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The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated ( e.g. joint areas, superficial vasculature).

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the LOBO Vascular Occlusion System does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to an AI/machine learning device.

The document is a standard FDA clearance letter for a medical device (a vascular occlusion system), confirming that the device is substantially equivalent to legally marketed predicates. It briefly describes the indications for use but does not delve into performance studies, acceptance criteria, sample sizes, expert adjudication, or any details relevant to AI/ML device testing as described in your request.

Therefore, I cannot fulfill your request using the provided text. To answer your query about acceptance criteria and study details for an AI/ML device, you would need to provide a document that specifically details such a study, for example, a clinical study report or a 510(k) summary for an AI/ML-driven device.

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The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature).

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I am sorry, but the provided text from the FDA letter does not contain the information required to answer the questions about the acceptance criteria and the study that proves the device meets those criteria. The letter is a 510(k) clearance letter for the "LOBO Vascular Occlusion System," which is a vascular embolization device. This type of device is a physical medical device, not an AI/software device that would typically undergo the kind of performance studies described in your request (e.g., studies involving AI algorithms, expert readers, ground truth establishment, MRMC studies, etc.).

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices and outlines the regulatory basis for its marketing, general controls, and other administrative requirements. It provides the device name, regulation number, regulation name, regulatory class, product code, and indications for use.

Therefore, I cannot populate the table or answer the specific questions about AI/software performance studies, sample sizes, expert qualifications, or ground truth methodologies based on the provided document.

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Intended Use: The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature).

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This FDA 510(k) clearance letter for the Okami Medical LOBO Vascular Occlusion System primarily deals with the substantial equivalence determination of a medical device based on its indications for use, without detailing specific performance studies against acceptance criteria in the manner that would be expected for a novel AI/ML-based device.

Therefore, many of the requested elements for an AI/ML device (e.g., sample sizes for training/test sets, expert qualifications, MRMC studies, ground truth establishment) are not applicable to the content provided in this 510(k) letter.

However, I can extract the relevant information from the document as it pertains to the device and its intended use, and indicate where the requested information is absent.

Device Name: Okami Medical LOBO Vascular Occlusion System
Regulation Name: Vascular Embolization Device
Regulatory Class: Class II

Indications for Use: The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature).

Here's an attempt to answer your questions based solely on the provided text, acknowledging that much of the detailed study information for AI/ML devices is not present.

1. A table of acceptance criteria and the reported device performance

The provided document, a 510(k) clearance letter, does not contain specific acceptance criteria or reported device performance in a measurable format like sensitivity, specificity, accuracy, or other quantitative metrics. The basis for clearance in a 510(k) is "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a legally marketed device. Performance data, if submitted, would have been part of the 510(k) submission but are not typically detailed in the clearance letter itself.

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

• Sample Size (Test Set): Not mentioned in this document.
• Data Provenance (e.g., country of origin, retrospective/prospective): Not mentioned in this document.

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

This information is not applicable as this is a physical medical device (vascular occlusion system), not an AI/ML diagnostic or image analysis device that requires expert-established ground truth for performance evaluation in the context of an AI model.

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

This information is not applicable as this is a physical medical device, not an AI/ML device requiring expert adjudication of ground truth for performance evaluation.

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 as this is a physical medical device, not an AI-assisted diagnostic tool.

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

This information is not applicable as this is a physical medical device, not an algorithm.

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

For a device like a vascular occlusion system, performance data would likely involve outcomes data from preclinical studies (e.g., animal models) and potentially clinical studies (human trials), focusing on aspects like successful occlusion, patency of collateral vessels, complication rates, and device integrity. However, the specific type and details of ground truth/performance verification are not provided in this clearance letter.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI/ML model that undergoes training.

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

This information is not applicable as this is a physical medical device, not an AI/ML model.

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Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord and spine.

The TRUFILL DCS ORBIT Detachable Coil System is indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT Detachable Coil is also intended for arterial and venous embolization in the peripheral vasculature.

