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The EOCVC Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements.

PediaSat Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements in adults and/or pediatric patients.

The pressure injectable EOCVC Oligon catheters are indicated for short term (

The Edwards Oximetry Central Venous Catheter is a non-balloon catheter that provides the means for infusion of solutions, measuring pressure, and taking blood samples through the distal lumen (terminates at the catheter tip), the proximal lumen (terminates 7 cm proximal to the tip), and the medial lumen (terminates 5 cm proximal to the tip). Edwards Oximetry Central Venous Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module.

The PediaSat oximetry catheters are non-balloon catheters that provide the means for infusion of solutions, measuring pressure, and taking blood samples. These catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor or compatible bedside module.

The EOCVC Oligon catheter is a non-balloon catheter that provides the means for infusion of solutions measuring pressure injecting contrast media, and taking blood samples through the distal lumen (terminates 7 cm proximate to the tip), and the medial lumen (terminates 5 cm proximal to the tip). The EOCVC Oligon catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences monitor and compatible bedside module. All catheters are manufactured with a polyurethane-based Oligon polymer (containing silver, platinum, and carbon black) which has antimicrobial properties.

Oxygen saturation is monitored by fiberoptic reflectance spectrophotometry. The amount of light absorbed, refracted, and reflected depends on the relative amounts of oxygenated and deoxygenated hemoglobin in the blood.

The PediaSat Oximetry Catheter is a 3 lumen catheter available with a diameter of 4.5 French (F) and 8 cm in length. The EOCVC Oximetry Catheters are 3 lumen catheters available with a diameter of 8.5F and in lengths of 16 and 20 cm. EOCVC and PediaSat catheters are manufactured from polyurethane.

A suture loop and a specially molded box clamp are provided with each EOCVC (Oligon and non-Oligon) and PediaSat Oximetry Catheter to facilitate suturing of the catheter at the site of insertion. The suture loop and box clamp can be placed anywhere along the catheter body at the discretion of the clinician.

The dilator, included with each catheter, is indicated for enlarging the opening in a vessel for preparation of percutaneous entry of the catheter.

The EOCVC (Oligon and non-Oligon) and PediaSat Kits consist of accessories previously cleared for marketing as well as accessories that are the subject of this submission.

This submission is for clearance of proposed modifications to the accessories (suture loop, box clamp and dilator) for use with the previously cleared EOCVC Oligon (K160645), PreSep (now EOCVC), and PediaSat (K053609) Oximetry Catheter Kits. Additional accessories are listed on table below.

The provided text is a 510(k) summary for the Edwards Oximetry Central Venous Catheter (EOCVC), Edwards Oligon Oximetry Central Venous Catheter, and PediaSat Oximetry Catheters. The submission aims for clearance of proposed modifications to accessories (suture loop, box clamp, and dilator) for use with previously cleared catheters. The study described focuses on demonstrating the substantial equivalence of these modified accessories to predicate device accessories.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, 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 used for the functional and performance testing of the accessories. It only mentions that "Testing was conducted." The provenance of the data (e.g., country of origin, retrospective or prospective) is also not specified. These studies are typically conducted in a laboratory setting by the manufacturer.

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

This information is not provided in the document. The testing described appears to be primarily bench testing and performance verification against engineering specifications, rather than clinical studies requiring expert ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to establish ground truth from subjective evaluations (e.g., image interpretation). The tests described are objective engineering and performance verification tests.

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

No, an MRMC comparative effectiveness study was not done. This type of study investigates the impact of a device on human reader performance, usually in diagnostic imaging. The submission focuses on the substantial equivalence of modified catheter accessories through bench and performance testing.

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

Not applicable. This device is a physical medical catheter and its accessories, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for these tests would primarily be engineering specifications and established performance benchmarks derived from the predicate devices and industry standards. For example, "tensile strength" would be compared against a defined maximum or minimum force, and "dimensional verifications" against specified measurements.

8. The Sample Size for the Training Set

Not applicable. The described study is not a machine learning study requiring a training set. It involves physical product testing.

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

Not applicable, as there is no training set for this type of device submission.

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The pressure injectable PreSep Oligon Oximetry Catheters are indicated for short term (

The PreSep Oligon Oximetry Catheter is a pressure injectable antimicrobrial catheter intended to provide the means for infusion of solutions, measuring pressure, delivering contrast media and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheter also provides the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor.

