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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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The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is designed 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 intended for single use only.

The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead which contains a distal, discrete, ring electrode (1), a discrete, tip electrode (2); and a coaxial conductor lead body (3). Each discrete electrode is crimped onto a conductor and terminates in an atraumatic, myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) 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 (6). To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.

The provided text is a 510(k) premarket notification for a medical device: the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead. This document is focused on establishing "substantial equivalence" to a predicate device, specifically due to a material change in a component (shrink band).

The information requested in the prompt, particularly regarding acceptance criteria and studies proving device performance in the context of AI/machine learning (e.g., ground truth, expert consensus, MRMC studies, training/test set sample sizes), is not present in this document. This document pertains to a traditional medical device (a pacing lead), not an AI-enabled one. Therefore, the questions related to AI-specific performance metrics, ground truth establishment, and training/test sets are not applicable to the content provided.

The document primarily focuses on:

• Device Description: What the pacing lead is and how it functions.
• Intended Use: Temporary post-surgical pacing for 7 days or less.
• Comparison to Predicate Device: Emphasizing similarity in intended use, performance (claimed as substantially equivalent), principles of operation, technology, design, and materials.
• Description of Change: The specific change being submitted – a material change to the shrink band.
• Summary of Testing: Only lists "Biocompatibility" and "Manufacturability" tests for the new shrink band material, both of which "Passed." These are standard tests for material changes in medical devices, not performance studies of an AI algorithm.
• Conclusion: States that the device is substantially equivalent to the legally marketed predicate device based on the data submitted.

To directly answer your prompt based only on the provided text, many fields will be "Not Applicable" or "Not Provided" because the document describes a physical medical device, not an AI/ML algorithm.

Here's how the provided information maps to your questions:

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

Note: The document doesn't explicitly state quantitative acceptance criteria beyond "passed" for the listed tests. The overarching "acceptance criterion" for a 510(k) is demonstrating substantial equivalence.

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

• Sample Size: Not specified for any testing. The testing summary is very high-level ("Tests conducted").
• Data Provenance: Not specified.
• Retrospective or Prospective: Not applicable, as this refers to clinical study design which is not detailed here for this device.

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 document describes a physical pacing lead, not an AI/ML device requiring expert-established ground truth for image/data interpretation.

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

• Not Applicable. This refers to expert consensus in AI/ML performance evaluation, which is not relevant here.

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. An MRMC study is not relevant for this type of device.

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

• Not Applicable. This refers to AI/ML algorithm performance.

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

• Not Applicable. Ground truth, in the context of AI/ML, is not relevant for the testing described for this physical device. The "ground truth" for the device's function would be its demonstrated physical and electrical properties, and biocompatibility, as tested in labs, not human interpretation or outcomes analysis as in an AI study.

8. The sample size for the training set

• Not Applicable. There is no AI training set for this device.

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

• Not Applicable. There is no AI training set or ground truth establishment relevant to AI for this device.

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