The intent of endovascular treatment using embolic microcoils is to pack the lumen of the aneurysm with the microcoil mass, thereby eliminating the influx of blood into the aneurysm. As blood flow is disrupted within the aneurysm, intraluminal thrombosis leads to exclusion of blood flow from the parent artery into the aneurysm. Blood flow in the parent artery is then secluded from the aneurysm and the weakened wall of the aneurysm is isolated from arterial pressures. Coil embolization may also be used to treat arteriovenous malformations and fistulas by packing coils into the lumen of the parent vessel feeding into the unwanted arteriovenous structure, resulting in cessation of blood flow. Stagnated blood within the arteriovenous malformation or fistula then thromboses, leading to involution and absorption of the aberrant vessels.

The TRUFILL Vascular Occlusion System:
The Vascular Occlusion System consists of the TRUFILL Pushable Coils and TRUPUSH Coil Pusher. The TRUFILL Pushable Coil is loaded into the proximal end of a compatible microcatheter and advanced through the catheter to the desired vessel location. The coil is deployed using the TRUPUSH Coil Pusher which is sold separately. The TRUFILL Pushable Coils are made from platinum/tungsten and synthetic fibers, and are designed for use under fluoroscopy with the TRUPUSH Coil Pusher and microcatheters having a minimum ,021" I.D. (0.5 mm). The TRUFILL Pushable coils are available in straight and shaped configurations.

The TRUFILL DCS ORBIT Detachable Coil System:
The TRUFILL DCS ORBIT Detachable Coil System consists of a delivery system (delivery tube and coil introducer) and an embolic coil. The embolic coil is the implantable segment of the device, and is comprised of a vasoocclusion coil wound from a platinum alloy wire into a primary coil and then formed into a secondary helical or complex shape. The embolic coil is detached from the delivery tube via a proprietary hydraulic release mechanism using the TRUFILL DCS Syringe II which is sold separately. The TRUFILL DCS ORBIT Detachable Coil System is designed for use under fluoroscopy with compatible infusion catheters, and is available in Standard and Fill configurations.

The provided 510(k) summary (K123560) describes the TRUFILL® Pushable Coils and TRUFILL® DCS ORBIT™ Detachable Coil System.

Acceptance Criteria and Device Performance:

The submission aimed to demonstrate substantial equivalence to previously cleared predicate devices. Since no new technological characteristics were introduced, the primary acceptance criteria revolved around demonstrating that the packaging modifications did not negatively impact the device's design, safety, operation, or performance.

Study Details:

The study described in this 510(k) summary is non-clinical testing, specifically bench testing, to demonstrate substantial equivalence for packaging modifications.

• Sample size used for the test set and the data provenance: The document does not specify the exact sample sizes for each bench test conducted (e.g., number of packages tested for dye leak). It only states that "Codman performed non-clinical testing necessary to demonstrate substantial equivalence to the predicate devices." The data provenance is internal testing performed by Codman & Shurtleff, Inc., as stated in section G. "Summary of Nonclinical Testing" and H. "Summary of Clinical Testing". Given the nature of bench testing, it is prospective for the specific tests performed to evaluate the modified packaging components.

• Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This was bench testing of physical properties and packaging, not clinical interpretation requiring expert consensus.

• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This was bench testing of physical properties and packaging, not clinical interpretation.

• 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: No. This submission is for physical medical devices (catheters and coils) and does not involve AI or human reader interpretation.

• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This submission is for physical medical devices and does not involve algorithms.

• The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this non-clinical testing was defined by established engineering and material science standards for device performance, packaging integrity, biocompatibility, and sterilization, as confirmed through the various bench tests listed.

• The sample size for the training set: Not applicable. This was non-clinical testing of physical products, not an AI or machine learning model that requires a training set.

• How the ground truth for the training set was established: Not applicable.

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The intended use of the TRUFILL® Vascular Occlusion System (TRUFILL® Pushable Coils and TRUPUSH® Coil Pusher) is as follows:

Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.

The TRUPUSH® Coil Pusher is used in coil embolization procedures in both the neuro and peripheral vascular systems. An embolic coil is loaded into the proximal end of a compatible microcatheter and the Coil Pusher is used to advance the device through the catheter lumen until it has exited the distal tip of the catheter.