The PreSep Oligon Oximetry Catheter is a 3 lumen catheter available in 8.5 French, 16 and 20cm lengths. The lumens exit at the tip of the catheter for the distal; medial and proximal exit at the ports. The catheter is manufactured from a base material of barium sulfate-filled polyurethane. Barium sulfate makes the material more radiopaque. Carbon, silver, and platinum are added to the base material. The silver and platinum render the polymer antimicrobial, by oligodynamic iontophoresis. The antimicrobial agent is silver, which is ionized and electrochemically released from the inside and outside surfaces of the catheter material into the lumens and subcutaneous space. The Oligon polymer technology provides antimicrobial protection on both the inside and outside of the catheter.

With the use of the Oligon material, the catheter has demonstrated significant antimicrobial activity, within 48 hours after inoculation, against the following organisms: Staphylococcus epidermidis, Staphylococcus aureus, Enterococcus faecalis, Candida albicans, Escherichia coli, Serratia marcescens, Acinetobacter calcoaceticus, Corynebacterium diptheriae, Enterobacter aerogenes, Klebsiella pneumoniae, Staphylococcus aureus Gentamicin and Methicillin resistant (GMRSa), Pseudomonas aeruginosa, Candida glabrata, and VRE (Enterococcus faecium)

The provided text describes the 510(k) summary for the PreSep Oligon Oximetry Catheter (K160645). However, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria in the context of an AI/ML-based medical device.

The document discusses:

• The device's trade name, regulation, and classification.
• Indications for Use, which are for hemodynamic monitoring, blood sampling, infusion, continuous oxygen saturation monitoring, pressure injection of contrast media, and central venous pressure monitoring for short-term use (

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The Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter (PICCOx), is indicated for access to the central venous system for continuous in vivo measurement of the oxyhemoglobin saturation of blood (ScvO2), intravenous therapy, blood sampling, pressure injection of contrast media, and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the PICCOx may not exceed 300 psi.

The Peripherally Inserted, Pressure Injectable Central Venous Oximetry Catheter (PICCOx) is a single or multi-lumen catheter capable of intravenous infusion including pressure infusion up to 300psig, central venous pressure monitoring, venous blood sampling, and allows for continuous measurement of central venous oxygen saturation (ScvO2) in the superior vena cava. The device includes fiber optics in a dedicated lumen for light transmission and single or multiple fluid lumens. Constructed of barium sulfate filled polyurethane, these catheters are radiopaque enabling the use of fluoroscopy or X-ray, to guide insertion and verify position. The maximum recommended infusion rate for the pressure injectable lumen is 5 mL/sec. Distance markings on the catheters provide a visual indication of insertion depth. Every 5cm the insertion depth is printed with an actual number and in between the numbers are black dots which are printed every 1cm. The catheter is non-trimmable, and offered in usable lengths of 40cm, 45cm, 50cm, and 55cm. Individual lumen hubs are ISO standard female luers which are adaptable to NeedleFree Connectors, syringes or IV tubing compliant with the ISO standard. The fiber optic lumen which is terminated in a housing, can be plugged into a compatible Optical Module. PICCOx is intended to be used with a user defined convenience kit. These "kits" are cleared under 510(k) K052865. All kits are terminally sterilized. The contents of the kit are sterile, medical devices intended for single patient use only with fluid path and invasive surfaces non-pyrogenic (or as indicated on the labeling of internal component packaging.)

This is a medical device 510(k) premarket notification summary for the PICCOx Peripherally Inserted, Pressure Injectable, Central Venous Oximetry Catheter. The submission aims to demonstrate substantial equivalence to predicate devices, and the provided text focuses on the device's technical characteristics and non-clinical performance data. There is no information in the provided text that describes a study comparing the device's performance against acceptance criteria using patient data or expert assessments. The information primarily covers device description, intended use, and a comparison of features with predicate devices.

Therefore, the following information is not available in the provided text:

• Acceptance criteria table and reported device performance based on a study of that nature.
• Sample size used for the test set and data provenance specific to such a study.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone (algorithm only) performance study.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data) for a performance study.
• Sample size for the training set.
• How ground truth for the training set was established.

The provided text focuses on non-clinical performance testing and biocompatibility, as stated:

"The successful results of the key tests involving dynamic response, fiber optics, flow rates, leakage, force at break, lead tubing, markings, priming volumes, radiopacity, needlefree connector compatibility, and catheter to introducer fitment demonstrate that the proposed PICCOx Peripherally Inserted Central Venous Oximetry Catheter has met the pre-determined acceptance criteria applicable to the safe use of the devices."

