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The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, popliteal, infra popliteal and renal arteries.

The POWERFLEX P3 PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The OPTA PRO PTA catheter is intended to dilate stenoses in ilio-femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The modified PTA catheters described in this submission are virtually identical to its original cleared devices, which received 510(k) concurrence.

The Cordis over-the-wire (OTW) PTA balloon catheters have a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilatation section of the balloon and aid in balloon placement. The radiopaque marker bands indicate the nominal length of the balloon. The balloon inflation lumen is used to inflate and deflate the balloon. The guide wire lumen is used to track the catheter over a pre-positioned guide wire or to inject contrast medium and/or saline.

Compared to the previously cleared predicate devices, the devices in this submission are identical, except for the following feature: Polyamide hub instead of polycarbonate hub Injection molded hub instead of UV-glued hub Slight design configuration change for user preference.

The provided text is a 510(k) Premarket Notification for Cordis PTA Balloon Catheters, and it does not include information about a study proving the device meets specific acceptance criteria in the way a clinical trial or AI/ML performance study would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices based on non-clinical design verification tests and analyses. This approach is typical for 510(k) submissions where the new device is very similar to an already approved one.

Therefore, many of the requested points related to acceptance criteria, ground truth, expert adjudication, MRMC studies, standalone performance, and training/test set details are not applicable or discoverable in this type of submission.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no explicit table of acceptance criteria and reported device performance in the context of a clinical performance study with defined metrics (e.g., sensitivity, specificity, accuracy).

Instead, the "performance" demonstrated is that the modified devices are "virtually identical" to their original cleared devices, with changes limited to non-clinical aspects like hub material and design configuration for user preference. The regulatory "acceptance criteria" here are implicitly that these minor design changes do not negatively impact the safety and effectiveness, and the device continues to meet the safety and performance of its predicate.

• Acceptance Criteria (Implicit): The modified devices demonstrate biocompatibility, and their non-clinical performance (e.g., inflation/deflation, tracking over a guidewire, radiopacity) is equivalent to the predicate devices, and the changes do not introduce new safety concerns.
• Reported Device Performance: "Safety and The safety and effectiveness of the affected PTA Balloon Catheters have been Performance demonstrated via data collected from non-clinical design verification tests and Data analyses. All materials used in these modified devices have been tested according to ISO 10993-Part 1 and were found biocompatible."

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

• Test Set Size: Not applicable. This submission relies on non-clinical design verification tests, not a clinical test set with patient data.
• Data Provenance: Not applicable, as there are no patient data. The "data" are from non-clinical laboratory tests.

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

• Number of Experts: Not applicable. Ground truth as typically understood for clinical performance studies (e.g., diagnosis, lesion identification) is not established here.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Not applicable. There is no clinical test set 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:

• MRMC Study: No. This is a medical device (balloon catheter), not an AI/ML diagnostic or assistive device that would involve human readers.

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

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• Ground Truth: For biocompatibility, the "ground truth" is adherence to ISO 10993-Part 1 standards. For functional performance, the "ground truth" is equivalence in non-clinical bench testing to the predicate device. This is a technical (engineering/materials) ground truth, not a clinical ground truth.

8. The sample size for the training set:

• Not applicable. There is no AI/ML component, so no training set.

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

• Not applicable.

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This test detects hCG in urine. hCG is a hormone produced by the placenta shortly after implantation. Since hCG is present in the urine of a pregnant woman, it is an excellent marker for confirming pregnancy. This device is intended for clinical laboratories (labs) and physician's office labs (POLs) as an IVD test for the qualitative measurement of hCG in urine.

Immunoassay for the Qualitative Detection of Human Chorioni Gonadotropin (hCG) in Urine for the Early Pregnancy. The QuickCard Pro™ HCG Test, like many commercially available pregnancy test kits, qualitatively measures the presence of HCG by visual color sandwich one step immunoassay technology.

Here's an analysis of the provided text regarding the QuickCard Pro™ HCG Test, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" because the document states the device needs to be "substantially equivalent to the reported performance characteristics of other commercially available tests" and then reports actual performance which exceeds 99% for all metrics. It doesn't explicitly state "acceptance criteria must be >99%" but this is the threshold achieved for substantial equivalence.

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

The document states:

• "The product performance characteristics of the QuickCard Pro™ HCG Pregnancy Test were evaluated in a clinical sample correlation study and a blind labeled spiked HCG study."
• "Correlations studies, using clinical specimens, produced a >99% correlation..."
• "A clinical laboratory study was performed..."

Sample Size: The exact sample size for the test set is not explicitly stated in the provided text.
Data Provenance: The data came from "clinical sample correlation study" and "clinical laboratory study" using "clinical specimens." This suggests prospective collection from human subjects, although the specific country of origin is not mentioned. Given the manufacturer's location (San Diego, California, USA) and the FDA submission, it's highly probable the studies were conducted in the USA.

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

The document makes no mention of specific "experts" used to establish ground truth or their qualifications. The ground truth for this type of immunoassay is typically derived from the results of a highly accurate reference method or a predicate device.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method. For a quantitative test like hCG detection, adjudication (e.g., 2+1 or 3+1 reader consensus) is generally not applicable in the same way it would be for subjective image interpretation. The outcome (positive/negative for hCG) is typically determined by a threshold or comparison to a reference.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed. This is not typically relevant for a simple positive/negative immunoassay where human interpretation is minimal beyond observing a color change. The study evaluated the device's performance directly, not how human readers improve with or without AI assistance, as "AI" is not involved in this device.

6. Standalone (Algorithm Only) Performance

This device is a standalone test (an immunoassay), and its performance metrics (sensitivity, specificity, accuracy, correlation) directly represent its "standalone" performance. There is no human-in-the-loop component in the evaluation of its core analytical function; it produces a result based on the chemical reaction. The "professional users" in the clinical laboratory study are performing the test according to instructions and observing its output, not providing an independent interpretation that is then augmented by the device.

7. Type of Ground Truth Used

The ground truth was established by:

• Comparison to predicate devices: "Correlations studies, using clinical specimens, produced a >99% correlation when compared to the Quidel Rapidvue (San Diego, CA 92121) and the Syntron Bioresearch Be Sure Pregnancy Test (Vista, CA 92083)." These predicate devices themselves would have established their accuracy against a recognized gold standard for hCG detection (e.g., a laboratory reference assay or clinical confirmation).
• "Blind labeled spiked HCG study": This indicates that samples with known, controlled concentrations of hCG (both positive and negative) were used, providing a definitive ground truth.

Therefore, the ground truth is a combination of reference device comparison and known spiked samples, which themselves are validated against established medical science for hCG detection.

8. Sample Size for the Training Set

The document does not mention a training set size. This device is an immunoassay, not a machine learning or AI-based diagnostic tool that would typically involve a "training set" in the computational sense. Its performance is based on the chemical principle and validation with physical samples.

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

As there is no concept of a "training set" for this type of immunoassay in the context of an algorithm, the question of how ground truth was established for it is not applicable. The device's design and manufacturing are based on established immunochemical principles, not on iterative machine learning from a dataset.

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