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Bioptimal Bipolar Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.

Bioptimal's Bipolar Pacing Catheter is made of radiopaque polyurethane catheter tubing at a usable length of 110 cm that allows the use of fluoroscopy for guiding the catheter during insertion or to verify its position when necessary. The catheter has radiopaque bands marked every 10 cm along their length to assist the physician in determining the depth of catheter insertion.

The Bipolar Pacing Catheter has an electrode lumen, which provides electrical conductor isolation from electrodes to the connector pins. It has two metal electrodes attached to the distal end of the catheter and the distal electrode forms its distal tip. The proximal electrode is 10 mm apart from the distal electrode.

Bipolar Pacing Catheters are available in two generic models: balloon-guided floatation (with balloon) and semi-floated (without balloon), with or without contamination shield. All models have the same basic design, construction and material. The balloon-guided models(BP2502-10 and BP2502CS-10) includes a latex balloon mounted between the distal and proximal electrodes and associated balloon lumen and tubing extension for inflating and deflating the balloon. The balloon is used for the advancement of the catheter tip by means of balloon flotation in the blood flow. The models with a contamination shield (BP2502CS-10 and BPX2502CS-10) have an expandable shield up to 110cm that provides a sterile environment for the enclosed catheter, and hence prevents the contamination of a catheter as it is inserted into and withdrawn from a body cavity or lumen.

Balloon guided models are supplied with a 1.0cc syringe for balloon inflation.

Bipolar Pacing Catheters are supplied sterile (through ethylene oxide sterilization), non-pyrogenic and are for single use only.

The catheter primary packaging: the catheter is packed in a blue thermoformed polystyrene tray and is covered with a clear APET cover held in place by snap buttons. White label printed with the product name, model ID, manufacturer and authorized representative's information, lot number, expiry date, UDI, symbols and other product information is pasted on the clear APET tray cover. The catheter tray is placed inside a sealed Tyvek bag which forms a single sterile barrier primary packaging.

The catheter is supplied sterile in a box of 5 units of single sterile barrier primary packaging with IFU.

The provided FDA 510(k) clearance letter and summary for the Bioptimal Bipolar Pacing Catheter focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance. Therefore, typical acceptance criteria and a study design to meet them (as would be seen for a new AI/software device often requiring standalone performance and MRMC studies) are not present in this document.

However, based on the information provided, we can extract the performance goals and reported performance as though they were acceptance criteria, particularly for the clinical data analysis.

Here's an analysis based on the provided text, categorized by your requested information:

Acceptance Criteria and Reported Device Performance

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Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Bard® Temporary Pacing Electrode Catheters:
Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device. Certain catheters may incorporate a lumen for balloon inflation.

Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.

Needle / Cannula (Introducer):
The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits.

The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter.

The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle is then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

The provided FDA 510(k) clearance letter and summary describe the Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer). The submission is a "Special 510(k)" primarily focused on removing a warning label related to unknown electromagnetic compatibility (EMC) with low-frequency emissions.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

The core of this Special 510(k) is the demonstration of electromagnetic compatibility, specifically concerning immunity to proximity magnetic fields, to justify the removal of a previous warning label.

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

• Sample Size: The document does not explicitly state a numerical sample size (e.g., "N=X devices were tested"). It refers to "representative external pulse generator equipment and the sample Temporary Pacing Electrode devices." This typically implies a limited number of devices/systems sufficient to represent the product line for EMC testing as per regulatory guidelines for in-vitro/bench testing.
• Data Provenance: The study was a bench (in-vitro) test performed to a recognized international standard (IEC 60601-1-2). There is no patient data involved, so there is no country of origin or retrospective/prospective distinction.

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

Not applicable. This was a bench-top engineering test evaluating electromagnetic compatibility against a defined international standard (IEC 60601-1-2). "Ground truth" in the clinical sense (e.g., diagnosis by experts) is not relevant here. The "ground truth" is the established test methodology and performance limits defined by the IEC standard.

4. Adjudication Method for the Test Set

Not applicable. As a bench test against objective standards, there is no expert adjudication process like those used in clinical studies for diagnostic accuracy. The results are objectively measured against the specified limits of the IEC standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a passive pacing electrode catheter and introducer, not an AI-powered diagnostic or therapeutic tool with a human-in-the-loop component.

