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The PV 1900 Synchro® 0.016" Neuro Guidewire series of products is intended for peripheral and neurovascular use. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

The PV 1900 is a member of the Synchro® Guidewire family of products having a 0.016" 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 peripheral and neuro diagnostic and interventional procedures. The guidewire can be torqued to facilitate navigation through the vasculature. A torque device, (Boston Scientific (K903606)) 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 nor the torque device are intended to enter the body. The product is projected to be provided in a 100cm - 300cm length range with 140-180cm being nominal. The Nitinol tip length is projected to be presented in a 25cm - 35cm range. 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 portion 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.

This is a 510(k) premarket notification for a medical device (a guidewire), not an AI/ML device. Therefore, the typical acceptance criteria and study design for AI/ML performance evaluation are not applicable.

However, I can extract the information relevant to the device's performance given the context of this document.

Summary of Device Performance Information Provided:

Since this is a filing for a traditional medical device (guidewire) and not an AI/ML diagnostic or prognostic system, the requested information (acceptance criteria, sample size, ground truth, experts, MRMC, standalone performance) for AI/ML devices is not directly applicable in the sense of predictive or classification performance metrics.

Instead, the "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to predicate guidewires by meeting various physical and mechanical performance characteristics. The "study" refers to the engineering and biological testing performed on the device.

Here's an attempt to map the requested AI/ML-centric questions to the provided information for this traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present acceptance criteria in a quantifiable table with corresponding performance values for each criterion as one would for an AI/ML device (e.g., sensitivity >X%, specificity >Y%). Instead, it states that "Performance testing of materials comprising the PV 1900 Synchro® 0.016" Guidewire was conducted in accordance with ISO 11070:1998, Sterile, Single-Use Intravascular Catheter Introducers." and "Subject product testing has yielded acceptable safety & performance outcomes."

   The performance aspects tested and the general outcome are listed.

   Acceptance Criteria (Implicit)	Reported Device Performance
   Compliance with ISO 10993-1 for Biocompatibility (for external communicating, blood contact, short duration <24 hours device)	Biocompatibility verified; materials test results confirmed biocompatibility.
   Compliance with ISO 11070:1998 for Performance Testing (dimensional, fatigue, tip flexibility, tip shaping, tensile strength, guidewire compatibility, performance under simulated conditions)	Acceptable safety & performance outcomes.
   Torsional Strength (Specific test)	Acceptable results.
   Torqueability (Specific test)	Acceptable results.
   EO Sterilization (Specific test)	Acceptable results.
   Substantial equivalence in design, materials, sterilization, principles of operation, and indications for use to cited predicates	Demonstrated through testing and comparison, leading to FDA's determination of substantial equivalence (K050964). No new questions raised regarding safety or efficacy compared to the predicate PVS 1300 Synchro® 0.014" Guidewire, and similarity in basal design, dimensions, generic materials & construction, and hydrophilic coating to competitive predicates.

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

   • Sample Size: Not explicitly stated in terms of a "test set" like in an AI/ML study. Performance testing involved various physical and mechanical tests on the guidewire. The number of guidewires or samples used for each specific test (e.g., fatigue, tensile strength) is not detailed.
   • Data Provenance: Not applicable in the context of human data. The tests were laboratory and engineering tests on the materials and finished guidewire device.

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

   • Not applicable as "ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant here. Performance was assessed through objective physical and mechanical tests following established standards. While engineers and quality control personnel would have interpreted test results, their role is not "ground truth establishment" in this context.

4. Adjudication method for the test set:

   • Not applicable. Performance was assessed against pre-defined engineering and biocompatibility standards, not through expert adjudication of an output.

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 physical medical device (guidewire), not an AI system intended to assist human readers (e.g., radiologists).

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" here is the adherence to established international standards (ISO 10993-1 for biocompatibility, ISO 11070:1998 for catheter introducers, and other specific engineering tests for torsional strength, torqueability, sterilization). The product's physical and biological properties were measured against these objective standards.

8. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI/ML algorithm that requires training data.

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

   • Not applicable. As above, no training set for an AI/ML algorithm.

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