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Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

The reprocessed Cordis Catheters are available in a broad variety of French sizes and configurations. These catheters combine an atraumatic tip with a braided body.

The provided text describes the 510(k) summary for Reprocessed Cordis Super Torque and Super Torque Plus Diagnostic Angiographic Catheters. This document is a premarket notification for a medical device and thus does not contain information about studies related to AI or ground truth as it pertains to AI/ML models. Instead, it focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing.

Here's the relevant information based on the provided text, adapted for the requested format where applicable, and noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each of the listed functional and safety tests. It generally refers to "Bench and laboratory testing." It is a regulatory submission for a reprocessed medical device, not an AI/ML study. Therefore, the concept of "test set" in the context of AI/ML models, data provenance (country of origin), and retrospective/prospective data collection is not applicable here. The testing would have been performed on samples of the reprocessed devices.

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

This information is not applicable. The device is a physical medical device (angiographic catheter), and "ground truth" as it relates to expert-labeled data for an AI/ML model is not relevant to this submission. The "ground truth" in this context would be the established performance specifications for diagnostic angiographic catheters, and the testing validates that the reprocessed device meets those specifications.

4. Adjudication Method for the Test Set

This information is not applicable, as it pertains to expert consensus on AI/ML model outputs, which is not relevant for this device.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable as this is a physical medical device (angiographic catheter) and does not involve AI or human readers evaluating images or data.

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

This information is not applicable as the device is a physical medical device and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance criteria would be the established performance specifications and safety standards for diagnostic angiographic catheters as defined by relevant industry standards (e.g., ISO, ASTM) and FDA guidance for these types of devices and for reprocessed devices. This includes physical properties, biocompatibility, sterility, and functional performance. It is based on engineering specifications and scientific testing standards, not expert consensus on medical images or pathology.

8. The Sample Size for the Training Set

This information is not applicable. This is not an AI/ML model; therefore, there is no "training set."

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

This information is not applicable as there is no "training set" for this physical medical device.

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The Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial reqion of the heart and the coronary sinus.

The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.

The tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The provided text describes a 510(k) premarket notification for a Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against clinical acceptance criteria with a study designed to evaluate such. As such, the information typically found in a clinical study report regarding acceptance criteria and performance against those criteria (especially for AI/software devices) is not present in this document.

Here's an analysis based on the document:

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

This document does not contain a table of acceptance criteria and reported device performance in the context of clinical efficacy or diagnostic accuracy. The testing described is primarily for functional and safety testing to demonstrate that the reprocessed device performs comparably to the original device.

The "acceptance criteria" here are implied by the battery of tests performed to ensure the reprocessed device is safe and effective and functions like the new device. These include:

• Biocompatibility: The reprocessed device must be biocompatible.
• Cleaning Validation: The cleaning process must effectively remove contaminants.
• Sterilization Validation: The sterilization process must render the device sterile.
• Functional Testing:
  • Visual Inspection: Device appearance must meet specifications.
  • Dimensional Verification: Dimensions must be within specified tolerances.
  • Electrical Continuity and Resistance: Electrical properties must be within specifications.
  • Simulated Use: The device must perform as expected under simulated use conditions.
  • Mechanical Characteristics: Mechanical properties (e.g., tip deflection) must be maintained.
• Electrical Safety Testing:
  • Dielectric and Current Leakage: Electrical safety must be within acceptable limits.
• Packaging Validation: Packaging must maintain device integrity and sterility.

The document states, "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheters." It then lists the above tests, implying that the device "met" the unstated acceptance criteria for each of these tests to conclude that it is "as safe and effective as the predicate devices."

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

The document does not detail the sample sizes for the functional and safety tests. Studies for reprocessed medical devices typically involve testing a representative sample size of reprocessed units. No information on data provenance (e.g., country of origin, retrospective/prospective) is provided, as these are lab-based performance tests, not clinical studies with patient data.

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

This information is not applicable and not provided. The testing described is laboratory-based mechanical, electrical, and material testing, not human-interpretation-based evaluation requiring expert ground truth establishment.

