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The PVS 1700 Steerable Delivery System®-10 Microcatheter is intended to be used to access tortuous vasculature for sub-selective controlled infusion or delivery of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic or interventional procedures.

The PVS 1700 Steerable Delivery System®-10 is a 1.9F/2.4F (nominal distal/proximal) tubular device, 155 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polymeric material and has an inside diameter of 0.0165". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the lumen. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.

The provided document is a 510(k) summary for a medical device (PVS 1700 Steerable Delivery System®-10 Microcatheter), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results for novel acceptance criteria.

Therefore, many of the requested details about specific acceptance criteria from a clinical study, sample size, expert ground truth establishment, and MRMC studies are not applicable or available in this type of regulatory submission. The device is primarily evaluated through bench testing and comparison to existing, cleared devices.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each test, nor does it provide detailed performance numbers in a table. Instead, it generally states that tests "yielded acceptable results" or "confirmed biocompatibility."

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

The document does not specify a "test set" in the context of patient data for clinical studies, as the evaluation primarily involved bench testing (performance testing) and biocompatibility testing. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).

For bench tests, typically multiple units of the device are tested, but the exact sample sizes for each specific test (e.g., how many catheters were burst tested) are not provided in this summary.

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

Not applicable. The ground truth for this device's evaluation (bench testing) is based on engineering specifications, material science standards (ISO), and direct physical measurements/observations, not on expert consensus from clinical cases.

4. Adjudication Method for the Test Set

Not applicable, as this device was evaluated via bench testing rather than through a clinical study requiring human interpretation or adjudication of patient cases.

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

No. This type of study is not relevant for the regulatory pathway (510(k) for a microcatheter) and the type of evidence presented (bench testing for substantial equivalence).

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

Not applicable. This device is a physical microcatheter, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for proving the device meets acceptance criteria is primarily:

• Engineering specifications and design requirements: For dimensional inspection, flow rate, tensile strength, burst strength, torqueability, torsional strength, and guidewire compatibility.
• International Standards (ISO 10993-1 and ISO 10555-1): For biocompatibility and performance testing of intravascular catheters.
• Comparison to predicate devices: To establish substantial equivalence in terms of technological characteristics and indications for use.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable.

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The PVS 1300 Synchro® 0.014" & 1600 Synchro® 0.010" Neuro Guidewire series of products are intended for general intravascular use, which includes peripheral and neurovascular use. The device can be used to selectively introduce and position catheters and other interventional devices within the peripheral & neurovasculature. The device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

products having a 0.014" & 0.010" outside diameter respectively, being sterile, single use/disposable products, with shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for peripheral, neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical Systems (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer or the torque device are intended to enter the body. The products are projected to be provided in a 180cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 65cm range, with 35-45cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from support (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.

The provided text describes a 510(k) submission for guidewires, which are physical medical devices, not software or AI-powered devices. Therefore, the questions related to AI/algorithm performance metrics, expert reviews, ground truth, and training sets are not applicable to this document. The submission focuses on demonstrating substantial equivalence to predicate guidewires through material properties and performance testing.

Here's the relevant information that can be extracted from the provided text, structured to best fit your request:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a series of "Safety and Performance Tests" on the materials comprising the PVS 1300 Synchro® 0.014" & PVS 1600 Synchro® 0.010" guidewires. These tests were performed in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each individual performance test (e.g., how many guidewires were tested for tensile strength or fatigue). It generally states "Subject product testing has yielded acceptable safety & performance outcomes."

The data provenance is from laboratory testing of the manufactured guidewires by Precision Vascular. It is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate the device's performance. The country of origin of the data is not explicitly stated, but the manufacturer is based in West Valley City, UT, USA, suggesting the testing was likely conducted in the USA or by a contracted lab.

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

This question is not applicable. The "ground truth" for a physical medical device like a guidewire is its adherence to predefined engineering specifications and performance standards through physical testing, not expert interpretation of data.

4. Adjudication Method for the Test Set

This question is not applicable, as there was no expert review or "ground truth" establishment in the context of interpretation that would require an adjudication method. The results are from objective physical tests.

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

This question is not applicable. This is a physical medical device, not an AI or imaging device that would involve human readers.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by engineering and material specifications and internationally recognized standards (e.g., ISO 10993-1, ISO 11070:1998). The performance tests directly assess whether the device meets these objective, quantifiable standards.

