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The Bipore Balloon Dilatation Catheter is recommended for percutaneous transluminal angioplasty of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.

The Bipore PTA Balloon Dilatation Catheter is also indicated for post deployed stent expansion. Use of the Bipore Balloon Dilatation Catheter for post-deployed stent expansion was demonstrated on the bench with the Cordis Palmaz™ stent*.

The Bipore Balloon Dilatation catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessel. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guide wire to locate the balloon at the site of stenosis. This submission adds two balloon sizes to the existing product line, as follows, and does not affect the safety or effectiveness of the device.

The document provided is a 510(k) premarket notification for a medical device, the Bipore Balloon Dilatation Catheter. It outlines the device's description, indications for use, and confirms substantial equivalence to a predicate device. However, it does not contain the detailed acceptance criteria and study results typically found in reports specifically designed to prove a device meets acceptance criteria for efficacy or performance in a clinical setting.

The "Testing included" section only mentions "Rated Burst pressure within the stent" and "Balloon Fatigue within the stent." These are likely engineering or bench tests for device integrity and durability, not clinical performance metrics.

Therefore, many of the requested details cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the input:

1. Table of acceptance criteria and the reported device performance

Explanation: The document only lists "Rated Burst pressure within the stent" and "Balloon Fatigue within the stent" under "Testing included." It does not provide the specific acceptance criteria (e.g., minimum burst pressure, number of cycles for fatigue) nor the actual performance results (e.g., "device achieved X burst pressure," "device endured Y fatigue cycles"). These details would typically be found in an engineering report or a full test report, which is not part of this 510(k) summary.

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

Cannot be determined from the provided document.

Explanation: The document refers to "bench" testing, implying laboratory-based engineering tests rather than clinical trials with patient data. As such, concepts like "test set," "data provenance," "country of origin," "retrospective," or "prospective" do not apply in the usual clinical sense. The sample size for the devices tested on the bench (e.g., number of catheters subjected to burst pressure or fatigue tests) is not mentioned.

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 / Cannot be determined from the provided document.

Explanation: This question pertains to studies involving human interpretation or assessment, often in diagnostic imaging or clinical outcomes. The mentioned "bench" testing does not involve human experts establishing ground truth in this manner.

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

Not applicable / Cannot be determined from the provided document.

Explanation: Adjudication methods are used in studies where multiple human readers or evaluators independently assess data, and a process is needed to resolve discrepancies. This is not relevant to the "bench" testing described.

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

No MRMC comparative effectiveness study was mentioned or performed.

Explanation: The device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.

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

Not applicable.

Explanation: The device is a physical medical instrument, not an algorithm. Standalone algorithm performance is not relevant.

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

Not applicable in the clinical sense for the described tests.

Explanation: For the "Rated Burst pressure" and "Balloon Fatigue" tests, the "ground truth" would be engineering specifications and physical properties measured against those specifications (e.g., a pressure gauge reading, a cycle counter). This isn't "expert consensus," "pathology," or "outcomes data" as typically used in medical device performance evaluation for clinical effectiveness.

8. The sample size for the training set

Not applicable (no training set mentioned).

Explanation: This question relates to machine learning models, which are not involved in the description of this physical medical device's testing.

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

Not applicable (no training set mentioned).

Explanation: This question also relates to machine learning models, which are not involved.

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The Bipore PTA catheters are indicated for percutaneous transluminal angioplasty of the illac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.

The Birgore, Inc. PTA Balloon Dilatation Catheter is also indicated for post-deployed stent expansion. Use of the Signe Dilatation Catheter for post-deployment sten expansion was demonstrated on the bench with the Cordi's Palmaz™ stent *.

All sterts must be implanted and deployed according to the stent manufacturer's indications, contraindications, and instructions for use.

The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessel. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guide wire to locate the balloon at the sire of stenosis. This submission adds two balloon sizes to the existing product line, as follows, and does not affect the safety or effectiveness of the device.

This is a 510(k) premarket notification for a medical device (Bipore Balloon Dilatation Catheter), not an AI/ML device. Therefore, many of the requested categories regarding AI/ML performance, such as sample size for training data, ground truth establishment for training data, number of experts for ground truth, and MRMC studies, are not applicable.

However, I can extract information related to the device's acceptance criteria and the studies performed to demonstrate its safety and effectiveness based on the provided text.