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

This is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not described here.

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 and no such study was done. This device is a reprocessed electrophysiology catheter, not an AI or software device.

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

This is not applicable as the device is not an algorithm or software.

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

The "ground truth" for the performance claims of this reprocessed device is the established performance specifications and accepted safety and efficacy profiles of the original, new Webster Duo-Decapolar Diagnostic EP Catheter (K101991), and the performance standards for the specific functional and safety tests (e.g., electrical resistance limits, sterilisation assurance levels, biocompatibility standards). The reprocessed device is deemed safe and effective if it meets these engineering and performance standards, thereby being substantially equivalent.

8. The sample size for the training set:

This is not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

This is not applicable. There is no training set.

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The Reprocessed VersaCross Steerable Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The Reprocessed SureFlex Steerable Guiding Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The Reprocessed VersaCross Steerable Sheath consists of three components; a Reprocessed VersaCross Steerable Sheath, a Reprocessed VersaCross Transseptal Dilator, and a 0.035" J-tipped mechanical quidewire.

The Reprocessed VersaCross Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The Reprocessed VersaCross Transseptal Dilator provides support for the sheath, features a tapered tip and a shaft that can be reshaped manually. Radiopaque tips maximize visualization of the sheath the dilator during manipulation.

The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.

The Reprocessed SureFlex Steerable Guiding Sheath consists of three components: a reprocessed sheath, a reprocessed dilator and a J-tipped Mechanical Guidewire.

The Reprocessed SureFlex Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip.

The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating.

Note: Only the steerable sheaths and dilator are subject of this submission. The guidewires are purchased off-the shelf and packaged with the reprocessed devices.

The provided text is a 510(k) summary for the reprocessing of medical devices, specifically VersaCross Steerable Sheaths and SureFlex Steerable Guiding Sheaths. It describes the regulatory review process and confirms that the reprocessed devices are substantially equivalent to their predicate devices.

However, the document does not describe a study that proves a device meets acceptance criteria using an AI/algorithm-driven component. The entire document discusses the reprocessing of physical medical devices and their functional and safety testing to establish substantial equivalence, not the performance of an AI or software-based device.

Therefore, I cannot extract the information required to answer your prompt questions about acceptance criteria for an AI device, sample sizes for test sets, establishment of ground truth by experts, MRMC studies, or training sets, because this information is not present in the provided text.

The closest relevant information relates to functional and safety testing of the reprocessed physical medical devices, which is presented as:

Functional and Safety Testing (of physical reprocessed catheters):

Bench and laboratory testing evaluated substantial equivalence to the predicate devices. This included the following:

• Biocompatibility
• Cleaning Validation
• Sterilization Validation
• Functional Testing
  • Visual Inspection
  • Dimensional Inspection
  • Tip Deflection
  • Tip Buckling
  • Valve/Joint leak
  • Radiopacity
  • Simulated Use
  • Torque Testing
  • Tensile Testing
  • Corrosion Testing
• Packaging Validation

This list represents the acceptance criteria (or areas of testing) for the reprocessed physical device, not an AI or software device. The document does not provide specific numerical performance metrics for these tests, nor does it detail sample sizes, expert involvement, or adjudication methods for these physical device tests in the way your prompt requests for an AI study.

In summary, the provided text does not contain any information about an AI/algorithm-driven device or a study related to its performance against acceptance criteria.

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The Insignis™ Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The system is intended for use by clinicians and lay users. It is intended for use in adults and in adolescents ages 13-21. For adolescents, it is to be operated under the supervision of an adult after instruction is provided by a healthcare provider.

The Insignis TM Syringe Infusion System with the Insignis Syringe Driver and Intravenous Controller, is specifically indicated for the intravenous infusion of fluids such as 0.9% Sodium Chloride (normal saline) and dextrose solutions, and the following antibiotics when used according to the FDA approved drug product labeling: vancomycin, ertapenem, meropenem, oxacillin, and tobramycin.

