests:
The document mentions that the device has been evaluated for:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electrical, electromagnetic, and mechanical safety
And has been found to conform with applicable medical device safety standards, including:
- UL 60601-1
- IEC 60601-2-37
- AIUM/NEMA UD-3
- AIUM/NEMA UD-2
- EN/IEC 60601-1, 60601-1-1, 60601-1-2
- ISO 10993-1 (Biocompatibility)
These non-clinical tests serve as the basis for demonstrating the safety of the device, implying that meeting these standards is an "acceptance criteria" for the non-clinical aspects, but they do not relate to clinical performance criteria for diagnosis or imaging quality against a ground truth.
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(57 days)
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
- 활 ISO 10993-1 Biocompatibility
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it discuss AI or machine learning.
The document is a 510(k) summary for the AcuNav Diagnostic Ultrasound Catheter, stating its substantial equivalence to a previously marketed device. It primarily focuses on regulatory approval based on equivalence and safety testing (biocompatibility), not on performance metrics against specific acceptance criteria for diagnostic accuracy.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria, device performance, study methodology, or AI-related information. This information is simply not present in the provided text.
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(131 days)
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER
For use directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging. The device is specifically indicated for use in visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow. The company anticipates that the device will be used for a variety of intravascular and intracardiac imaging applications, consistent with its intended use, including vascular stent placement, monitoring left ventricular function post-surgery; identifying congenital abnormalities before therapeutic procedures; visualizing the relative orientation of diagnostic and therapeutic catheters; and visualizing procedures such as transseptal insertions of other catheters, valvuloplasties, balloon septostomies, septal defect closures, and pacemaker or defibrillator lead insertion or extraction.
The AcuNav™ Diagnostic Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The AcuNav™ is intended for use in right heart only.
The AcuNav is an ultrasound-tipped catheter device which is used directly within the vasculature and/or the right heart for intravascular or intracardiac ultrasound imaging. The AcuNav incorporates a single-use, disposable ultrasonic phased-array imaging transducer, which must be used in conjunction with an Acuson ultrasound imaging platform to generate the acoustic waves and process the information for display to the physician. The catheter is 10 French in diameter and 90 cm in insertable length. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to the image plane) and anterior-posterior (in a plane coincident with the image plane). The distal end of the catheter contains the transducer, which is oriented to provide a two-dimensional (90 degree vector) image in a plane parallel to the axis of the catheter. The transducer offers all imaging modes at frequencies between 4.0 and 10.0 MHz.
This 510(k) summary for the AcuNav™ Diagnostic Ultrasound Catheter does not contain specific acceptance criteria or an explicit study that proves the device meets such criteria in a quantitative manner. The document focuses on establishing substantial equivalence to predicate devices rather than providing detailed performance metrics against predefined acceptance criteria.
However, based on the provided text, we can infer the overarching "acceptance criterion" to be Substantial Equivalence to the identified predicate devices, meaning the device performs equivalently in terms of safety and effectiveness. The study supporting this is described as performance testing, animal testing, and human clinical testing.
Below is an attempt to structure the information, acknowledging the limitations of the provided text in terms of detailed, quantitative acceptance criteria and study specifics.
Acceptance Criteria and Device Performance
The core acceptance criterion for this 510(k) submission is the demonstration of substantial equivalence to predicate devices. This implies that the device's technological characteristics and performance do not raise new questions of safety or effectiveness. The reported "performance" is implicitly deemed equivalent to the predicate devices through the testing conducted.
| Acceptance Criterion (Inferred from 510(k) process) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Confirmed by performance testing, animal testing, and human clinical testing. The device has the same intended use and very similar principles of operation and technological characteristics as the predicate devices. Minor technological differences (acoustic parameters, transducer configuration, imaging format, steering mechanism, materials, sterilization methods) do not raise new questions of safety or effectiveness. |
| Biocompatibility | Demonstrated to be biocompatible. |
| Non-pyrogenicity | Demonstrated to be non-pyrogenic. |
Study Information
Due to the nature of a 510(k) summary, detailed study parameters are not typically included. The document refers generally to "performance testing, animal testing, and human clinical testing" to support substantial equivalence. Specifics on each of these are absent.
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Sample size used for the test set and the data provenance: Not specified in the provided text. The document mentions "human clinical testing" but does not provide details on the number of subjects or the geographical origin of the data (e.g., country of origin, retrospective or prospective nature).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified in the provided text.
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Adjudication method for the test set: Not specified in the provided text.
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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 device is an ultrasound catheter, not an AI-powered diagnostic tool. The concept of "human readers improve with AI vs without AI assistance" does not apply to this type of medical device submission.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is an ultrasound catheter requiring human operation and interpretation; it is not an algorithm-only standalone diagnostic tool.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated. For "human clinical testing," the ground truth would typically come from a combination of clinical assessments, other imaging modalities, and potentially pathology or procedural outcomes, but this is not detailed. For "performance testing" and "animal testing," the ground truth would be based on controlled experimental conditions and established biological models.
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The sample size for the training set: Not applicable. This device is an ultrasound catheter, not a machine learning or AI model that requires a "training set" in the conventional sense.
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How the ground truth for the training set was established: Not applicable, as it's not an AI/ML device.
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