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The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter and as a conduit for retrieval devices.

The Modified HD Guide Catheters are single lumen, braided, variable stiffness shaft catheters designed for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular system. The catheters include a radiopaque marker on the distal and for angiographic visualization and a luer hub on the proximal end allowing attachments for flushing and aspiration. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

Here's an analysis of the acceptance criteria and study details for the Modified HD Guide Catheter, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document categorizes testing into "Testing and Non-Clinical Performance Data" (bench testing) and "Clinical Performance Data" (review of existing clinical studies and post-market data).

• Non-Clinical Performance Data (Bench Testing):

  • The document states "All samples met acceptance criteria." but does not specify the exact number of samples used for each bench test (e.g., Tip Patency during Aspiration, Lumen Compatibility, etc.). It only implies that multiple samples (denoted by "All samples") were tested for each criterion.
  • Data Provenance: The bench testing utilized a "neurovascular model cast from actual human neurovascular arteries." This is a controlled experimental setup, not data from live patients.
  • Specifically for the expanded indications, "Finished sterilized devices were used for the simulated use testing."

• Clinical Performance Data:

  • TREVO 2 Study: 99 patients where the DAC (Modified HD Guide Catheter) was used.
    • Provenance: Retrospective analysis of an IDE trial ("TREVO 2 study... designed to support FDA clearance of the Trevo Retriever in the U.S."). Enrolled at 26 sites in the United States and one site in Spain.
  • TREVO Study: 30 patients where aspiration through DAC was applied (a subset of 34 patients where DAC was used).
    • Provenance: Retrospective analysis of a post-marketing prospective, multi-center, single-arm study performed at seven sites in Europe.
  • Post-Market Surveillance: A review of product complaints and Medical Device Reports (MDRs) from 2008 to July 31, 2013. The exact number of complaints reviewed is not given, but it is stated that 10 MDRs were filed.
    • Provenance: Real-world post-market data.
  • Literature Review: 15 published articles pertaining to DAC use.
    • Provenance: Published scientific literature.

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

• Non-Clinical (Bench) Testing: The document does not specify the number or qualifications of experts involved in observing and confirming the "Pass" results for the bench tests. It likely involved internal engineering or research staff.
• Clinical Performance Data (TREVO and TREVO 2 Studies):
  • The original TREVO 2 and TREVO studies would have had clinical investigators and potentially core labs or adjudication committees, but their specific roles in establishing "ground truth" for catheter performance (as opposed to primary study endpoints for the Retriever device) are not detailed here.
  • The 510(k) summary states that "None of the procedure related or CEC adjudicated events were related to DAC," implying that a Clinical Events Committee (CEC) was used in the TREVO study to adjudicate events. Their specific qualifications are not provided in this 510(k) summary.

4. Adjudication Method for the Test Set

• Non-Clinical (Bench) Testing: No specific adjudication method is mentioned. Results were simply reported as "Pass" based on visual verification or adherence to specified methods.
• Clinical Performance Data: The TREVO study mentioned events being "CEC adjudicated," indicating a Clinical Events Committee (CEC) was involved in reviewing adverse events. The specific method within the CEC (e.g., 2+1, 3+1) is not detailed. The TREVO 2 study also implies similar clinical oversight.

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

There is no MRMC comparative effectiveness study mentioned, nor is there any AI assistance component to this device. This is a physical medical device (catheter), not an AI-powered diagnostic tool. Therefore, this section is not applicable.

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

Not applicable, as this device is a physical catheter and does not involve an algorithm.

7. The Type of Ground Truth Used

• Non-Clinical (Bench) Testing:
  • For most bench tests, the "ground truth" was based on pre-defined acceptance criteria and direct observation of the device's physical performance characteristics (e.g., patency, resistance, integrity, absence of fracture/leakage) in a simulated environment (neurovascular model).
• Clinical Performance Data (TREVO 2 and TREVO Studies):
  • The "ground truth" in these studies relates to the clinical outcomes of the overall thrombectomy procedure, specifically revascularization rates and the absence of device-specific adverse events. While the primary ground truth would be patient outcomes as assessed by clinicians (e.g., angiography for revascularization, neurological exams for NIHSS), the review here focuses on whether the DAC was implicated in any negative outcomes.

8. The Sample Size for the Training Set

Not applicable. This is a physical device and not an AI/machine learning model that requires a training set. The existing clinical data reviewed served as real-world performance evidence, not a "training set."

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

Not applicable, as there is no training set for this device.

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The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance of an occlusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. A rotating hemostatic valve with side-arm adapter is provided with each catheter for flushing, catheter insertion and aspiration. Modified HD Guide Catheter dimensions are indicated on product label. The Modified HD Guide catheter family is being extended to include a 6.3 F size.

