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Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. The device also will deliver therapeutic solutions administered through the stopcock sidearm to the vasculature wall surrounding the sheath.

The Emcee Infusion Introducer Sheath Set is comprised of a percutaneous introducer sheath and a dilator. The Emcee Infusion Introducer Sheath Set may also contain a guidewire. Design features have been added to the Emcee Introducer Set (K980504) to enhance the facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature. These design features include the addition of the dilator (from a point slightly distal to the dilator hub to a point proximal to the sheath tip). These design features permit a fluid ulfator nub to a point proximal to the space between the outer dilator wall and the inner sheath wall, and exiting into the vasculature lumen via the sheath sideholes.

The provided text describes a 510(k) summary for the Emcee™ Infusion Introducer Sheath Set. It focuses on demonstrating substantial equivalence to predicate devices and includes information about non-clinical performance testing, specifically biocompatibility. However, it does not contain information related to acceptance criteria, a study proving the device meets acceptance criteria, or any of the detailed questions about sample sizes, ground truth, expert involvement, or multi-reader multi-case studies typically associated with AI/algorithm performance evaluations.

Therefore, I cannot populate the table or answer most of the specific questions as the provided document pertains to a medical device's 510(k) submission, not an AI/algorithm study.

Here's what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions "non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses." Specifically, it states:

Missing Information:

The document does not provide details for the following:

• Sample sized used for the test set and the data provenance: Not applicable as this is a physical medical device, not an AI/algorithm.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of available information:

The 510(k) summary primarily focuses on demonstrating the substantial equivalence of the Emcee Infusion Introducer Sheath Set to existing predicate devices (Emcee™ Introducer Set and LocalMed™ InfusaSleeve™ II). The performance testing mentioned is non-clinical, with biocompatibility being the only specifically detailed test, based on ISO 10993-1. The document does not describe any studies involving algorithms, human readers, or performance metrics typically associated with AI device evaluations.

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Intended for use in facilitating the percutaneous introduction of catheters, interventional devices, and temporary pacing leads into the vasculature (including the radial artery).

The Emcee™ Introducer Set is comprised of a percutaneous introducer sheath and dilator. The set may also contain a guidewire and/or an obturator. The Emcee™ Introducer Sheath is comprised of an insert molded hemostatic sheath hub and cap design which encapsulates a hemostatic gasket system. The hub also incorporates a sideport extension line with an attached stopcock. The tubing portion of the sheath is percutaneously introduced into the patient's vasculature. The sideport extension is used for purposes of blood access maintenance and fluid administration. Subsequent to the physician gaining access to the patient's vasculature, a guidewire is inserted into the blood vessel. The Sheath/Dilator combination may be backloaded over the Guidewire to direct the device into the lumen of the vessel. Once the Sheath/Dilator assembly is in place, the dilator and Mini Guidewire (if used) are removed. The Emcee™ Dilator is a tapered plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Dilator is longer than the Sheath and with its tapered distal tip, serves to facilitate and support the entry of the Sheath into the patient's vasculature. Once the Emcee™ Introducer Sheath is in place, the Dilator is removed. The Emcee™ Introducer Set will be offered with dilators to accommodate the following guidewire diameters: .018", .025", .032", .035", and .038". Other sizes of dilators will also be provided to address physician preferences. The Emcee™ Obturator is a plastic tube with an integral luer hub which is inserted into the Emcee™ Introducer Sheath. The Obturator is approximately the same length as the Sheath and is intended to support the tubing portion of the Sheath while the device remains In Vivo. Components of the Emcee™ Introducer Set have a lubricious coating for a smooth entrance and removal from the vasculature.

The provided document is a 510(k) summary for the Emcee™ Introducer Set, a medical device. It describes the device, its intended use, and states that performance testing was done, but it does not provide specific acceptance criteria or the detailed results of a study that proves the device meets those criteria.

Instead, it states: "The new Emcee™ Introducer Set has been subjected to non-clinical performance testing to provide data supporting its safety and effectiveness for its intended uses." It also mentions "Biocompatibility testing having its basis in International Standards Organization (ISO) 10993-1 (1992)E..." and concludes the device "is considered to be biocompatible."

