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BIOTRONIK's endocardial leads are designed for use with implantable pulse generators that require pacing leads with a bipolar IS-1 connector configuration they may be used with single or dual chamber pacing systems. The leads are designed for use in patients for whom single or dual chamber pasing of pasing therapy is medically indicated. This indication for them single of the Class I definition of the ACC/AHANASPE This Indication This Indication inal recommended in Title Class I demind of the of Cardiac Pacemakers Reports, Aladoa Aloon More 2 2002 Ghuelle Opdate of Inplantabon CordialemyAmadon Mond Anad Anada Arabarhythmia Devices: A Report of the American Colleg CardiologyAmerican Heart Association Task Force on Practice Guidelines (ACCAHANASPE Committee on Pacemaker Implantation)" (Gregoratos et al. 2002).

The straight lead models are intended for placement in either the right atrium or right ventricle. The JBP lead models have a pre-formed distal end to facilitate lead placement in the ight atrial appendage.

BIOTRONIK proposes modifications to the packaging process and containers for bradycardia pacing leads, at BIOTRONIK's manufacturing and sterilization facility (BIOTRONIK GmbH & Co. KG) in Pertin, Germany and contract manufacturing facility (BIOTRONIK AG) in Bülach Switzerland.

The provided document is a 510(k) premarket notification for "Packaging Changes for Endocardial Pacing Leads." This submission is about modifications to the packaging process and containers for existing, previously approved bradycardia pacing leads, not the leads themselves or any associated AI/software-based device.

Therefore, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of device performance, as typically understood for AI/software devices (e.g., accuracy, sensitivity, specificity studies), is not applicable here.

This 510(k) is demonstrating substantial equivalence for a manufacturing/packaging change. The "proof" for this type of submission would typically involve:

• Engineering studies and validation reports showing that the new packaging maintains the safety, sterility, and functional integrity of the leads as established for the predicate devices. This would include tests like:
  • Sterilization validation (if the sterilization method or cycle is affected by packaging changes).
  • Packaging integrity tests (e.g., seal strength, burst testing, dye penetration).
  • Shelf-life studies to ensure sterility and material integrity are maintained over the claimed shelf-life.
  • Biocompatibility assessments (if new packaging materials are introduced that could interact with the device).
  • Transit testing to simulate shipping stresses.

Since the document provided is only the 510(k) summary and the FDA's clearance letter, it does not contain the detailed study reports or acceptance criteria for these packaging validation tests. The FDA's clearance indicates that they reviewed these underlying data and found them acceptable to demonstrate substantial equivalence.

Therefore, I cannot populate the requested table and sections regarding acceptance criteria and performance statistics because the nature of this 510(k) submission does not involve a "device performance study" in the context of typical AI/software or diagnostic devices.

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Permanent pacing lead, Model PY2, is indicated for pacing and sensing of the ventricle. The permanent pacing lead, Model PY2, is used in conjunction with a compatible, market cleared, implantable pulse generator (pacemaker).

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Permanent Pacing Lead, Model PY2." It's a regulatory document and does not contain information about acceptance criteria or a study proving the device meets them in the format requested. The letter primarily confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot provide the requested information from this document. This kind of detail would typically be found in the manufacturer's 510(k) submission itself, or in a separate clinical study report, which is not provided here.

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Permanent pacing lead, Model Refino ™ is indicated for pacing and sensing of the ventricle and / or atrium of the heart. The lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Permanent Pacing Lead, Model Refino

The provided text is a 510(k) clearance letter from the FDA for a Permanent Pacing Lead, Model Refino. This document primarily focuses on the regulatory clearance process, indicating substantial equivalence to a predicate device.

It does NOT contain information about specific acceptance criteria for a device's performance, nor does it describe a study proving the device meets such criteria.

Therefore, I cannot provide the requested information. The document is a regulatory approval, not a performance study report.

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The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated.

The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated. Two leads may be used for bipolar pacing. The lead's screw-in electrode is designed to be secured to the myocardium with two clockwise turns. A polyester mesh allows fibrous ingrowth for additional fixation. The lead requires no stab wounds or sutures for electrode placement and fixation. Tissue damage from electrode insertion may be compared to the insertion of a 15guage needle. The lead features a MP35N nickel alloy conductor, silicone rubber insulation, and an IS-1 Unipolar (UNI) lead connector.

