Search Results
Found 3 results
510(k) Data Aggregation
(90 days)
U-CLIP DEVICE
The U-CLIP™ Device is intended for endoscopic and non-endoscopic dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures.
The U-CLIP™ Device is a self-closing clip for dura mater and prosthetic material approximation or attachment applications. The U-CLIP™ consists of a self-closing Nitinol clip connected to surgical needles via flexible members. The U-CLIP™ includes a Nitinol wire coil surrounding the Nitinol wire core. This design allows precise placement of clips prior to closure and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured from a standard implantable grade of Nitinol.
The provided document is a 510(k) summary for the U-CLIP™ Device, specifically focusing on its use in neurosurgical procedures. It establishes substantial equivalence to previously cleared U-CLIP™ devices and non-absorbable sutures for dura approximation.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate devices (U-CLIP™ K062057, K053252, K013664, Ethicon PRONOVA Suture K001625, Surgilon/Polyamide Suture K981582) for dura mater and prosthetic material approximation/attachment and/or ligation in neurosurgical procedures. | "In vivo testing confirmed that the U-CLIP Device is comparable to the predicate, standard non-absorbable suture, for dura approximation application." The device design, fabrication, packaging, specifications, and fundamental scientific technology are stated to be identical to previously cleared U-CLIP™ devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific in vivo tests. The document refers generally to "in vivo testing."
- Data Provenance: Not specified (e.g., country of origin). The study is described as "in vivo testing," implying a pre-clinical study rather than human clinical data. It is a retrospective notification of previous testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The study does not involve expert readers establishing ground truth for image interpretation or similar diagnostic tasks. It's an in vivo comparability study for a surgical device.
4. Adjudication Method for the Test Set
Not applicable. The study does not involve expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes an "in vivo testing" comparing the device to a predicate, not a study evaluating human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone performance study in the form of "in vivo testing" was done to confirm comparability of the U-CLIP™ Device to the predicate non-absorbable suture for dura approximation. This assesses the device's performance directly without human intervention in its function.
7. Type of Ground Truth Used
The ground truth used was the performance of the predicate device (standard non-absorbable suture) in dura approximation applications, as established through "in vivo testing." The study aimed to demonstrate comparability to this established performance.
8. Sample Size for the Training Set
Not applicable. This device is a surgical clip, and the study described is an in vivo comparability test, not an AI/algorithm-based system requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device/study type.
Ask a specific question about this device
(13 days)
U-CLIP DEVICE, MODEL NC65
The U-CLIP™ Device 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™ device is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The device is a self-closing Nitinol clip that is constrained in an open position in a stainless steel hypotube until released by the surgeon after placement. This design allows precise placement of clips prior to closure, and facilitates the device is manufactured with a standard implantable grade of Nitinol.
Here's an analysis of the provided text regarding the U-CLIP™ device, focusing on the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the specific quantitative acceptance criteria are not explicitly detailed. However, the qualitative performance objective was "substantially equivalent" to predicate devices.
| Acceptance Criteria (Qualitative) | Reported Device Performance (Qualitative) |
|---|---|
| Functional characteristics substantially equivalent to predicate device | "Verification and validation testing confirms that functional characteristics are substantially equivalent to the predicate device cited. This included clip strength and clip deployment angle. All test data obtained satisfied the documented product and performance specifications." |
| Substantially equivalent in terms of materials, use, and application to predicate devices | "The U-CLIP™ device is substantially equivalent to the U-CLIP™ Predicate Device(s): devices cleared in K031623, K024366, K060400, K023125, K021407, K013664, K012317, K994160, and K971588 in terms of materials, use and application." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set. It mentions "Verification and validation testing" which included "in vitro, in vivo, and clinical performance information." However, details on the number of clips tested or the number of subjects (for in vivo/clinical) are absent.
