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The Intermedics leads which are the subject of this 510(k) Notification are endocardial pacing leads designed for use with implantable pulse generators for long-term cardiac pacing, This indication is identical to the indication for use of the legally marketed predicate devices, the Intermedics Models 430-07 and 432-03 Endocardial Pacing Leads.

The indications for ventricular pacing include, but are not limited to: sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block. In the presence of normal atrioventricular (A-V) conduction, the indications for atrial pacing include, but are not limited to: sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias. In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual-chamber pacing system to restore A-V synchrony.

The Intermedics Model 430-07, 431-07, 432-03, and 433-03 Endocardial Pacing Leads are designed for use with implantable cardiac pulse generators for long-term cardiac pacing. Passed transvenously through the cephalic, subclavian, or jugular vein (external or internal), the tip electrode (cathode) is positioned at the endocardial surface to permit contact with the heart. The tip fixation mechanism consists of four silicone rubber tines. The lead body, which consists of insulated conductor coils, carries electrical impulses from the heart to the pulse generator, resulting in sensing. The lead body also carries impulses from the pulse generator to the endocardial surface, causing cardiac depolarization (pacing), The proximal end of the lead is connected to the header of the implanted pulse generator.

The electrodes of the Intermedics Model 430-07, 431-07, 432-03, and 433-03 Endocardial Pacing Leads are made of titanium coated with inidium oxide (IROX™).

The provided text describes a 510(k) submission for Intermedics Endocardial Pacing Leads, focusing on a new performance claim regarding their low stimulation threshold.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

• Mean pacing threshold at 1.5 volts:
  • Ventricle (2 weeks): 0.32 millisecond
  • Atrium (2 weeks): 0.35 millisecond
  • Both chambers (6 months): 0.26 millisecond
• Statistical analysis demonstrated an upper confidence bound of 97.5% on the capturing pulse width to be at or below 0.38 millisecond at a pulse amplitude of 1.5 volts. |

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

• Sample Size: Not explicitly stated as a single "sample size" for a traditional test set. However, the clinical study was conducted on humans using the Models 430-07 and 432-03. The number of patients or leads implanted in this clinical study is not provided.
• Data Provenance: Prospective (clinical study with follow-up points). Country of origin is not specified but the submitter is based in Angleton, TX, USA, suggesting the study might have been conducted in the US or internationally under US regulatory oversight.

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

This question is not directly applicable. This is a medical device performance study, not an AI or imaging-based study requiring expert ground truth for interpretation. The "ground truth" here is the actual measured electrical performance of the pacing leads in human subjects, as verified by clinical measurements. No "experts" were needed to establish interpretive ground truth.

4. Adjudication Method for the Test Set

Not applicable. There was no need for adjudication as the "test set" involved direct measurement of physiological parameters (pacing thresholds).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve With AI vs. Without AI Assistance?

Not applicable. This is a medical device performance study, not an AI-assisted diagnostic or interpretive study involving human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done?

Not applicable. This is a medical device performance study, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used was direct physiological measurement/outcomes data (stimulation thresholds measured acutely and chronically in human subjects).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning study, so there is no concept of a "training set" in the context of algorithm development. The animal study could be considered a preliminary data gathering phase, but not an algorithmic "training set."

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

Not applicable, as there is no "training set" in the AI sense. The animal study data involved direct electrical performance measurements of different lead types over 24 weeks.

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The models 436-07 and 437-07 pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block.

In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias.

In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual chamber pacing system to restore A-V synchrony.

The Intermedics Models 436-07 (bipolar) and 437-07 (unipolar) endocardial pacing leads are designed for use with implantable cardiac pulse generators configured for ventricular applications for long term cardiac pacing. The nominal lead length for the model 436-07 lead is 58 cm and is available in lengths from 40 to 110 cm. The nominal lead length for the model 437-07 lead is also 58 cm and is available in lengths from 40 to 110 cm. The lead connectors are designed to meet VS-1 specifications (an intra-industry agreement standardizing lead-to-pulse generator connection dimensions) for lead connectors.