This document describes the 510(k) premarket notification for the TRUPUSH® Coil Pusher, a component of the TRUFILL® Vascular Occlusion System. The submission aims to demonstrate substantial equivalence to a predicate device, focusing on process changes, packaging changes, and manufacturing site transfer.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly detailed with quantitative targets in the provided document. Instead, the "Design Verification Testing" and "Design Validation Testing" sections list the types of tests performed. The implication is that the device met the inherent acceptance criteria for each test to support substantial equivalence. Without specific numerical thresholds, we can only infer that the performance was deemed acceptable for regulatory clearance.

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

The document does not explicitly state the sample sizes used for each of the "Design Verification Testing" or "Design Validation Testing" items. It also does not specify the provenance of the data (e.g., country of origin).

The document mentions "in-vitro and in-vivo testing." In-vitro testing typically refers to tests conducted in a controlled environment, such as a lab bench, using bench models or simulators. In-vivo testing often involves animal models or human subjects. Given the context of a 510(k) for a device like a coil pusher, in-vivo testing likely refers to animal studies to simulate real-world use conditions, as human clinical trials are typically not required for 510(k) unless there are significant performance or safety questions not addressed by bench testing or animal studies. The text does not specify sample sizes or details of these studies.

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

This information is not applicable and not provided in the document. The studies conducted are engineering and performance tests (e.g., dimensional measurements, mechanical strength, pushability, retractability, package integrity), not diagnostic or interpretative tasks requiring human expert ground truth.

4. Adjudication Method for the Test Set

This information is not applicable. The tests described are objective engineering and performance measurements, not subjective evaluations requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or algorithms where human readers interpret medical images, and the AI's impact on their performance is assessed. The TRUPUSH® Coil Pusher is a physical medical device, not an AI or diagnostic tool.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

No, a standalone study (in the context of an algorithm's performance) was not done. The device is a physical medical instrument, not an algorithm. The "standalone" performance here refers to the physical device's function as designed, which is what the design verification and validation tests aim to assess.

7. Type of Ground Truth Used

The "ground truth" for the tests described are engineering specifications, measurement standards, and functional performance requirements for mechanical and material properties, as well as operational characteristics like pushability and retractability. For example, the ground truth for "Total Product Length" would be the engineering drawing's specified length with its permissible tolerance range. The ground truth for "Seal Integrity Test (Dye Penetration)" would be the absence of dye penetration under specified conditions.

8. Sample Size for the Training Set

This information is not applicable. The TRUPUSH® Coil Pusher is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not applicable, as there is no training set for a machine learning model.

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The Cordis Endovascular Systems, Inc. Vascular Occlusion System may be used to reduce or block the rate of blood flow in vessels of the peripheral and neurovasculature. They are intended for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas, and other vascular lesions of the brain, spinal cord, and spine.

The Vascular Occlusion System consists of straight and shaped TRUFILL Pushable Coils (made from platinum allow and synthetic fibers) and the TRUPUSH Coil Pusher (with 1 or 2 radiopaque markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" inner diameter.

This document, K983483, is a 510(k) premarket notification for the Cordis Endovascular Systems, Inc. Vascular Occlusion System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not applicable or not provided in this type of regulatory document. 510(k) submissions primarily rely on comparison to previously cleared devices.

Here's a breakdown of what is and is not present based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Hilal Embolization Microcoil (Cook, Inc., K901337)
• Helix Shaped Coils with Dacron Fibers (Target Therapeutics, K901721)
• Vascular Occlusion System (Cordis Endovascular Systems, Inc., K964367, K972881) (The core acceptance criterion for a 510(k) is demonstrating substantial equivalence.) |
  | Performance Standards | The FDA has not established performance standards under Section 514 of the Food, Drug and Cosmetic Act for this device type. (No specific performance acceptance criteria are mentioned beyond biocompatibility and equivalence). |

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

• Not applicable / Not provided. This document does not describe a clinical or performance study with a "test set" in the context of an algorithm or device performance study. The "testing" referred to is biocompatibility, which typically involves laboratory assays, not human subject data sets in the way implied by the question. The substantial equivalence argument relies on comparison to existing devices, not a new performance study.

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

• Not applicable / Not provided. As no "test set" for performance evaluation is described, there's no mention of experts establishing ground truth for such a set.
  • The "experts" involved are the FDA reviewers and the manufacturer's regulatory affairs personnel.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided. No test set requiring adjudication in the context of performance metrics is described.

