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P.D. Access Device: Is intended for use when blood flow must be detected for percutaneous vessel cannulation. The vessel must be of a caliber which would normally be punctured with a needle and introducer of this size or larger. These additional probe/needle models are being incorporated to broaden the product line in order to accommodate both user preference and patient anatomies for all age groups.

P.D. Access Monitor: Is intended for use to audibly indicate the doppler response of blood flow within an artery or vein. It is intended for use only in conjunction with the P.D. Access Vascular Access Device.

The P.D. Access™ device is intended to be used in conjunction with the P.D. Access Dual Frequency Monitor for general vascular use. The P.D. Access device is intended for general vascular use for audibly indicating the Doppler response to blood flow within an artery or vein. The indications and intended use for the P.D. Access device is the same as the predicate devices manufactured by CardioVascular Dynamics (i.e., P.D. Access/SmartNeedle). Product technology, performance characteristics, specifications, components and materials of the P.D. Access device are similar to those of predicate devices.

The CardioVascular Dynamics, Inc. P.D. Access™ Vascular Access Device and P.D. Access™ Dual Frequency Monitor received 510(k) clearance based on substantial equivalence to predicate devices, rather than a study demonstrating meeting specific acceptance criteria with performance metrics. The submission focuses on comparing the new device's characteristics to already legally marketed devices.

Here's an analysis based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

The provided documents do not define specific quantitative acceptance criteria or present performance metrics in a manner typical for a study proving device efficacy or accuracy like sensitivity, specificity, or AUC. Instead, the acceptance is based on demonstrating substantial equivalence in design, materials, indications, and overall safety and effectiveness compared to predicate devices.

The "reported device performance" is described qualitatively as:

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

• The documents do not mention a specific "test set" in the context of an accuracy or performance study involving patient data or clinical outcomes.
• The testing described ("dimensional, strength, ultrasonic performance and biocompatibility testing") would have involved physical samples of the device components, not patient data.
• No information on provenance (country of origin, retrospective/prospective) of data is provided, as no clinical study data is presented for performance evaluation against ground truth.

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

• Not applicable. No clinical test set requiring expert ground truth establishment is described. The evaluation was primarily based on engineering and biocompatibility testing against predefined specifications, and a comparison to predicate devices, not an expert-adjudicated test set for diagnostic accuracy.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set requiring adjudication is described.

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

• No, an MRMC comparative effectiveness study was not done. The submission solely focuses on demonstrating substantial equivalence to predicate devices, not on comparing performance with and without AI assistance or evaluating human reader improvement. This device is a diagnostic tool (Doppler monitor and access device), not an AI-powered image analysis system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone performance study in the context of an algorithm or AI is not applicable. The P.D. Access device is a physical medical device (vascular access and Doppler monitor) that audibly indicates blood flow, designed for human clinical use, not a standalone algorithm. The "ultrasonic performance" testing would have verified its function, but this is distinct from AI algorithm performance.

7. Type of Ground Truth Used

• The "ground truth" for the engineering and biocompatibility tests would be the established device specifications and regulatory standards for material properties, dimensions, ultrasonic output, and biocompatibility.
• For the substantial equivalence claim, the "ground truth" is effectively the performance and safety profiles of the predicate devices, against which the new device was compared.

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Not applicable. As the device does not involve AI/ML, there is no training set and therefore no ground truth establishment for one.

Summary based on the 510(k) submission:

The 510(k) cleared the P.D. Access™ Vascular Access Device and Dual Frequency Monitor based on its substantial equivalence to existing predicate devices. The evidence provided included:

• Engineering and material testing (dimensional, strength, ultrasonic performance, biocompatibility) demonstrating the device met its own specifications and performed without failures.
• A detailed comparison chart showing product technology, performance characteristics, specifications, components, and materials were "similar" to predicate devices.
• An assertion that its indications for use and intended use were "the same" as predicate devices.

The FDA decision letter confirms this, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976... or to devices that have been reclassified." There were no clinical studies or performance accuracy studies against a "ground truth" as would be seen for new diagnostic algorithms or complex AI devices.

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FOCUS™-PV Balloon Dilatation Catheters are recommended for percutaneous transluminal angioplasty of the large vessels of the renal, femoral, popliteal, tibial, peroneal, iliac and profunda arteries and for treatment of obstructive lesions of native or synthetic arterovenous dialysis fistulae.

Not Found

The provided text describes a 510(k) premarket notification for a medical device, the FOCUS™-PV Balloon Dilatation Catheter. A 510(k) submission is primarily for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets specific acceptance criteria through a formal study with detailed performance metrics as one might find in a de novo application or a clinical trial for a novel device.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them in the way clinical trials or performance studies for novel devices typically would.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This document focuses on comparing the new device's specifications and intended use to predicate devices, not on setting and meeting specific performance acceptance criteria from a study.
2. Sample size used for the test set and the data provenance: No test set is described. The 510(k) primarily relies on substantial equivalence to existing devices rather than new performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment is mentioned.
4. Adjudication method for the test set: Not applicable.
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 a medical device (balloon 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.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Explanation based on the provided text:

The document is a 510(k) summary for the FOCUS™-PV Balloon Dilatation Catheter. The core of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a predicate device already legally marketed. This means the device has:

• The same intended use as a predicate device.
• The same technological characteristics as a predicate device; OR
• Different technological characteristics from a predicate device but does not raise different questions of safety and effectiveness, and the new device is as safe and effective as the predicate device.