The models 436-07 and 437-07 pacing leads are packaged with the model 367-01 vein lifter and the following stylets: model 367-11 (straight stylet, limber), model 365-12 (straight stylet, firm), model 365-81(tapered stylet, limber), and model 365-82 (tapered stylet, firm).

The model 437-07 is also packaged with the following adapters: model 366-29 (Step up adapter, VS-1 unipolar lead to 5 mm unipolar pacer) and model 366-30 (Step up adapter, VS-1 unipolar lead to 6 mm unipolar pacer).

The minimum introducer size recommended for both lead models is 10 French.

The models 436-07 and 437-07 pacing leads are identical to the Intermedics models 436-02 (K883602, K954719) and 437-02 (K883602, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the electrodes. The IROX-coated electrodes are identical to those used in models 430-07 (K902672, K954719) and 431-07 (K902672, K954719).

The provided text is a 510(k) summary for pacing leads, not an AI/ML device. Therefore, it does not contain information about acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies typically associated with AI/ML device submissions.

The document focuses on demonstrating substantial equivalence to predicate devices for traditional medical devices (pacing leads) through:

• Device Description: Highlighting similarities in design and materials.
• Biocompatibility Studies: Testing the materials to ensure safety.
• Qualification Testing: Relying on previous testing of predicate leads.
• Clinical Summary: Referencing the low incidence of complications and effective performance of existing, similar devices.

Therefore, I cannot fulfill the request as the necessary information for Acceptance Criteria and Study details for an AI/ML device is not present in the provided text.

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Pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, and certain conditions of asymptomatic second-degree block.

In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias.

In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual-chamber pacing system to restore A-V synchrony.

Active fixation leads are specifically indicated for use in cases where passivefixation leads provide unsatisfactory positional stability in either the atrium or the ventricle, or in cases where the atrial appendage has been sacrificed due to open-heart surgery or is abnormal because of congenital or acquired heart disease.

The Intermedics Models 430-07, 432-03, 436-02, 436-07, 438-05, and 438-07 endocardial pacing leads are designed for use with implantable cardiac generators for long term cardiac pacing. With the exception of the solution used during the manufacturing process, the listed pacing leads manufactured with the CFC-free process are identically configured to the commercially available Intermedics pacing leads with the same model numbers. The general characteristics of the pacing leads include electrodes, lead body, tip fixation, and connector assembly.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Intermedics pacing leads, specifically focusing on the new CFC-free manufacturing process.

It’s important to note that this 510(k) summary, typical for medical devices in 1996, focuses heavily on demonstrating equivalence to a predicate device rather than establishing novel safety and effectiveness from scratch. Therefore, many of the performance metrics and study designs common in modern AI/ML device submissions are not directly applicable or present.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:

  • Biocompatibility: Not explicitly stated as a "sample size" in terms of number of devices. However, the tests were performed on "all of the tissue/fluid contacting materials" and specific material types (silicone, 80A polyurethane, 55D polyurethane) after the manufacturing change. The individual tests (e.g., animal tests for implantation, in vitro tests) would have their own sample sizes, which are not detailed here. For the repeated tests on IPA/heptane cleaned materials, these were performed on "the following materials," implying a material-level test rather than a full product-level "test set."
  • Qualification Testing: Performed on a single lead model: Model 430-07. This model was selected as "representative of the changes in the manufacturing processes."
  • Clinical Data: No new clinical test set was used for the CFC-free leads. The clinical performance claim relies on the "clinical experience of the commercially available Intermedics pacing leads" (predicate devices).

• Data Provenance: The biocompatibility and qualification testing data are prospective, generated specifically for this 510(k) submission. The clinical performance data for predicate devices is retrospective, based on prior commercialization and post-market experience. The country of origin of the data is not specified, but Intermedics Inc. is based in Angleton, TX, USA, suggesting testing was likely conducted in the US or by its chosen test laboratories.

