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The GENICON implantable clips are intended for use during procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.

The ligation clips are composed exclusively of titanium, and are supplied as sterile products in various sizes (mini-micro, micro, smallmedium, medium, medium-large, large and extra large) with six clips per disposable holder. The titiaum used meets all requirements for A.S.T.M. specifications F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and ISO 5832-2-93 and 10993 "Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium".

The provided text is a 510(k) summary for the GENICON Titanium Ligation Clip. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain information about a study that proves the device meets specific acceptance criteria in the way a diagnostic AI/ML device would.

Instead, the summary focuses on:

• Material Composition: Stating the device is made of titanium meeting specific ASTM and ISO standards.
• Substantial Equivalence: Claiming the device is substantially equivalent in material and function to a predicate device (Ethicon K830503).
• Safety and Efficacy: Asserting that titanium is "well recognized as being safe and effective for long term implantation" and that millions of titanium clips applied yearly "attest to the wide acceptance of this method of hemostatic and ligation control."
• Compliance with Standards: Stating that devices are manufactured according to GMP, AAMI, ASTM, and ISO 13485 requirements.

Therefore, many of the requested items related to an AI/ML device performance study cannot be answered from this document.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This document describes a medical device (titanium ligation clip), not an AI/ML diagnostic or predictive model that would use a "test set" in this context. The "safety and efficacy information" refers to general acceptance of titanium clips over time, not a specific clinical study with a test set.

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

Not applicable. This is not an AI/ML device's performance study.

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

Not applicable. This is not an AI/ML device's performance study.

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 not an AI/ML device, nor is an MRMC study described.

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

Not applicable. This is a physical medical device.

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

The document implicitly relies on:

• Material Standards: ASTM and ISO specifications for titanium.
• Historical Clinical Use/Outcomes: "Millions of titanium clips are applied yearly...attest to the wide acceptance of this method of hemostatic and ligation control."
• Substantial Equivalence: Ground truth for equivalence is based on comparison to a legally marketed predicate device, likely involving material properties, design, and intended use.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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The Applied Medical Implantable Clip is indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures.

The Implantable Clip is a sterile single use device indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. The clip is manufactured from implant grade titanium. The clips are supplied pre-packaged in a preassembled cartridge loaded with 14 functional clips. The clip applier system used to deliver the clips consists of the disposable clip cartridge and a reusable handle which provide the mechanical mechanism for storing, advancing and delivering the implantable clips. The system is designed for use with an 11mm diameter or larger trocar cannula.

The provided text is a 510(k) summary for an Implantable Clip and does not contain detailed information about acceptance criteria and a study that definitively proves the device meets those criteria in the way a diagnostic AI device disclosure would.

The document states:
"PERFORMANCE DATA SUMMARY: The performance and functional testing of the Implantable Clip included tests to analyze the jaw occlusion force of the clip appliers used with the clips discussed in this submission, leak pressure tests on vessels ligated by the clips and clip retention force of the clips. The performance and functional testing demonstrated that the Implantable Clip is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed."

This is typical for a medical device 510(k) submission where "substantial equivalence" to a predicate device is the primary pathway for clearance, rather than a performance study demonstrating meeting specific quantitative acceptance criteria for a novel diagnostic algorithm.

Therefore, many of the requested details about acceptance criteria, study design involving test sets, experts, ground truth, and AI-specific metrics (MRMC, standalone performance, training sets) are not applicable or provided in this type of submission.

However, I can extract the implied acceptance criteria based on the testing performed and articulate what would be expected if this were a typical AI/diagnostic device submission.

Here's an attempt to answer based on the provided text, highlighting what is present and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: Not specified. The document refers to "performance and functional testing" which would involve a sample size but the specific number of clips, appliers, or vessels tested is not provided.
• Data Provenance: Not specified. Given the nature of a 510(k) for a physical implantable device, this would typically involve in-house laboratory testing or animal studies, rather than a clinical dataset from a specific country. It is almost certainly prospective testing performed for the submission.

3. Number of Experts and Qualifications

• Number of Experts: Not applicable/not specified. The testing described (jaw occlusion, leak pressure, retention force) would typically be performed by engineers or technicians in a laboratory setting, not by clinical "experts" establishing ground truth in the way a diagnostic study would.
• Qualifications: Not applicable/not specified.

4. Adjudication Method

• Adjudication Method: Not applicable. This type of testing does not involve subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No. This is a physical implantable device, not a diagnostic algorithm, so an MRMC study is not relevant or performed.

6. Standalone Performance (Algorithm Only)

• Standalone Performance: Not applicable. This is a physical device, not an algorithm.

7. Type of Ground Truth Used

• Ground Truth: For the "Performance and Functional Testing," the ground truth would be based on physical measurements and objective criteria established through engineering specifications and industry standards for surgical clips, often benchmarked against predicate devices. For example:
  • Jaw Occlusion Force: Measured in units of force (e.g., Newtons) against a predefined threshold.
  • Leak Pressure: Measured in units of pressure (e.g., mmHg) at which a leakage occurs, verified against predicate device performance or clinical requirements.
  • Clip Retention Force: Measured in units of force required to dislodge the clip, against predefined thresholds.