Therefore, based only on the provided text, I cannot fill in most of the requested information. The document focuses on regulatory approval (510(k) process) based on substantial equivalence to predicate devices, rather than detailed performance study results against predefined acceptance criteria.

However, I can extract the following:

1. A table of acceptance criteria and the 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)

• Sample size for test set: Not specified.
• Data provenance: Not specified (implied to be from non-clinical testing, likely in a lab setting).
• Retrospective or prospective: Not specified.

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/Not specified. This information would typically be relevant for studies involving subjective human assessment (e.g., image interpretation), which is not the nature of the described "non-clinical performance testing" for an introducer set.

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

• Not applicable/Not specified, for the same reasons as point 3.

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

• No. This is a physical medical device (catheter introducer), not an AI/imaging diagnostic device.

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

• Not applicable. This is a physical medical device.

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

• For biocompatibility, the ground truth was "International Standards Organization (ISO) 10993-1 (1992)E "Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests"."
• For other "non-clinical performance testing," the specific ground truth is not detailed but would likely involve established engineering standards, material science properties, and functional benchmarks relevant to introducer sheaths (e.g., insertion force, hemostasis, flow rates, structural integrity).

8. The sample size for the training set

• Not applicable. As a physical device undergoing non-clinical testing, there isn't a "training set" in the machine learning sense.

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

• Not applicable.

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These devices are intended for balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures.

The Breeze Digital Inflation Device, like its predicates, the Morse Balloon Inflation Device and the Merit Monarch Inflation Syringe is a Balloon Inflation Syringe. These devices are intended for balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures.

A Balloon angioplasty catheter provides a fluid column which communicates pressure inside the balloon to the digital pressure gage. The gel acts as a vibratory membrane, allowing the signal to be passed to the sensor. The analog signal from the sensor is then displayed on the liquid crystal display of the gage. The manual timer operates independently of the above mentioned pressure gage. The timer is started and stopped by depressing the Start/Stop button and can be reset to 00m00s by depressing the Reset Button.

The Breeze Digital Inflation Device shares a common design with the Morse Balloon Inflation Device in that they both are comprised of a clear syringe barrel with an attached pressure gauge, a threaded plunger and a latching mechanism that operate in tandem to generate and control balloon inflation pressure. The Breeze Digital Inflation Device has in common with the Merit Monarch Inflation Syringe, a digital pressure gauge.

This 510(k) summary describes a medical device, the Breeze™ Digital Balloon Inflation Device, but it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth, or expert involvement.

The document focuses on:

• Device Description: What the device is and its intended use (balloon inflation/deflation and pressure measurement during angioplasty).
• Comparison to Predicates: How it's similar to and different from previously cleared devices (Morse Balloon Inflation Device, Merit Monarch Inflation Syringe).
• Material Equivalence: Mentions biocompatibility testing on predicate devices and states the fluid path material is identical.
• Key Design Differences: Highlights changes like the latching mechanism, digital vs. analog gauge, O-ring vs. stopper, increased pressure rating, and increased syringe volume.
• Digital Gauge Specifics: Notes that the Breeze device's digital gauge uses non-software driven solid-state circuitry, unlike the Merit Monarch's software-driven microprocessor.
• Performance Testing (Limited): It mentions "non-clinical performance testing" for gauge pressure rating and accuracy, and states "The results of the tests do support the claimed pressure and accuracy."