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 to this submission. The device is a physical medical device (pacing lead) and not an AI/ML diagnostic or predictive tool that relies on expert interpretation for ground truth establishment. The "performance" being evaluated is material biocompatibility, physical and electrical function, and manufacturing process validation, not diagnostic accuracy against a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

• This information is not applicable as the evaluation is not based on expert interpretation of results that would require adjudication. Test results for biocompatibility and qualification would be interpreted against predefined pass/fail criteria.

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. This is a submission for a physical medical device (pacing lead), not an AI-assisted diagnostic or decision support system. Therefore, no MRMC study was performed.

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

• This information is not applicable. This is not an algorithm or software-only device.

7. The Type of Ground Truth Used

• For Biocompatibility: The "ground truth" is established by standard, validated biological and chemical test methodologies (e.g., ISO standards or USP monographs for hemolysis, cytotoxicity, implantation tests, pyrogen tests, etc.). The expected outcome (e.g., "no toxic liability") serves as the ground truth.
• For Qualification Testing: The "ground truth" is the established performance characteristics of the predicate device (Freon-TMS manufactured leads). The new leads are tested to ensure their performance (e.g., electrical properties, mechanical strength if tested) is equivalent to these established characteristics.
• For Clinical Performance: The "ground truth" for clinical effectiveness and safety is derived from the established long-term clinical outcomes and low complication rates of the predicate devices.

8. The Sample Size for the Training Set

• This information is not applicable. This is not an AI/Machine Learning device that requires a training set. The "training" for this device would be the manufacturing process development and optimization, not data-driven model training.

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

• This information is not applicable as there is no "training set" in the context of an AI/ML device.

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The models 438-07 and 435-07 pacing leads are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, symptomatic second-degree heart block, and certain conditions of asymptomatic second-degree block. In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias. Active-fixation leads are specifically indicated for use in cases where passivefixation leads provide unsatisfactory positional stability in either the atrium or the ventricle, or in cases where the atrial appendage has been sacrificed due to open-heart surgery or is abnormal because of congenital or acquired heart disease. In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual chamber pacing system to restore A-V synchrony.

The Intermedics Cardifix™ EZ Models 438-07 (bipolar) and 435-07 (unipolar) endocardial pacing leads are designed for use with implantable cardiac pulse generators configured for atrial or ventricular applications for long term cardiac pacing. The nominal length for the model 438-07 lead is 58 cm and is available in lengths from 40 to 110 cm. The nominal length for the model 435-07 lead is also 58 cm and is available in lengths from 40 to 110 cm. The lead connectors are designed to meet VS-1 specifications (an intra-industry agreement standardizing lead-to-pulse generator connection dimensions) for lead connectors. The models 438-07 and 435-07 pacing leads are packaged with the model 367-01 vein lifter and the following stylets: model 365-11 (straight stylet, limber), model 365-12 (straight stylet, firm), model 365-89 ("J" stylet, limber), and model 365-90 ("J" stylet, firm). The model 435-07 is also packaged with the following adapters: model 366-29 (Step up adapter, VS-1 unipolar lead to 5 mm unipolar pacer) and model 366-30 (Step up adapter. VS-1 unipolar lead to 6 mm unipolar pacer). The minimum introducer size recommended for the model 438-07 is 10 French. The minimum introducer size recommended for the model 435-07 is 7.5 French. The models 438-07 and 435-07 pacing leads are identical to the Intermedics models 438-05 (K922972, K954719) and 435-05 (K922972, K954719) respectively, except for the use of iridium-oxide (IROX) coated titanium for the electrodes. The IROX-coated electrodes are identical to those used in models 430-07 (K902672, K954719) and 431-07 (K902672, K954719) except that the dimensions of the cathode tip have been slightly modified to accommodate the active fixation corkscrew.