The provided document is a 510(k) summary for the Medtronic Model 5071 Myocardial Pacing Lead, seeking substantial equivalence to an already marketed predicate device (the original Model 5071 Lead). This type of submission focuses on demonstrating that a modified device is as safe and effective as a legally marketed predicate device, rather than proving efficacy from scratch with a new device.

Therefore, the document does not contain information typically found in studies designed to prove a device meets specific performance acceptance criteria through clinical trials or detailed standalone algorithm performance evaluations. Instead, it relies on bench testing and material characterization to show that the modified device is still substantially equivalent to the predicate device.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting when the information is not applicable or present for a 510(k) submission of this nature:

1. Table of acceptance criteria and the reported device performance

This information is not provided in the document. A 510(k) Special submission for minor modifications typically focuses on showing that the modifications do not affect the safety or effectiveness, often by referencing existing predicate device performance and material equivalency. Specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy for an AI device) are not part of this submission type for a pacing lead.

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

The document mentions "bench test results for lead Models 5568, 5024M, and 5524M and the MED-4719 material characterization and biocompatibility testing," but does not specify sample sizes for these tests nor the data provenance (e.g., country of origin, retrospective/prospective). These are likely internal engineering tests rather than clinical studies with patient data.

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

This information is not applicable as the document describes bench testing and material characterization for a pacing lead, not a device requiring expert interpretation of diagnostic output (like an AI imaging device). Ground truth for a pacing lead would involve physical integrity, electrical performance, and biocompatibility, typically assessed through engineering standards and laboratory analyses.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. The device is a myocardial pacing lead, not an AI-powered diagnostic tool that involves human readers.

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

This information is not applicable. The device is a physical medical implant (pacing lead), not a standalone algorithm.

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

For the "Summary of Studies," the "ground truth" implicitly refers to engineering standards, material specifications, and validated characterization methods for the lead and insulation material. For example, biocompatibility testing would compare against established safety profiles for materials in contact with human tissue.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of a physical medical device like a pacing lead. This concept applies to AI/machine learning algorithms.

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

This information is not applicable as there is no training set for this type of device.

In summary:

The provided K031274 document is a 510(k) submission for a modification to a myocardial pacing lead, focusing on demonstrating substantial equivalence to a predicate device. It primarily relies on bench test results and material characterization to support this claim, rather than clinical studies with human subjects or AI algorithm performance evaluations. As such, most of the requested information pertains to study designs not relevant to this specific regulatory submission for this type of product.

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The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated.

The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated. Two leads may be used for bipolar pacing.

The lead features a platinized electrode that can be secured to the heart by gently pushing the barbed tip into the epicardium and securing it in myocardial tissue. Suture holes in the polyurethane base pad are provided for greater security. A polyester mesh allows for fibrous ingrowth for additional fixation. The lead also features an MP35N nickel alloy conductor, polyurethane insulation, and an IS-1 Unipolar (UNI) lead connector.

This document is a 510(k) summary for a medical device lead, which assesses its substantial equivalence to a predicate device. It doesn't contain information about machine learning algorithms, AI performance, or studies with acceptance criteria comparing device performance against specific metrics using expert-derived ground truth.

Therefore, most of the requested information cannot be extracted from the provided text. The document focuses on regulatory approval based on similarity to an existing device, rather than a performance study involving AI or complex statistical analysis against defined acceptance criteria.

Here's a breakdown of what can be inferred or stated as unavailable based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on showing the modified device's characteristics are substantially equivalent to a previously cleared predicate device, rather than setting and meeting specific performance criteria.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no described test set of data (in the context of AI/ML) is mentioned. The "Summary of Studies" refers to bench tests and material characterization, not performance on a data set.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no mention of a test set requiring expert-established ground truth.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no mention of a test set.
• 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 document pertains to a physical medical device (a lead), not an AI-assisted diagnostic or interpretative system.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document pertains to a physical medical device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The document describes bench testing and material characterization for a physical device, not an AI/ML algorithm requiring ground truth annotation.
• 8. The sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
• 9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for a training set is mentioned.

