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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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The Coalescent Surgical U-CLIP™ and accessories is indicated for use in general soft tissue approximation and /or ligation, including use in cardiovascular procedures.

The Coalescent Surgical U-CLIP™ device is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip (optionally containing suture) and connected to needles via flexible members (optionally including various types of suture). 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 removal devices and vessel retention tools.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Coalescent Surgical U-CLIP™ and Accessories:

Acceptance Criteria and Device Performance

Study Details

It's important to note that the provided text is a 510(k) summary for a medical device submitted to the FDA for market clearance, not a detailed scientific study publication. As such, specific methodological details often found in a peer-reviewed research paper are condensed or omitted.

1. Sample Size used for the Test Set and Data Provenance:

   • Test Set Sample Size: Not explicitly stated in the provided summary. The text mentions "in vitro and in vivo data," implying animal or human testing, but no specific numbers for the test subjects or samples are given.
   • Data Provenance: Not explicitly stated. The nature of in vitro and in vivo studies suggests laboratory and potentially animal testing, but the country of origin or whether it was retrospective/prospective is not specified.

2. Number of Experts used to establish the ground truth for the test set and their qualifications:

   • Not applicable/Not mentioned. The "ground truth" here is less about expert consensus on interpretations (as in imaging studies) and more about objective functional performance measurements against established specifications and predicate device performance. The testing would likely be performed by engineers and technicians according to documented protocols.

3. Adjudication method for the test set:

   • Not applicable/Not mentioned. Adjudication methods like 2+1 or 3+1 typically apply to studies where human interpretation of data (e.g., images) requires consensus. Here, the "ground truth" is based on objective measurements and comparisons.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This type of study assesses human reader performance (e.g., radiologists interpreting images) with and without AI assistance. The U-CLIP is a surgical device, not an AI interpretation tool.

5. Standalone (Algorithm Only) Performance:

   • No, a standalone algorithm-only performance study was not done. The U-CLIP is a physical medical device, not an algorithm. The assessment is of its physical and functional properties.

6. Type of Ground Truth Used:

   • The ground truth for the performance claims appears to be:
     • Objective Functional Measurements: Data derived from in vitro (laboratory) and in vivo (live organism) testing.
     • Comparison to Predicate Device Performance: The functional characteristics and safety profile of the U-CLIP were compared against already legally marketed predicate devices (other U-CLIP models and Ethicon sutures).
     • Compliance with Standards: Adherence to internal specifications, external standards (not explicitly named but implied by "external standard requirements"), and USP suture testing requirements.

7. Sample Size for the Training Set:

   • Not applicable/Not mentioned. The U-CLIP is a manufactured device; there isn't a "training set" in the machine learning sense. Its design involved engineering, material science, and prior iterations (as indicated by the predicate devices).

8. How the Ground Truth for the Training Set was Established:

   • Not applicable/Not mentioned. As there is no "training set" in the AI sense, this question is not relevant. The "ground truth" for its development would be based on design specifications, material properties, biomechanical principles, and the performance characteristics of its predecessors.

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

The modified Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation/attachment applications. The U-CLIP consists of a specially designed vascular clip connected to needles via flexible members. This design allows precise placement of clips prior to closure and facilitation of an interrupted "suture" technique. The device is fabricated from standard medical and implantable grade materials. Accessories include Clip removal devices and vessel retention tools.

The provided text describes a 510(k) summary for the Coalescent Surgical U-CLIP™ and accessories, focusing on its substantial equivalence to a predicate device. This type of regulatory submission primarily relies on demonstration of equivalence rather than extensive de novo clinical trials with predefined acceptance criteria and performance metrics in the way a novel AI algorithm would.

Therefore, the requested information about acceptance criteria, detailed study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance is not present in the provided document, as it is not typically required for a 510(k) submission based on substantial equivalence to a predicate device.

However, I can interpret the available information to answer what data was presented and how the device met its 'acceptance criteria' in the context of a 510(k).

Here's how the information relates to your request:

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

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

• Sample size for test set: Not specified. The document only mentions "In vitro data" and "product technical information." Clinical data with specific sample sizes for a "test set" in the context of an AI device are not present.
• Data provenance: Not specified. The data is described as "In vitro data." No information about country of origin or whether it was retrospective/prospective is provided, as this is not relevant for an in-vitro performance test of a mechanical device.

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)

• Not applicable/Not specified. This information is relevant for AI algorithms relying on expert annotations for ground truth. This document pertains to a medical device (surgical clip), where "ground truth" would be established through engineering specifications, material testing, and performance against defined physical standards.

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

• Not applicable/Not specified. Adjudication methods are typically used when human experts review and categorize data, often in the context of AI model evaluation or clinical trials with subjective endpoints. This document focuses on a physical 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

• No. An MRMC study is completely irrelevant for this type of medical device (surgical clip). MRMC studies are designed to evaluate the impact of medical imaging devices or AI aids on human reader performance, which isn't the function of the U-CLIP.

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

• Not applicable. The U-CLIP is a physical surgical device, not an algorithm. Therefore, "standalone algorithm performance" doesn't apply.

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

• The "ground truth" for this device would be based on engineering specifications, material properties, and performance benchmarks for mechanical strength, biocompatibility, and functional operation (e.g., clip closure force, material integrity under stress, sealing capability). The document states "internal specification requirements, as well as external standard requirements and device performance expectations." This implies that the device was tested against established physical and material standards.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm, so there is no "training set."

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

• Not applicable. As above, there is no "training set" for this physical device.