The provided text details:

• Intended Use: The FOCUS™-PV Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty of large vessels in various arteries and for treatment of obstructive lesions in arteriovenous dialysis fistulae. This is compared to the intended uses of several predicate devices, demonstrating similarity.
• Comparison of Characteristics: A detailed table (TABLE 1) compares the physical and material characteristics of the FOCUS™-PV catheter with several predicate PTA catheters (Schneider Match 35™, Schneider Total Cross™, Medi-tech MS Classique™, Medi-tech Ultra-Thin™, and previous versions of CardioVascular Dynamics' FOCUS™). This comparison highlights similarities in balloon size ranges, lengths, shaft sizes, materials, and guidewire compatibility.

The FDA's letter states that they "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified..." This "substantial equivalence" determination is the "acceptance criteria" met in the context of a 510(k) process, rather than specific performance metrics from a dedicated clinical study.

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The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmanNeedle® Monitor for general vascular use. The SmanNeedle® Monitor will also be marketed as the P.D. Access™ Monitor; and the Monitor graphics and labeling will be changed to reflect the name. Other than the name, the Monitors will be equivalent. There will be no change in safety and efficacy.

The P.D. Access™ / SmartNeedle® Device is indicated and intended for general vascular use for monitoring the flow of blood within the vasculature. The indications and intended use for of the P.D. Access™ / SmartNeedle® Device are the same as predicate devices manufactured by CardioVascular Dynamics (the SmartNeedle").

The P.D. Access™ / SmartNeedle® Device is intended to be used in conjunction with the SmanNeedle® Monitor for general vascular use. The SmanNeedle® Monitor will also be marketed as the P.D. Access™ Monitor; and the Monitor graphics and labeling will be changed to reflect the name. Other than the name, the Monitors will be equivalent. There will be no change in safety and efficacy. Product specifications, components and materials of the P.D. Access™ / SmartNeedle® Device are similar to those of predicate devices.

This 510(k) notification describes the P.D. Access™ / SmartNeedle® Device, a vascular access device intended for monitoring blood flow. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Testing of the P.D. Access™ / SmartNeedle® Device included dimensional, strength, ultrasonic performance and biocompatibility testing. These tests demonstrated that the all items tested were within specification tolerances. There were no failures during these tests."

However, the specific quantitative "acceptance criteria" and "reported device performance" are not detailed in this summary. The summary only provides a qualitative statement of compliance. For example, it doesn't list a specific "strength tolerance" in Newtons and then a "reported strength" of X Newtons.

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

The document does not specify the sample sizes used for the dimensional, strength, ultrasonic performance, or biocompatibility tests. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

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

This information is not applicable and not provided. The study described focuses on device performance against engineering specifications (dimensional, strength, ultrasonic, biocompatibility) rather than a diagnostic performance where expert ground truth would be required.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided, as the testing was against engineering specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. An MRMC comparative effectiveness study was not done. The device is a vascular access device with a monitoring function (audible blood flow). Its effectiveness is judged by meeting engineering specifications and being substantially equivalent to predicate devices, not by radiologists' diagnostic performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The concept of "standalone performance" as it applies to AI algorithms is not relevant here. This is a physical medical device. The "ultrasonic performance" testing would be considered the standalone performance of its monitoring capability. The document states this performance was within specification tolerances.

7. The Type of Ground Truth Used:

The "ground truth" for the tests described would be the pre-defined engineering specifications for dimensions, strength, ultrasonic output characteristics, and biocompatibility standards. These are objective measures rather than expert consensus, pathology, or outcomes data in the typical sense of diagnostic performance.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. This device does not involve a "training set" in the context of machine learning or AI algorithms.

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

This information is not applicable and not provided, as there is no training set for this type of device.

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The FOCUS™-PV Balloon Dilatation Catheter is a balloon dilatation catheter intended for use in percutaneous transluminal balloon dilatation (PTA) of large vessels of the peripheral vasculature.

The FOCUSTM PV Balloon Dilatation Catheter, styled after the Grüntzig technique, is a double lumen catheter with a balloon mounted at the distal tip. Dilatation Balloon catheters are used to exert radial force to dilate narrow vessel segments, based on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end of a catheter.

The provided text describes a 510(k) premarket notification for the FOCUS™-PV Balloon Dilatation Catheter. This document is a submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device. It is not a clinical study report proving device performance against acceptance criteria in the traditional sense of a clinical trial. Instead, it relies on demonstrating equivalence through comparison to existing devices and engineering testing.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts for ground truth, MRMC study, ground truth for training set) are not applicable to this type of regulatory submission and device.

Here's an analysis based on the information provided:

Acceptance Criteria and Reported Device Performance

The document describes the device, its intended use, and compares it to predicate devices. The "acceptance criteria" for a 510(k) submission primarily revolve around demonstrating substantial equivalence to existing, legally marketed devices and successful completion of engineering (bench) testing to ensure safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance:

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

This information is not applicable to this 510(k) submission, as it primarily relies on bench testing and comparison to predicate devices, not clinical data from a "test set" as would be used in a diagnostic algorithm study. The "test set" for the engineering tests would be the manufactured devices themselves, but specific numbers are not provided.

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)

This is not applicable. Ground truth, in the context of expert consensus, is typically used for diagnostic or screening devices. For a catheter, performance is evaluated through engineering specifications and comparison to existing devices.

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

This is not applicable. Adjudication is relevant for interpreting clinical data, not for engineering bench tests or demonstrating substantial equivalence.

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 is not applicable. The FOCUS™-PV Balloon Dilatation Catheter is a medical device for intervention (angioplasty), not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.

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

This is not applicable, as it is not an algorithm-based device.

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

For engineering tests, the "ground truth" is typically the established engineering specifications and accepted industry standards for medical device safety and performance. For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

This is not applicable, as this is not an AI/machine learning device requiring a training set.

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

This is not applicable, as this is not an AI/machine learning device.

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