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The Coalescent Surgical PG-CLIP™ and accessories are intended for endoscopic and non-endoscopic peripheral vascular and general surgical soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in peripheral vascular blood vessels, grafts and other tubular structures. The PG-CLIP is not intended for use in cardiac and/or thoracic procedures; including, but not limited to intra-cardiac and coronary artery bypass grafting (CABG) procedures.

The Coalescent Surgical PG-CLIP™ device is a self-closing clip for peripheral vascular anastomosis and tissue approximation/attachment applications. The PG-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may or may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools.

The provided text is a 510(k) summary for the Coalescent Surgical PG-CLIP™ device. It's a premarket notification to demonstrate that the device is substantially equivalent to legally marketed predicate devices. This type of submission focuses on comparing a new device to an existing one, rather than proving the new device's performance against specific acceptance criteria through extensive new studies.

Therefore, the document does not contain the kind of information requested regarding acceptance criteria, a study proving the device meets those criteria, or specific performance metrics in the way a clinical trial or algorithm validation study would.

Here's why the requested information cannot be extracted and what the document does state:

• No new performance data was acquired for this specific submission. The crucial sentence is: "No test data has been acquired related to this restricted indication for use." This means the submission relies on the existing performance data and substantial equivalence demonstrated for the predicate devices.
• The submission is based on "substantial equivalence." This regulatory pathway avoids the need for a full clinical trial to establish new safety and effectiveness criteria if the device is sufficiently similar to an already cleared device.

Given this, I cannot fill out the requested table and answer the specific questions about performance studies. However, I can explain why based on the provided text.

Reason For Inability to Fulfill Request:

The provided 510(k) summary explicitly states: "No test data has been acquired related to this restricted indication for use." (Section: Test Data). This means that for this particular submission (K040821), no new studies, performance data, or acceptance criteria beyond those established for the predicate devices were used or provided to the FDA. The submission relies on establishing "substantial equivalence" to previously cleared devices (Coalescent Surgical U-CLIP™ K031623, K024366, K023125, K021407, K013664, K012317, K994160, and K971588).

Therefore, specific information regarding:

1. A table of acceptance criteria and reported device performance
2. Sample sizes used for the test set and data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance
7. Type of ground truth used
8. Sample size for the training set
9. How training set ground truth was established

is not available within this document because such studies were not conducted or reported for this specific 510(k) submission. The FDA clearance for K040821 was based on the substantial equivalence to predicate devices, leveraging their existing pre-market notification data.

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The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

The Coalescent Surgical U-CLIP™ device is a self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel cutting and retention tools.

The provided document, K031623, is a 510(k) summary for the Coalescent Surgical U-CLIP™ and Accessories. It outlines the device's intended use and claims substantial equivalence to previously cleared predicate devices. However, this document does not contain specific acceptance criteria or an analytical study proving the device meets those criteria in the way you've outlined for AI/ML devices.

The information provided about testing is very high-level and focused on demonstrating substantial equivalence to predicate devices and adherence to USP standards, not on detailed performance metrics as would be expected for a diagnostic or AI-driven system.

Therefore, I cannot fully complete your request based on the provided text. Here's what I can extract and what is missing:

Acceptance Criteria and Device Performance

Missing Information as per Request:

The provided document does not include the following information, as it describes a surgical device and not an AI/ML-driven diagnostic or analytical tool. The questions below are tailored for AI/ML performance studies and are not applicable to this 510(k) submission for a surgical clip.

1. 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 this is not an AI/ML diagnostic device with a "test set" of data in the typical sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a surgical device would be its mechanical and biological performance in a physiological environment, not discrete data labels.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

Summary of what the document provides regarding testing:

The document briefly states: "In vitro and in vivo data have confirmed that functional characteristics are substantially equivalent to the predicate device cited as well as applicable USP suture testing requirements. All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations."

This indicates that a series of tests (both laboratory/benchtop and animal/human studies, usually) were conducted to ensure the U-CLIP performs similarly to existing, legally marketed surgical clips and meets recognized performance standards for surgical materials. However, it does not provide the granular detail about specific performance metrics, sample sizes, or ground truth establishment that would be present in a submission for an AI/ML device.

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The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.

The Coalescent Surgical U-CLIP™ device is a self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of specially designed vascular clips optionally connected to needles via flexible members. These clips may not include coils surrounding a Nitinol wire core. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique through elimination of knot tying. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip delivery and removal devices as well as vessel retention tools.

Due to the nature of the provided text, which is an FDA 510(k) summary for a medical device and not a study report, it does not contain the specific acceptance criteria or the detailed results of a study as typically presented for AI/ML device evaluations. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against quantified acceptance criteria for a novel AI/ML application.

Therefore, many of the requested items (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC study results, ground truth types for AI/ML) are not applicable or extractable from this document.

However, I can extract information related to the device characteristics and the claim of equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't define explicit numerical acceptance criteria for AI/ML performance metrics. Instead, it states:

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

• Not Applicable. This document describes a medical device, not an AI/ML algorithm. The "test set" would refer to the in vitro and in vivo studies performed, but specific sample sizes are not provided in this summary.
• Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective.

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

• Not Applicable. As this is not an AI/ML study, there is no mention of experts establishing a "ground truth" in the context of an algorithmic evaluation. The evaluation is based on standard biomedical testing.

4. Adjudication Method for the Test Set:

• Not Applicable. No information on adjudication methods for an AI/ML test set is present.

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

• Not Applicable. This is not an AI/ML device, so an MRMC comparative effectiveness study in the context of human readers analyzing AI output is not relevant nor mentioned.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• The "ground truth" for this device's performance relies on established in vitro and in vivo biological and mechanical testing methods, and adherence to applicable USP suture testing requirements and internal/external standard requirements. It's not a "ground truth" in the sense of expert-annotated data for an AI/ML system.

8. The Sample Size for the Training Set:

• Not Applicable. This document does not describe the development or training of an AI/ML algorithm; therefore, a "training set" in that context is not relevant.

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

• Not Applicable. See point 8.

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