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The BridgePoint Medical System (consisting of the CrossBoss™ Catheter, Stingray™ Orienting Balloon Catheter, and Stingray™ Guidewire) is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) prior to PTCA or stent intervention.

The CrossBoss Catheter is a single use over the wire disposable percutaneous catheter consisting of a full length coiled stainless steel shaft with polyester and polyurethane exterior. The coiled shaft provides torque and makes it possible to push the device, and also provides a guidewire lumen. The distal shaft transitions to an enlarged (1mm diameter) rounded distal tip. This stainless steel tip provides an atraumatic element that is intended to enhance the catheter's ability to move within the vasculature with reduced risk of arterial tissue engagement while providing radiopaque visibility. The distal portion of the CrossBoss Catheter is hydrophilic coated to enhance lubricity. The proximal portion includes an internal stainless steel hypotube stiffener that provides additional push. A torque device, coaxially positioned over the proximal portion of the CrossBoss Catheter, provides a comfortable user interface for device manipulation. The torque device (similar to a guidewire torque device) is positionable along the proximal portion of the catheter and includes a torsion release safety mechanism. This safety mechanism insures the torque input generated by the user remains within the torsional operating strength of the catheter shaft.

The Stingray Orienting Balloon Catheter is a single use, over-the-wire, disposable, dual lumen percutaneous catheter that facilitates the placement, support and steering of a guidewire into discrete regions of the coronary and peripheral vasculature through the central guidewire lumen or through one of two side-ports (identified by radiopaque markers). The side-ports connect with the central guidewire lumen and facilitate guidewire steering (at an angle to the central lumen) by allowing the guidewire to exit the catheter. The catheter contains a small non-compliant balloon segment used for fluoroscopic orientation on the distal tip of the flexible shaft.

The Stingray Guidewire is a conventionally constructed 0.014" diameter, single use, disposable guidewire that consists of a full-length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft is taper ground to provide distal flexibility. The distal portion also includes a coaxially positioned coil constructed of platinum/tungsten material for visibility under fluoroscopy. The coil is fixed to the stainless steel core wire via silver alloy solder and is coated with hydrophilic coating. The distal tip of the guidewire is supplied with an angled geometry which transitions to a conventional rounded tip. The core wire (~0.0035" diameter) extends approximately 0.007" distal of the rounded tip.

The provided document is a 510(k) summary for the BridgePoint Medical System. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence. However, this document does not contain acceptance criteria for device performance or a study proving that the device meets specific performance criteria in the way typically associated with AI/ML-driven medical devices.

Instead, the submission focuses on demonstrating substantial equivalence to existing predicate devices based on identical designs, prior bench testing, and biocompatibility tests. It briefly mentions a clinical study to support the system's function, but this study is not presented with acceptance criteria or detailed results in the context of device performance metrics.

Therefore, many of the requested items (e.g., specific acceptance criteria, sample size for test sets directly related to acceptance criteria, ground truth establishment, MRMC studies, standalone performance) are not present in this type of regulatory submission.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices, asserting that the prior bench testing and biocompatibility of the identical predicate devices are directly applicable. There are no explicit performance acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific mechanical thresholds) outlined as part of this particular submission for the BridgePoint Medical System.

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

• Test Set (Clinical Study):
  • Sample Size: A "147 patient study" was conducted.
  • Data Provenance: "in the United States."
  • Retrospective or Prospective: Not explicitly stated, but clinical studies for regulatory submissions are typically prospective.

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

This information is not provided. The document states the clinical study "demonstrated the BridgePoint Medical System could successfully allow the placement of guidewires beyond chronic total occlusions with no significant increase in risk to the patient." It does not detail how the success or risk was formally adjudicated or who the experts were.

4. Adjudication Method for the Test Set:

This information is not provided.

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

This information is not provided and is highly unlikely to be applicable to this type of device (catheters and guidewires), which are not typically "AI-assisted reader" devices. The device described is a physical medical instrument, not a diagnostic imaging AI algorithm.

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

This information is not applicable/provided. The device is a physical catheter system used by a human interventionalist, not an algorithm.

7. Type of Ground Truth Used:

• For the 147-patient study: The "ground truth" or primary outcome likely relates to the successful intraluminal placement of conventional guidewires beyond stenotic coronary lesions (including chronic total occlusions) and patient safety/risk assessment as determined by clinical observation and physician assessment during the procedure. The document states the study "demonstrated the BridgePoint Medical System could successfully allow the placement of guidewires beyond chronic total occlusions with no significant increase in risk to the patient." This implies clinical outcomes and expert judgment as the ground truth.