The Insignis™ Syringe Infusion System is a portable mechanical infusion system that operates without electricity. The Insignis system is intended to deliver indicated fluids subcutaneously or intravenously, depending on the prescribed medicine type, route of administration, and dose. The Insignis system incorporates into its design, a means to maintain a constant nominal pressure (13.5 psi), a controlled flowrate within a restrictive tubing circuit and needles to ensure the desired flowrate of medication to the patient is achieved. The spring-loaded Insignis™ Syringe Driver a constant mechanical force to the plunger of a BD 50 mL syringe (ref. #309653), that dispenses fluid through a restricted flowrate tubing and / or needle set. The Insignis system can infuse the rated BD syringe volume of 0 - 50 mL. Through a selection of IHS products total flowrates of 8 mL/hr -250 mL/hr are available: application specific.

• A. For subcutaneous immunoglobulin (SCIg) administrations, the Insignis system includes the OneSett™ Subcutaneous Administration Set, which consists of a selectable rate flow controller connected in-line to an administration set comprised of 1 - 4 needle set configurations (6mm, 9mm, 12 mm, and 14mm lengths). The OneSett is dedicated to deliver 20% concentrate SCIg drugs at specific flowrates which meet the drug manufacturer's package inserts recommended flowrate limitations. The selectable rate flow controller controls the flowrate delivered to each subcutaneous needle site.

• B. For intravenous administrations, the Insignis system includes the Intravenous Controller, which consists of a selectable rate flow controller connected in-line to a tubing set. The Intravenous Controller is dedicated to delivering select antibiotics, and saline and dextrose solutions. Again, the selectable rate flow controller allows for selectable and controllable flowrates.
  For administering the prescribed medications, the Insignis system requires that the user fill the syringe with the prescribed medications, connect the infusion set to the syringe, eliminate air from the fluid line, secure the syringe into the Insignis™ Syringe Driver, connect to the infusion set to the patient, and load the syringe driver to begin the infusion.

The system is comprised of the Insignis™ Syringe Driver, a syringe, and either intravenous or subcutaneous infusion sets. To elaborate:

• a. The Insignis™ Syringe Driver provides the constant driving force to dispense fluids.
• b. The syringe is the reservoir that holds the fluids (manufactured by Becton & Dickinson).
• c. The infusion sets (intravenous or subcutaneous) form the fluid path and delivers the fluid to the patient at controlled flowrates.

This document is a 510(k) Summary for the Insignis™ Syringe Infusion System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device, not on proving clinical efficacy via a multi-reader multi-case (MRMC) study or complex AI-driven ground truth establishment. Therefore, many of the requested points regarding AI model performance, expert adjudication, and training/test set details are not applicable as this is a traditional medical device submission, not an AI/ML product submission.

The document primarily details the results of non-clinical performance testing (bench testing) to verify the device meets its intended use and design requirements. The "acceptance criteria" can be inferred from the performance data presented, particularly the acceptable flow rate ranges and deviations.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides tables of flow rate performance for different configurations and medications. The "acceptance criteria" are implied by the ranges and percentage deviations provided for each labeled flowrate. The reported device performance is these very ranges and deviations. There isn't a separate, explicit table of acceptance criteria before the results, but the results themselves define the product's performance specifications.

Intravenous Controller (for 0.9% NaCl, Vancomycin, Ertapenem, Meropenem, Oxacillin, Tobramycin):

*KVO for saline and dextrose only.

Subcutaneous IgG Infusion - Hizentra® for Primary Immunodeficiency (PI):
Throughout the infusion, the measured flow rate may vary ±36% from the flow rate labeled on the dial.

*Subsequent infusion after initial infusion.
= Outside of drug's prescribing information recommended minimum - maximum flowrate.

Subcutaneous IgG Infusion - Hizentra® for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP):
Throughout the infusion, the measured flow rate may vary ±36% from the flow rate labeled on the dial.

*Subsequent infusion after initial infusion.
= Outside of drug's prescribing information recommended minimum - maximum flowrate.

Subcutaneous IgG Infusion - Xembify® for Primary Immunodeficiency (PI):
Throughout the infusion, the measured flow rate may vary -48.4%, +9% from the flow rate labeled on the dial.