The data provenance is described as "in vitro, in vivo, and clinical performance information provided in previous vivo, and cimical performanos information." This suggests a mix of laboratory testing, animal studies, and potentially human clinical data, but the geographic origin of this data is not specified. It's described as "provided in previous... included in this submission," implying it was accumulated over time and presented for this submission. The nature of the studies (retrospective/prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text focuses on the device's substantial equivalence to predicate devices and its functional performance, rather than an expert-driven ground truth assessment for a specific medical condition.
4. Adjudication Method for the Test Set
This information is not provided in the document. The testing described (clip strength, deployment angle, in vitro/in vivo/clinical performance) doesn't inherently suggest an adjudication process for subjective assessments, but rather objective measurements and functional evaluations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and not provided. The U-CLIP™ is a physical surgical implant (a self-closing clip), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant in this context.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable and not provided. As explained above, the U-CLIP™ is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the functional performance specifications for the clip (e.g., clip strength, deployment angle) and the established safety and efficacy profile of the predicate devices for achieving tissue approximation/ligation. The testing aimed to demonstrate that the new U-CLIP™ met its own specifications and performed comparably to already-approved devices, suggesting the "ground truth" was a combination of engineering specifications and the historical performance of predicate devices. There is no mention of pathology, outcomes data, or expert consensus in relation to a specific diagnostic task.
8. The Sample Size for the Training Set
This information is not applicable and not provided. As the U-CLIP™ is a physical medical device, not an AI or machine learning algorithm, there is no "training set" in the conventional sense. The development of the device would involve engineering design, prototyping, and iterative testing, but not the training of a model on a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons mentioned in point 8.
Ask a specific question about this device
(25 days)
U-CLIP DEVICE, MODELS B140, B160 AND B180
The U-CLIP™ Device 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.
The U-CLIP™ device is a self-closing clip for anastomosis and tissue and prosthetic material approximation or attachment applications. The U-CLIP" consists of a self-closing Nitinol clip connected to surgical needles via flexible members. These U-CLIPs'" include a Nitinol wire coil surrounding the Nitinol wire core. This design allows precise placement of clips prior to closure, and facilitates an interrupted "suture" technique by eliminating knot tying. The device is manufactured from a standard implantable grade of Nitinol.
Here's a breakdown of the acceptance criteria and study information for the U-CLIP™ Devices, Models B140, B160 & B180, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (510(k) summary) does not explicitly list quantitative acceptance criteria in a table format alongside specific performance metrics. Instead, it states a general conformity to specifications and equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional characteristics substantially equivalent to predicate device | "Verification and validation testing confirms that functional characteristics are substantially equivalent to the predicate device cited." |
| Clip strength meets documented specifications | "This included clip strength... All test data obtained satisfied the documented product and performance specifications." |
| Tissue drag forces meet documented specifications | "...and tissue drag forces. All test data obtained satisfied the documented product and performance specifications." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the test set in terms of number of devices or clinical cases. The testing mentioned appears to be primarily in vitro and in vivo (though the clinical context is referring to previous submissions, not this one specifically).
- Sample Size (Test Set): Not explicitly stated. The document refers to "Verification and validation testing" which included "clip strength and tissue drag forces."
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be entirely pre-market verification and validation testing, implying controlled laboratory conditions rather than retrospective or prospective clinical data from human subjects in this specific submission. However, the summary does mention reliance on "in vitro, in vivo, and clinical performance information provided in previous pre-market notifications," suggesting that real-world or animal data might have supported prior iterations of the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not describe the use of experts to establish "ground truth" for the test set, as the testing focuses on engineering performance (clip strength, tissue drag) directly measured against specifications. There's no indication of human interpretation or diagnostic accuracy being evaluated for this device.
4. Adjudication Method for the Test Set
Not applicable. The testing described is against engineering specifications, not human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC study is not mentioned or implied, as this is a medical device for approximation/ligation, not an imaging or diagnostic device that relies on human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical, implantable medical device, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the verification and validation testing appears to be documented product and performance specifications for clip strength and tissue drag forces. These are engineering specifications that the device must meet.
8. Sample Size for the Training Set
Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1