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The VITALITEC INTERNATIONAL, INC. Hemostatic Clip is designed for the intended use of figure occlusion of vessels and prevent any slippage once applica. The clip masters is required or radiographic marking is necessary. Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The clip can be left in vivo without sequela as it is biologically inert.

The clips are composed exclusively of titanium and are supplied sterile in various sizes (mini-micro, micro, small/medium, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and International Organization Standard , ISO 5832-2-93 "Implants for Surgery - Metallic Materials -Part 2: Unalloyed Titanium".

Acceptance Criteria and Device Performance Study for Titanium Hemostatic Clip

This document describes the acceptance criteria for the Vitalitec International, Inc. Titanium Hemostatic Clip and the supporting data demonstrating its performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided 510(k) summary does not describe specific device performance testing with a "test set" in the traditional sense of a clinical trial or algorithm validation. Instead, the safety and efficacy information relies on:

• Data Provenance: The primary basis for safety and efficacy is stated as "The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control." This suggests a reliance on a retrospective analysis of widespread clinical use and long-term historical data for titanium hemostatic clips in general, rather than a prospective study on the specific Vitalitec device.
• Sample Size: No specific sample size or cohort is mentioned for a dedicated "test set" for this particular device. The "millions of clips" reference implies a very large, real-world population of patients who have received titanium hemostatic clips, though this is not a controlled sample.

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

Since evidence is based on widespread historical use rather than a specific test set requiring ground truth establishment by experts, this information is not applicable in the context of the provided document. The "ground truth" seems to be established through the long-standing clinical acceptance and observation of outcomes over decades of use by numerous medical professionals.

4. Adjudication Method for the Test Set

As there is no described test set requiring expert adjudication for specific cases, this information is not applicable.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is a physical medical device (titanium hemostatic clip), not an AI algorithm or imaging device that would typically involve human readers or AI assistance.

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

No, a standalone (algorithm-only) performance study was not done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the safety and efficacy of the Titanium Hemostatic Clip is based on:

• Long-term Clinical Outcomes Data: The statement "The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control" indicates reliance on decades of real-world clinical experience and observed patient outcomes for titanium hemostatic clips.
• Expert Consensus/Clinical Acceptance: The "wide acceptance" by the medical community of this method of hemostasis serves as a form of ground truth based on collective expert experience and consensus.
• Material Standards Compliance: Ground truth for material composition is established by compliance with recognized international standards (ASTM F-67 95, ISO 5832-2-93).
• Predicate Device Equivalence: The safety and efficacy are also heavily supported by the "substantial equivalence" claim to predicate devices, which implies that the safety and performance characteristics are well-established for similar products already on the market.

8. The Sample Size for the Training Set

This product is a physical medical device. There is no concept of a "training set" as would be used for machine learning algorithms.

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

As there is no training set, this question is not applicable.

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The EISNER USA Hemostatic Clip is designed for the intended use of ligating blood vessels. The clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The Clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary.

The clips are composed exclusively of titanium and are supplied sterile in various sizes (small, medium/large, and large) six clips per disposable holder. The titanium used meets all the requirements of the American Society for Testing and Materials (ASTM) standard specification F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I.

The provided 510(k) summary for K972745, the Titanium Hemostatic Clip by EISNER USA, is for a pre-amendment device type and does not contain detailed performance studies with acceptance criteria in the manner typically found in more recent submissions for novel or higher-risk devices.

Instead, the submission largely relies on a claim of substantial equivalence to predicate devices and the established safety and efficacy of the material (titanium) for long-term implantation. Therefore, many of the requested fields cannot be directly extracted from the provided text.

Here's an analysis based on the available information:

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

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

The document does not describe a specific "test set" for a performance study in the context of clinical or in-vitro validation of the device's functional performance (e.g., clip retention strength, occlusion efficacy). Instead, the submission relies on:

• Manufacturing standards compliance: "Devices are manufactured according to cGMP's, AAMI and ASTM requirements, and applicable Harmonized Standards ISO 9002/ EN 46002." These involve quality control and material testing, which would use representative samples, but specific sample sizes are not detailed for a dedicated "test set" demonstrating clinical performance.
• Material properties: The claim about ASTM F-67 95 Grade I Titanium is based on the material specification itself, not a specific study conducted for this submission.
• Historical use/predicate device data: "The millions of clips applied yearly and the years in use (since 1963) attest to the wide acceptance of this method of Hemostatic control." This refers to retrospective, broad-based clinical experience with similar devices, not a controlled study with a defined sample size for this specific device.

Therefore, no specific sample size or data provenance for a test set (in the typical sense of a clinical or rigorous bench performance study) is provided.

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. No performance study requiring expert ground truth is described.

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

Not applicable. No performance study requiring adjudication is described.

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 a medical device (hemostatic clip), not an AI/imaging diagnostic device.

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

Not applicable. This is a medical device, not an algorithm.

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

For material properties, the "ground truth" is defined by ASTM standard specifications (ASTM F-67 95). For safety and effectiveness for its intended use, the "ground truth" is implicitly derived from historical clinical outcomes and wide acceptance of predicate devices and the material itself.

8. The sample size for the training set

Not applicable. This is a medical device, not an algorithm that requires a training set.

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

Not applicable. This is a medical device, not an algorithm that requires a training set.

Ask a specific question about this device

Ask a specific question about this device