= Outside of drug's prescribing information recommended minimum - maximum flowrate.

Subcutaneous IgG Infusion - Cuvitru® for Primary Immunodeficiency (PI):
Throughout the infusion, the measured flow rate may vary from the flow rate labeled on the dial.

*Subsequent infusion after first two infusions.
*Subsequent infusion after first two information recommended minimum - maximum flowrate.

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

• Sample Size: The document states, "Flow rate was measured by visually assessing the change in volume in a graduated cylinder every 30 seconds." It does not specify the number of individual tests, number of devices, or number of runs for each configuration. It only describes the method of measurement and the resulting performance ranges.
• Data Provenance: The data is from "bench testing conditions," which generally implies a controlled laboratory environment. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S.-based company (Innovative Health Sciences, LLC, Chester, NY), implying the testing was likely conducted in the US. The data is prospective, generated specifically for this submission.

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

• Not Applicable. This is a mechanical/fluid dynamics device, not an AI/ML diagnostic device requiring expert interpretation of medical images or data for ground truth. The "ground truth" for flow rate performance is established through direct, objective physical measurements using calibrated equipment (graduated cylinder, timing device, etc.), as described in the "Flowrate Performance" section: "Flow rate was measured by visually assessing the change in volume in a graduated cylinder every 30 seconds, when using the Insignis™ Syringe Infusion System as intended."

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

• Not Applicable. There is no expert adjudication for this type of performance testing.

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-assisted diagnostic device. No MRMC study was conducted or is relevant for this type of submission.

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

• Not Applicable. This is a mechanical infusion system, not an algorithm. Bench testing evaluates the device's standalone physical performance parameters.

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

• The ground truth for flow rate performance is based on direct, objective physical measurements (volume over time) under controlled bench testing conditions, as described.

8. The sample size for the training set:

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

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

• Not Applicable. No training set was used.

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The AVEOtsd (Tongue Stabilizing Device) Mouthpiece is intended as an aid in the reduction of snoring for adults at least 18 years old.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "The AVEOtsd (Tongue Stabilizing Device) Mouthpiece." It states that the device is substantially equivalent to a predicate device for its intended use as an aid in the reduction of snoring for adults.

However, this document does not contain any information about acceptance criteria, device performance testing, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types and establishment methods.

The letter is a regulatory approval document confirming market clearance, not a technical report detailing the device's performance study. Therefore, I cannot answer the questions posed in the prompt based on the provided text.

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Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.

There are three models of the Phoenix Contact Lens Case:
CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side
CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side
CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side
All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural.
The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.

The provided document is a 510(k) premarket notification for Phoenix Contact Lens Cases (CL-01, CL-02, CL-03). It outlines the device's substantial equivalence to legally marketed predicate devices.

Based on the provided text, the device in question is a contact lens case, not an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving the performance of AI/ML medical devices, is not applicable to this submission.

The document details non-clinical tests performed on the contact lens cases to demonstrate their substantial equivalence. These tests primarily focus on the biocompatibility and safety of the materials used in the contact lens cases, not on the performance of a diagnostic or therapeutic algorithm.

Here's a summary of the non-clinical tests and their conclusions, which serve as the "acceptance criteria" and "device performance" for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The following numbered points are not applicable to this device, as it is a physical contact lens case and not an AI/ML software device.

2. Sample sizes used for the test set and the data provenance: Not applicable. The tests involved in vitro cell cultures and in vivo animal models, with sample sizes determined by the respective ISO standards and USP guidelines for biocompatibility testing (e.g., specific numbers of cells, guinea pigs, rabbits, or mice as per the standard). The provenance is "laboratory testing conditions" and "experimental conditions." These are typically prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective biological responses measured in a laboratory setting per standardized protocols, not human expert consensus on images or clinical data.
4. Adjudication method for the test set: Not applicable. The tests evaluate direct biological and material responses, not subjective interpretations requiring adjudication.
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 study type is for AI/ML diagnostic performance, not for a physical medical device like a contact lens case.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. The "ground truth" for these biocompatibility tests is the presence or absence of a specific biological or toxicological reaction as defined by the international standards (e.g., cell viability, skin erythema/edema, systemic toxicity, fever induction, ocular irritation).
8. The sample size for the training set: Not applicable. This document describes pre-market testing for a physical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established: Not applicable.