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

Not applicable. The device is a medical hardware component, not an algorithm. The testing focused on the physical and electrical compatibility of the hardware with relevant external equipment.

7. The Type of Ground Truth Used

The "ground truth" for this study is compliance with international consensus standards for electromagnetic compatibility, specifically IEC 60601-1-2 (Edition 4.1): 2020, with particular focus on Clause 8.11 and the methods specified in IEC 61000-4-39 (2017). This standard defines objective tests and acceptance limits for device performance under various electromagnetic conditions.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

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

Not applicable, as there is no training set.

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Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device.

Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Pacing Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits. The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter.

The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle in then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

The provided text is a 510(k) Summary for a medical device (Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)). It describes the device, its intended use, and comparability to predicate devices. However, this document does not contain acceptance criteria or detailed study results in the format requested.

The text focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of Technological Characteristics: Tables comparing the subject device and the predicate device in terms of design, materials, and dimensions.
• Performance Data Summary: A list of various performance tests conducted (e.g., biocompatibility, electrical safety, mechanical tests, functional testing to standards like ISO 10555-1, IEC 60601-1, ISO 80369 series, ISO 11070). The document states that the devices met the requirements of the above standards and performance endpoints.

Therefore, I cannot provide the specific details requested in your prompt (a detailed table of acceptance criteria and reported device performance with numerical values, sample sizes for test sets, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment).

The document explicitly states that the device "met the requirements of the above standards and performance endpoints," implying that the acceptance criteria are defined by these referenced standards and internal specifications, but the specific numerical acceptance criteria and the quantitative results are not disclosed in this summary.

If you have a document that contains the detailed study results and acceptance criteria, please provide it.

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The rotatable connector is intended for use as part of a temporary cardiac pacing system. It connects a cardiovascular stimulating instrument to a cardiac pacing lead. It is intended for use by trained clinicians in a clinical environment.

The Model 5944RL rotatable connector is a pair of single use, disposable surgical cables with two adaptors. The cables are designed to connect a cardiovascular stimulating instrument to a cardiac pacing lead system.

The provided document is a 510(k) Premarket Notification Submission for a medical device called "Rotatable Connector (5944RL)". This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results to prove meeting specific acceptance criteria in the way a diagnostic AI/ML device would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets them in the context of an AI/ML or diagnostic device.

Specifically, the document states:

• "The subject of this premarket submission did not require clinical studies to support substantial equivalence." This means no clinical trials were performed to establish the device's performance against specific clinical acceptance criteria.
• The comparison is primarily focused on technical characteristics, intended use, and safety standards against a predicate device.

Given this, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: No such clinical performance metrics or acceptance criteria are listed.
2. Sample sizes used for the test set and the data provenance: No test set or data provenance from a clinical study are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no clinical test set for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is a physical medical device (a connector), not an AI/ML diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on non-clinical tests (e.g., biocompatibility, sterilization, electrical safety) to demonstrate substantial equivalence to a previously cleared predicate device.

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Streamline temporary leads and wires treat an irregular heartbeat during or after cardiac surgery by providing electrical stimulation to the heart.

• Models 6491, 6494, 6495, and 6500 are intended for atrial and ventricular use.
• Model 6492 is intended for atrial use only.
• Model 6491 and Model 6492 have smaller chest fixation coils and are appropriate for use in thin heart tissue and, in the case of Model 6491, a smaller chest cavity (for example, in a pediatric patient).

Each Streamline temporary pacing lead or wire comprises a lead body with a distal and a proximal segment. The distal segment has a separate electrode. A polypropylene monofilament (PP) fixation coil (except for model 6494) extends from the distal electrode end and is attached to a small, curved needle. The curved needle creates a channel in the myocardium for embedding the electrode. The PP fixation coil provides a means of securing the electrode in place. The proximal lead body terminates into a chest needle used to penetrate the chest wall, followed by pulling the proximal portion of the lead through the chest. The device is supplied sterile and intended for single use only.

The provided text describes a 510(k) premarket notification for Medtronic Streamline Temporary Pacing Leads and Wire. The submission is a "Special 510(K)" which indicates changes to a previously cleared device. The focus of the changes and the study conducted is related to Magnetic Resonance Imaging (MRI) compatibility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" are implied by adherence to established ASTM standards for MRI safety, and the "reported device performance" is the conclusion that the devices are "MR Conditional" under specific conditions.

