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The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The i-ED COIL System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and venous embolizations in the peripheral vasculature.

i-ED COIL System is a neurovascular and vascular embolization device, which consists of two component devices, i-ED COIL Detachable Coil (hereafter i-ED COIL) and ELECTRO DETACH GENERATOR v4 Detachment System (hereafter EDG v4).

The i-ED COIL is composed of a detach coil and a sheath adapter. Furthermore, the detach coil consists of a platinum coil (embolization material), to be placed at the site of vascular diseases, a pusher (delivery wire) to guide the platinum coil to the site and a PVA (polyvinyl alcohol) rod that connects the platinum coil and the pusher. The sheath adapter consists of a PP (polypropylene) sheath and an adapter. The i-ED COIL is designed for use with the EDG v4.

The EDG v4 consists of a power source and connection cables attached with clips. EDG v4 is a medical electrical equipment to be used to detach the implantable platinum coil from the delivery wire of the i-ED COIL. It is intended for use in multiple coil detachments performed during a single procedure.

The i-ED COIL and EDG v4 are provided sterile (EtO), and separately packaged and distributed in the U.S.

The provided document describes the performance testing, biocompatibility testing, electrical safety, electromagnetic compatibility, and software verification and validation testing for the i-ED COIL System. However, it does not explicitly define "acceptance criteria" as a single, consolidated table with specific numerical thresholds for each test, nor does it present a "study" in the traditional sense (e.g., a multi-reader multi-case clinical study for an AI algorithm).

The document details various performance tests to demonstrate that the device meets pre-specified acceptance criteria. These acceptance criteria are generally qualitative or described in terms of meeting manufacturing specifications, equivalence to a control device, or compliance with standards.

Here's an attempt to extract the requested information based on the provided text, with not applicable (N/A) for information that is not present for this type of device (e.g., AI-specific metrics, ground truth for AI):

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: Specific numerical sample sizes are generally not provided for each test, other than phrases like "All samples" or "all EDG v4 samples," implying multiple units were tested. For particulate evaluation, an unspecified "test sample solution" was analyzed. For shelf life, "samples" that underwent simulated transportation and accelerated aging were tested.
• Data Provenance: The studies are described as "in vitro tests," "bench testing," and "simulated use tests." Given the nature of a neurovascular embolization device, these are laboratory and simulated environment tests. There is no mention of country of origin for the data or whether it's retrospective or prospective, as these are not clinical studies primarily.

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

• Number of Experts: For the "Simulated use evaluation on i-ED COIL System," "Physicians who participated in this study, semi-quantitatively evaluated trackability and delivery performance..." The exact number of physicians is not specified, but it implies more than one. For "Usability evaluation on i-ED COIL System," it states "physician trained for neuro-interventional procedures" and "all of physicians scored the usability," again implying multiple.
• Qualifications of Experts: For simulated use and usability evaluation, the experts are identified as "Physicians who participated in this study" and "physician trained for neuro-interventional procedures," suggesting relevant medical expertise in the field where the device would be used. Specific years of experience are not provided.

4. Adjudication method for the test set

• Adjudication Method: Not explicitly stated. For the evaluations involving physicians (Simulated Use, Usability), it's implied that their assessments directly formed the "results" for those tests. There's no mention of a formal adjudication process (e.g., 2+1, 3+1 consensus) for these types of bench or simulated use tests.

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, an MRMC comparative effectiveness study was not done. This device is a neurovascular embolization coil system, not an AI or imaging diagnostic algorithm that involves human readers interpreting images. Therefore, the concept of human readers improving with AI assistance is not applicable.

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

• Standalone Performance: Not applicable. The device is a physical medical device, not an AI algorithm. There is no "algorithm only" performance to assess in this context. While software verification and validation were performed for the EDG v4, this refers to the control software of the detachment generator, not a diagnostic or prescriptive AI algorithm.

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

• Type of Ground Truth: For the performance tests, the "ground truth" is typically defined by pre-specified manufacturing specifications, established engineering standards (e.g., ISO, ASTM), and the performance of legally marketed control devices. For aspects like simulated use and usability, the "ground truth" comes from the qualitative or semi-quantitative assessments of qualified physicians using the device in a simulated environment. There is no biological "ground truth" like pathology or outcomes data directly for these bench and simulated tests, though the biocompatibility section relates to biological responses.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This document does not describe the development or testing of an AI model, so there is no training set. The device is a physical medical device.

