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The SENDERO MAX Delivery Catheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

The SENDERO MAX Delivery Catheter is a single lumen, variable stiffness catheter with a radiopaque marker on the shaped distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guide wire, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.

This document is a 510(k) summary for the SENDERO MAX Delivery Catheter, a medical device. It describes the device's indications for use, technological characteristics, and performance testing conducted to demonstrate its substantial equivalence to a predicate device. This type of document is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the information required to answer your specific questions about acceptance criteria for an AI/CADe device or a study proving its performance.

The questions you've asked (about acceptance criteria, sample sizes, ground truth, experts, MRMC studies, standalone performance, and training sets) are typically relevant for AI/CADe devices or clinical studies used to prove the performance and safety of a device.

This document pertains to a physical medical device, specifically a catheter, not an AI or software device. The "performance testing" described (dimensional, coating, burst pressure, tensile strength, etc.) are standard engineering and material tests for physical medical devices to ensure they meet design specifications and regulatory requirements.

Therefore, it is not possible to answer your questions using the provided document because the device described is a physical catheter, not an AI/CADe device, and the document is a regulatory summary, not a clinical study report.

The document states: "No clinical studies were required." This further confirms that this submission does not contain the kind of study data you are asking about for AI/CADe performance.

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The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic and therapeutic agents.

The SENDERO Microcatheter is a single lumen, variable stiffness catheter with a radiopaque marker on the distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guidewire, guide catheter, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.

The provided text is a 510(k) summary for the SENDERO Microcatheter, a medical device. This document describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.

However, the request asks for information typically associated with a study proving that an AI/Software as a Medical Device (SaMD) meets acceptance criteria, including details about a test set, expert ground truth establishment, MRMC studies, standalone performance, and training set information.

The provided FDA 510(k) summary for the SENDERO Microcatheter does NOT contain information about an AI/SaMD, nor does it describe a study involving human readers, expert adjudication, or AI performance metrics.

The SENDERO Microcatheter is a physical medical device (a microcatheter) used for infusion, and its clearance relies on non-clinical performance testing (e.g., mechanical testing, biocompatibility) to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request as the necessary information regarding AI/SaMD acceptance criteria and study details (test set, ground truth experts, MRMC, training set, etc.) is not present in the provided text.

The document explicitly states: "No clinical studies were required." This further indicates that the type of study described in the prompt (involving human readers, AI performance, etc.) was not conducted for this device's regulatory clearance.

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The SENDERO Microcatheter is intended for the peripheral vasculature for the infusion of diagnostic agents.

The SENDERO Microcatheter is a single lumen, variable stiffness catheter with a radiopaque marker on the distal end and a Luer-lock hub on the proximal end. A hydrophilic coating on the catheter shaft reduces friction during navigation through the vasculature. The device is delivered to the target location using standard interventional techniques (e.g. use of guidewire, guide catheter, etc.) under fluoroscopic guidance. Once at the target location, the lumen of the device allows for the introduction of diagnostic and therapeutic agents into the peripheral vasculature.

The provided text is a 510(k) Premarket Notification from the FDA regarding the Okami Medical SENDERO Microcatheter. It discusses the device's substantial equivalence to predicate devices based on non-clinical performance testing.

However, the document does not contain the kind of detailed information typically associated with Acceptance Criteria and Study Proof for a device like an AI/ML algorithm or software. Specifically, it lacks:

• A table of acceptance criteria and reported device performance for metrics like sensitivity, specificity, or image quality (as would be seen for an AI diagnostic device).
• Details on sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set information. This submission is for a medical device (microcatheter), not a software or AI product.
• The type of ground truth used as this applies to diagnostic/AI devices, not typically a physical catheter.

The document primarily focuses on demonstrating the physical and functional equivalence of the SENDERO Microcatheter to existing, legally marketed predicate devices through non-clinical performance testing. The acceptance criteria for this type of device are related to its physical properties, material compatibility, and functional performance, rather than diagnostic accuracy metrics.

Here's a summary of what is available in the document, framed in the context of device acceptance, even if not precisely what the prompt asked for regarding AI/ML:

1. Acceptance Criteria and Reported Device Performance (Non-Clinical Testing):

The acceptance criteria for the SENDERO Microcatheter are implicitly defined by the successful completion of various non-clinical performance tests, demonstrating its suitability for its intended use and substantial equivalence to predicate devices. The "reported device performance" is a statement that the device met these criteria.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is the comprehensive Non-clinical Performance Testing regimen described. The document states: "The results of the testing indicate that the SENDERO Microcatheter is substantially equivalent to the predicate device." And "The non-clinical performance data submitted in this premarket notification clearly supports the substantial equivalence of the SENDERO Microcatheter to the predicate, and demonstrates the subject device should perform as intended when used as instructed."

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

• The document does not specify sample sizes for each non-clinical test. These tests are typically conducted on a defined number of device units (e.g., a certain number of catheters for burst pressure, tensile strength, etc.) according to recognized standards (like ISO or ASTM) or internal validated protocols.
• Data provenance: This is a physical medical device. The data comes from laboratory testing of manufactured devices, not from patient data, so concepts like "country of origin of the data" or "retrospective/prospective" patient studies are not applicable here.

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

• This is not applicable as the tests are for physical properties and biocompatibility. Ground truth is established by validated measurement techniques and adherence to engineering and scientific standards, not expert adjudication of patient data.

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

• Not applicable as this is not a diagnostic interpretation or clinical data review 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 a physical medical device (microcatheter), not an AI/ML diagnostic tool.

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

• Not applicable. This is not an algorithm or software.

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

• For this device, "ground truth" relates to the physical and chemical properties meeting predefined specifications and standards (e.g., a specific tensile strength value, a certain flow rate, absence of cytotoxicity). It is established through validated laboratory methods and measurements.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the machine learning sense.

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

• Not applicable.

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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).

Not Found

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).

Not Found

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).

Not Found

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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