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The Hexapolar Electrode Balloon Floatation Catheter is designed to provide diagnostic information. It is intended to be used for the following:

1. Temporary use in electrophysiology studies;
2. Intra-cardiac ECG; and
3. Electrical stimulation.

The Hexapolar Electrode Balloon Flotation Catheter (HEBFC) is furnished in both five and seven French sizes. The device has an electrode mounted at the distal tip with a latex balloon proximal to the tip electrode. There are five electrodes mounted on the shaft proximal to the balloon. The shaft has bands every ten centimeters. At the manifold, the extension with a Stopcock is connected to the Air Lumen. The electrode wire are connected to wire extensions with pin connectors. These are coded with numbers for identification.

The provided FDA 510(k) summary for the Hexapolar Electrode Balloon Flotation Catheter does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a premarket notification (510(k)) seeking substantial equivalence to a predicate device. The information provided focuses on:

• Device Description: Comparing the new device (Hexapolar Electrode Balloon Flotation Catheter) to a previously approved predicate device (J-LLoyd Medical, Inc. Bipolar Balloon Pacing Catheter).
• Technological Characteristics: Highlighting similarities in materials, design, and assembly, and the addition of four electrodes with expanded functions (electrophysiology studies and intracardiac ECG recording).
• Performance Data: Stating that mechanical strengths and electrical tests remain the same as with the Predicate Device.
• Safety Statement: Emphasizing inherent hazards of invasive procedures are identified, and that the basic design has been in use for a long time by many physicians.
• Intended Use/Indications for Use: Listing the specific applications for the device.
• FDA Clearance: The letter from the FDA confirming substantial equivalence.

Therefore, I cannot populate the requested table and answer the study-related questions based on the input text.

Here's why and what's missing:

• Acceptance Criteria & Performance: The document states that "The performance data such as mechanical strengths and electrical tests remain the same as with the Predicate Device." It does not provide what those specific performance data points or acceptance criteria are, nor does it present new test results for the Hexapolar device against those criteria. It implies that since the core technology is similar, the existing predicate device's performance data applies.
• Study Details: There is no mention of a specific study, sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This type of information is typically required for novel devices or when significant changes warrant new performance testing. For a 510(k) based on substantial equivalence, especially for a device that is essentially an enhanced version of an existing product, extensive new performance studies are often not required if the changes are deemed minor and do not alter the fundamental safety and effectiveness.

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The Electrode Semi-Floatation Catheter is designed to provide diagnostic information. It is intended to be used for the following:

1. Temporary use in electrophysiology studies;
2. Intra-cardiac ECG; and
3. Electrical stimulation.

The Electrode Semi-Flotation Catheter is furnished in five, six and seven French sizes. The device has an electrode mounted at the distal tip. There are one to five electrodes mounted on the shaft proximal to the tip. The shaft has bands every ten centimeters. The electrode wires are connected to wire extensions with pin connectors. These are coded with numbers for identification.

The provided text describes a 510(k) submission for the J-LLoyd Medical, Inc. Electrode Semi-Flotation Catheter. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies with specific acceptance criteria as might be seen for novel technologies.

Therefore, many of the typical acceptance criteria and study details for a new device are not explicitly present in the provided documentation. The "study" here is essentially a comparison to the predicate device and the existing knowledge about such devices.

Here's an analysis based on the provided text, addressing your points where possible:

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

The submission does not define specific, quantifiable acceptance criteria in the format of a typical clinical trial (e.g., sensitivity, specificity thresholds). Instead, the primary "acceptance criterion" is substantial equivalence to the predicate device, the J-LLoyd Medical, Inc. Bipolar Balloon Pacing Catheter (K930069), regarding materials, basic design, assembly methods, and performance data.

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is described for the new device itself. The evidence relies on:

• Engineering testing on the device (not quantified in terms of sample size).
• The established performance and safety of the predicate device.
• The long history of similar basic designs in use since before May 28, 1976.

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

Not applicable. This was a 510(k) submission based on substantial equivalence, not a study requiring expert readers to establish ground truth for a new diagnostic or prognostic device's performance. The "judgement" of safety is provided by the submitter (James L. Skaggs, Sr., General Manager), referencing widespread physician use over a long period.