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

The Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-CLIP consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure and facilitation of an interrupted technique. The device is fabricated from standard medical and implantable grade materials.

I am sorry, but the provided text does not contain the specific information required to complete the table and answer the questions asked about acceptance criteria and study details. The document is a 510(k) summary for a medical device (Coalescent Surgical U-CLIP™), which primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing specific performance acceptance criteria and study results in the manner requested.

The document mentions "Clinical data confirm that functional characteristics are substantially equivalent to the predicate, and fall within, both, internal specification requirements, as well as device performance expectations," but it does not provide:

• A table of specific acceptance criteria.
• Reported device performance against those criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Details about expert involvement, adjudication, or ground truth establishment.
• Information on MRMC studies or standalone algorithmic performance.

Therefore, I cannot fulfill your request based on the provided text.

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The Coalescent Surgical U-Clip™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures.

The Coalescent Surgical U-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.

The provided text describes a 510(k) summary for the Coalescent Surgical U-Clip™. However, it does not contain the detailed information required to fill out all sections of your request regarding acceptance criteria and the specific study proving the device meets them. The document states that "in vitro data confirm that functional characteristics are substantially equivalent to the predicate device cited. Testing included in vitro studies. All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations." This is a high-level summary and lacks the specifics you're asking for.

Here's an attempt to answer based on the available text, with explicit notes where information is missing:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It generally claims that "All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations."

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document mentions "in vitro studies" but does not specify the sample size for any test set or the data provenance. It only states these were "in vitro test data."

2. 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 information is not provided in the document. The testing described is "in vitro data," implying laboratory or bench testing rather than human subject testing requiring expert ground truth establishment in a clinical context.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not provided in the document. Given the "in vitro" nature, clinical adjudication methods are unlikely to be relevant here.

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:
   No MRMC study was mentioned. This device is an implantable surgical clip, not an AI/software diagnostic tool, so such a study would not be applicable.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   No standalone algorithm performance study was mentioned. This device is a physical surgical implant, not an algorithm. The "in vitro" testing implies standalone device performance, but not in the context of an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For "in vitro data," the "ground truth" would likely be established engineering specifications, material properties, mechanical test standards, and comparison to the predicate device's known performance characteristics. The document does not explicitly state the type of ground truth beyond fulfilling "internal specification requirements" and "external standard requirements."

7. The sample size for the training set:
   This information is not applicable as the device is a physical medical device, not a machine learning algorithm that requires a training set.

8. How the ground truth for the training set was established:
   This information is not applicable as the device is a physical medical device, not a machine learning algorithm.

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The Coalescent Surgical Sutured-Clip™ is intended for endoscopic and non-endoscopic use in the creation of anastomoses in blood vessels, grafts and other tubular structures.

The Coalescent Surgical Sutured-Clip™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The Sutured-Clip consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure. The device is fabricated from standard medical and implantable grade materials.

The provided text is a 510(k) summary for the Coalescent Surgical Sutured-Clip, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria or extensive study data as one might find for a novel device undergoing clinical trials to prove efficacy.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, or standalone algorithm performance for AI devices is not explicitly available within the provided K994160 document.

However, based on the text, I can infer and extract some relevant information as best as possible within the limitations of the provided document.

Acceptance Criteria and Reported Device Performance

The document states:
"All data fell well within, both, internal specification requirements, as well as external standard requirements and predicate performance expectations."
"Design analysis, in vitro, in situ and in vivo data confirm that basic functional characteristics are substantially equivalent to the predicate devices cited."

Given this, the "acceptance criteria" are implicitly tied to demonstrating substantial equivalence to the predicate devices and meeting "internal specification requirements" and "external standard requirements." The reported device performance is that it met these unstated criteria.

Study Details (Based on available information)

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

• Sample Size for Test Set: Not specified. The document mentions "in vitro, in situ and chronic in vivo studies" but does not quantify the number of tests or subjects.
• Data Provenance: Not specified, but generally, pre-market studies for medical devices like this would be conducted by the manufacturer, likely in a controlled laboratory setting or animal models for in vivo studies. No country of origin for data is stated, nor is it explicitly retrospective or prospective, though in vivo studies would typically be prospective for testing a new device.

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

• Not applicable/not specified. The document describes engineering and biological performance testing, not diagnostic performance where expert ground truth would be established.

4. Adjudication method for the test set:

• Not applicable/not specified.

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 is not an AI-powered diagnostic device, but a physical surgical implant.

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

• Not applicable.

7. The type of ground truth used:

• For the in vitro and in situ testing, ground truth would likely be based on established engineering principles, physical measurements (e.g., tensile strength, leak resistance, securement force), and comparison to the performance of predicate devices.
• For the in vivo studies, ground truth would be biological outcomes (e.g., successful anastomosis, tissue integration, absence of adverse reactions, long-term patency of vessels) assessed against expected physiological norms and predicate device performance.

8. The sample size for the training set:

• Not applicable/not specified. This is a physical device, not an AI model requiring a "training set."

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

• Not applicable.

Conclusion from the K994160 Summary

The K994160 summary focuses on demonstrating "substantial equivalence" of the Coalescent Surgical Sutured-Clip to existing predicate devices based on design analysis, in vitro, in situ, and in vivo testing. The document highlights that the device met internal specifications and external standards, confirming its basic functional characteristics are on par with marketed devices. It does not provide the detailed statistical analysis or reader study information typically associated with AI/diagnostic device approvals, as it is a different class of medical product.

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