8. Sample Size for Training Set

• Sample Size: Not applicable. This is a physical device, not an AI algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

• Ground Truth Establishment: Not applicable.

Summary of what the document does tell us about meeting acceptance criteria:

The primary "acceptance criterion" for this 510(k) submission is substantial equivalence to existing predicate devices (Applied Medical Clip Applier and LIGACLIP™ ERCA). The study, referred to as "performance and functional testing," aimed to demonstrate this substantial equivalence in terms of:

• Jaw occlusion force of the clip appliers.
• Leak pressure of vessels ligated by the clips.
• Clip retention force of the clips.

The document states that this testing "demonstrated that the Implantable Clip is substantially equivalent to the predicate devices and it introduces no new safety and effectiveness issues when used as instructed." This statement serves as the proof that the device meets the implied acceptance criteria for a 510(k) clearance.

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The AUTO SUTURE* VCS* Anastomotic** clip cartridge is intended to apply titanium clips for use in the creation of vascular anastomoses and in the attachment of synthetic vascular prosthesis.

The AUTO SUTURE* VCS*Anastomotic** clip cartridge fires multiple titanium clips simultaneously around the junction of 2 vessels to create a vascular anastomosis.

The provided document is a 510(k) premarket notification for a medical device (Auto Suture VCS Anastomotic Clip Cartridge). It primarily focuses on demonstrating substantial equivalence to a predicate device and does not include detailed acceptance criteria or a study proving the device meets those criteria in a typical AI/software context.

Therefore, I cannot provide the requested information for acceptance criteria and a study that proves the device meets those criteria because the document does not contain this type of information.

The document is a regulatory approval letter and a summary of information for a medical device that uses pre-formed titanium clips for vascular anastomoses. This is a physical, mechanical device, not a software-based AI device. The regulatory pathway for such devices typically involves demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance metrics against specific acceptance criteria in the manner one would see for AI/ML algorithms.

Here's why the requested information isn't present in this document:

• Acceptance Criteria & Reported Performance: The document states, "The AUTO SUTURE* VCS* Anastomotic**clip cartridge has been subjected to substantial safety and effectiveness testing." However, it does not detail specific quantitative acceptance criteria (e.g., success rates, force thresholds, leakage rates) or the reported performance outcomes against such criteria.
• Sample Size, Data Provenance, Experts for Ground Truth, Adjudication, MRMC Study, Standalone Performance, Ground Truth Type, Training Set Sample Size/Ground Truth Establishment: These categories are typically relevant for AI/Machine Learning algorithms or diagnostic devices where performance is measured against a "ground truth" derived from expert interpretation, pathology, or outcomes. The Auto Suture Clip Cartridge is a surgical instrument. Its "performance" would be assessed through preclinical (e.g., in vitro, animal studies) and potentially clinical studies focusing on aspects like clip integrity, vessel occlusion, patency, and absence of adverse events, not through the metrics typically used for AI.

In summary, the provided text is a regulatory submission for a physical medical device and does not contain the specific type of information requested regarding acceptance criteria and performance studies commonly found in evaluations of AI-powered devices.

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The PermaClip™ Cartridge with implantable titanium clips is intended for use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.

The Microsurge Laparoscopic PermaClip™ Cartridge with implantable titanium clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The PermaClip ™ cartridge contains up to 12 implantable titanium clips. The closed clip length is approximately 9 mm. The device is designed to be used in conjunction with a separately supplied reusable PermaClip™ Multi-Use Clip Applier to occlude blood vessels and other tubular structures during laparoscopic surgical procedures. The clip cartridge is attached to the clip applier handle via a lock/release mechanism, and inserted through a trocar to gain laparoscopic access. The clip cartridge jaws with the open clip in the jaws is placed around the vessel or other tubular structure. Actuation/compression of the clip applier handle/trigger drives a mechanism within the cartridge to close the cartridge jaws, thereby forming the clip securely around the vessel. Release/decompression of the clip applier handle/trigger allows the iaws of the cartridge to open and releases the clip from the cartridge jaws. The automatic feeding cartridge releases the next clip into the jaws for another application. The cartridge is sized to fit through a 10 mm cannula. The overall shaft length of the cartridge plus the clip applier handle is approximately 33 mm, consistent with other endoscopic instruments.

The provided 510(k) summary for the Microsurge Laparoscopic PermaClip™ Cartridge with Implantable Titanium Clips does not include any information about acceptance criteria or a study demonstrating device performance against such criteria.

The summary focuses on:

• Description of the device: How it works and its components.
• Intended Use: What the device is designed to do (occlude vessels/tubular structures during laparoscopic surgery).
• Technological Characteristics: Stating similarities to predicate devices in design, materials, and intended use.
• Conclusion: Reinforcing that it has the same intended use and basic technology as predicates, posing no new safety or effectiveness questions.

Therefore, I cannot provide the requested information in the table or answer the subsequent questions because the provided text does not contain any details about:

1. A table of acceptance criteria and reported device performance.
2. Sample size or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This type of 510(k) summary, particularly from 1996, often relies heavily on substantial equivalence to predicate devices rather than requiring extensive new performance data. Clinical trials or performance studies with acceptance criteria might not have been a primary requirement for this specific submission based on the presented information.

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