This indicates that internal performance specifications were met through non-clinical bench testing, but these acceptance criteria and results are not detailed in a way that allows for filling out the requested table. The summary confirms that "No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices." Instead, the device "has been tested in accordance with its performance specification which accommodates known functional requirements."

Without further details on these specific "performance specifications" and their corresponding results, the requested table and other study-related information cannot be generated from the given text.

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The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.

The PreSep Oligon Oximetry Catheters (K060093) are used with Edwards oximetry monitors to continuously measure oxygen saturation. The catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples. The PreSep Oligon Oximetry Catheters can be used with an uncoated stainless steel guidewire or a PTFE-coated Nitinol core guidewire, which are included in kits or as separately packaged components.

This 510(k) summary describes a medical device, the PreSep Oligon Oximetry Catheters, and demonstrates its substantial equivalence to a predicate device, rather than providing a study proving performance against defined acceptance criteria in the typical sense of an AI/algorithm-driven device.

Therefore, many of the requested categories regarding AI-specific studies and ground truth establishment are not applicable. I will extract the relevant information from the provided text.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly present a table of quantitative acceptance criteria for specific performance metrics (e.g., accuracy, sensitivity, specificity) with corresponding reported device performance values. Instead, it describes a comparative analysis to a predicate device for safety and effectiveness.

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

The document states "side-by-side comparative bench and pre-clinical performance testing."

• Sample Size: Not explicitly stated. The term "pre-clinical animal studies" implies a test set of animals, but the number is not provided. "Bench" studies typically involve physical device testing, not data samples in the same way an AI algorithm uses data.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies are described as "pre-clinical animal studies," indicating they were conducted in a controlled, non-human environment. The nature (retrospective/prospective) is not explicitly given, but "pre-clinical" and "bench" studies are typically prospective tests designed for device evaluation.

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

Not Applicable. This device is a physical catheter, not an AI algorithm requiring expert ground truth for image or data interpretation. The "ground truth" would be objective measurements and observations from the bench and animal studies to assess the catheter's physical performance, safety, and functionality.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in human-AI studies involving subjective interpretations. For this device, the "adjudication" would be based on direct measurement, observation, and comparison to the predicate device's measured performance in the bench and animal studies.

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

Not Applicable. This is not an AI/software device whose performance depends on human-in-the-loop interaction. Therefore, an MRMC study comparing human readers with and without AI assistance was not conducted.

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

Not Applicable. This is a physical medical device (catheter) with associated oximetry monitors. It is not an algorithm, so a standalone algorithm performance study is not relevant. The device itself performs the function.

7. The Type of Ground Truth Used

For a physical device like this, the "ground truth" for the test (verification and validation) would be based on:

• Physical Measurements and Observations: Direct measurements of catheter dimensions, material properties, flow rates, pressure readings, oxygen saturation readings, and observations of device interaction within the test environment (bench models, animal models).
• Biocompatibility Testing: Results from standardized tests to ensure the material is safe for contact with biological tissues.
• Predicate Device Performance: The established and legally marketed performance and safety profile of the predicate device serves as the benchmark against which the new device is compared to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device that requires a training set.

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

Not Applicable. As there is no training set for an AI algorithm, no ground truth was established for a training set in this context.

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Hospira Advanced Sensor Catheters:

Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output. Oxyhemoglobin Saturation, and Venous Blood Sampling. A secondary indication is for the therapeutic infusion of solutions.

Hospira Critical Care Catheters;

Indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients including the following : acute heart failure; differentiating ruptured ventricular septum form mitral regurgitation; diagnosis of tamponate; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of the placenta; cardiac output determination by thermodilution method; and blood sampling.

Additional indication for Hospira Critical Care Pacing Lead Catheters:

Indicated for temporary transluminal ventricular pacing using a temporary ventricular lead.

The Hospira Critical Care and Advanced Sensor Catheters have multi-lumens that incorporate some or all of the following components and features: a distal balloon for positioning the catheter tip via blood flow within the pulmonary artery, a heater coil for determining continuous cardiac output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvQ2), and access ports for drug delivery or blood sampling. In addition, the Hospira Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the balloon.