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The Reprocessed Agilis NxT Introducer is indicated when introducing various cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.

The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and quidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The provided text is a 510(k) premarket notification for a Reprocessed Agilis NxT Steerable Introducer. This document is for a medical device that facilitates the introduction of catheters into the heart. It is not an AI/ML medical device, and therefore the provided document does not contain information on acceptance criteria for AI models, nor studies that prove an AI device meets acceptance criteria.

The information requested in the prompt (acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, etc.) is typically found in submissions for AI/ML-driven medical devices, especially those related to diagnostic imaging or analysis.

Since this document pertains to a reprocessed physical medical device (a catheter introducer), the "studies" mentioned are bench and laboratory testing to prove the device's physical and mechanical performance, biocompatibility, cleaning validation, sterilization validation, and packaging validation. These are standard tests for physical medical devices, not for AI model performance.

Therefore, I cannot extract the requested information from the provided text because it describes a different type of medical device assessment.

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The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.

The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode, which is in compliance with IEC 60601-2-2. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and optionally to an external pressure monitoring system via a luer connection. The dimensions for the reprocessed NRG Transseptal Needle can be found on the device label. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. As well, the active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Reprocessed NRG Transseptal Needle.

Important Note: The provided document is an FDA 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel efficacy or performing clinical trials with the same rigor as for a new drug or a high-risk de novo device. Therefore, the "study" described is primarily a series of bench and functional tests to ensure the reprocessed device performs comparably to the original and remains safe. It does not involve human subjects, AI performance, or typical clinical effectiveness measures that would require ground truth established by medical experts for a diagnostic algorithm.

Acceptance Criteria and Reported Device Performance

Given the nature of this submission (reprocessed device seeking 510(k) clearance), the "acceptance criteria" are primarily related to the device's functional integrity, safety, and equivalence to the original predicate device after reprocessing.

Study Information

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

   • The document does not specify numerical sample sizes for each test mentioned (e.g., how many devices were subjected to cleaning validation, electrical safety, etc.).
   • The "data provenance" is derived from internal testing conducted by Innovative Health, LLC, the reprocessor and applicant. It's a retrospective evaluation of reprocessed devices. The country of origin for the data is implicitly the United States, where the company operates.

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

   • This question is not directly applicable to this type of device clearance. The "ground truth" for a reprocessed medical device is its ability to meet engineering specifications and safety standards, not a diagnostic accuracy against expert consensus. These "bench and laboratory tests" are typically performed against pre-defined engineering requirements and international standards by qualified engineers and technicians, not medical experts.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for human evaluation of diagnostic images or clinical scenarios where expert disagreement is possible. For functional and safety testing of a physical device, the outcome is typically an objective pass/fail against a standard, not subject to expert adjudication of subjective interpretations.

4. 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, an MRMC comparative effectiveness study was not done. This is a reprocessed medical device (a transseptal needle), not an AI diagnostic algorithm or a device requiring human interpretation of data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant to this submission.

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

   • Not applicable. This device is a physical medical instrument, not an algorithm.

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

   • The "ground truth" for this device's performance is established by engineering specifications, international performance standards, and safety requirements for medical devices (e.g., ISO, ASTM, IEC standards for biocompatibility, sterility, electrical safety, mechanical strength, etc.). It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or therapeutic clinical trial. The premise is that if the reprocessed device consistently meets these defined physical and chemical parameters, it is substantially equivalent and safe for its intended use as the original device.

7. The sample size for the training set:

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

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

   • Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.

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The reprocessed cable provides an electrical connection between the IntellaMap Orion Mapping Catheter and the Signal Station of the Rhythmia Mapping System. The reprocessed Umbilical Cable is intended to be used with an Orion Mapping Catheter during electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing) and/or recording of electrical potentials.