What the document does describe in terms of "studies" and "equivalence":

• Summary of Studies: "Based on the bench test results for lead Model 4073 and the MED-4719 material characterization and biocompatibility testing, MED-4719 was qualified by similarity as a strain relief material in Model 4951M."
  • This indicates that bench testing and material characterization were performed. However, specific acceptance criteria or performance numbers from these tests are not provided in this summary. The "qualification by similarity" implies that the new material performed equivalently to a previously validated material, but the details of that equivalence are not here.
• Predicate Device: The predicate device is "the currently market released Model 4951M Lead." This means the current submission is for a modified version of an already approved device.
• Technological Characteristics: "The technology used with the Model 4951M Lead has is the same technological characteristics as the predicate device."
• Conclusion: "Through data and information presented, numerous similarities support a determination of substantial equivalence and show the device modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device."

In essence, this is a regulatory document focused on demonstrating that minor modifications to an existing device do not change its fundamental nature or intended use, thereby justifying approval via the Special 510(k) pathway. It does not provide the kind of performance data with acceptance criteria that would be found in a study for an AI/ML device.

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BIOTRONIK's ELOX P transvenous, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers. The leads may be used with single or dual chamber pacing systems.

The ELOX P lead models are intended for placement in either the right atrium or right ventricle.

Elox P leads are straight, bipolar endocardial pacing leads that utilize an electrically active extendable/retractable fixation helix. The extendable/retractable fixation helix is comprised of a 70% Pt / 30% Ir alloy with a fractal tridium coating. The fixation helix is additionally coated with Parylene C. The non-insulating distal sleeve, consisting of an inner and outer sleeve, is composed of Polyurethane (Pellethane 2363-75D). The leads contain two conductors composed of quadrifilar MP35N wire in coaxial configurations and are insulated with silicone tubing. A 3.2 mm 15-1 bipolar connector attaches the lead to the pulse generator. The Elox P lead is available in lead lengths of 45 cm, 53 cm, and 60 cm.

Here's an analysis of the provided text regarding the Elox P Active-Fixation Endocardial Lead, focusing on acceptance criteria and study information.

It's important to note that this document is a Special 510(k) Notification, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, novel clinical study results with specific acceptance criteria in the same way a PMA or a de novo application might. Therefore, some of the requested information (like specific effect sizes of AI-assisted vs. human readers, or detailed ground truth establishment for a test set) is not directly applicable or present in this type of submission.

Acceptance Criteria and Device Performance

The document does not explicitly present a table of "acceptance criteria" with numerical targets and corresponding "reported device performance" for a new, standalone clinical study demonstrating efficacy in the way a pharmaceutical trial or a software AI product might. Instead, the core of this Special 510(k) is to demonstrate that the modified Elox P lead is substantially equivalent to its predicate devices (existing Elox leads and other cleared pacemaker leads).

The key "performance" being evaluated for this modification (addition of Parylene C coating to the fixation helix to increase electrical impedance) would be that the lead continues to meet established performance standards for pacemaker leads and that the modification doesn't adversely affect safety or effectiveness. The comparison is primarily against the performance of the predicate Elox leads which have already undergone testing and received clearance.

For pacemaker leads, substantial equivalence is often demonstrated through:

• Bench testing: Electrical performance (e.g., impedance, current leakage), mechanical properties (e.g., tensile strength, fatigue), material biocompatibility.
• Animal studies: To assess acute and chronic pacing and sensing performance, fixation, and tissue response.
• Clinical experience/literature review: Referencing the known performance of the predicate device.

Given this is a Special 510(k), the focus is on a modification and demonstrating that the modified device is as safe and effective as the original. The performance criteria are implicitly those that a pacemaker lead must meet to be considered safe and effective, as established by prior device clearances and relevant standards.

Implicit Acceptance Criteria and Demonstrated Performance:

Study Information (as inferable from the document type)

This document is a Special 510(k) focusing on a device modification. It refers to predicate devices for establishing substantial equivalence rather than presenting a detailed new clinical study with a prospectively defined test set and ground truth.