The provided document is a 510(k) summary for Hospira Critical Care and Advanced Sensor Catheters. It describes the device, its intended use, and a comparison to a predicate device.

However, it does not contain detailed information about specific acceptance criteria and the comprehensive study results that would typically prove a device meets those criteria.

The document states:
"The Hospira Critical Care and Advanced Sensor Catheters have been tested for biocompatibility and for expansion symmetry, over inflation, multiple inflations, deflation time, and burst strength and have passed all of the acceptance criteria." (page 2)

This is a high-level summary and does not provide the quantitative acceptance criteria or the reported device performance in a table format, nor does it detail the specifics of the study, such as sample sizes, data provenance, ground truth establishment, or expert involvement.

Therefore, I cannot fully complete the requested table and study details based solely on the provided text. The following is extracted from the available information, with specific limitations noted for the missing data.

1. Table of Acceptance Criteria and Reported Device Performance

Limitations: The document provides a high-level statement that tests were passed but does not specify quantitative acceptance criteria or detailed reported device performance for each test.

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

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified, but generally, medical device testing for regulatory submission like this would be conducted in a controlled lab or manufacturing environment. It is not patient or country-specific data in the clinical sense. This type of testing is typically prospective for engineering and material performance.

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

• Number of Experts: Not applicable. These tests appear to be engineering and material performance tests, not clinical evaluations requiring expert interpretation of results like medical imaging. The "ground truth" would be established by the physical/chemical properties and design specifications of the device.
• Qualifications of Experts: Not applicable for the type of testing described (biocompatibility, mechanical performance). These tests are typically performed by engineers, quality control specialists, and lab technicians.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests described (biocompatibility, mechanical tests) yield objective pass/fail results based on predefined engineering or regulatory standards, rather than requiring subjective adjudication of interpretations.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on manufacturing methods, materials, and functional performance tests of the device itself, not on the interpretation of results by human readers with or without AI assistance. This device is a catheter, not an AI diagnostic tool.
• Effect Size of Human Readers with/without AI: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: No, a standalone (algorithm only) performance study was not done. This device is a physical medical catheter, not an algorithm or AI product.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth for this device's performance relies on engineering and material specifications, and validated test methods. For example, the burst strength is compared against a pre-defined safety margin derived from engineering principles and regulatory guidelines for medical devices. Biocompatibility would be assessed against ISO standards (e.g., ISO 10993).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI model. For the device itself, the "ground truth" for its design and manufacturing is established through design specifications, material characterization, and adherence to quality systems and regulatory standards (e.g., Good Manufacturing Practices).

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The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) is intended for measuring the oxygen saturation of blood.

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) is indicated for the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice. The probe with fluidic seal is also indicated for pressure monitoring, and infusion of fluids.

The Central Venous Oximetry Probes (Heparin Coated) are non-pyrogenic, sterile, single patient use, disposable oxygenation monitoring sets for use with central venous catheters for continuous monitoring of central venous oxygen saturation. The probes are manufactured from medical-grade polymers and incorporate a closed-ended fiber optic lumen at the tip to measure central venous oxygen saturation. The exterior of the proposed device is coated with Heparin using the same Heparin agent and coating method used on Oximetry Catheters being marketed by Hospira today. The method of operation is the same as the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal.

The Fluidic Seal is a non-pyrogenic, sterile, single patient use device that facilitates the introduction of a Central Venous Oximetry Probe into any size-compatible central venous catheter. The Fluidic Seal also maintains the relative insertion of the oximetry probe within the central venous catheter. The Fluidic Seal consists of a lateral flush port for the administration of fluids and/or for pressure monitoring.

The subject devices are modifications of the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal.

The modification is to add Heparin coating to the probe and change the lead tubing material to a PE-lined polyvinyl chloride.

Both the predicate and the proposed devices can be used with marketed central venous catheters for obtaining critical cardiac performance parameters.

The provided 510(k) summary (K062999) describes a device modification rather than a new device and does not include detailed performance studies with acceptance criteria in the manner typically seen for complex diagnostic algorithms. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device.

Therefore, the information requested for acceptance criteria and a detailed study proving device performance is not present in the provided text.

The document states:

• "The subject devices are modifications of the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal."
• "The modification is to add Heparin coating to the probe and change the lead tubing material to a PE-lined polyvinyl chloride."
• "The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) meets the functional claims and intended use as described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicate OPTICATH® Central Venous Oximetry Probe with Fluidic Seal."

