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510(k) Data Aggregation
(21 days)
The U-CLIP™ Uni-Fire is intended for endoscopic and non-endoscopic general soft tissue and prosthetic material approximation/attachment and/or ligation and the creation of anastomosis in blood vessels, grafts and other tubular structures; including use in cardiovascular and coronary artery bypass grafting procedures.
The U-CLIP™ is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The Model M65 U-CLIP" Uni-Fire device consists of a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after placement. The clip is released from a slot in the side of the hypotube. After release, the arms of the clip attempt to regain their preferred, closed configuration, thereby holding the tissue layers together. This design allows precise placement of clips prior to closure, and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured with a standard implantable grade of Nitinol.
The provided text describes a 510(k) premarket notification for the U-CLIP™ Uni-Fire, Model M65, not a study involving AI or complex performance metrics. The information is solely about demonstrating substantial equivalence to a predicate device based on design, materials, intended use, and general function. Therefore, most of the requested fields are not applicable or cannot be extracted from this document, as they pertain to clinical studies, AI performance, and expert evaluations.
Here's an attempt to answer the questions based only on the provided text, explicitly stating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Verification and validation testing confirms that functional characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment. All test data obtained satisfied the documented product and performance specifications."
However, specific quantitative acceptance criteria or reported performance values (e.g., exact clip strength in Newtons, deployment success rate) are not provided in this summary.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Functional Characteristics (e.g., clip strength, clip deployment) | "Substantially equivalent to the predicate device." "All test data obtained satisfied the documented product and performance specifications." (Specific metrics and values not provided.) |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The text mentions "in vitro, in vivo, and clinical performance information provided in previous pre-market notifications," but no details for this submission's testing.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
Not applicable. This is a medical device submission, not an AI or diagnostic tool study requiring expert-established ground truth. The "ground truth" for the device's function would be its physical performance against engineering specifications.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based diagnostic studies. For this device, performance is likely assessed against engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC study was not done. This device is an implantable clip, not a diagnostic or AI-assisted tool that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done:
Not applicable. This is a physical medical device, not an algorithm or software. The "standalone" performance here refers to the device's functional characteristics (clip strength, deployment), which were tested.
7. The Type of Ground Truth Used:
For a medical device like the U-CLIP, the "ground truth" refers to its compliance with fundamental engineering and design specifications (e.g., material properties, dimensions, mechanical strength, deployment mechanism). The text implies its performance was verified against "documented product and performance specifications," which serve as the ground truth for its functional characteristics. No pathology, outcomes data, or expert consensus as a ground truth for performance is mentioned for this particular submission.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set.
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(589 days)
The Cardica® C-Port™ Anastomosis System is intended for the creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures.
The Cardica C-Port™ Anastomosis System is a sterile, single-patient use device. The Cardica® C-Port™ Anastomosis System is designed to create a reliable and consistent end-to-side anastomosis between a conduit and a small vessel. The product consists of accessories to assist in conduit loading and a device that completes the anastomosis with stainless steel clips. Once the conduit has been loaded onto the device, and the device positioned against the target vessel, the anastomosis is created by pushing an actuation button.
The provided text states that "All necessary bench, animal, and clinical testing has been performed on the C-Port™ Anastomosis System and packaging to ensure substantial equivalence to the predicate devices and to ensure the safety and effectiveness of the device." However, no specific details about acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, or different types of studies (MRMC, standalone) are provided.
Therefore, I cannot extract the requested information. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a study proving the device meets specific acceptance criteria.
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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
| Acceptance Criteria (Expected Performance) | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | "All data fell well within, both, internal specification requirements, as well as external standard requirements and device performance expectations." |
| Substantial equivalence to predicate devices (K024366, K023125, K021407, K013664, K012317, . K994160, and K971588) in terms of materials, use, and application. | Confirmed through in vitro and in vivo data. |
| Compliance with applicable USP suture testing requirements. | Confirmed. |
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.
- 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.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 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.
- The sample size for the training set: Not applicable.
- 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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