8. The Sample Size for the Training Set

This question is not applicable. There is no algorithm or AI model being "trained" for this device.

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

This question is not applicable.

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The PVS 1600 Synchro® 0.010" Neuro Guidewire series of products is intended for neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

The PVS 1600 is a member of the Synchro® Neuro Guidewire family of products having a 0.010" outside diameter, being a sterile, single use/disposable product, with a shapeable tip which is used to gain intravascular access to and facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Merit Medical Systems (K936032)) is supplied with the wire to facilitate deployment & positioning. A guidewire introducer (B. Braun (K760389)) is also supplied and may be used to aid introduction of the guidewire into the catheter hub and/or hemostasis valve and to gently shape the guidewire's distal flexible tip, if desired, according to standard practice. Neither the guidewire introducer or the torque device are intended to enter the body. The product is projected to be provided in a 180cm - 300cm length range, with 200cm being nominal. The Nitinol tip length is projected to be presented in a 35cm - 65cm range, with 55cm being nominal. A traditional range of flexibility profiles shall also be provided, ranging from standard (stiff) to flex (soft). The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. The marker coil is platinum wire at the distal tip of the device to aid visualization under fluoroscopy. The subject device has the ability to access distal, tortuous vasculature, with steerability and torque transmission properties.

The provided document describes the PVS 1600 Synchro® 0.010" Neuro Guidewire and its demonstration of substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics as would typically be presented for a new or significantly modified device under a comprehensive clinical trial.

However, based on the information provided, I can extract the relevant details regarding the safety and performance tests conducted to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria with corresponding performance statistics in a tabular format as one would expect from a controlled study with predefined thresholds. Instead, it states that "Subject product testing has yielded acceptable safety & performance outcomes" and that tests "also yielded acceptable results." The criteria are implied to be met if the PVS 1600 Synchro® 0.010" Neuro Guidewire is comparable to its predicate devices and conforms to relevant standards.

Therefore, the table below provides the performance tests conducted and the general outcome stated in the document. The "Acceptance Criteria" are inferred from the context of demonstrating substantial equivalence to predicate devices and adherence to relevant standards (ISO 10993-1, ISO 11070:1998).

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

• Sample Size: The document does not specify numerical sample sizes for the performance tests conducted. It refers to "Performance testing of materials" and "Subject product testing."
• Data Provenance: The document does not provide details about the country of origin of the data or whether the tests were retrospective or prospective. These appear to be laboratory-based engineering performance tests rather than clinical studies on patient data.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):

Not applicable. The document describes engineering and materials performance tests, not clinical studies involving expert interpretation or ground truth establishment based on human review.

4. Adjudication Method (Test Set):

Not applicable, as no adjudication by experts for ground truth is mentioned. The tests appear to be objective measurements against engineering standards and comparison to predicate devices.

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

No, an MRMC comparative effectiveness study was not done. The document describes a 510(k) submission for substantial equivalence based on technological characteristics and performance testing, not a clinical trial evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The device is a physical medical instrument (guidewire), not an AI algorithm or software device that would perform a standalone analysis. The performance studies focus on the physical and material properties of the guidewire.

7. Type of Ground Truth Used:

For the performance tests, the "ground truth" is implied to be:

• Compliance with established international standards (ISO 10993-1 for biocompatibility, ISO 11070:1998 for catheter introducers).
• Comparative performance against existing legally marketed predicate devices, demonstrating similar safety and efficacy profiles.
• Objective measurements of physical and mechanical properties.

8. Sample Size for the Training Set:

Not applicable. The guidewire is a physical device, not an AI, machine learning, or software device that requires a training set.

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

Not applicable. There is no training set mentioned or implied as this is not an AI/ML device.

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The PVS 1500 SDS is intended to be used to access tortuous vasculature for infusion of diagnostic, embolic, and therapeutic agents into the distal, peripheral, coronary, and neurovasculature, and for guide wire exchange/support during diagnostic Or interventional procedures.

The PVS 1500 SDS is intended for use in accessing distal peripheral, coronary, and neurovasculature for selective, controlled, regional delivery of diagnostic, embolic, and therapeutic agents into selected vessels.