This indicates that the primary method for demonstrating safety and effectiveness was through showing that the modified device is substantially equivalent to the previously cleared predicate device, rather than through a new, comprehensive performance study with specific acceptance criteria.

To directly answer your questions based only on the provided text, most of the information is not available:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission relies on substantial equivalence to the predicate device.
2. Sample size used for the test set and the data provenance: Not provided. No specific test set data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
8. The sample size for the training set: Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. No training set is mentioned.

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The OPTICATH® Central Venous Oximetry Catheter is indicated for central venous pressure monitoring, drug and fluid administration, vascular access, venous blood sampling and the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice.. The OPTICATH® Central Venous Oximetry Catheter is intended for onetime use.

The OPTICATH® Central Venous Oximetry Catheter is a disposable single use central venous catheter with integrated fiber optics for measurement of blood oxyhemoglobin levels. It is compatible with existing Oximetrix 3, Q2 or Q2 Plus SO₂ oxylicmographili lovols: 1015 computactured by Philips, GE Medical and Spacelabs. The Central Venous Oximetry – Integrated Catheter is a component within a Hospira Central Venous Catheter (CVC) kit.

The provided text describes a 510(k) summary for the OPTICATH® Central Venous Oximetry Catheter but does not contain detailed information about the acceptance criteria or a specific study designed to prove the device meets those criteria.

However, the closest information regarding performance and evaluation is in the following statement:

"The proposed modifications have been evaluated using bench testing as well as in-vivo non-clinical studies of which the results met the acceptance criteria and do not raise new issues of safety and/or effectiveness."

This statement confirms that studies were performed, and acceptance criteria were met, but it does not specify what those criteria were, the reported device performance, or the details of the studies themselves. As a result, I cannot populate the requested table or provide detailed answers to many of the specific questions.

Here's an attempt to answer what can be inferred or directly stated from the provided document, with many fields marked as "Not specified in the provided text":

Acceptance Criteria and Study Details for OPTICATH® Central Venous Oximetry Catheter

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided text. The document only states "bench testing as well as in-vivo non-clinical studies."
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The term "in-vivo non-clinical studies" suggests animal studies or simulated human models, but details are lacking.

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

• Not specified in the provided text.

4. Adjudication method for the test set

• Not specified in the provided text.

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 device is a medical catheter with integrated fiber optics for continuous in-vivo measurement, not an AI-assisted diagnostic imaging device or software that involves "human readers."

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

• Not applicable in the context of an "algorithm only" study. The device performs a measurement, which is then used by clinicians for monitoring. The performance evaluation would focus on the accuracy and reliability of the measurement itself, which is inherently "standalone" in its measurement function, but then integrated into a human workflow. The text refers to "bench testing as well as in-vivo non-clinical studies" to evaluate the device.

7. The type of ground truth used

• Not explicitly stated. For a device measuring oxyhemoglobin saturation, the "ground truth" for the in-vivo non-clinical studies would likely involve established reference methods for blood gas analysis or oximetry. For bench testing, it would involve controlled conditions with known reference values.

8. The sample size for the training set

• Not applicable. This is a hardware medical device, not a machine learning algorithm that requires a "training set."

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

• Not applicable (as above).

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Hospira Latex-Free Advanced Sensor Catheters:

Indicated for the assessment of the hemodynamic status of a patient, including but not restricted to the following: Venous Pressures, Cardiac Output, Oxyhemoglobin Saturation, and Venous Blood Sampling, A secondary indication is for the therapeutic infusion of solutions.

Hospira Latex-Free Critical Care Catheters:

Indicated for the assessment of hemodynamic status through right ventricular, and pulmonary artery and / or wedge pressure monitoring for patients including the following: acute heart failure; differentiating ruptured ventricular septum from mitral regurgitation; diagnosis of tamponade; severe hypovolemia; complex circulatory situations (e.g., fluid management with acute burn patients); medical emergencies; adult respiratory distress syndrome; gram negative sepsis; drug intoxication; acute renal failure; hemorrhagic pancreatitis; intra- and postoperative management of high risk patients; history of pulmonary or cardiac disease; fluid shifts (such as extensive intra-abdominal operations); management of high risk obstetrical patients; known cardiac disease; toxemia; premature separation of placenta; cardiac output determination by thermodilution method; and blood sampling.

