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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environment for the enclosed catheter, and hence prevents the contamination of a catheter as it is inserted into and withdrawn from a body cavity or lumen.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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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 Model 6491 Unipolar Pediatric Temporary Pacing Lead is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary postsurgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY

The Model 6494 Unipolar Temporary Myocardial Pacing wire is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY.

The Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for use in both the atrium and the ventricle. The unipolar lead is comprised of a lead body with the distal and proximal segment. The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. A curved atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall.

The Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for use in the atrium. The unipolar lead is comprised of a lead body with distal and proximal segments. The Model 6492 Unipolar Temporary Atrial Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall.

The Medtronic Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for use in both the atrium and the ventricle. The two leads are comprised of a lead body with distal and proximal segment. The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of two insulated multi-filament wire. At one end of each wire has been stripped to have an electrode surface. This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle. An atraumatic chest needle at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall.

The Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for use in both the atrium and the ventricle. The bipolar lead is comprised of a lead body with distal and proximal segments which includes the integrated bifurcated proximal lead connection. The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead, which contains a distal, discrete, ring electrode, a discrete, tip electrode, and a coaxial conductor lead body. Each discrete electrode is crimped onto a conductor and terminates in an atraumatic myocardial curved needle. The curved needle is used to create a channel in the myocardium for embedding the electrodes. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. Terminated on the back of the chest needle are two breakaway connector pins, which provide an attachment to an external pulse generator.

This document describes a 510(k) premarket notification for Medtronic Streamline Temporary Pacing Leads (Models 6491, 6492, 6494, and 6495). The submission primarily addresses a minor formulation change to the base polyethylene (PE) material used for the insulation coating of the pacing wires.

Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" values for each criterion. Instead, it states that the devices successfully passed the acceptance criteria for various tests. The acceptance criteria are "pre-established specifications," but these specifications are not detailed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the precise sample sizes used for each of the bench tests (Biocompatibility, Component Qualification, Design Verification, Shelf Life). It only states that "Bench testing was used to verify the performance characteristics."

The data provenance (country of origin, retrospective/prospective) is not mentioned. Given that this is bench testing for a medical device, it's typically conducted in a controlled laboratory environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the information provided. The study described is bench testing, not a clinical study involving diagnostic interpretation or "ground truth" established by medical experts in the traditional sense (e.g., radiologists, pathologists). The "ground truth" for bench testing would be the engineering and material science standards and specifications that the device is required to meet, established by Medtronic's internal R&D and quality teams, and aligned with regulatory requirements.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. Bench testing involves objective measurements against predefined specifications, not subjective interpretation.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required." This submission is for a material change in a physical medical device (pacing leads), not an AI-powered diagnostic or assistive tool.

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

This question is not applicable. The device is a physical medical device (pacing leads) and does not involve an algorithm or AI.

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

As mentioned in point 3, the concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For bench testing of a physical medical device, the "ground truth" is defined by the technical specifications, industry standards, and regulatory requirements that the device must meet. This involves objective measurements and adherence to predefined engineering and material science parameters.

8. The sample size for the training set

This question is not applicable. There is no AI or machine learning component to this device, and therefore no "training set" in the context of AI development.

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

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

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Temporary Cardiac Pacing Wire is intended for use in temporary epicardial cardiac pacing or monitoring and should be removed after temporary pacing has been discontinued.

The Temporary Cardiac Pacing Wire is a sterile single-use product. Temporary cardiac pacing wires consist of the following configurations and optional accessories:

1. The monopolar leads consist of one insulated multifilament stainless steel conductor coated with colored polyethylene.
2. The intracorporeal end of the wire has a section of exposed, uninsulated wire electrode which terminates with an attached stainless steel needle.
3. The exposed, uninsulated section of the intracorporeal end of the wire is either straight or has one or more multiple pre-formed curves (pre-formed wave).
4. The extracorporeal end of wire has a straight needle with breakaway tip attached.
5. The wire length is 60 cm.
6. Wires range in multiple diameters from 0 to 2-0, depending on the product code.

