Search Results

The Interlock-35 Fibered IDC Occlusion System is indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. This device is not intended for neurovascular use.

The Interlock - 35 Fibered IDC Occlusion System includes a coil manufactured from platinum-tungsten alloy that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock - 35 Fibered IDC Occlusion System is designed to be delivered under fluoroscopy through a 5F (1.70 mm) OD (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Imager™ II Selective Diagnostic Catheter without side flushing holes. The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

The document does not specify the exact sample sizes used for each bench test conducted. It generally states that "The following bench testing was conducted for design elements and performance characteristics deemed appropriate to demonstrate equivalence to the predicate device." It also doesn't mention data provenance in terms of country of origin or whether a test set was retrospective or prospective, as the study described is a series of bench tests rather than a clinical study 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 to the provided document. The study described involves bench testing of a medical device (Interlock™ -35 Fibered IDC™ Occlusion System) rather than evaluating an AI medical device that requires expert-established ground truth from images or patient data.

4. Adjudication method for the test set

This information is not applicable to the provided document, as the study is bench testing and not a clinical study involving human readers or adjudicators.

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 (or at least not reported in this document). The device is a vascular embolization system, not an AI software/device.

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 device for embolization, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the bench tests would have been the established engineering specifications and performance standards for each test (e.g., minimum tensile strength, maximum bend resistance, etc.). The document states the device "met the predetermined acceptance criteria," indicating these criteria served as the ground truth.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as above.

Ask a specific question about this device

The Interlock-35 Fibered IDC Occlusion System is indicated for obstructing or reducing blood flow in the peripheral vasculature during embolization procedures. This device is not intended for neurovascular use.

The Interlock-35 Fibered IDC Occlusion System includes a coil manufactured from a platinum-tungsten alloy that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock-35 Fibered IDC Occlusion System is designed to be delivered under fluoroscopy through a 5F (1.70 mm) (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Imager™ II Selective Diagnostic. The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.

Acceptance Criteria and Study Analysis for Interlock™-35 Fibered IDCT™ Occlusion System (K113651)

This submission (K113651) is a 510(k) premarket notification seeking clearance for a revision to the Directions for Use (DFU) for the Interlock™-35 Fibered IDCT™ Occlusion System, not for a new device or significant modification to the existing device itself. Therefore, the information provided primarily addresses the regulatory implications of this labeling change rather than a study proving new device performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a DFU revision and explicitly states "Non-clinical performance data was not required since there were no changes made to the device," there are no specific acceptance criteria for device performance or reported device performance metrics in this document. The "acceptance criteria" here relate to the regulatory acceptance of the DFU changes.

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

Not applicable. As this submission is for a DFU revision, there was no "test set" of device performance data used. The modifications were purely textual to the labeling.

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

Not applicable. No ground truth for a test set was established for device performance in this submission. The "ground truth" for the DFU changes would be regulatory compliance and clarity, which would have been assessed internally by Boston Scientific's regulatory team and subsequently by the FDA.

4. Adjudication Method for the Test Set

Not applicable. There was no test set or adjudication process for device performance in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices to assess human reader performance with and without AI assistance. This submission pertains to a physical embolization device and a labeling revision.

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

No. This device is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

Not applicable for device performance. The "ground truth" for the DFU revision was the clarity, accuracy, and regulatory compliance of the instructional language presented in the DFU, ensuring it accurately reflects the device and its intended use without introducing new risks or unclear information.

8. The Sample Size for the Training Set

Not applicable. There was no training set for an algorithm or device performance study in this submission.

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

Not applicable. There was no training set or associated ground truth establishment for this regulatory submission.

Ask a specific question about this device

The Interlock-35 Fibered IDC Occlusion System is indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.

The Interlock-35 Fibered IDC Occlusion System includes a coil manufactured from a platinum-tungsten alloy that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock-35 Fibered IDC Occlusion System is designed to be delivered under fluoroscopy through a 5F (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Diagnostic Catheter (e.g. Imager™ II Diagnostic Catheter). The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.

This 510(k) submission describes the Interlock™-35 Fibered IDC™ Occlusion System, which is a vascular embolization device. The submission is for a revision to the Directions for Use (DFU) to include results of non-clinical MRI testing, demonstrating the device's MR Conditional status. It's important to note that this submission is not for a new device but for an updated label based on non-clinical testing. Therefore, the traditional acceptance criteria and study design focused on clinical performance metrics (like sensitivity, specificity, accuracy) are not applicable here.

