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The Pacific Surgical Patties are intended for use in neurosurgical procedures to protect tissue, absorb fluids and stop bleeding. They are supplied to the user in sterile packages. These patties are X-ray detectable and are provided in a variety of sizes necessary to meet clinical needs.

To be used in surgery to protect nervous tissue, absorb fluids, or stop bleeding.

A cotton pad used during surgery to protect nervous tissue, absorb fluids or stop bleeding.

This document describes the marketing authorization for the Pacific Surgical Patties, a surgical cotton pad. The authorization is based on a finding of substantial equivalence to a predicate device, the Codman Surgical Patties.

Here's an analysis of the acceptance criteria and the study presented:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided text does not explicitly describe a "test set" in the context of an algorithmic or AI-based device. The approval is for a physical medical device (surgical patties). The performance data cited appears to be based on an internal assessment or comparison of the Pacific Surgical Patties to the predicate device, focusing on material and functional equivalence. There is no mention of a traditional "test set" as would be used for evaluating the performance of a diagnostic or predictive algorithm.

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

This information is not applicable as the document does not describe a study involving expert-established ground truth for a test set in the context of diagnostic performance. The evaluation is based on the physical and functional characteristics of the surgical patties compared to a predicate device.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no described test set requiring adjudication in the context of diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. This type of study is not relevant to the described medical device (surgical patties). MRMC studies are typically used to evaluate the diagnostic accuracy of imaging or AI systems with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No. This is not an AI-based device, so standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used:

The "ground truth" implicitly used for this device is the performance and characteristics of the legally marketed predicate device (Codman Surgical Patties). The key argument for acceptance is that the Pacific Surgical Patties are "as safe and effective" and "meets all regulatory requirements to be found substantially equivalent" to this predicate. The performance data focuses on demonstrating this equivalence through properties like material composition, dimensional specifications, quality, sterility, X-ray detectability, and fluid absorption capacity.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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Permanent placement in the brain for occlusion of cerebral aneurysms. They are only to be applied with PSI clip appliers with titanium alloy jaw inserts

Bent titanium wire which provides a spring operated, self Closing aneurysm clip of various lengths/sizes.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PSI Titanium Aneurysm Clip:

It's important to note that the provided documents (K991959 510(k) Summary and FDA clearance letter) are for a legacy device that was cleared in 2000. The regulatory requirements for device clearance, particularly regarding the rigor of performance studies and detailed reporting of clinical evidence, have evolved significantly since that time. Therefore, the level of detail regarding acceptance criteria and study methodology is much less than what would be expected for a modern submission.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria and a detailed table of performance are not explicitly stated in the modern format of performance goals (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance claims are qualitative and comparative to predicate devices.

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

The document does not describe a test set or data provenance in the context of a clinical study or a statistically powered performance evaluation as would be expected today. The "Performance Data" section describes the device's functional and MRI characteristics, likely derived from bench testing, material characterization, and possibly comparison of existing literature or specifications of predicate devices. There is no mention of patient data.

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

This information is not provided as there is no mention of a human-read test set or an expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a human-read test set.

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

No, an MRMC comparative effectiveness study was not conducted or described. This type of study, especially with "AI assistance," is a modern concept that was not relevant to medical device submissions in 1999/2000, particularly for a mechanical implant like an aneurysm clip.

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

No, a standalone algorithm performance study was not conducted or described. This device is a passive mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

Based on the information, the 'ground truth' for this device appears to be:

• Material Standards: Conformity to ISO and ASTM standards for the titanium alloy.
• Predicate Device Specifications/Performance: Comparative analysis against the established design specifications and reported performance of the predicate aneurysm clips (Aesculap Titanium Aneurysm Clip, Taka Aneurysm Clip). This would have involved reviewing the predicate device's 510(k) or available technical data.
• Bench Testing: Implicitly, functional testing to confirm the spring-operated, self-closing mechanism, appropriate closure force, and MRI compatibility (e.g., magnetic susceptibility testing).

There is no mention of pathology, outcomes data, or expert consensus in relation to establishing performance criteria for this device.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a mechanical implant; it does not involve an "algorithm" or "AI" that would require a training set.

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

This information is not applicable and not provided for the same reasons as #8.

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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.

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.

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Temporary occlusion of intracranial blood verssels/aneurysms.

Permanent placement in the brain for occlusion of aneurysms.

Not Found

I am sorry, but the provided text from the FDA document (K972750) is a 510(k) clearance letter for the Taka Aneurysm Clip. This type of document primarily confirms that a medical device is substantially equivalent to a predicate device and is generally focused on regulatory approval rather than detailed performance study reports.

The document does not contain the information necessary to answer your request about acceptance criteria and the specifics of a study proving device performance, such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts, their qualifications, or adjudication methods for ground truth.
• Information on Multi-Reader Multi-Case (MRMC) studies or any effect sizes.
• Details about standalone algorithm performance.
• The type of ground truth used (pathology, outcomes data, etc.), or how it was established.
• Sample size for training sets.

The letter primarily covers:

• Confirmation of device clearance (K972750).
• Device name: Taka Aneurysm Clip.
• Regulation details (21 CFR 882.5200, Aneurysm clip, Class II).
• Indications for Use: Temporary occlusion of intracranial blood vessels/aneurysms, and permanent placement in the brain for occlusion of aneurysms.

To find the kind of detailed study information you're asking for, you would typically need to consult a different part of the 510(k) submission, such as the full premarket notification, or scientific publications related to the device, which are not included in this FDA clearance letter.

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Ask a specific question about this device