Additional indication for Hospira Latex-Free Critical Care Pacing Lead Catheters:

Indicated for temporary transluminal ventricular pacing a temporary ventricular pacing lead.

The HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters have multi-Iumens that incorporate some or all of the following components and features: a distal balloon for positioning the catheter tip via blood flow within the pulmonary artery, a heater coil for determining continuous cardiac output, a thermistor for monitoring core temperature and cardiac output, fiber optics for monitoring mixed venous oxygen saturation (SvO2), and access ports for drug delivery or blood sampling. In addition, the HOSPIRA Latex-Free Critical Care Pacing Lead Catheters include an access port for use with Transluminal Right Ventricular Pacing Leads. The catheters also incorporate insertion distance markings and are provided with a syringe for inflating the latex-free balloon.

The provided text describes a 510(k) summary for the HOSPIRA Latex-Free Critical Care and Advanced Sensor Catheters. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study of the proposed device itself. The key study mentioned relates to the material of the new balloon.

Here's an analysis of the provided information relative to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a table of specific device performance acceptance criteria for the overall catheter system with corresponding reported results. Instead, it describes tests performed on the gamma sterilized Polyisoprene-Polyurethane balloon material.

The overall device is stated to "meet the functional claims and intended use as described in the product labeling, and are as safe and effective in terms of substantial equivalence as the predicate catheters." This statement implies an equivalency review rather than a direct performance study against novel criteria.

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

The document does not specify the sample size used for the tests conducted on the Polyisoprene-Polyurethane balloon.
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective/prospective), but these would typically be lab-based, pre-clinical tests for a material change, not human clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the described tests are laboratory/material performance tests, not clinical evaluations requiring expert interpretation for ground truth.

4. Adjudication Method

This information is not applicable as the described tests are laboratory/material performance tests, not clinical evaluations requiring adjudication.

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

There is no mention of an MRMC comparative effectiveness study involving human readers. This type of study is not relevant for the described material and device equivalency assessment.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

There is no mention of a standalone performance study. This type of study is typically relevant for AI/software devices, which this is not. The described tests are material/physical performance tests.

7. Type of Ground Truth Used

For the balloon material tests, the ground truth would be based on engineering specifications and established test methodologies for biocompatibility, mechanical properties (expansion symmetry, over inflation, multiple inflations, deflation time, burst strength). There is no "expert consensus," "pathology," or "outcomes data" in the traditional clinical sense for these specific tests as described.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The tests are for material and device physical integrity.

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

This information is not applicable as there is no "training set" to establish ground truth for.

In summary, the provided 510(k) notification focuses on demonstrating substantial equivalence of the new latex-free catheters to previously cleared predicate devices, primarily by showing that the new balloon material (Polyisoprene-Polyurethane) meets established performance and safety criteria, and that manufacturing process changes (gamma sterilization) are acceptable. The study highlighted is a set of laboratory tests on the balloon component, not a clinical study of the entire device's performance in humans against specific numerical clinical efficacy acceptance criteria.

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The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is intended for measuring the oxygen saturation of blood.

The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal is indicated for the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO2) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice. The probe with fluidic seal is also indicated for pressure monitoring and infusion of fluids.

The OPTICATH® Central Venous Oximetry Probe is a sterile, non-pyrogenic, single use, disposable probe for use with compatible optical modules/oximeters and central venous catheters. The probe incorporates optic fibers that enable continuous in vivo monitoring of oxyhemoglobin saturation within circulating blood using the principle of reflection spectrophotometry.

The Fluidic Seal is a non-pyrogenic, sterile, single use accessory to the OPTICATH® Probe that facilitates the introduction of the Probe into any sizecompatible central venous catheter and maintains the insertion position of the probe tip. The Fluidic Seal has a lateral flush port for pressure monitoring or for infusion of fluids.

The subject device is a modification of the predicate OPTICATH® Oximetry Catheter (K820674). The modifications include:

1. reducing the usable length of the probe and removing the guiding balloon since the probe is intended to monitor the oxyhemoglobin saturation of blood in the superior vena cava (central venous oxygen). (i.e., the additional length and balloon that facilitate placement of the predicate catheter into the pulmonary artery are not required) and

2. addition of a Fluidic Seal, which is an accessory to the OPTICATH® Probe, that facilitates placement of the probe into a previously-inserted central catheter and maintains the position of the probe tip.

