Search Results

The CardioOptics Augmentative Cardiac Optical Imaging System is intended to image and onical structures within the chambers of the heart and great vessels. The system is to be used in conjunction with fluoroscopic imaging.

The system is also indicated for accessing the coronary sinus for pacemaker lead implantation. The system includes visualization means to image anatomical structures to augment navigation into the coronary sinus.

The CardioOptics Augmentative Cardiac Optical Imaging System is composed of a single-use catheter, accessories, and an Image Acquisition System. The system incorporates infrared light (IR) technology to provide visualization through flowing blood. This submission modifies the indications for use originally cleared in 510(k) No. K050808 to include visualization of the cardiac chambers and great vessels.

I'm sorry, but based on the provided text, I cannot find the information needed to describe the acceptance criteria, the study that proves the device meets those criteria, or any of the detailed aspects like sample sizes, ground truth establishment, or MRMC studies.

The document is a 510(k) summary for the CardioOptics Augmentative Cardiac Optical Imaging System, primarily focused on its regulatory clearance. It identifies the device, its indications for use, and confirms that it was found substantially equivalent to predicate devices. However, it does not include performance data, detailed study designs, or acceptance criteria usually found in a clinical study report.

Ask a specific question about this device

The CardioOptics Coronary Sinus Access (CSA™) System is intended to provide subclavian access to the right heart for accessing the coronary sinus and placing a quide sheath suitable for pacemaker lead implantation into the coronary sinus. The system includes visualization means to image anatomical structures to augment navigation.

The Coronary Sinus Access (CSA™) System provides a catheter and sheath system for providing percutaneous access to the coronary sinus. In addition, the catheter provides visualization to augment the user's ability to locate the coronary sinus for placement of a guide sheath. The system includes a sterile, single use Coronary Sinus Access Kit, which includes a deflecting tip catheter with visualization capability (FLAIR™ CS Catheter), a Guide Sheath Set including a dilator and sheath slitters, and a Sterile Sleeve to drape over the camera pod. The system also includes an Imaging Acquisition System to collect and display video images present in front of the catheter tip.

The CardioOptics Coronary Sinus Access (CSA™) System underwent performance testing, including mechanical, functional, and animal studies, to establish substantial equivalence to predicate devices. Biocompatibility testing was also conducted.

Here is a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it states that various tests were performed to support "substantial equivalence" to predicate devices.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: The document does not specify the sample sizes used for the mechanical, functional, or animal testing.
• Data Provenance: The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. Animal testing implies prospective data collection in a controlled environment.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The device's performance is described in terms of "substantial equivalence" to predicate devices and meeting general testing requirements, rather than an evaluation against human expert-defined ground truth in a clinical setting.

4. Adjudication Method for Test Set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document focuses on demonstrating substantial equivalence through device testing.

6. Standalone Performance Study

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not explicitly described or conducted, as the device is a system with visualization to augment human navigation rather than an autonomous algorithm. The visualization aspect of the FLAIR™ CS Catheter was shown to be substantially equivalent to angioscopes and associated video display systems.

7. Type of Ground Truth Used

The ground truth used for assessing the device's performance appears to be established through:

• Engineering and pre-clinical testing standards: Mechanical and functional performance would be measured against predefined specifications or engineering benchmarks.
• Biocompatibility standards: ISO 10993 serves as the ground truth framework for biocompatibility.
• Comparison to predicate devices: The concept of "substantial equivalence" implies that the device's performance or characteristics are compared to those of already legally marketed predicate devices, which serve as a de facto "ground truth" for regulatory clearance.
• Animal models: Animal testing provides a physiological environment to assess aspects like access and visualization, where observations by skilled operators in the animal model would serve as the ground truth.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI, as the device is not described as an AI/ML product. The testing performed relates to the physical and functional aspects of the medical device.

9. How Ground Truth for the Training Set was Established

As there is no mention of a training set for an AI/ML component, this information is not applicable.

Ask a specific question about this device

The KSEA Fiberscope is indicated for use to provide visualization of the pericardium and cardiac chambers during endoscopic heart surgery procedures.

The KSEA Fiberscope is a manually operated surgical device. The KSEA Fiberscope is flexible fiberoptic telescope which utilizes fiber-optic technology.

The provided document is a 510(k) summary for the KSEA Fiberscope, a medical device for visualization during endoscopic heart surgery. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and detailed performance metrics as would be found in a clinical trial report for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth is not explicitly available in this type of regulatory submission.