The provided text is a 510(k) Premarket Notification summary for a medical device called "Temporary Cardiac Pacing Wire." It describes the device, its intended use, and compares it to a predicate device. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed device rather than proving the device meets a set of acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically for an AI/algorithm-based device. The device in this document is a physical medical device (cardiac pacing wire), and the "performance modification" mentioned refers to testing its compatibility with an MRI environment, not a software algorithm's performance.

To answer your request, if this were an AI/algorithm-based device, the document would need to outline the specific performance metrics (e.g., sensitivity, specificity, accuracy), the thresholds for those metrics (acceptance criteria), and details of a clinical or performance study (e.g., test set size, expert ground truth establishment, MRMC studies) to demonstrate that the algorithm met those criteria.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment for an AI/algorithm. The document focuses on showing substantial equivalence of a physical device with a predicate through design and material comparisons, and non-clinical performance testing related to MRI compatibility.

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The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary post-surgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY.

The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary post-surgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY.

The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary post-surgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less/ the device is supplied sterile and is intended for SINGLE USE ONLY.

The Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary post-surgical pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY

The Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for use in both the atrium and the ventricle. The unipolar lead is comprised of a lead body with the distal and proximal segment. The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead remains in the body.

The Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for use in the atrium. The unipolar lead is comprised of a lead body with distal and proximal segments. The Model 6492 Unipolar Temporary Atrial Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead remains in the body.

The Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for use in both the atrium and the ventricle. The bipolar lead is comprised of a lead body with distal and proximal segments which includes the integrated bifurcated proximal lead connection. The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead, which contains a distal, discrete, ring electrode, a discrete, tip electrode, and a coaxial conductor lead body. Each discrete electrode is crimped onto a conductor and terminates in an atraumatic myocardial curved needle. The curved needle is used to create a channel in the myocardium for embedding the electrodes. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. Terminated on the back of the chest needle are two breakaway connector pins, which provide an attachment to an external pulse generator. No part of the Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead remains in the body.

The Medtronic Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for use in both the atrium and the ventricle. The unipolar lead is comprised of a lead body with the distal and proximal segment. The Model 6500 Unipolar Temporary Myocardial Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body, except the silicone rubber disc in the case of atrial application.

The provided text is a 510(k) summary for the Medtronic Streamline family of temporary pacing leads. It focuses on demonstrating substantial equivalence to predicate devices based on bench testing and does not include information about acceptance criteria or studies related to AI/algorithm performance. Therefore, I cannot extract the requested information.

Here's why each point cannot be addressed with the given text:

1. A table of acceptance criteria and the reported device performance: The document mentions "bench testing" to "verify the performance characteristics," but it does not specify what those characteristics are, what the acceptance criteria were, or the reported performance values. It only lists the types of tests conducted (Biocompatibility, Junction Strength, Component Qualification).
2. Sample sized used for the test set and the data provenance: Not mentioned. The document only refers to "bench testing" generally.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document describes a medical device, not an AI/algorithm where expert-established ground truth would be relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device submission.
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 a physical pacing lead, not an AI-assisted diagnostic tool.
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 for this type of device. Performance is likely measured against engineering specifications or established standards for medical leads.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

The document makes it clear that:

• "Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required." (Page 9)
• The submission is a "Special 510(k)" primarily due to a minor formulation change and a new supplier for the blue monofilament suture (Page 8). The focus is on demonstrating "substantial equivalence" to existing predicate devices, not on proving new performance claims through extensive clinical trials or AI/ML evaluations.

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Pacel™ Flow Directed Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.