The reprocessed umbilical cable is an insulated, multi-conductor cable that us 200 cm (6.6 ft) in length with multi-pin connectors at each end.

The provided document is a 510(k) summary for a Reprocessed Umbilical Cable, not an AI/medical imaging device. As such, it does not contain the information required to answer the prompt, which is specifically looking for details about the acceptance criteria and study proving performance for an AI device.

The document describes the reprocessing of a physical medical cable and includes information on:

• The device description and its intended use (providing an electrical connection between a mapping catheter and a signal station).
• Bench and laboratory testing performed for safety and effectiveness, such as cleaning validation, sterilization validation, visual inspection, dimensional verification, electrical continuity testing, HiPOT testing, and packaging validation.
• The reprocessed cable's substantial equivalence to a predicate device.

It does not contain any information about:

• Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets or training sets for an algorithm.
• Data provenance for AI training/testing data.
• Expert involvement in establishing ground truth for AI.
• Adjudication methods for AI ground truth.
• MRMC studies or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Ground truth types like pathology or outcomes data for AI.

Therefore, I cannot fulfill the request as the source document does not pertain to an AI device.

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The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Reprocessed Eagle Eye Platinum RX Digitial IVUS Catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels.

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cut down into the vascular system.

Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge. starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy.

The Eagle Eye Platinum RX Digital IVUS Catheters are exclusive use with Volcano s5 Series and CORE Series of Systems. This catheter will not operate if connected to any other imaging system.

A hydrophilic coating is applied externally to a distal portion of the catheter.

This is a medical device submission, specifically a 510(k) premarket notification for a reprocessed intravascular ultrasound (IVUS) catheter. The document details the device, its intended use, and substantial equivalence to predicate devices. However, it does not contain detailed information about acceptance criteria for a study or the results of such a study proving the device meets those criteria in a way that allows for the extraction of the requested information regarding AI device performance, sample sizes, expert ground truth, adjudication methods, or MRMC studies.

The document focuses on demonstrating that the reprocessed device is substantially equivalent to legally marketed predicate devices, a requirement for 510(k) clearance. The testing mentioned in this document (biocompatibility, cleaning validation, sterilization validation, functional testing, etc.) are standard tests for reprocessed medical devices to ensure they are safe and effective after reprocessing, not necessarily a clinical study to evaluate diagnostic performance against a specific set of acceptance criteria for an AI algorithm.

Therefore, for most of your specific questions, the information is not available in the provided text.

Here's a breakdown of what can and cannot be answered based on the provided text:

Information Not Available in the Provided Text:

• A table of acceptance criteria and the reported device performance (in the context of an AI device or a diagnostic performance study): The document lists functional and safety testing for a reprocessed physical device, not an AI or diagnostic performance study with specific criteria like sensitivity, specificity, or AUC.
• Sample size used for the test set and the data provenance: Not applicable as no diagnostic performance study of an AI device is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method 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. This is not an AI device submission.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable for a diagnostic performance study.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information that can be partially inferred or is directly stated (though not in the context of an AI study):

• Device Name: Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
• Device Type: Intravascular Ultrasound (IVUS) Catheter (a physical medical device, not an AI algorithm)
• Purpose: Evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image.
• Testing Conducted (Functional and Safety, not diagnostic performance):
  • Biocompatibility
  • Cleaning Validation
  • Sterilization Validation
  • Functional testing (Visual Inspection, Dimensional Verification, Simulated Use, Mechanical Characteristics, Hydrophilic Coating, System Compatibility)
  • Drying Validation
  • Packaging Validation
• Conclusion from the document: Innovative Health concludes that the Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter is as safe and effective as the predicate devices described herein, based on the functional and safety testing for a reprocessed device.

In summary, this document is a 510(k) submission for a reprocessed medical device (an IVUS catheter) and does not describe the evaluation of an AI-powered diagnostic device or a study with "acceptance criteria" in the sense of diagnostic performance metrics for an algorithm.

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