This document is a 510(k) summary for pacing leads, which are medical devices, not AI/ML software. Therefore, many of the requested categories related to AI/ML software performance studies are not applicable.

Here's an analysis of the provided text in relation to your request, indicating where information is present and where it is not applicable or unavailable:

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

The document does not present a formal table of acceptance criteria with reported quantitative performance metrics in the way one would describe for an AI/ML model (e.g., sensitivity, specificity, AUC thresholds). Instead, safety and effectiveness are established through:

• Design and Material Equivalence: The new models (438-07 and 435-07) are stated to be identical to predicate devices (438-05, 435-05, 430-07, 431-07) except for a minor modification to the cathode tip (IROX coating and slight dimension change to accommodate the corkscrew). This implies the acceptance criterion is equivalence to previously cleared devices.
• Biocompatibility Testing: The materials were evaluated in in vitro and in vivo tests (Hemolysis, MEM Elution Cytology, Ames Mutagenicity, USP Class V, Intramuscular Implantation, Maximization Sensitization, USP Pyrogen Test). The reported performance is that the materials "were not found to present any toxic liability under physiological conditions."
• Qualification Testing: "Complete qualification testing was performed on the predicate leads." For the new leads, specific testing was done on the modified tip to corkscrew joint "to verify the strength of this joint." The reported performance is "All of the test samples successfully completed the qualification testing."
• Clinical Experience of Predicate Devices: The "extremely low incidence of clinical complications" of the predicate devices (438-05, 435-05, 430-07, and 431-07) is cited as evidence of effective performance, and based on similarity, the new devices are "expected to perform with comparable efficacy."

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

• Test set sample size: Not explicitly stated. For biocompatibility, it refers to "test systems" and "test data." For qualification testing, it mentions "All of the test samples." No specific numbers or human patient count are provided for these tests.
• Data provenance: Not specified. The biocompatibility and qualification tests are laboratory/bench tests, not clinical studies with human data tied to specific locations or retrospective/prospective designations. The "clinical experience" cited is from commercially available predicate devices, implying real-world data but without details on its origin or nature (e.g., registries, individual reports).

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)

• Not applicable. This pertains to establishing ground truth for AI/ML models based on expert review. The studies described are engineering qualification tests and biocompatibility tests, not studies requiring expert review for ground truth in the context of diagnostic accuracy.

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

• Not applicable. This is relevant for studies where multiple readers or experts assess cases. The studies here are focused on device engineering and material properties.

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 medical device approval, not an AI/ML software. No MRMC study was performed, and there is no AI component.

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

• Not applicable. This is a medical device approval, not an AI/ML software. No algorithm is being evaluated.

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

• Ground truth for Biocompatibility: Laboratory test results based on established international standards (e.g., ISO for hemolysis, USP for pyrogen).
• Ground truth for Qualification Testing: Engineering specifications and successful completion of designed tests (e.g., strength of a joint).
• Ground truth for "Clinical Experience": Implied real-world performance data (low incidence of complications) from existing, commercially available predicate devices. This aligns somewhat with "outcomes data," but is presented as a general summation rather than a specific study.

8. The sample size for the training set

• Not applicable. There is no AI/ML model, and thus no training set.

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

• Not applicable. There is no AI/ML model, and thus no training set or ground truth establishment for it.

In summary: The provided document is a 510(k) submission for conventional medical devices (pacing leads), relying on equivalence to predicate devices and results from engineering and biocompatibility tests. It does not involve AI/ML technology, and therefore, most of your questions related to AI/ML study design and performance metrics are not applicable to this specific document.

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Pacing leads and accessories are intended for use with implantable cardiac pulse generators for long-term pacing of the heart. The indications for ventricular . pacing include, but are not limited to: Sick sinus syndrome, sinus bradycardia, complete heart block, and certain conditions of asymptomatic second-degree block.