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

   • Test Set Sample Size: Not applicable in the context of a new, standalone clinical test set as described for AI algorithms. The "test set" here refers to the comprehensive data (bench tests, biocompatibility tests, potentially limited animal or pre-clinical data, and comparison to predicate device data) used to demonstrate substantial equivalence of the modified device. No specific patient sample size is provided for a new clinical study.
   • Data Provenance: The modification is described by BIOTRONIK, Inc. (USA) and manufactured by BIOTRONIK GmbH & Co. (Germany) and BIOTRONIK AG (Switzerland). The data would originate from their internal testing and regulatory submissions. The nature of a Special 510(k) means this data would be primarily retrospective in terms of referencing the performance of the predicate device and potentially prospective for specific bench or animal tests on the modified component.

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

   • Not applicable in this type of submission. "Ground truth" in the context of a pacemaker lead's performance is established through objective measurements (e.g., electrical impedance, mechanical strength), animal studies, and long-term clinical observation of predicate devices. There isn't an "expert consensus" on imaging or diagnostic interpretation similar to an AI algorithm.

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

   • Not applicable. This concept is typically relevant for studies where human expert disagreement needs to be resolved for ground truth labeling (e.g., radiological interpretation).

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

   • Not applicable. This device is a pacemaker lead, not an AI diagnostic algorithm. There are no "human readers" interpreting data with or without AI assistance in this context.

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

   • Not applicable. This device is a hardware medical device (pacemaker lead), not a standalone algorithm.

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

   • For a pacemaker lead, "ground truth" for proving safety and effectiveness involves a combination of:
     • Objective physical measurements: Electrical parameters (impedance, current), mechanical strength/durability.
     • Biocompatibility testing: Standardized tests (e.g., ISO 10993 series) on materials.
     • Animal study results: Acute and chronic pacing/sensing, tissue response, lead fixation.
     • Clinical performance of predicate devices: Long-standing data on similar devices provides the most significant "ground truth" for the overall concept and previous versions of the product.

7. The sample size for the training set:

   • Not applicable. There is no AI model or "training set" in the context of this pacemaker lead modification.

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

   • Not applicable, as there is no training set.

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Permanent pacing lead, Model Physique™ is indicated for pacing and sensing of the ventricle and/or atrium of the heart. This lead is used in conjunction with a compatible implantable pulse generator (pacemaker).

Permanent Pacing Lead, Model Physique™

The provided text is a 510(k) clearance letter from the FDA for a medical device: a Permanent Pacing Lead, Model Physique™. This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.

However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The letter explicitly states that the device is approved based on its substantial equivalence to a legally marketed predicate device. This means that the FDA reviewed existing data and information for similar devices already on the market and determined that the new device is as safe and effective as those already approved.

Therefore, I cannot provide the requested information from this document. The document's purpose is to grant marketing clearance, not to detail the specific studies and acceptance criteria for product development and validation.

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Arox and Merox bipolar, passive-fixation, endocardial pacing leads are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

The BIOTRONIK Arox and Merox leads are bipolar, passive-fixation, endocardial pacing leads available in straight and "J"-shaped configurations, for placement in the ventricle or atrium. The Arox and Merox xx-JBP models have a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage. The device modification only applies to the atrial Arox xx-JBP bipolar, passive-fixation, endocardial, pacing leads. The modification consists of an exact specification for the J-shape of the leads.

The presented document is a 510(k) premarket notification for a medical device (Arox and Merox Leads), not a study report or clinical trial. Therefore, it does not contain the detailed information typically found in a study that proves a device meets acceptance criteria. The submission is for a "Special 510(k)" due to a device modification – specifically, the precise specification of the J-shape for the atrial Arox xx-JBP leads.

Based on the provided text, here's an analysis of what information is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the document. A 510(k) summary typically focuses on substantial equivalence to a predicate device rather than detailed acceptance criteria and performance data from a specific study for the modification. The modification is described as an "exact specification for the J-shape of the leads," implying a design control change, likely validated through engineering and bench testing, rather than a clinical performance study.

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

This information is not present. No test set or study data is described in this regulatory submission.