Here's an analysis based on the available information, noting what cannot be extracted from this document:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not contain a table of acceptance criteria or quantitative performance metrics in the way a study for an AI/ML device would. For 510(k) submissions, the acceptance criteria are generally met by demonstrating that the new device has "substantially equivalent" features, design, body contact material, and general intended uses to legally marketed predicate devices, and that it does not raise new safety or effectiveness issues.

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

Not applicable. This is a 510(k) summary demonstrating substantial equivalence, not a study evaluating performance on a specific test set of data. It describes the device itself and its equivalence to others.

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

Not applicable. No "ground truth" establishment in the context of a data-driven test set is described here. The evaluation is based on comparing device specifications and intended use against predicate devices.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication is described.

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

Not applicable. This document is for a fiberscope, a manually operated surgical device, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is not an algorithm.

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

Not applicable. The ground truth for this type of submission is the regulatory knowledge and performance history of the predicate devices. The device's "truth" is its ability to visualize as intended, which is assumed to be similar to its predicates.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product developed with a training set.

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

Not applicable. This device is not an AI/ML product requiring a training set with established ground truth.

Ask a specific question about this device

The Smith & Nephew Vascular VideoEndoscope is indicated for use in subcutanous endoscopy, specifically for endocopically gaining access to, ligating and/or harvesting vessels within the subcutaneous and subfascial surgical planes in the lower extremities.

The proposed Smith & Nephew Vascular VideoEndoscope is designed in an "L" shaped configuration as to have the horizontal optical train and working channel as the part that is introduced into the leg and the vertical shaft as a handle. The connecting cables and tubing are conveniently located far from the leg to minimize any interference with the surgeon's hand movements. The function of the Smith & Neohew Vascular VideoEndoscope is to create and maintain a subfascially working space, provide visualization of the working space, and provide access to hand instruments to the working space. The attachments utilize the same locking feature located on the endoscope which allows the Smith & Nephew Vascular VideoEndoscope to be used as a multi-purpose device.

This document is a 510(k) summary for the Smith & Nephew Vascular VideoEndoscope. It focuses on demonstrating substantial equivalence to predicate devices, rather than performing a clinical study with detailed performance metrics and acceptance criteria for a new AI-powered diagnostic device. Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert qualifications, and AI-related metrics is largely not available in this document.

However, I can extract the relevant information that is present and indicate where the requested information is absent based on the nature of this regulatory submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not available. This document does not describe a test set or data provenance in the context of device performance evaluation. It is a regulatory submission comparing a new device to existing predicate devices.

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

Not available. This document does not mention experts establishing ground truth for a test set.

4. Adjudication method for the test set

Not available. No test set or adjudication method is described.

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

Not available. This document does not mention any MRMC study or AI assistance. The device described is a video endoscope, not an AI-powered diagnostic tool.

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

Not applicable. The device is an endoscope, not an algorithm.

7. The type of ground truth used

Not available. This document does not describe the establishment of a ground truth in the context of device performance.

8. The sample size for the training set

Not available. This document does not describe a training set.

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

Not available. This document does not describe a training set or its ground truth establishment.

Summary of available information from the document:

• Device Name: Smith & Nephew Vascular VideoEndoscope
• Intended Use: For use in subcutaneous endoscopy, specifically for endocopically gaining access to, ligating, and/or harvesting vessels within the subcutaneous and subfascial surgical planes in the lower extremities.
• Predicate Devices:
  • Olympus Endoscopic System for Vessel Harvesting (K963184)
  • Ethicon's EndoPath Ultra Retractor and Vessel Dissector (K973139)
  • Smith & Nephew's Images Endoscopes (K971850)
• Basis for Clearance: Substantial equivalence to predicate devices in "design, materials of construction and function and intended use."

The document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is as safe and effective as a legally marketed predicate device. This process typically relies on comparing the new device's technical characteristics and intended use to predicate devices, rather than conducting new clinical performance studies with detailed statistical analyses as would be required for a novel AI/ML device.

Ask a specific question about this device

Ask a specific question about this device

The angioscopic valvulotome kit is intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass.

The angioscopic valvulotome kit, intended to be used for venous valve incision and intravascular tributary identification during vein preparation for in-situ bypass, consists of commercially available components cleared under previous and/or separate 510k premarket notifications: the GORE EZE-Sit Valvulotome, an angioscope, and an irrigation system. All kit components will be used within their labeled and FDA-cleared indications; the only difference is that GORE will write a single Instructions for Use document to facilitate surgical use.

This document is a premarket notification summary for a medical device (K964061) and does not contain information about acceptance criteria or a study proving the device meets those criteria. The submission focuses on device description, predicate devices, intended use, and technological characteristics to establish substantial equivalence with existing devices, rather than presenting new performance study data.

Therefore, I cannot provide the requested information.

Ask a specific question about this device