This document describes a 510(k) submission for the OPTICATH® Central Venous Oximetry Probe with Fluidic Seal. The submission primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing and in vivo non-clinical testing. While the general nature of the testing is mentioned, detailed acceptance criteria and performance data in a format typically seen for modern AI/ML device submissions are not present.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific numerical acceptance criteria or performance metrics for the device. It generally states that "Results of all non-clinical testing met associated acceptance criteria" but without detailing what those criteria were or the exact performance achieved against them.

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

The document does not specify the sample size for the test set used in either the bench testing or the in vivo non-clinical testing. It also does not mention the country of origin of the data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. The study appears to be focused on device functionality and accuracy rather than clinical interpretation by experts.

4. Adjudication Method

Not applicable as there is no mention of expert review or adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is not an AI/ML diagnostic tool, but rather a medical probe for continuous physiological monitoring.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a hardware probe with an optical measurement principle, not a standalone algorithm.

7. Type of Ground Truth Used

For the in vivo non-clinical testing for accuracy of oxygen saturation measurements, the ground truth would have been derived from a reference method for measuring oxyhemoglobin saturation. The specific reference method is not stated, but typically involves laboratory-based blood gas analysis or a highly accurate research oximeter. For the bench testing, the ground truth would be based on engineering specifications and measurement standards.

8. Sample Size for the Training Set

Not applicable. This device does not involve training a machine learning model.

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

Not applicable. This device does not involve a training set for machine learning.

Summary of Study and Device Evidence:

The provided document describes a 510(k) submission for a modified medical device, specifically an oximetry probe. The study conducted to support its substantial equivalence involved bench testing (fluid flow, fluid leakage, pressure frequency response, plunger activation force, probe drag force) and in vivo non-clinical testing (accuracy of oxygen saturation measurements). The general conclusion is that all testing "met associated acceptance criteria," but the specific criteria and quantitative results are not detailed. This type of submission predates the common requirements for detailed AI/ML device performance reporting, and therefore many of the requested categories (like expert involvement, MRMC studies, or training data) are not relevant to this specific device and its regulatory pathway.

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The PreSep Oligon Oximetry Catheters are intended to provide the means for infusion of solutions, measuring pressure and taking blood samples through the distal, proximal and medial lumens. The PreSep Oligon Oximetry Catheters also provide the means for continuously monitoring oxygen saturation using an Edwards Lifesciences oximetry monitor.
The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.

The PreSep Oligon Oximetry Catheters are used with Edwards oximetry monitors to continuously measure oxygen saturation. These catheters also provide the means for infusion of solutions, measuring pressure and taking blood samples.

This is a 510(k) premarket notification for a medical device, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to establish de novo performance criteria. Therefore, the traditional concept of "acceptance criteria" and a "study proving the device meets acceptance criteria" as would be seen in a clinical trial for a novel device, is not explicitly present in the provided text.

Instead, the submission focuses on demonstrating that the PreSep Oligon Oximetry Catheters are as safe and effective as the predicate devices through comparative analysis and functional/safety testing.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document
does not specify quantitative acceptance criteria (e.g., specific thresholds for accuracy, precision, or durability). The acceptance is based on demonstrating equivalence to the predicate devices.

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

The document does not provide details on the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission states "functional testing" was performed, but no specifics about the testing methodology or data are given.

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

This information is not provided in the document. Given that this is a 510(k) for an oximetry catheter, "ground truth" would likely refer to established methods for measuring oxygen saturation or relevant physiological parameters, and not typically involve a panel of experts reviewing images or clinical cases in the way an AI-based diagnostic device might.

4. Adjudication Method for the Test Set

This information is not provided.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the document. MRMC studies are typically used to assess the impact of medical imaging devices or AI algorithms on human reader performance, which doesn't directly apply to an oximetry catheter for continuous physiological monitoring. The comparative analysis focused on device characteristics and performance against predicate devices.

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

This concept is not applicable to this device. The PreSep Oligon Oximetry Catheter is a physical medical device for continuous physiological monitoring, not an algorithm, and therefore does not have "standalone" algorithmic performance in the context of AI.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. For an oximetry catheter, "ground truth" would generally refer to established, validated methods for measuring oxygen saturation (e.g., co-oximetry of blood samples) or other physiological parameters measured by the catheter (pressure, blood sampling). The functional testing would compare the device's measurements against these established methods or against the performance of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

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