Specific MR Conditions (from IFU - effectively performance details):

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

The document specifies "Each Streamline Model" was tested in "two configurations (bundled and extended)". The exact number of individual devices or test samples per model is not provided.

The testing is described as "nonclinical MRI testing" which implies a controlled laboratory environment rather than patient data. Therefore, data provenance is "laboratory setting" and not retrospective or prospective from human subjects.

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

This information is not provided as the study described is nonclinical testing of physical devices (MRI compatibility) against engineering standards, not a diagnostic assessment where expert ground truth would be established. The "ground truth" here is the physical measurement against an engineering standard.

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

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation studies where expert consensus is needed. For nonclinical engineering tests, the results are typically objectively measured against pre-defined thresholds from standards.

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 information is not provided and is not applicable to the type of device and study presented. The Streamline Temporary Pacing Leads are physical medical devices, not an AI software diagnostic tool.

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

This information is not provided and is not applicable. The device is a physical pacing lead, not an algorithm.

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

The "ground truth" for this nonclinical study is the physical measurement against established engineering standards (ASTM F2192-19e2 for RF Heat, and ASTM F2052-15w for Force and Torques).

8. The sample size for the training set

This information is not applicable/provided. The study is nonclinical testing of physical devices, not a machine learning model, so there is no "training set."

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

This information is not applicable/provided as there is no training set.

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The Swan-Ganz pacing-TD catheters are indicated for use for temporary, atrial, ventricular, or A-V sequential cardiac pacing of adult surgical and/or critically ill patients. This includes, but is not limited to, patients with arrythmias, acute myocardial infarction, cardiac surgery, and coronary angiography. In addition, these catheters are indicated for use in hemodynamic monitoring of patients experiencing medical conditions such as, but not limited to, post-major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, stroke, and cardiac disease including heart failure.

The Swan-Ganz bipolar pacing catheters are indicated for use in surgical and/or critically ill cardiac patients who may benefit from temporary, transvenous right ventricular pacing.

The Chandler transluminal V-pacing probe is a transluminal bipolar pacing probe, which must be used with a Swan-Ganz Paceport catheter is indicated for use in adult surgical and/or critically ill cardiac patients. This includes, but is not limited to, patients with arrhythmias, acute myocardial infarction, cardiac surgery and coronary angiography.

The Swan-Ganz Pacing Catheters and Pacing Probes are a series of specialized catheters and pacing probes, which are temporarily inserted into the central circulatory system vasculature to facilitate temporary atrial, ventricular, or A-V sequential pacing and to serve as diagnostic and/or therapeutic tools. The catheters may be used to overdrive suppression of arrhythmias and diagnosis of complex arrhythmias. The pacing catheters and probes may be used for ECG detection during placement but are not intended to be used for ECG monitoring.

I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving the device meets those criteria in the context of an AI/ML powered medical device. The document is a 510(k) summary for a set of physical medical devices (catheters and pacing probes) and does not mention any AI or machine learning components.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and data provenance
3. Number of experts used to establish ground truth and their qualifications
4. Adjudication method for the test set
5. MRMC comparative effectiveness study results or effect size
6. Standalone (algorithm only) performance
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

The document focuses on the substantial equivalence of the Swan-Ganz Pacing Probe and Catheters to predicate devices based on design, material, chemical composition, principle of operation, and compliance with biocompatibility and bench testing standards.

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The PacePro Wire is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures.

Additionally, the PacePro Wire can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.

The proposed PacePro Wire is a guidewire that includes functions for a structural wire and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either PacePro Wire or Opsens Pacing Wire (OPW). These two names are interchangeable and represent branding name vs. internal descriptive name.

The provided text is a 510(k) summary for the PacePro Wire. It primarily focuses on demonstrating substantial equivalence to a predicate device (SavvyWire) and does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/human reader performance study. The device is a medical guidewire with temporary pacing capabilities, not an AI-powered diagnostic device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of AI/human reader studies, as this information is not present in the provided document.

However, I can extract information related to the device's performance testing as described in the summary, which serves a similar purpose of demonstrating the device meets its design requirements and is safe and effective.