4. Adjudication method for the test set

Not applicable, as there was no test set requiring multi-expert 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 device is an electrode catheter, not an AI-powered diagnostic tool.

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

Not applicable. This device is an electrode catheter.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic performance studies is not relevant here. The "truth" in this context is the demonstrated safety and performance of the predicate device and the manufacturing/design equivalence of the new device to that predicate. This relies on:

• Engineering Test Data: Mentioned for mechanical strengths and electrical tests, and for safety, though specifics are not provided.
• Historical Data/Clinical Experience: The widespread use of the basic design by "thousands of physicians, in hundreds of hospitals world wide" since before May 28, 1976, forms the basis for the safety judgment.
• Predicate Device Approval (K930069): The predicate device's prior FDA approval provides the basis for substantial equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning device.

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

Not applicable. This is not a machine learning device.

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This catherer is intended for:

• Temporarily occlude blood vessel.
• Irrigating facility for heparin or contrast media.
• USed for the non-surgical removal of emboli and thrombi,

This balloon catheter is furnished in three, four, five, six, seven, eight and nine French sizes. The device has an balloon mounted at the distal tip. The shaft has bands every ten centimeters. The proximal end has a manifold and one extension with a hub and a second extension with a stopcock.

The provided text is a 510(k) summary for the Embolectomy Irrigation - Occlusion Balloon Catheter (EIOBC). This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or medical imaging device. Therefore, much of the requested information regarding acceptance criteria, study details, and AI performance is not applicable to this submission.

Here's an analysis based on the provided text, addressing the points where information is available or noting when it's not applicable:

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

The submission does not present a table of specific acceptance criteria or reported device performance in the typical sense of a clinical or technical effectiveness study with quantifiable metrics. Instead, the "acceptance criteria" for a 510(k) submission like this are met by demonstrating "substantial equivalence" to a legally marketed predicate device. The performance is assessed by comparison to the predicate device.

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

This submission does not describe a "test set" in the context of an AI or diagnostic device study. The comparison is based on the design, materials, and intended use to a predicate device already on the market. The "engineering testing" mentioned for safety and performance (mechanical strengths, balloon tests) would have been conducted internally by the manufacturer, likely on a sample of devices, but the size of this sample is not specified, nor is the data provenance in terms of country or retrospective/prospective nature.

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 applicable. There is no "ground truth" establishment in the context of expert consensus, as this is not a diagnostic device or an AI performance study. The assessment is based on comparison to an existing device.

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

Not applicable. There is no test set or adjudication method described for performance evaluation in this 510(k) summary.

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 not an AI-assisted device, and no MRMC study was performed.

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

Not applicable. This is a physical medical device (catheter), not an algorithm or AI.

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

Not applicable. The validation for this device is based on demonstrating substantial equivalence to a predicate device, which includes equivalence in design, materials, manufacturing, intended use, and performance claims derived from engineering testing (rather than clinical ground truth via expert consensus, pathology, or outcomes data).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI or machine learning device.

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

Not applicable. There is no training set mentioned in this 510(k) summary.

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The catherer is designed to provide vital diagnostic information. It is indicated for: Accessing the cystic duct and injecting radiopaque medium during Laparoscopic Cholecystomy procedures.

This Cholangiographic Balloon Catheter is furnished in four French two lumen size, with a radiopaque band proximal to the balloon

The provided text is a 510(k) summary for a Cholangiography Balloon Catheter (K974336). It claims substantial equivalence to a predicate device (K935403), the J-LLoyd Medical, Inc. Wedge Pressure Catheter.

Based on the provided information, the submission describes the device and its intended use, but it does not contain details about specific acceptance criteria or an analytical study proving the device meets those criteria. Instead, it relies on the substantial equivalence argument, stating that the new device is "basically the same" as the predicate device with the addition of a radiopaque band, and that "performance data such as mechanical strength tests remain the same as with the Predicate Device."

Therefore, I cannot populate the requested table and study details directly from the provided text. The document indicates that the device's acceptable performance is presumed based on its similarity to a previously approved device.