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

This information is not present. No ground truth establishment is described, as it's not a diagnostic AI device or a study requiring expert consensus.

4. Adjudication Method

This information is not present. No adjudication method is described.

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

This information is not present. The device is a pacing lead, not an AI-assisted diagnostic tool. An MRMC study would be irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This information is not present. The device is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

This information is not present. No ground truth is mentioned. The modification is a design specification for a physical characteristic.

8. Sample Size for the Training Set

This information is not present. Since this is a physical device modification, not an AI algorithm, there would be no "training set."

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

This information is not present. As above, there is no training set mentioned.

Summary of Device and Modification relevance to Acceptance Criteria:

The core of this 510(k) submission is a "Special 510(k)" for a modification to existing, previously approved pacemaker leads (Arox and Merox). The modification is:

• Device Modification: "The modification consists of an exact specification for the J-shape of the leads. Previously, BIOTRONIK did not specify the precise J-shape of the leads."

For such a modification, acceptance criteria would typically revolve around:

• Dimensional Accuracy: Does the new manufacturing process consistently produce the J-shape within the specified tolerances? This would be verified through manufacturing quality control and possibly bench testing.
• Mechanical Integrity/Performance: Does the precisely defined J-shape maintain the lead's mechanical properties (e.g., flexibility, durability, resistance to kinking, ability to be positioned as intended)? This would involve bench testing for fatigue, tensile strength, and simulated use.
• Biocompatibility: (Likely unchanged, as materials are not mentioned as being modified).
• Electrical Performance: (Likely unchanged if electrodes and insulation are not modified).

The current document only states that the FDA reviewed the submission and found the device to be "substantially equivalent" to predicate devices, subject to general controls. This implies that the modification was deemed not to raise new questions of safety or effectiveness. The specific evidence (e.g., engineering reports, bench test results) demonstrating that the modified J-shape meets the internal design and performance specifications (the "acceptance criteria" for this specific change) would have been part of the full 510(k) submission to the FDA, but it is not provided in this summary document.

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Arox bipolar, passive-fixation, endocardial pacing leads (Arox xx-BP and Arox xx-JBP) are intended to provide permanent pacing and sensing in the atrium and or ventricle when used with a compatible pulse generator.

The BIOTRONIK Arox lead is a bipolar, passive-fixation, endocardial pacing lead available in straight and " J"-shaped configurations, for placement in the ventricle or atrium. The designation Arox xx-BP refers to Arox straight leads, which are available in lengths (xx) of 53 or 60 cm; Arox xx-JBP refers to Arox "J"-shaped leads, which are available in lengths of 45 and 53 cm.

The Arox xx-JBP model has a permanent bend proximal to both lead electrodes, resulting in the distal portion of the lead body having what is commonly referred to as a "U" or "J" shape. This lead shape facilitates placement in the right atrial appendage.

Arox xx-BP and Arox xx-JBP leads feature four silicone tines for passive-fixation in the heat's trabeculae. The tip electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 3.5 mm². The ring electrode is made of a platinum/iridium base material, with a fractal iridium surface and electrically active surface area of 22.6 mm². The lead conductor consists of quadrifilar MP35N wire in a coaxial configuration, insulated with silicone rubber tubing. All Arox leads utilize a 3.2 mm IS-1 connector.

The provided text is a 510(k) summary for the BIOTRONIK Arox Passive-Fixation, Bipolar, Endocardial Pacing Lead. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement for a study proving device performance against acceptance criteria.

The 510(k) process is primarily a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, not necessarily a comprehensive clinical study to prove performance against specific acceptance criteria in the way a clinical trial would. Therefore, I cannot extract the requested information from this document.

The document mainly focuses on:

• Device Description: Physical characteristics, materials, and configurations.
• Device Modification: Differences from a previously marketed device (Merox leads) and similarities to another (Polyrox leads).
• Predicate Devices: Identification of existing devices to which the Arox leads are compared for substantial equivalence.
• Indications for Use: The medical conditions and manner in which the device is intended to be used.

To answer your questions, one would typically need access to the full 510(k) submission, including any testing reports, bench test results, or, if applicable, clinical study summaries, which are not provided in this specific excerpt.

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