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The Chase Cardiac Analysis System is indicated for use by trained physicians to derive anatomical and functional information from cardiac magnetic resonance image (MRI) studies. This information is presented as both an interactive 3D model and as text reports. The System is designed to automate the segmentation of cardiac structure and calculate anatomical and functional parameters and this information, when interpreted by a trained physician, may be helpful in diagnosis and therapeutic decisions.

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I am sorry, but the provided text from the FDA 510(k) summary for the "Chase Cardiac Analysis System" does not contain the information requested regarding acceptance criteria and the study proving device performance.

The document is a clearance letter from the FDA stating that the device has been found substantially equivalent to a legally marketed predicate device. It defines the device indications for use but does not detail the specific performance studies, acceptance criteria, or the results of such studies.

Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text. This type of detailed performance data is typically found in the full 510(k) submission, which is not publicly available in this format.

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The CHASE Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.

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The provided document is a 510(k) clearance letter from the FDA for a cardiac patch. This type of document does not contain the detailed information requested regarding acceptance criteria, study design, expert involvement, or algorithm performance for an AI/ML medical device.

The letter is a regulatory approval based on substantial equivalence to a predicate device, which means the manufacturer demonstrated that their device is as safe and effective as a legally marketed device, not that it met specific performance metrics in a clinical study as would be required for AI/ML device validation.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory classification, general controls, and compliance requirements.

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The CHASE Cardiovascular Patch With Radiopaque Markings is indicated for cardiac and vascular patch grafting.

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The provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. This document is an FDA 510(k) clearance letter for a medical device called "Cardiovascular Patch With Radiopaque Markings," indicating it has been deemed substantially equivalent to a legally marketed predicate device. It does not include the details of a study with acceptance criteria and performance metrics.

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The CHASE Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Chase Cardiovascular Patch Kit." It indicates that the device has been found substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, study details, or performance data for the Chase Cardiovascular Patch Kit. Therefore, I cannot generate the requested table and detailed information based on the input.

This type of FDA letter typically confirms that a device has passed the regulatory hurdle of substantial equivalence, but it does not usually include the technical performance data or specific study results used to demonstrate that equivalence. Those details would normally be found in the 510(k) submission itself, which is not provided here.

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The Chase Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Chase Cardiovascular Patch Kit). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... [because] the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the clearance is based on substantial equivalence to a predicate device, rather than a detailed study proving the device meets specific performance acceptance criteria as would be described in a clinical or performance study report.

Therefore, I cannot provide the requested information from this document.

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The CHASE Cardiovascular Patch is indicated for use in cardiovascular patching.

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The provided text is a 510(k) clearance letter from the FDA for a cardiovascular patch. It does not contain information about acceptance criteria, device performance, study details, expert qualifications, or ground truth establishment. Therefore, I cannot answer your request based on the provided input.

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The Chase Medical Femoral Access Cannulation Set is intended for use in situations which require rapid femoral venous and arterial access for short term cardiopulmonary bypass. Venous and arterial access is left to the discretion of the physician.

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The provided text describes a 510(k) premarket notification for the Chase Femoral Access Cannulation Set. The cornerstone of the submission is the claim of substantial equivalence to an existing predicate device, the RMI Femoral Access Cannulation Set (K891576). Therefore, the study proving the device meets acceptance criteria is not a typical performance study with defined acceptance criteria and statistical analysis, but rather a direct comparison demonstrating identical characteristics to the predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the traditional sense of a "test set" for a performance study. The "test set" is essentially the Chase Femoral Access Cannulation Set itself, compared directly to the RMI predicate device. No statistical sample size for performance evaluation is mentioned.
• Data Provenance: The comparison is based on the design, materials, and manufacturing specifications of both the Chase Medical device and the RMI device, which are claimed to be identical. The RMI device has been marketed worldwide for 6 years (retrospective information about the predicate). The Chase device implicitly uses prospective validation for packaging integrity.