Here's why I cannot fulfill your request based on the provided text:

1. Acceptance Criteria Table: The document states the claimed pressure and accuracy (0-30 ATM ± 2% of full scale) and that the test results support this claim. However, it does not provide a table outlining the acceptance criteria (e.g., what would be considered unacceptable performance within that tolerance) and the "reported device performance" beyond a general statement of compliance.
2. Study Details (Sample Size, Data Provenance, # Experts, Adjudication, MRMC, Standalone): This document is a 510(k) summary, which is a high-level overview. It does not include the detailed methodology of the performance testing. Therefore, it lacks:
   • Sample size for the test set.
   • Data provenance (country, retrospective/prospective).
   • Number or qualifications of experts.
   • Adjudication methods.
   • Any mention of MRMC comparative effectiveness studies or their results.
   • Clarification on whether the performance testing was "standalone" in the way you're asking (i.e., algorithm only without human-in-the-loop performance, though for a manual device, this specific question might not fully apply).
3. Ground Truth, Training Set: These concepts are typically relevant for AI/ML devices or diagnostic accuracy studies. For a mechanical device like a balloon inflation device, "ground truth" often refers to a verified standard (e.g., a calibrated pressure transducer). While it states non-clinical performance testing was done, it does not specify the ground truth used (e.g., what type of calibrated reference device was used), nor does it mention any "training set," as this device does not appear to involve machine learning or AI.

In summary, the provided text is insufficient to answer your comprehensive questions about acceptance criteria and study details. It confirms performance testing was done for pressure accuracy, but without the granular details you're requesting.

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The PERCEPTOR® Compensator MORSE® Manifold, like its predicates, the MORSE® DT Manifold and the Stand Alone Transducer, is a physiological blood pressure transducer. Both devices are intended for invasive pressure monitoring, catheterization procedures, fluid delivery and/or blood access maintenance.

A device which integrates a physiological pressure transducer directly into the side port lumen of a manifold. A catheter provides a fluid column which communicates pressure in the heart from the tip of the catheter to the transducer. The gel acts as a vibratory membrane, allowing the signal to be passed to the sensor. The signal is communicated to the monitor via the cable.

The provided text is a 510(K) summary for a medical device called the PERCEPTOR® Compensator MORSE® Manifold, which is a physiological blood pressure transducer. This document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety standards. It does not contain information about a study involving acceptance criteria, device performance metrics, sample sizes for test or training sets, ground truth establishment, expert involvement, or any form of AI/algorithm performance.

The document addresses compliance with engineering standards rather than clinical performance metrics in the way you've outlined for AI or diagnostic devices.

Therefore, I cannot populate the requested table or answer the subsequent questions based on the input provided. The summary is about a physical device's design, materials, and compliance with general transducer standards, not about a study assessing its diagnostic or interpretive accuracy.

Here's a breakdown of what can be inferred from the text, and why the other information is missing:

What's available in the text:

• The device is a physiological blood pressure transducer.
• It's intended for invasive pressure monitoring, catheterization procedures, fluid delivery, and/or blood access maintenance.
• It's expected to conform to specifications in ANSI/AAMI BP22-1994 "Blood Pressure Transducers."
• Biocompatibility testing was performed on predicate devices (implying the new device, using identical materials, doesn't need new biocompatibility testing).
• The fundamental design principles are outlined (integrates transducer into manifold, catheter communicates pressure, gel acts as vibratory membrane).
• Differences from predicates are described: redirected lumen for accurate zero balancing and pressure monitoring at any height, and discontinuation of an Over Pressure Protection Band.

Why the requested information is absent:

The 510(k) summary is for a physical medical device (a blood pressure transducer) that measures a physiological parameter. The "performance" in this context refers to its ability to accurately measure blood pressure according to established engineering standards (like ANSI/AAMI BP22-1994), not its ability to interpret images, diagnose conditions, or provide AI-assisted insights.

Therefore, there are no:

• "Acceptance criteria" in the sense of accuracy, sensitivity, or specificity for a diagnostic task. The acceptance criteria would be conformance to the ANSI/AAMI standard.
• "Reported device performance" in terms of diagnostic metrics. Performance is implied by adherence to the ANSI/AAMI standard.
• "Sample sizes for test set" related to diagnostic accuracy.
• "Experts" establishing ground truth for a diagnostic task.
• "Adjudication method."
• "MRMC comparative effectiveness study" involving human readers and AI.
• "Standalone algorithm performance."
• "Type of ground truth" (pathology, expert consensus, etc.).
• "Training set" or "how ground truth was established for training" because this isn't an AI/algorithm-driven device.

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