In the presence of normal A-V conduction the indications for atrial pacing include, but are not limited to: Sinus arrest, sick sinus syndrome, sinus bradycardia and conditions requiring increased cardiac efficiency, enhanced cardiac output or the overdrive of certain cardiac arrhythmias.

In the absence of normal A-V conduction, an atrial lead may be used with a ventricular lead in a dual-chamber pacing system to restore A-V synchrony.

Active fixation leads are specifically indicated for use in cases where passivefixation leads provide unsatisfactory positional stability in either the atrium or the ventricle, or in cases where the atrial appendage has been sacrificed due to open-heart surgery or is abnormal because of congenital or acquired heart disease.

Suture-on epicardial leads (model 439-04) and screw-on (sutureless) myocardial leads (model 439-07), placed on the outside of the heart, are indicated for use when cardiac pacing is indicated and a suture-on lead is preferred, or when an endocardial lead cannot achieve satisfactory results. Such leads are particularly well suited to patients whose age or heart condition requires that the potential for lead dislodgment be minimized (i.e. patients who have not reached full physical maturity) and patients who may require cardiac pacing following openchest surgery.

The Intermedics Models 431-04, 431-07, 433-02, 433-03, 435-02, 435-05, 435-07, 435-08, 437-02, and 437-07 endocardial pacing leads, model 439-04 epicardial pacing lead, model 439-07 myocardial pacing lead, implantable accessory models 365-07, 365-09, 365-14, 365-17, 365-19, 365-22, 365-33, 365-34, 365-44, 365-49, 366-13, 366-15, 366-27, 366-28, 366-29, and 366-30, and non-implantable accessory models 365-62, 365-77, 365-29, 366-02, 366-17, and 367-01, are designed for use with implantable cardiac generators for long term cardiac pacing.

The provided text is a 510(k) Summary for a change in the manufacturing process of Intermedics Pacing Leads and Accessories, specifically the elimination of Chlorofluorocarbons (CFCs). It is not a study proving device performance against acceptance criteria in the typical sense of a diagnostic medical device with performance metrics like sensitivity, specificity, etc.

Instead, this document describes how the CFC-free manufactured devices are substantially equivalent to previously approved devices. The "acceptance criteria" here are demonstrating that the change in manufacturing process does not negatively impact the device's safety and effectiveness, meaning the performance remains comparable to the predicate devices.

Here's a breakdown based on your request, interpreting "acceptance criteria" in this context as demonstrating equivalence:

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

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

• Test Set (Qualification Testing): Models 431-07 and 435-08 were selected for qualification testing. The document does not specify the number of units tested for each model, only that these models were "selected as they consist of processes representative of the changes."
• Data Provenance: Not explicitly stated as country of origin. The document is a 510(k) submission to the FDA (United States), so testing would typically be compliant with US regulatory standards. It describes testing of manufactured devices which is prospective in the sense of testing the new manufacturing process. The "clinical experience" cited for predicate devices is retrospective.

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)

Not applicable, as this is not a diagnostic device or a study involving expert interpretation of medical images/data to establish ground truth. The "ground truth" here is the established safety and effectiveness of the previously approved predicate devices and the performance metrics from standard engineering and biocompatibility tests.

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

Not applicable. This is not a study requiring human adjudication of medical findings.

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 is for pacemaker leads, not AI-assisted diagnostic tools involving human readers.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance relates to the physical and biological performance of the device components themselves.

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

The "ground truth" in this context is established through:

• Predicate Device Performance: The known long-term safety and effectiveness of the Intermedics pacing leads manufactured with Freon-TMS, which has been demonstrated through extensive clinical use.
• Biocompatibility Standards: Established in-vitro and in-vivo test systems (e.g., Hemolysis Test, MEM Elution Cytology, Ames Mutagenicity, USP Class V, Intramuscular Implantation, Maximization Sensitization, USP Pyrogen Test).
• Engineering Qualification Testing: Performance measured against engineering specifications for the device (though specific metrics are not detailed in this summary).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable.

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