Here's what can be extracted based on the provided text, reinterpreting "acceptance criteria" and "study" in the context of a medical device submission focused on substantial equivalence:

1. Table of Acceptance Criteria (or Performance Tests) and Reported Device Performance

The document details performance tests conducted to show the PacePro Wire's equivalence to its predicate. While not explicitly "acceptance criteria" for an AI algorithm's performance, these are the criteria for the device's physical and functional performance.

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

• Sample Size: Not explicitly stated for each test. For physical device testing, sample sizes typically refer to the number of devices tested for each characteristic (e.g., tensile strength, flexibility, etc.). This detail is not provided in a summary document like a 510(k).
• Data Provenance: The tests are conducted by the manufacturer, Opsens Inc. The data provenance would be internal laboratory testing and third-party lab testing as required for standards like ISO 10993. It's prospective testing conducted specifically for this submission. Country of origin for data is likely Canada (where Opsens Inc. is located) or certified testing labs they utilize elsewhere.

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

This question is not applicable. The device is a physical guidewire, not a diagnostic AI system requiring expert human interpretation as ground truth. The "ground truth" for this device's performance is established by objective engineering and biological tests against established standards.

4. Adjudication method for the test set

Not applicable, as it's not an AI/human reader study.

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-powered device.

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

Not applicable. This is not an AI-powered device.

7. The type of ground truth used

The "ground truth" for this medical device is based on:

• Compliance with established international and national standards (e.g., ISO 11135-1, ISO 11607-1, ISO 10993-1, FDA Guidance documents for guidewires).
• Engineering specifications and functional requirements of the device.
• Biocompatibility testing results for material safety.

8. The sample size for the training set

Not applicable. This is not an AI-powered device with a training set.

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

Not applicable. This is not an AI-powered device with a training set.

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OSYPKA TME Temporary Myocardial Electrodes are intended for temporary cardiac pacing and sensing of the cardiac chambers after cardiac surgery to prevent postoperative bradycardia and conduction disorders.

OSYPKA TME® temporary myocardial electrode is a device consisting of flexible insulated electrical conductors with one end connected to an external pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

The conductors or wires are typically 60cm or 220cm long and can be fixated to the heart either with the help of a suture (V-hook ), or directly with the attached heart needle (zigzag, and tines fixation types). The heart needle is cut off after fixation (Zigzag, Tines anchor) and disposed of. The thoracic needle is used to lead the wires to the outside of the patient's body to allow connection to the external pulse generator. The thoracic needle(s) is then also disposed of.

OSYPKA TMEs are supplied as unipolar, bipolar, and quadripolar version. There are two options for connection to an external cardiac pacemaker or cable: with 2 mm adapter or Confix. The preassembled Confix connectors can be connected directly to an extension lead or to the cardiac pacemaker after the thorax needle has been cut off. The device is supplied sterile, non-pyrogenic and intended for single use only.

The provided text describes a 510(k) premarket notification for the "TME Temporary Myocardial Electrode" device. This document outlines the device description, indications for use, comparison to predicate devices, and non-clinical performance testing.

However, the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way typically found for AI/ML-driven medical devices.

The document details the device's technical specifications and biocompatibility testing, but it does not present a table of acceptance criteria for a specific performance metric (like sensitivity, specificity, accuracy) and the device's reported performance against those criteria. It also lacks details on:

• Sample size for a test set: The document mentions non-clinical performance testing without specifying a test set for a comparative effectiveness or standalone performance study.
• Data provenance: Not applicable here as no clinical or image data is being evaluated.
• Number of experts used to establish ground truth: Not applicable.
• Adjudication method: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm-only) performance: Not mentioned.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Oscor Inc. Model TME 64S Bipolar Temporary Heart Wire) through:

• Identical construction: "The construction of the subject device and predicate device are identical. Osypka AG manufactures the complete line of Unipolar, Bipolar & Quadripolar Temporary Myocardial Heartwires for Oscor. There are no material, construction, specification, manufacturing process, or sterilization process differences."
• Similar indications for use: "The Indications for Use are very similar to the predicate device."
• Identical environment of use and patient population: "The use environments are the same... The patient populations are the same as the predicate and reference devices."
• Non-clinical performance testing: This includes tests like Bending Strength, Dielectric Strength, Tensile Strength, Corrosion Resistance, etc., to verify product specifications and user requirements. These are engineering-focused tests rather than clinical performance metrics.
• Biocompatibility testing: According to ISO 10993-1.