Instead, the acceptance criteria relate to the device's compatibility with MRI environments, and the study in question is a non-clinical (i.e., benchtop) evaluation.

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

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

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

• Sample Size for Test Set: Not explicitly stated in terms of number of devices tested. The studies were non-clinical, so "sample size" would refer to the number of devices or coils subjected to MRI testing. The document refers to "the Coils."
• Data Provenance: The studies were non-clinical benchtop testing, not involving human or animal subjects. Therefore, there's no country of origin or retrospective/prospective nature in the typical sense. The testing was performed in a laboratory setting according to specified ASTM standards.

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

• Not applicable. This was a non-clinical safety evaluation for MRI compatibility, not a diagnostic or performance study requiring expert interpretation of results to establish ground truth. The "ground truth" was determined by adherence to established ASTM standards and measurement of physical parameters (e.g., temperature rise, magnetic susceptibility artifacts, force).

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

• Not applicable. As this was a non-clinical, objective assessment based on ASTM standards, there was no subjective interpretation or adjudication process involving multiple experts.

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 submission describes a medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

• Not applicable. This describes a physical medical device, not an algorithm.

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

• Objective measurements based on recognized ASTM standards. The "ground truth" for MRI compatibility is defined by the parameters and limits stipulated in the following ASTM standards:
  • ASTM F2182-02a (Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging)
  • ASTM F2052-06e1 (Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment)
  • ASTM F2213-06 (Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment)
  • ASTM F2119-07 (Standard Test Method for Quantitative Measurement and Assessment of Magnetically Induced Distortion of an MR Image by a Medical Device)

8. The sample size for the training set

• Not applicable. There is no "training set" as this is a non-clinical evaluation of a physical device, not a machine learning model.

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

• Not applicable. There is no "training set" or "ground truth" for a training set in this context.

Ask a specific question about this device

The Interlock-35 Fibered IDC Occlusion System is indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.

The Interlock-35 Fibered IDC Occlusion System includes a coil manufactured from a platinum-tungsten alloy that is mechanically attached to a coil delivery wire. This assembly is contained within an introducer sheath. The platinum coil contains synthetic fibers for greater thrombogenicity. The Interlock-35 Fibered IDC Occlusion System is designed to be delivered under fluoroscopy through a 5F (0.035 in [0.89 mm] or 0.038 in [0.97 mm] inner lumen) Diagnostic Catheter (e.g. Imager™ II Diagnostic Catheter). The interlocking delivery wire design allows the coil to be advanced and retracted before final placement in the vessel, thus aiding in more controlled delivery including the ability to withdraw the coil prior to deployment.

The provided text describes a 510(k) submission for the "Interlock™-35 Fibered IDC™ Occlusion System," a vascular embolization device. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness.

Therefore, the information you requested about acceptance criteria and associated studies is not directly applicable to this type of device submission as it is typically presented for AI/ML device clearances.

Here's why and what can be extracted:

• No "Acceptance Criteria" for Clinical Performance: This submission is for a modified device, not a new one requiring extensive clinical trials to establish its own performance metrics. The goal is to show it's as safe and effective as its predicate.
• No "Device Performance" Metrics in the AI/ML Sense: The device is a physical medical implant (an embolization coil), not a diagnostic or therapeutic AI algorithm. Therefore, "device performance" here refers to mechanical and material properties, not accuracy, sensitivity, or specificity.
• No "Study that Proves the Device Meets Acceptance Criteria" in the AI/ML Sense: The "study" is a collection of non-clinical, bench-top tests designed to demonstrate that the modifications to the device do not negatively impact its safety and performance compared to the predicate.

Given this context, I will address your points by extracting the relevant information about the non-clinical performance data and explaining why other points are not present.

Acceptance Criteria and Device Performance (Non-Clinical)

Since this is a physical medical device and not an AI/ML diagnostic, the "acceptance criteria" relate to engineering and material specifications, and "device performance" refers to the results of non-clinical tests. The text indicates that all testing performed and data demonstrate passing results according to executed verification protocols. This implies that the acceptance criteria for each test were met.

Information Not Applicable/Provided for This Type of Submission:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for non-clinical bench testing of a physical device. There isn't an "image test set." The tests are performed on manufactured device samples.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical tests is based on engineering specifications and validated test methods, not expert consensus on images.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to non-clinical bench testing.
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 is not an AI-enabled device nor one requiring evaluation of human reader performance.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is defined by established engineering and material science standards, measurement techniques, and specifications. Not clinical outcomes or pathology.
7. The sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device