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

• No. An MRMC study was not done or described in this 510(k) premarket notification. These studies are typically for evaluating the impact of AI on human reader performance, which is not the focus of this device (a physical embolization coil system).

6. Standalone (Algorithm Only) Performance Study:

• No. This is a physical medical device (embolization coils), not an algorithm or software device. Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

• Not applicable / Not provided directly. For biocompatibility, the "ground truth" would be the established safety profiles and recognized standards for biological compatibility. For substantial equivalence, the "ground truth" is the established regulatory clearance and safety/effectiveness of the predicate devices. There's no clinical "ground truth" (e.g., pathology, outcomes data) presented from a de novo study.

8. Sample Size for the Training Set:

• Not applicable / Not provided. This is not an AI/ML device where a "training set" would be used.

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

• Not applicable / Not provided. As this is not an AI/ML device, there's no training set or ground truth establishment for such a set.

In summary: This 510(k) submission primarily focuses on demonstrating that the "Vascular Occlusion System" is "substantially equivalent" to predicate devices already on the market, as opposed to presenting novel clinical study data against defined acceptance criteria. The only performance detail provided is the successful completion of biocompatibility testing.

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CES Pushable Coils may be used to reduce or block the rate of blood flow in vessels of the neurovasculature for the interventional radiologic management of arteriovenous malformations, arteriovenous fistulas and other vascular lesions of the brain, spinal cord and spine.

The CES Vascular Occlusion System consists of straight and shaped CES Pushable Coils (made from platinum alloy and synthetic fibers) and the CES Coil Pusher (with two radiopaque tip markers). The pushable coils are designed for use under fluoroscopy with microcatheters having a minimum 0.21" I.D.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text from the 510(k) summary for the CES Vascular Occlusion System does not contain information about specific performance acceptance criteria or details of a study designed to demonstrate meeting those criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, sterilization, and indications for use. It lists predicate devices and their 510(k) numbers, and indicates that "All applicable biocompatibility tests were successfully performed on the CES Pushable Coils." However, it does not state what the acceptance criteria for these tests were, nor does it provide any quantitative performance data from a specific study that would demonstrate the device meets any defined acceptance criteria for effectiveness or safety beyond biocompatibility.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study details, sample sizes, expert involvement, or comparative effectiveness.

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CES Occlusion Devices may be used to reduce or block the rate of blood flow in small or tapering vessels. They are indicated for use in the interventional radiologic management of arteriovenous malformations and other vascular lesions of the brain, spinal cord and spine when devascularization prior to definitive surgical resection is desired.

CES Vascular Occlusion System (occlusion device and coil pusher)

This document is a Premarket Notification 510(k) for the Cordis Corporation CES Vascular Occlusion System, submitted in 1997. It is a regulatory submission for a medical device and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The document focuses on:

• General provisions (common/proprietary names, classification).
• Identification of predicate devices for substantial equivalence.
• Intended use and device description.
• Biocompatibility testing (stated as successfully performed, but no details of the tests or results are provided).
• Summary of substantial equivalence to predicate devices based on design, construction, indication for use, and performance characteristics (again, without detailed performance studies).

Therefore, I cannot provide the requested information in the table format because the source document does not contain any of the following:

• 1. A table of acceptance criteria and the reported device performance: This document is a summary of safety and effectiveness based on substantial equivalence to predicate devices, not a report of a specific clinical performance study with predefined acceptance criteria.
• 2. Sample sized used for the test set and the data provenance: No performance test set is described.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable.
• 4. Adjudication method: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not performed or reported in this document.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an algorithm.
• 7. The type of ground truth used: Not applicable as no detailed performance study is presented.
• 8. The sample size for the training set: Not applicable as no machine learning algorithm is involved.
• 9. How the ground truth for the training set was established: Not applicable.

The document states that "All appropriate biocompatibility tests were successfully performed on the CES Occlusion System," but it does not detail these tests, their acceptance criteria, or the specific results. The basis for clearance is "Summary of Substantial Equivalence," meaning the device is considered as safe and effective as previously cleared predicate devices, rather than through a new, specific performance study against defined criteria.

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