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

• Not applicable. The "ground truth" for this submission is established by the identity of the components and manufacturing processes between the new device and the predicate device, as supplied by the same vendor. No independent expert panel was involved in establishing a "ground truth" for a performance test.

4. Adjudication Method for the Test Set

• Not applicable. There's no performance "test set" requiring adjudication in the context of clinical outcomes or diagnostic accuracy. The adjudication is essentially the FDA's review of the documentation supporting the claim of substantial equivalence.

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

• No. This is not a diagnostic imaging device, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a medical device (cannulation set), not an algorithm or AI system. Its performance is inherent to its physical characteristics and functionality, not a computational output.

7. The Type of Ground Truth Used

• The "ground truth" is the demonstrated identity (physical form, material composition, functional characteristics, sterilization, biocompatibility, packaging) between the Chase Medical Femoral Access Cannulation Set and its predicate device, the RMI Femoral Access Cannulation Set. This is a technical and manufacturing "ground truth" rather than a clinical or diagnostic one.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device. There is no "training set" in the context of this 510(k) submission.

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

• Not applicable, as there is no training set.

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The Chase Anastomosis Visualization Device is indicated for use during procedures wherein clearing of a wound or surgical site, for enhanced visibility, must be maintained by non-contact means.

The Chase Anastomosis Visualization Device consists of a malleable wand, a 0.2 micron filter, and a sterile fluid inlet line. The overall length of the wand is approximately 10.125 inches in length. The stainless steel wire is completely embedded within the wall along its length for the purpose of maintaining a user chosen shape. The distal tip is designed to provide a fan-shaped irreigation mist pattern. The remaining proximal length of the wand is the regulated gas inlet which consists of a 0.2 micron medical grade in-line bacterial filter made of a hydrophobic membrane and a 1/4 inch tubing connecter. A 1/4 inch PVC tube which connects the in-line filter to the regulated gas source. A fluid inlet line extends from a point near the proximal end of the malleable section of the wand and terminates in a female luer-lock adaptor for conneciton to a standard fluid administration set which provides for flow control and on-off capacity

The provided documentation describes the CHASE ANASTOMOSIS VISUALIZATION DEVICE, a Class II medical device. The submission is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than providing extensive de novo clinical study data. Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, training/test set details, ground truth establishment for AI performance) is not applicable in this context.

The safety and effectiveness of this device are based on its substantial equivalence to an existing device (the RMI Surgical Site Visualization Wand) and functional testing demonstrating that it meets specific engineering and manufacturing performance criteria.

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

1. Acceptance Criteria and Reported Device Performance

The document also states that "All functional characteristics of the Chase Medical Anastomosis Visualization Device are nondifferentiable as compared with the predicate." This implies that the performance of the Chase device is considered equivalent to the predicate device for all unlisted functional characteristics.

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

This information is not applicable as the document describes functional and engineering testing, not a clinical study with a "test set" in the context of AI/ML evaluation. The tests are for device integrity, material strength, and package durability.

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

This information is not applicable for this type of device submission. Ground truth, in the context of expert consensus for diagnostic accuracy, is not relevant to the described functional and sterilization validation.

4. Adjudication Method for the Test Set

This information is not applicable. No adjudication method for a clinical test set is described.

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

An MRMC comparative effectiveness study was not performed and is not applicable for this type of device. This device is a mechanical tool for surgical site visualization, not an AI/ML diagnostic or assistive technology that would typically warrant such a study.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not performed and is not applicable. The device is a physical, non-AI tool.

7. Type of Ground Truth Used

The "ground truth" for the tests performed are defined by engineering specifications and industry standards. For example, a leak-free device at 10 psi defines the target performance, and exceeding 10 lb. tensile strength is the target for tubing bond strength. For sterilization, the ground truth is a sterility assurance level (SAL) of 10^-6^ achieved through a validated sterilization cycle.

8. Sample Size for the Training Set

This information is not applicable as there is no "training set" in the context of AI/ML. The device's design is based on established engineering principles and materials, and its performance is validated through defined tests, not machine learning.

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

This information is not applicable for the reasons stated above.

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