The PVS 1500 SDS is a 2.4 F tubular device, 155 cm in length, with a lumen to be used for delivery of contrast, drugs, or embolics. The lumen is constructed from a polyment material and has an inside diameter of 0.021". The device is coated on the outer diameter with a lubricious coating over the distal segment of the device. Two radiopaque markers are positioned 31 mm apart at the distal tip of the device to aid visualization under fluoroscopy. The proximal end of the device has a standard luer adapter for attachment of accessories and can be used to flush the 1500 SDS. The subject device has the ability to access distal, tortuous vasculature over a guide wire, deliver embolics and agents, and has the ability to be steered like a guide wire as needed.

The provided text describes a medical device, the PVS 1500 SDS (an infusion catheter), and its testing to demonstrate substantial equivalence to predicate devices, rather than a study evaluating an AI/ML powered device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance for PVS 1500 SDS

The study primarily focused on demonstrating the PVS 1500 SDS's substantial equivalence to existing predicate devices by meeting established performance standards for infusion catheters.

Table of Acceptance Criteria and Reported Device Performance

Information Not Applicable or Not Provided in the Text (Primarily relevant for AI/ML studies):

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): The document doesn't specify sample sizes for each performance test, nor does it mention data provenance in the context of an AI/ML test set. The tests described are laboratory-based engineering and material performance tests.
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. "Ground truth" in this context refers to the physical and chemical properties of the device, established through standardized testing procedures, not expert interpretation of data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Performance was measured against established engineering standards.
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/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from standardized engineering and biocompatibility testing against recognized industry standards (ISO 10993-1, ISO 10555-1).
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary of Study Approach:

The study for the PVS 1500 SDS was a series of benchtop and laboratory-based engineering and biocompatibility tests. The objective was to demonstrate that the device's physical, mechanical, and biological properties met established standards for infusion catheters and were substantially equivalent to legally marketed predicate devices. The "acceptance criteria" were the thresholds and specifications defined by relevant ISO standards (ISO 10993-1 and ISO 10555-1) for medical devices of this type. The device "met the acceptance criteria" by yielding "acceptable results" in all conducted tests.

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These guidewires are intended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and peripheral vasculature.

The PVS 1400 Guidewire is a 0.014" outside diameter, single-use guidewire, which is used to gain intravascular access to and to facilitate the positioning and exchange of catheters in small diameter, tortuous vasculature for coronary and peripheral diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The proximal wire material is stainless steel. The guidewire is coated to provide lubricity. The tip material of the guidewire is nitinol.

Here's an analysis of the provided text regarding the PVS 1400 Guidewire, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance criteria for various physical characteristics of the guidewire. Acceptance for these criteria is demonstrated by achieving "similar," "better," or meeting specific numerical thresholds compared to predicate devices.

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

• Sample Size: The document does not explicitly state the sample size for each performance test. It refers to "testing" that was performed on the PVS 1400 Guidewire, implying a set of units were tested.
• Data Provenance: The data appears to be prospective in nature, as it describes tests specifically conducted on the PVS 1400 Guidewire to compare it to predicate devices. The country of origin for the data is not specified, but the submission is to the US FDA.

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

Not applicable. This device, being a guidewire, relies on objective physical performance tests rather than expert opinion for its "ground truth" or performance evaluation. The "experts" would be the engineers and technicians conducting the physical tests according to established protocols.

4. Adjudication Method for the Test Set:

Not applicable. The performance evaluation is based on objective measurements and comparisons to predicate devices, not on expert adjudication of subjective assessments.

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

No. This type of study (MRMC) is typically used for diagnostic devices (e.g., imaging AI) where human readers interpret cases. The PVS 1400 Guidewire is a physical medical device (guidewire) whose performance is evaluated through bench testing.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

Yes, in essence. The performance data presented (tip flexibility, tensile strength, torqueability, etc.) are all standalone evaluations of the PVS 1400 Guidewire's physical characteristics, often compared to predicate devices. There is no "algorithm" in the sense of a software-based AI, but the device's inherent performance is tested independently of human intervention during its function in the context of these tests.

7. The Type of Ground Truth Used:

The ground truth used for performance validation is primarily objective physical measurements and comparisons to established predicate devices. For biocompatibility, the ground truth is established by standardized biological tests and their respective pass/fail criteria. For sterilization, the ground truth is the measured residual levels of sterilants compared to specified limits.

8. The Sample Size for the Training Set:

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. Its design and manufacturing process are refined based on engineering principles and material science, not data training.

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

Not applicable for the reasons stated above (no training set for a physical device). The "ground truth" for the device's fundamental design aspects would come from engineering specifications, material properties, and clinical requirements for guidewires.

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