Here's the breakdown:

Acceptance Criteria and Device Performance for Bipore Balloon Dilatation Catheter

1. Table of Acceptance Criteria and Reported Device Performance

The document describes in vitro functional tests and biocompatibility tests performed on the device. While specific quantitative acceptance criteria (e.g., "burst pressure must exceed X psi") are not explicitly listed in numerical form, the completion of these tests with acceptable results implies that the device met pre-defined performance standards for each. The document states that "it has been demonstrated that the Bipore Balloon Dilatation Catheter product line extensions are safe and effective for their intended use," which serves as the overall reported performance.

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

The document does not explicitly state the sample sizes for the functional and biocompatibility tests.
The provenance of the data is bench testing (in vitro) for functional tests and laboratory testing for biocompatibility, carried out by the manufacturer, Bipore, Inc. There is no indication of human subject data, retrospective or prospective studies.

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

Not applicable. This device is not an AI/ML device, and the "ground truth" for its performance is established through standard engineering and laboratory testing protocols rather than expert consensus on images or clinical data.

4. Adjudication Method for the Test Set

Not applicable. This device is not an AI/ML device relying on human interpretation or adjudication for its performance evaluation. Performance is determined by objective physical and chemical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is not an AI/ML device, and MRMC studies are not relevant to its evaluation.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by objective measurements and observations from validated in vitro functional tests and standard biocompatibility assessments. For instance, a balloon burst test has a physical burst pressure as its ground truth, not an expert's opinion. Similarly, biocompatibility is assessed against established biological response criteria.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. No training set is used for this physical device.

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The Bipore Balloon Dilatation Catheter is indicated for Transluminal Percutaneous Angioplasty (PTA) of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.

The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessels. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guidewire to locate the balloon at the site of stenosis.

The Bipore Balloon Dilatation Catheter will be offered in three balloon sizes and one shaft length, as follows:
Inflated Balloon Diameter (mm): 6, 8, 10
Balloon Length (cm): 4, 4, 4
Catheter Size (Fr): 5, 5, 5
Usable Length (cm): 100, 100, 100

The provided text is a summary of a 510(k) premarket notification for the "Bipore Balloon Dilatation Catheter" from 1996. It describes the device, its intended use, and lists some in vitro functional tests and biocompatibility tests performed.

However, the document does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving those criteria. Specifically, it lacks:

• Quantitative acceptance criteria values. It lists the types of tests performed (e.g., "Balloon Burst"), but not the specific thresholds for passing those tests (e.g., "Balloon Burst pressure > X atm").
• Reported device performance values. While it mentions tests were performed, it doesn't provide the results of these tests (e.g., "Balloon Burst pressure was Y atm").
• Information about a specific study to prove device performance against acceptance criteria. The document states "The following in vitro functional tests were performed..." and "The following biocompatibility tests were performed...", implying tests happened, but it doesn't describe these as a formal "study" with the characteristics you've requested (e.g., sample size, ground truth establishment, expert involvement, MRMC study, etc.). This is a medical device, not an AI/ML-driven diagnostic, so many of your questions, particularly those about experts, ground truth, and AI-assistance, are not applicable in this context.

Below is an attempt to answer the questions based on the limited information provided, acknowledging the significant gaps.

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

Note: The document concludes the device is "safe and effective for its intended use" based on these tests, implying all criteria were met, but specific numerical values for criteria and performance are not given.

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

The document does not specify the sample size for the in vitro or biocompatibility tests. It also does not discuss "data provenance" in the context of geographical origin or retrospective/prospective nature, as these tests are laboratory-based device characterization.

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

This question is not applicable to the type of device and testing described. The tests are in vitro functional and biocompatibility tests, which rely on established laboratory protocols and measurements, not human expert interpretation of data points to establish a "ground truth."

4. Adjudication method for the test set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human interpretation or subjective assessment where consensus is needed. For in vitro and biocompatibility testing, results are typically objective measurements or observations against predetermined criteria.

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 question is not applicable. The device is a physical medical device (balloon catheter) and does not involve AI or human readers for its operation or performance evaluation as described.

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

This question is not applicable. The device is a physical medical device (balloon catheter) and does not involve an algorithm.

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

For the in vitro functional tests, the "ground truth" would be established physical measurements and engineering specifications. For biocompatibility tests, the "ground truth" would be established biological and toxicological standards and observations. These are objective measures, not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or predictive devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" for physical device testing in the context of machine learning or AI.

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

This question is not applicable for the reasons stated above.

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