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The LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.

The LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm, 40mm, 45mm to accommodate different sizes of LAA. The LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.

The provided text describes a 510(k) premarket notification for a medical device called the "LAA Exclusion System." This document is a submission to the FDA demonstrating that the modified device is substantially equivalent to a previously cleared predicate device.

The essential information related to acceptance criteria and performance data is found under the "Performance Data" section. However, it's crucial to understand that this document does not contain the detailed study results, specific numerical acceptance criteria, or the methodology (like sample size, number of experts, ground truth establishment) for proving the device meets these criteria in the way one would expect for an AI/ML medical device submission.

This document describes a mechanical device (an implantable clip and delivery system), not an AI/ML diagnostic or prognostic tool. Therefore, the questions related to MRMC studies, training/test set sample sizes for algorithms, number of experts for ground truth, and adjudication methods for AI models are not applicable to this type of device submission.

The "acceptance criteria" for this mechanical device are performance specifications met through engineering verification tests, not clinical performance metrics based on diagnostic accuracy.

Here's an attempt to answer the questions based on the provided text, acknowledging the limitations due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document states that "All pre-determined acceptance criteria were met" for the following tests, indicating successful performance. The specific numerical acceptance criteria themselves are not detailed in this summary document, only the types of tests performed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for each of these engineering verification tests, nor does it explicitly state the data provenance (e.g., country) or whether the testing was retrospective or prospective. These are typically internal design verification tests conducted by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to this type of mechanical device verification. Ground truth in this context is based on engineering specifications and measurements, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies, typically for AI/ML performance evaluation, not for mechanical device testing.

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, an MRMC study was not done. This device is a mechanical implantable clip and delivery system, not an AI-assisted diagnostic tool. Therefore, effects on human reader performance are not relevant or measured here.

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

No, a standalone algorithm performance evaluation was not done. This is a mechanical device, not an algorithm.

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

The "ground truth" for this device's performance demonstration relies on engineering specifications and physical measurements validated against those specifications. For example, "Implant Tip Opening" would be measured directly and compared to a pre-defined minimum opening distance. It's not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a training set.

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

This question is not applicable, as there is no training set for an AI/ML model for this mechanical device.

Summary of Inapplicability due to Device Type:
The provided document describes a 510(k) submission for a mechanical medical device (LAA Exclusion System), focused on demonstrating substantial equivalence to a predicate device based on engineering performance specifications and biocompatibility. The framework of your questions (e.g., sample size for AI test/training sets, expert readers, ground truth for AI models, MRMC studies) is primarily relevant to the FDA's evaluation of Artificial Intelligence/Machine Learning (AI/ML) based medical devices. Since the device in question is not an AI/ML product, many of your specific inquiries are not addressed in this type of submission document.

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The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.

The Syntheon LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm. 40mm, 45mm, and 50mm to accommodate different sizes of LAA. The Syntheon LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.

This document describes the Syntheon LAA Exclusion System and its substantial equivalence to a predicate device, focusing on various performance and safety aspects rather than an AI/ML component. Therefore, several of the requested categories for AI/ML device studies are not applicable.

Here's the summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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The EndoLok™ is indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy.

The EndoLok™ is a non-sterile, single-use device designed to be used in conjunction with standard colonoscopes. It consists of a handle with a trigger mechanism that is used to grip the colonoscope shaft.

The provided text describes the EndoLok™ device and its review by the FDA. However, it does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance in the format requested, nor does it describe a study involving specific performance metrics, sample sizes, expert involvement, or AI.

Here's an analysis of what is available and what is missing:

Available Information:

• Device Name: EndoLok™
• Intended Use: "indicated for use as a handle for standard colonoscopies. It is designed to provide a non slip grip to facilitate advancement, retraction, and angular orientation during diagnostic and therapeutic lower GI endoscopy."
• Predicate Device: EndoEase Advantage™ for Colonoscopy (K062805)
• Performance Data Summary: "Samples of the Syntheon LLC EndoLok™ were subjected to a 9-point bench test to demonstrate safety and effectiveness. All test samples met each test criterion. The device was determined to be safe and effective for its intended use."
• FDA Determination: Substantially Equivalent (SE) to the predicate device.

Missing Information (Crucial for requested table and study details):

• Specific Acceptance Criteria: The document states "All test samples met each test criterion" but does not list what those criteria were.
• Reported Device Performance against Criteria: Since the criteria aren't detailed, the specific performance values (e.g., specific grip strength in Newtons, precise friction coefficient, angular range) are also not provided.
• Details of the "9-point bench test": The nature of these 9 points is not elaborated upon.
• Sample size for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study details (effect size, AI assistance).
• Standalone algorithm performance study details (AI without human-in-the-loop).
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

Based on the provided text, here's what can be deduced, and what is explicitly not available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size (Test Set): Not specified. The document states "Samples of the Syntheon LLC EndoLok™ were subjected to a 9-point bench test." The exact number of samples is not provided.
• Data Provenance: The device manufacturer, Syntheon LLC, is based in Miami, Florida, USA. The testing was a "bench test," implying laboratory conditions rather than patient data from a specific country or clinical setting. It is inherently prospective as the device was manufactured and then tested.

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

• Not applicable / Not provided. This was a bench test of a physical medical device (a handle for a colonoscope), not an AI/imaging diagnostic device requiring expert interpretation for ground truth.

4. Adjudication method for the test set:

• Not applicable / Not provided. As this was a bench test against predefined criteria, an adjudication method for conflicting expert opinions (as in image interpretation) would not be relevant. The "adjudication" was likely whether the test sample met the objective test criterion.

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. This document describes a K080317 510(k) submission for a physical medical device (colonoscope handle), not an AI-powered diagnostic tool. Therefore, an MRMC study with AI assistance is not relevant or described.

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

• No. This device is a physical handle, not an algorithm. Therefore, standalone algorithm performance is not relevant or described.

7. The type of ground truth used:

• Objective Bench Test Criteria. The "ground truth" for this device's performance was whether it met the predefined technical specifications and performance characteristics established for the "9-point bench test." These would likely be engineering or physical metrics related to grip, force, durability, etc.

8. The sample size for the training set:

• Not applicable / Not provided. This device is a physical, non-AI medical device; therefore, there is no "training set" in the context of machine learning. The term "training set" is typically used for AI/ML model development.

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

• Not applicable / Not provided. As there is no AI/ML training set, this question is not relevant.

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