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The Metricath Gemini-P System is indicated for use in the renal, iliac and femoral arteries for:

• Balloon dilatation of the stenotic portion of an arterial lesion
• Post-delivery expansion of balloon expandable stents
• Measurement of arterial lumen cross sectional area and diameter proximal to a lesion, or within a stented section of artery.

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This document is a 510(k) clearance letter for the Metricath Gemini-P System. It is a regulatory document and does not contain information on acceptance criteria or a study proving device performance against such criteria. Therefore, I cannot provide the requested information based solely on the provided text.

Specifically, the document:

• States that the FDA has found the device to be "substantially equivalent" to legally marketed predicate devices.
• Lists the indications for use of the device: balloon dilatation, post-delivery expansion of balloon expandable stents, and measurement of arterial lumen cross-sectional area and diameter.
• Provides regulatory details such as regulation number, name, class, and product code.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts used to establish ground truth or adjudication methods for a test set.
4. Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size.
5. A standalone performance study of the algorithm (as this is a medical device, not an AI/algorithm-based one in the context of typical standalone performance studies for AI).
6. The type of ground truth used.
7. Sample size for a training set.
8. How ground truth for a training set was established.

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The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary, renal, iliac and femoral arteries. The Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous, transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of artery.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Angiometrix Inc. Metricath System, dated November 18, 2004. This type of document primarily confirms that a medical device is substantially equivalent to a predicate device already on the market and describes its intended use. It does not typically contain detailed information about specific acceptance criteria, study designs, or performance metrics in the way a clinical study report or a technical design document would.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The letter does not specify quantitative acceptance criteria or detailed performance results. It only states that the device is "substantially equivalent."
• Sample size used for the test set and the data provenance: No information on test set size or data origin (e.g., country, retrospective/prospective) is present.
• Number of experts used to establish the ground truth for the test set and their qualifications: No details about ground truth establishment or expert involvement are provided.
• Adjudication method: The document does not describe any adjudication process.
• Multi-reader multi-case (MRMC) comparative effectiveness study: There is no mention of such a study or any associated effect size.
• Standalone (algorithm only) performance: This device is a physical catheter system, not a software algorithm, so standalone performance in the sense of AI models is not applicable.
• Type of ground truth used: Not specified.
• Sample size for the training set: Not applicable for this type of device and document.
• How the ground truth for the training set was established: Not applicable.

What the document does provide is:

• Device Name: The Metricath System
• Indications for Use: "The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary, renal, iliac and femoral arteries. The Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous, transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of artery."
• Regulatory Classification: Class II (two), Product Code: DQO, Regulation Number: 21 CFR 870.1200 (Diagnostic Intravascular Catheter)
• Predicate Device: Not explicitly named, but the letter states the device is substantially equivalent to "legally marketed predicate devices."
• Date of Clearance: November 18, 2004

To get the specific information requested in the prompt, one would need to review the original 510(k) submission (K042685) itself, which would contain the technical data and study reports submitted to the FDA to demonstrate substantial equivalence. The clearance letter only summarizes the FDA's decision.

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The Metricath™ System is intended for measuring intravascular diameter and cross-sectional area, in the coronary arteries only.
The Metricath System is indicated for use as an adjunct to conventional angiographic procedures to provide measurements of arterial lumen cross sectional area and diameter of the coronary vasculature. Metricath Balloon Catheter is indicated for use in patients who are candidates for percutaneous transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of an artery.

The Metricath™ System consists of two parts, the Metricath™ 1000 computer console, and the sterile, disposable Metricath™ Balloon Catheter. The Metricath™ System measures both artery lumen diameter and cross sectional area using a low-pressure balloon catheter inserted into the artery using standard interventional procedures and techniques. The Metricath™ System is indicated for use in patients who are candidates for percutaneous transluminal interventional procedures to make arterial lumen measurements proximal to a lesion, or within a stented section of an artery.

The provided text describes the Metricath™ System, a device for measuring intravascular diameter and cross-sectional area in coronary arteries. It details the regulatory submission (K024000) and the FDA's clearance.

However, the provided document does not contain a table of acceptance criteria or the reported device performance in the way typically expected for a medical device study showing specific metrics (e.g., accuracy, precision) against predefined thresholds. The document focuses on regulatory compliance, substantial equivalence to predicate devices, and general safety and effectiveness.

Based on the provided text, here's what can be extracted and inferred:

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

The document doesn't provide specific numerical acceptance criteria for performance metrics (like accuracy of diameter measurement) nor does it report specific numerical performance results from a clinical study for these metrics. Instead, it states that the device "met or exceeded the requirements" of various standards and was found "safe and effective for its intended use."

Here's a table summarizing the stated compliance and general findings:

Regarding the study that proves the device meets the acceptance criteria:

The document broadly refers to "testing" and "evaluation" rather than detailing a specific, comprehensive clinical trial with explicit acceptance criteria and corresponding performance data. The core of the proof appears to be based on:

• Compliance with international standards: IEC 60601-1, IEC 60601-1-2, ISO 10555-1, ISO 10555-4, and ISO 10993.
• Software validation.
• In-vivo testing: It states, "The Metricath™ System has been tested in-vivo, and found safe and effective for its intended use." No further details on this in-vivo test (e.g., sample size, protocol, specific results) are given.
• Comparison to predicate devices: "The Metricath™ System has been tested and compared to the predicate devices, and found to be substantially equivalent with regards to device safety and intended use." Again, no specific comparative study details are provided.

The following information cannot be fully answered from the provided text as it primarily an FDA 510(k) summary focused on regulatory clearance based on substantial equivalence, not a detailed clinical study report.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not specified. The document only mentions "tested in-vivo" without providing the number of subjects or cases.
• Data Provenance: Not specified.

3. 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 specified. The document does not describe a process for establishing ground truth via expert review for the in-vivo testing.

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

• Not specified.

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 device is not an AI-assisted diagnostic tool for human readers; it is a physical measurement device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed/reported for this device. The comparison was for substantial equivalence to predicate devices, not diagnostic performance improvement for human readers.

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

• The device itself is a standalone system for measurement. The "in-vivo" testing and comparison to predicate devices would effectively be an assessment of its standalone performance. However, specific performance metrics (e.g., accuracy, precision) are not detailed.

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

• Not explicitly stated. For a device measuring lumen diameter and cross-sectional area, the "ground truth" in comparative testing would likely involve measurements from the predicate devices or potentially a highly accurate reference method (e.g., a gold standard imaging technique or physical model), but this is not specified.

8. The sample size for the training set:

• Not applicable as this is not an AI/machine learning device that requires a training set in the conventional sense. Its software was "successfully validated," which refers to standard software development lifecycle validation, not machine learning model training.

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

• Not applicable.

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