Here's a breakdown of why the specific information requested is not present:

Missing Information and Why:

• Acceptance Criteria Table and Reported Device Performance: This critical information is absent. The submission hinges on the new device being substantially equivalent to the predicate, implying that the predicate's performance is the benchmark. However, no specific performance metrics (e.g., burst pressure, flow rates, flexibility) for either the new or predicate device are listed, nor are the acceptance limits for these criteria.
• Sample Size for Test Set and Data Provenance: No dedicated test set or study is described for the new device. The document states that "performance data such as mechanical strength tests remain the same as with the Predicate Device," suggesting reliance on the predicate's testing.
• Number of Experts, Qualifications, Adjudication Method: These are relevant for studies involving human interpretation or subjective assessment. Since no such study is described for the Cholangiography Balloon Catheter, this information is not applicable or provided.
• MRMC Comparative Effectiveness Study: There is no mention of a comparative effectiveness study, especially one involving human readers with or without AI assistance, as AI is not a component of this medical device.
• Standalone Performance Study: No standalone (algorithm-only) performance is applicable as this is a physical medical device, not a software algorithm.
• Type of Ground Truth Used: This is also not applicable for the type of device and submission. Performance is typically assessed through engineering tests (e.g., material strength, functionality) rather than ground truth established by expert consensus or pathology in this context.
• Sample Size for Training Set & How Ground Truth was Established for Training Set: These are not applicable for this type of device submission. Training sets and ground truth are concepts usually tied to machine learning algorithms.

Summary of available information related to performance justification:

The justification for acceptance appears to be based on the following:

• Substantial Equivalence: The key argument is that the Cholangiography Balloon Catheter is substantially equivalent to the J-LLoyd Medical, Inc. Wedge Pressure Catheter (K935403).
• Minimal Design Change: The only physical difference is "the addition of Stainless Steel band" (radiopaque band).
• Shared Materials and Design: The new device uses "the same materials, the same basic design and the same methods of assembly" as the predicate.
• Presumed Performance: The document explicitly states: "The performance data such as mechanical strength tests remain the same as with the Predicate Device." This implies that the new device is expected to perform identically due to its fundamental similarity and that the predicate's established performance is sufficient.
• Biological, Chemical, and Sterilization: These specifications also "remain the same as the Predicate Device."

In conclusion, while the submission aims to demonstrate acceptable device performance for regulatory approval, it does so by arguing substantial equivalence rather than presenting detailed experimental data from a new study specific to the Cholangiography Balloon Catheter.

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to provide a means to obtain right heart pressure readings from various parts of the right heart and cardiac output.

Flow Directed Thermodilution / Infusion Balloon Catheter

This document is a summary of safety and effectiveness for a medical device submitted in 1997. It describes a Flow Directed Thermodilution / Infusion Balloon Catheter and compares it to a similar device by Nova Medical Specialties, Inc.

The document does not provide the level of detail requested in the prompt for AI/software-based medical devices. It's focused on the physical characteristics and basic functional equivalence of two catheters. Therefore, many of the requested fields cannot be filled.

Here's an attempt to answer the questions based only on the provided text, with many N/A or "Not Provided" answers:

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: Not provided. The text mentions "tests" but not how many units were tested.
   • Data Provenance: Not provided. It describes "engineering tests" but not where or when they were conducted, or if they involved human subjects/patient data. It's likely internal manufacturer testing.

2. 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)

   • Number of Experts: Not provided.
   • Qualifications of Experts: Not provided. The document mentions "Engineering tests" and implies assessment by "trained physician[s]" for proper use, but not for establishing ground truth for the device's technical specifications.

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

   • Not applicable/Not provided. This is typically relevant for subjective assessments, which isn't the primary focus of these physical device tests.

4. 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. This document predates the widespread use of AI in medical devices and describes a physical catheter, not an AI algorithm.
   • Effect Size: Not applicable.

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

   • No. This is a physical medical device, not an algorithm.

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

   • Type of Ground Truth: For the physical characteristics (material strength, bond strength), the ground truth would be based on engineering standards and physical test measurements (e.g., tensile strength in pounds per square inch, burst pressure in psi). For functionality, it would be direct measurement of pressure readings and cardiac output obtained.

7. The sample size for the training set

   • Not applicable/Not provided. This concept is relevant for machine learning models, not for engineering tests of a physical catheter.

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

   • Not applicable/Not provided.

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