The provided document is a 510(k) summary for a medical device called the "Modified HD Guide Catheter." It describes the device, its intended use, a summary of testing, and the FDA's substantial equivalence determination.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that "The same performance standards, test methods and specifications were applied as those previously submitted in the predicate HD Guide Catheter 510(k) submissions." It then lists the specific tests. The general finding for all these tests is that the device "demonstrate[s] that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device." While specific numerical performance values for acceptance criteria are not provided in this summary, the statement implies that the Modified HD Guide Catheter met the established performance standards of its predicate device for each of these tests.

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

• Sample Size: Not explicitly stated. The document mentions "verification and validation conducted on the Modified HD Guide Catheter" and that "The same performance standards, test methods and specifications were applied as those previously submitted in the predicate HD Guide Catheter 510(k) submissions." Without more detail on those predicate submissions, the exact sample sizes for each test listed (kink resistance, flow rate, etc.) are unknown.
• Data Provenance: Not explicitly stated. This is a medical device submission, so it's likely internal company testing data. There is no mention of country of origin of data, nor whether it was retrospective or prospective in this 510(k) summary.

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

This is a physical medical device (catheter), not an AI or diagnostic imaging device. Therefore, the concept of "ground truth" established by human experts in the context of diagnostic interpretation or classification does not apply. The "ground truth" for this device would be established by engineering specifications and physical test methods.

4. Adjudication method for the test set:

Not applicable, as this is a physical medical device and not related to interpretive diagnostic tasks requiring adjudication.

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 document is for a physical medical catheter, not an AI or diagnostic imaging device that involves human readers.

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

Not applicable. This is not an AI algorithm. The performance described relates to the physical characteristics of the catheter itself.

7. The type of ground truth used:

The "ground truth" for this device is based on engineering specifications and established test methods for medical catheters. For example, "kink resistance" would have a defined standard or threshold that the catheter must meet, which is determined by physical testing rather than human expert opinion on an image or medical case.

8. The sample size for the training set:

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

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

Not applicable, as there is no training set for a physical medical device like this catheter.

Ask a specific question about this device

The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

This submission K092298 for the Modified HD Guide Catheter is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics. For devices like this catheter, the acceptance criteria are generally related to demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's a breakdown based on the provided text, addressing the points where information is available or inferable:

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

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

The document states "The results of verification and validation conducted on the Modified HD Guide Catheter..." However, it does not provide details on specific sample sizes, the nature of the test set (e.g., patient data), or data provenance (e.g., country of origin, retrospective or prospective). Given that this is a catheter and the mention of "verification and validation," it's highly probable that the "testing" refers to bench testing and possibly animal studies, not human clinical trials with a test set of patient data in the context of AI/diagnostic device evaluation.

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 or provided in the context of this 510(k) submission. Establishing ground truth by medical experts is typically relevant for diagnostic devices (especially those using AI) where expert consensus, pathology, or outcomes data are needed to evaluate diagnostic accuracy. This submission is for a medical catheter, a therapeutic/interventional device.

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

This information is not applicable or provided. Adjudication methods are typically used in clinical trials for diagnostic accuracy or efficacy, which is not the type of study described for this device.

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

An MRMC comparative effectiveness study is not applicable and was not done for this device. This type of study is relevant for diagnostic devices that either incorporate AI or are intended to assist human readers in interpretation. The Modified HD Guide Catheter is an interventional/delivery device.

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

This is not applicable as the device is a physical medical catheter, not an algorithm or AI system.

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

For this type of device, ground truth would typically be established through engineering specifications, material science standards, and performance benchmarks as demonstrated through bench testing (e.g., tensile strength, burst pressure, lubricity, device dimensions) and potentially animal studies for biological compatibility and in-vivo performance. The document explicitly mentions "All materials used... are suitable for the intended use of the device and have been used in numerous previously cleared products," implying that material safety and suitability are established. "Verification and validation" results demonstrate performance as designed.

8. The sample size for the training set

This information is not applicable or provided. Training sets are relevant for machine learning models.

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

This information is not applicable or provided.

Ask a specific question about this device

The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.

The Modified HD Guide Catheter is a single-lumen, braided stiffness catheter with a radiopague marker on the distal end a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The radiopague shaft and distal marker facilitate fluoroscopic visualization. Device dimensions and configuration are shown on the product label. A rotating hemostatic valve with side-arm adapter is provided with each catheter.

The provided document K080583 is a Special 510(k) for a device modification, focusing on establishing substantial equivalence to a predicate device rather than a comprehensive study for initial device approval. As such, it does not contain the detailed information typically found in a clinical study report or a detailed stand-alone performance study for a new AI medical device.

Specifically, the document states: "The results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed and is suitable for its intended use." However, it does not provide the specific acceptance criteria, reported performance values, or details of the studies in the format requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. I also cannot fulfill the requests for sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information since these are not present in the provided text.

This submission is primarily focused on demonstrating that "Any differences in technological characteristics between the Modified HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness," which means the testing summarized would likely be engineering or bench performance tests rather than clinical or AI-specific performance evaluations against specific quantifiable metrics for decision support.

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