(78 days)
The Pacific Surgical Innovations, Inc. Titanium Micro-Ligation Hemostatic Clip is designed for temporary or permanent implantation for use in ligating blood vessels. The clip has applications in many surgical procedures including where hemostasis is required or radiographic marking is necessary, in general or intracranial procedures.
Bent titanium wire that is forcibly closed to occlude an intracranial blood vessel, stop bleeding, or hold tissue or mechanical device in place in a patient. Especially designed to prevent slippage when properly applied.
This document is a 510(k) summary for the PSI Titanium Micro-Ligation Hemostatic Clip. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed acceptance criteria and study report in the format typically used for software or AI-based medical devices.
Based on the provided text, here's an attempt to extract the requested information, with notable limitations due to the nature of the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" in the way one might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating equivalence in materials, manufacturing, and functional performance to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence: Manufactured from the same materials as the predicate device, meeting the same standards and dimensional specifications. | "The PSI Titanium Micro-Ligation Hemostasis Clip is manufactured from the same materials, meeting the same standards and dimensional specifications and manufactured by the same contract manufacturer as the predicate hemostasis clip." (Page 13) |
| Functional Equivalence: Functions in the same manner as the predicate device in occluding blood vessels when used with the appropriate clip applier. | "When used with the appropriate clip applier, as used with the predicate device, the PSI hemostasis clip functions in the same manner as the predicate device in occluding blood vessels." (Page 13) |
| Safety and Effectiveness: Deemed safe and effective for its intended use. | "The PSI Titanium Micro-Ligation Hemostatic Clip is safe and effective for its intended use and meets all regulatory requirements to be found substantially equivalent to the predicate device." (Page 13) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The submission relies on a comparison to a predicate device, implying that prior performance data for both the predicate and the proposed device were considered, but no specific "test set" or sample sizes for testing are mentioned in the provided text. This is typical for a 510(k) for a physical medical device demonstrating substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided. The concept of "ground truth established by experts" is more relevant to diagnostic or AI-driven devices assessing conditions. For a mechanical device like a hemostatic clip, performance is typically assessed through engineering tests, material analyses, and possibly animal or cadaveric studies, rather than expert interpretation of a "test set."
4. Adjudication Method for the Test Set
This information is not applicable/provided. No "adjudication method" for a test set is mentioned, as the device is not a diagnostic tool requiring expert review of outputs.
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
This information is not applicable/provided. An MRMC study is relevant for AI-assisted diagnostic devices. This document describes a physical hemostatic clip, not an AI system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a surgical implant, not an algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically understood for diagnostic or AI devices is not directly applicable here. For this physical device, "ground truth" for its performance would implicitly be based on:
- Material properties and manufacturing specifications: Verification that the materials and dimensions match the predicate and established standards.
- Functional tests: Verification that the clip physically occludes vessels as intended, likely through bench testing or possibly animal models not detailed here. The primary "truth" is its ability to perform its mechanical function.
8. The Sample Size for the Training Set
This information is not provided and is not applicable to a physical medical device. The concept of a "training set" is exclusive to machine learning or AI models.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable to a physical medical device.
Summary of Limitations:
The provided text details a 510(k) submission for a physical medical device (hemostatic clip), focusing on demonstrating substantial equivalence to a predicate device. Many of the questions (especially those related to sample sizes, expert ground truth, adjudication, and AI studies) are highly relevant to software-as-a-medical-device (SaMD) or AI/ML medical devices but are not typically part of a 510(k) for a mechanical implant. Therefore, the requested information for many points is either not present in the document or not applicable to the type of device described.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.