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The Applied Medical Modular Clip Applier System is indicated for ligation of tubular structures or vessels where a non-absorbable ligating device is indicated.

The Applied Medical Modular Clip Applier System (MCAS) is a modular reposable device intended for ligation of tubular structures or vessels where a nonabsorbable ligating device is indicated. The reusable clip applier is made of stainless steel and is similar to standard clip appliers and surgical clamp designs currently on the market. The disposable clip cartridge is made of various plastic and metal materials and will be sold sterile. The clip cartridges will be available in four sizes, small, medium/large, and large and will house six to ten titanium clips depending on the clip size to be used. The cartridges are color coded Yellow, Blue, Green and Orange respectively according to their size. The key difference between the Applied MCAS and the predicate device is the modular design which provides the user with multiple clips inside a cartridge which is loaded onto a reusable applier instead of manually loading individual clips into the applier during surgical procedures.

The provided text is a 510(k) summary for the Applied Medical Modular Clip Applier System (MCAS). It states that the device passed all testing to demonstrate substantial equivalence to the predicate device and introduces no new safety and effectiveness issues when used as instructed.

However, the document does not describe specific acceptance criteria or the details of any studies, including sample sizes, ground truth establishment, or expert involvement. It is a regulatory submission focused on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's an attempt to populate the table and answer the questions based only on the provided text, highlighting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of experts: Not specified.
• Qualifications of experts: Not specified.

4. Adjudication method for the test set

• Adjudication method: 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

• MRMC study: No. This device is a surgical instrument (clip applier), not an AI-powered diagnostic or interpretive system, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• Standalone performance: No. This device is a mechanical surgical instrument. "Standalone performance" in the context of an algorithm or AI is not applicable here.

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

• Type of ground truth: Not specified. The document refers to "testing to demonstrate substantial equivalence," which likely involved mechanical and functional testing against specifications and comparison to the predicate device, rather than a "ground truth" as might be established for diagnostic image analysis.

8. The sample size for the training set

• Sample size for training set: Not applicable/not specified. As a mechanical device, there is no "training set" in the sense of machine learning.

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

• Ground truth for training set: Not applicable/not specified.

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The Multifire Clip Applier is designed to automatically deliver small hemostatic clips for ligation of blood vessels. The device is intended for use on vessels, which in the opinion of the surgeon, require a small ligating clip. The Multifire Clip Applier may be used during endoscopic procedures such as the endoscopic harvesting of the Internal Mammary Artery.

The Heartport Multifire Clip Applier is a sterile, use disposable device containing 15 small Titanium ligating clips. The device is designed to automatically deliver small hemostatic clips for ligation of blood vessels.

This document is a 510(k) summary for the Heartport Multifire Clip Applier, submitted in 1996. It details the device's classification, intended use, and comparison to predicate devices, but it heavily lacks the specific information requested in your prompt regarding acceptance criteria and a structured study.

Here's a breakdown of why this document cannot fulfill your request comprehensively:

Missing Information:

• Acceptance Criteria Table: The document states the device "was safe and effective" and "meeting the anticipated clinical requirements," but it does not provide any quantitative acceptance criteria (e.g., success rates, force measurements, specific closure percentages) or numerical performance data to fill a table.
• Detailed Study Information:
  • Sample size for the test set: Not specified beyond "in vitro" and "in vivo studies."
  • Data provenance: Not mentioned (country of origin, retrospective/prospective).
  • Number of experts and qualifications: Not mentioned.
  • Adjudication method: Not mentioned.
  • MRMC comparative effectiveness study: Not mentioned.
  • Standalone algorithm performance: This is a physical device, so "standalone algorithm" doesn't apply in the typical sense of AI software. The performance here refers to the device itself.
  • Type of ground truth: Not explicitly stated, though "clip feeding and clip closure" are the performance elements observed.
  • Sample size for the training set: Not applicable for a physical device where "training" isn't a discrete software development phase.
  • How ground truth for the training set was established: Not applicable.

What can be extracted (and why it's limited):

The document broadly mentions performance testing and biocompatibility.

• Performance: "The Multifire Clip Applier was evaluated in vitro for clip feeding and clip closure In addition, the Clip Applier was evaluated during in vivo studies. functions. Performance testing demonstrated that the Heartport Multifire Clip Applier was safe and effective, while meeting the anticipated clinical requirements for its intended use."
• Biocompatibility: "The patient contacting materials used in the Multifire Clip Applier are identical to those used in the Pilling Weck - Hemoclip S15 Automatic Applier."

Conclusion:

This 1996 510(k) summary is very high-level and focused on demonstrating substantial equivalence to already approved predicate devices. It does not contain the detailed, quantitative acceptance criteria or a structured study description that would be required to complete your request. The standards for regulatory submissions, especially for device performance studies, have evolved significantly since 1996, and a modern submission would likely include much more of this specific information.

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