This catheter is designed to establish temporary right ventricular pacing with or without fluoroscopy guidance for placement. Catheters are depth marked as an aid in catheter placement under fluoroscopy. Electrodes at the catheter tip enable ECG monitoring and bipolar pacing. An inflatable balloon, located between two platinum electrodes, allows for flow directed positioning of the catheter in the right ventricle without fluoroscopy guidance. Once inflated, the balloon aids the operator in crossing the tricuspid valve. After the catheter has crossed the valve, the balloon is deflated and the catheter is advanced to the right ventricular apex in the usual manner. Electrograms are monitored to verify proper positioning in the right ventricular apex and pacing thresholds are obtained to confirm both proper location and reliable pacing. The catheters are available in two curve styles. The distal end of the catheter includes a platinum electrical connector ring and a tip electrode. The proximal end of the catheter includes a two pin electrical connector. The electrical signals can be transmitted to external equipment or from external equipment to the heart.

This document describes the 510(k) summary for the Pacel™ Flow Directed Pacing Catheters, which pertains to a change in the adhesive used to bond the latex balloon to the catheter and seal around the metal electrode ring edges. The submission aims to demonstrate substantial equivalence to a predicate device (Pacel™ Flow Directed Pacing Catheters K914185).

The information provided is not for a device that uses AI or performs any kind of diagnostic or analytical function that would require a study with acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance. This submission is for a physical medical device (a catheter) and the studies are primarily engineering design verification tests and biocompatibility studies related to a material change (adhesive).

Therefore, I cannot fulfill the request to provide information about the acceptance criteria and study proving the device meets those criteria in the context of AI/diagnostic device performance. The provided text does not contain any of the following details required:

• Acceptance Criteria Table (related to performance metrics like accuracy, sensitivity, specificity): Not applicable for this type of device. The document mentions "passed all acceptance criteria per the DV requirements" for design verification, but these are related to physical properties of the catheter (e.g., surface appearance, inflation strength, inflation decay).
• Sample size for test set and data provenance: No "test set" in the context of image analysis or algorithm performance. The design verification and animal study would use sample sizes relevant to engineering and animal studies, not AI validation.
• Number of experts for ground truth, qualifications, adjudication method: This is irrelevant for a physical medical device and adhesive change.
• MRMC comparative effectiveness study: Not applicable as there is no "human reader" component or effect size from AI assistance.
• Standalone (algorithm only) performance: Not applicable as there is no algorithm.
• Type of ground truth: Not applicable in the context of diagnostic accuracy.
• Training set size and ground truth establishment for training set: Not applicable as there is no AI algorithm being trained.

The study described is focused on the physical and biological properties of the catheter due to a change in adhesive.

Summary of Stated Device Performance (from the document):

The document reports the following for the non-clinical testing:

1. Design Verification:

   • Acceptance Criteria: "show that the proposed device will meet Product Specification through the labelled Shelf Life of the device (T=18 mo)." and "passed all acceptance criteria per the DV requirements."
   • Reported Performance:
     • Surface Appearance: Adhesive on the balloon and electrodes. Results: Conforming
     • Balloon Repeat Inflation Strength. Results: Conforming
     • Inflation Decay. Results: Conforming
   • Specifics on sample size or individual performance values are not detailed in this summary.

2. Biocompatibility:

   • Acceptance Criteria: "demonstrated an acceptable biocompatibility profile." and "passed all acceptance criteria."
   • Reported Performance: "Biocompatibility testing was performed in accordance with ISO 10993. The proposed adhesive, Loctite 4311, used to secure the balloon to the catheter shaft demonstrated an acceptable biocompatibility profile."
   • Specifics on sample size or individual performance values are not detailed in this summary.

3. Chronic GLP Animal Study:

   • Acceptance Criteria: To demonstrate safety comparable to the control device, and that both devices are "substantially equivalent regarding clinical pathology, thrombogenicity and pathology/histopathology."
   • Reported Performance: "Both the test and control devices were considered substantially equivalent regarding clinical pathology, thrombogenicity and pathology/histopathology. The use of both devices was well tolerated. This data demonstrates that the proposed Pacel Flow Direct catheter's safety is comparable to the control device."
   • Specifics on sample size or individual performance values are not detailed in this summary.

In conclusion, the document's purpose is to demonstrate substantial equivalence of a physical medical device (catheter) after a manufacturing material change, not the performance of an AI/diagnostic algorithm.

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