In summary, the provided FDA 510(k) clearance document for the TME Temporary Myocardial Electrode does not include the type of information requested regarding acceptance criteria and performance studies for AI/ML devices. It is a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device through engineering and biocompatibility testing.

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The NuCath™ Wedge Pressure Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure).

The NuCath Wedge Pressure Catheter is an intravascular catheter with a balloon at the distal tip intended to measure pressure in the right heart.

The provided text describes a 510(k) premarket notification for the NuCath Wedge Pressure Catheter. As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and detailed performance results in the way one might expect for a de novo submission or a clinical trial.

However, I can extract the information relevant to acceptance criteria and the study that proves the device meets the acceptance criteria by interpreting the "performance testing" section as the "study" conducted.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table with quantitative acceptance criteria values and corresponding quantitative performance values for each test. Instead, it states: "The subject device met all predetermined acceptance criteria as defined in the referenced and internal standards." This implies the tests were conducted with pass/fail criteria, and the device passed all of them.

Below is a table listing the performance tests conducted, with the understanding that the "Reported Device Performance" is implicit as meeting the (unspecified) acceptance criteria for each test.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes used for each performance test. It lists the types of tests performed.
• Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer (PFM Medical, Inc.). This implies the data is prospective in the sense that the tests were conducted specifically for this submission, and the country of origin would be where the manufacturer's testing facilities are located (implied to be the US based on the Carlsbad, California address).

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

This question is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical performance and design verification testing is established by engineering specifications, recognized standards (e.g., ISO, ASTM), and internal company standards. There are no "experts" in the sense of clinical reviewers establishing ground truth for a test set in this type of submission; rather, the data is compared against predefined technical criteria.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for medical image analysis where multiple readers evaluate cases and a consensus or tie-breaking mechanism is needed. For non-clinical bench testing, the results are objectively measured and compared against established engineering and material specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation of results, like imaging software) to assess the impact of a device on human reader performance. The NuCath Wedge Pressure Catheter is a physical diagnostic catheter, and its performance evaluation focuses on its physical and functional attributes.

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

Yes, the performance testing described is essentially a "standalone" evaluation of the device itself (algorithm only performance). The tests listed (e.g., burst strength, inflation/deflation, radiodetectability) assess the device's technical specifications and physical integrity without human interaction being part of the primary performance metric for the device's basic function. The device's primary function is to measure pressure, and the tests verify the components that enable this function.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests conducted on the NuCath Wedge Pressure Catheter is based on:

• Engineering Specifications: Designed values and tolerances for dimensions, material properties, and functional characteristics.
• Referenced Standards: International and national standards such as ISO 10555-1, ISO 10555-4, ASTM F640-12, ISO 80369 series, and ISO 10993-1. These standards define test methods and often acceptable performance ranges for specific aspects of medical devices.
• Internal Standards: Manufacturer's own established quality and performance criteria.

These form the objective criteria against which the device's physical and functional performance is measured.

8. The Sample Size for the Training Set

This question is not applicable. The NuCath Wedge Pressure Catheter is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. The "development" of the device involves engineering design, material selection, and manufacturing processes, not data-driven training.

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

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

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The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the Savvy Wire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.

The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.

The proposed SavvyWire™ is a new Catheter guidewire that includes functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either SavvyWire™ or Opsens Structural Wire (OSW). These two names are interchangeable and represent branding name vs. internal descriptive name. SavvyWire™ is intended to be used with the OptoMonitor 3 (K202943), and ideally with the OpM3-DU TAVI, which is based on the approved OptoMonitor 3 (K202943), with a fully integrated TAVI software update.

The provided text describes the performance data and substantial equivalence arguments for the SavvyWire™ and OptoMonitor 3 with TAVI, rather than detailing specific acceptance criteria and the results of a study designed to prove the device meets those criteria in a quantitative table. The document focuses on demonstrating substantial equivalence to existing predicate devices through various tests and studies.

Based on the provided text, a direct table of acceptance criteria and reported device performance with specific quantitative thresholds and met/not met status cannot be fully constructed as this information is not presented in that format. However, I can infer the general nature of the acceptance criteria from the tests conducted and the stated conclusions.

Here's a breakdown of the requested information based on the document, with inferred acceptance criteria where explicit quantitative values are not given:

Inferred Acceptance Criteria and Reported Device Performance

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