8. Sample Size for the Training Set:

This information is not provided and is not applicable in the context of this device. 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:

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

Summary of what the document does state regarding the study:

• Study Purpose: To demonstrate that the BridgePoint Medical System functions "to enhance medical practice in facilitating the placement of guidewires or other interventional devices beyond chronic total occlusions."
• Study Outcome: The "147 patient study... demonstrated the BridgePoint Medical System could successfully allow the placement of guidewires beyond chronic total occlusions with no significant increase in risk to the patient."
• Context: This study appears to be part of the justification for substantial equivalence, implying that the clinical performance observed was comparable or superior to predicate devices without introducing new safety concerns.

In conclusion, this 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device to existing predicate devices based on design, prior bench testing, and biocompatibility, supported by a general statement about a clinical study's positive outcome. It does not provide the detailed performance acceptance criteria or granular study details typically requested for AI/ML device evaluations.

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The Bridge Sentry™ System is intended for the infusion (or administration) of fluids of medications. It is also intended for the preparation (reconstitution, as required, and mixing) of single dose, intermittent, anti-infective and gastrointestinal medications. It is not intended for use with blood, blood products or lipids.

The Bridge Sentry™ Bedside Unit. The Bridge Sentry Pharmacy Utility and the Bridge Sentry™ Administration Sets are collectively referred to as the Sentry System. The Sentry System includes an electrical, external, volumetric drug compounder and infusion pump. The administration sets contain a dedicated cassette that is compatible with the Bridge Seotry Bedside Unit. The Sentry is an electro-mechanical device incorporating a sterile disposable cassette with ancillary fluid delivery tubing and components. The Sentov stores drug delivery preset information for reconstitution, dilution and delivery. These presets are based on industry standards derived from drug labeling. The preset information is downloaded into each Sentry device. The Sentry requires identification of the patient, the user, the drug, and the dillo oching part of the setup operation. The identification may be accomplished via bar code scan or menu selection. The Sentry uses the identification information in conjunction with the pharmacy presets to minimize emars and capture drig event information. The Sentry System provides accurate and continuous flow of fluids to the patient. The device operates using a proprietary Acoustic Volume Sensor, a form of actuation pressure and a precision fluid impedance in the set to for a closed loop flow control system. The system detect occlusions in the patient line downstream and determines if sufficient fluid can be drawn from an upstream source to continue patient delivery. The system also detects air in line and when possible eliminates the air. The administration sets are sterile, and for single patient use. The Administration Sets are composed of a unique cassette and various combinations of other standard administration set components including tubing, filters, spikes, drip chambers, injection sites, clamps, caps or protectors, and luer connectors. The Sentry Cassette contains 10 valves to control fluid flow, a precision control orifice for flow control, a front cover, rear cover, mid-body, an inlet port, outlet port, a luer connection, and three drug vial spikes. The Sentry device contains a System Management Module, a Fluid Delivery Module, bar code scanner, infusion stand base and pole(s), vial attachment mechanism, battery, pharmacy utility, air in line sensor, and a data acquisition computer.

Here's a breakdown of the acceptance criteria and study information for the Bridge Sentry™ System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the test sets for each performance test (Reconstitution, Mixing, Delivery, Rinse/Flush, Solution Materials Contact). It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, it refers to "manual reconstitution methods according to the drug manufacturers' guidelines" as the control for reconstitution, and standards like ANSI/AAMI ID26-1992 for delivery.

4. Adjudication Method for the Test Set

No adjudication method is mentioned. The tests appear to rely on objective measurements against specified standards or comparative performance.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on the device's technical performance against established standards and predicate devices, not on human reader performance with or without AI assistance.

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

Yes, the studies described are standalone performance tests of the device itself (the "Sentry System"), without human-in-the-loop performance measurement.

7. The Type of Ground Truth Used

The ground truth or reference standards used are:

• Reconstitution: Drug manufacturers' guidelines for manual reconstitution methods.
• Mixing: USP Drug Assay High Performance Liquid Chromatography (HPLC) to measure concentration accuracy.
• Delivery: ANSI/AAMI ID26-1992 guidelines for infusion devices, and comparison to predicate devices (Horizon Nxt and OmniFlow 4000).
• Rinse/Flush: USP Trace Drug Assay High Performance Liquid Chromatography (HPLC) to measure residual drug concentration.
• Solution Materials Contact: ISO10993 Standard Physicochemical Tests for Elastomers and Plastics.

8. The Sample Size for the Training Set

The document does not discuss a "training set" in the context of machine learning or AI. The Sentry System is an electro-mechanical device with preset information downloaded into it, which is based on "industry standards derived from drug labeling." It uses this information in conjunction with identification data to minimize errors. This does not align with a machine learning training paradigm.

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

Since there is no "training set" in the context of machine learning, this question is not applicable. The device's "presets" are based on "industry standards derived from drug labeling."

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