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

• Ground Truth for Training Set: Not applicable, as there is no AI training set for this device.

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The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of:

• Canalicular pathologies (stenosis, obstruction, lacerations),
• During Dacryocystorhinostomy (conventional or laser),
• Congenital nasolacrimal duct obstruction.

The LACRIFLOW CL is intended for the treatment of epiphora due to conditions including the obstructions of lacrimal punctum, lacrimal canaliculus, or nasolacrimal duct. The LACRIFLOW CL consists of the Lacrimal duct tube and the Bougie. The Lacrimal duct tube is intended to be inserted and placed inside the lacrimal canaliculus or other sites to dilate the lacrimal duct, and the Bougie is intended to be used for the Lacrimal duct tube and removed after insertion of Lacrimal duct tube. Lacrimal duct is dilated by insertion of the Lacrimal duct tube into the obstructed site.

The provided document is a 510(k) premarket notification for the Lacriflow CL device. It outlines the device's characteristics, indications for use, and a comparison to a predicate device (Lacriflow K120886). The primary focus of the document is to demonstrate "substantial equivalence" to the predicate device, especially considering modifications made.

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

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this document is implicitly defined by demonstrating that the modified Lacriflow CL device performs comparably to the predicate Lacriflow (K120886) and that the modifications do not introduce new safety or effectiveness concerns. The performance is assessed through specific verification tests rather than against explicit numerical thresholds for clinical outcomes (e.g., sensitivity, specificity, accuracy).

2. Sample Size for Test Set and Data Provenance

The document describes design verification tests. These are engineering/performance tests conducted on the device components or the device itself, not clinical studies involving human patients.

• Sample Size for Testing: For the "Tensile Strength of the Tube," the predicate device's performance is listed as "14.2 N (Average of 9 samples)." This is the only explicit sample size mentioned in relation to a performance characteristic. For the other "Performance tests" listed in Table 2, specific sample sizes are not provided in this document.
• Data Provenance: Not applicable as these are laboratory/engineering tests described, not clinical data from patients.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" here is defined by engineering specifications and comparative performance to the predicate device, verified through laboratory testing. There is no mention of experts establishing ground truth for a test set in the context of clinical, diagnostic, or interpretive performance.

4. Adjudication Method for Test Set

Not applicable. This is a technical performance assessment, not a clinical study requiring adjudicated interpretations of results.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This device is a lacrimal stent, and the evaluation focuses on its physical and functional equivalence to a predicate device, not on diagnostic accuracy improvements with AI assistance for human readers.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not conducted or described. This device is a physical medical device, not an AI/algorithmic diagnostic tool.

7. Type of Ground Truth Used

The "ground truth" for the evaluation described in this document is based on:

• Engineering Specifications and Performance Standards: The device's physical properties and functional performance (e.g., tip penetration, insertion load, bending strength, visual integrity) are evaluated against established engineering parameters and expectations for medical devices of this type.
• Predicate Device Performance: Comparison to the known performance and characteristics of the legally marketed predicate device (Lacriflow K120886) serves as a benchmark for substantial equivalence.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not an AI/machine learning system that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable. As there's no training set for an AI/machine learning model, this point is irrelevant.

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The Xpress-Way™ RX Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.

The Xpress-Way™ RX Extraction Catheter is not intended for use in the cerebral vasculature.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the XpressWay™ RX Catheter. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about acceptance criteria, device performance, or human studies for AI devices. It's a regulatory approval notice for a physical medical device (catheter), not an AI algorithm.

Therefore, I cannot fulfill your request using the provided input because the required information is not present in this document. The document describes the regulatory process for a physical medical device, not the validation of an AI algorithm.

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The Xpress-Way RX catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral system. The Xpress-Way RX is not intended for use in the cerebral vasculature.

Not Found

The provided documents are FDA 510(k) clearance letters for the Xpress-Way RX embolectomy catheter. These letters confirm the device's substantial equivalence to predicate devices but do not contain information about acceptance criteria, study designs, performance data, or ground truth establishment.

Therefore, I cannot provide the requested information based solely on the given text. To describe the acceptance criteria and the study that proves the device meets them, I would need to access the actual 510(k) submission (K101839) or related performance studies, which are not included in these documents.

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