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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.

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

The 018 Spiral / Helical 2D Interlock Fibered IDC Occlusion System is a product line consisting of 0.018 inch (0.457 mm) system compatible fibered interlocking detachable coils. The Interlock 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 Fibered IDC Occlusion Coil is designed to be delivered under fluoroscopy with a 0.021 inch (0.53 mm) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with one or two radiopaque (RO) tip markers. 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) summary for the Interlock™ 018 Fibered IDC™ Occlusion System, a vascular embolization device. The submission focuses on demonstrating substantial equivalence to predicate devices through bench testing and biocompatibility assessments, rather than clinical performance studies involving patient data or human readers. Therefore, many of the requested categories related to clinical study design and performance metrics are not applicable in this context.

Here's a breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission primarily based on bench and biocompatibility testing for substantial equivalence, the "acceptance criteria" are generally that the new device performs comparably to the predicate device in these tests, and meets established standards for safety (biocompatibility) and functional performance. Specific quantitative acceptance values are not explicitly stated in this summary for each test, but rather the successful completion of these tests.

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

• Sample Size (Test Set): Not specified in terms of number of units tested for each in-vitro or biocompatibility test. These tests typically involve a defined number of samples per test according to relevant standards, but the exact count is not detailed.
• Data Provenance: The tests are described as "bench testing" and "biocompatibility testing," which are laboratory-based studies. There is no patient data or geographical origin specified as it's not a clinical study. It's a prospective evaluation of the manufactured device.

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

• Not applicable. The "ground truth" here is determined by the results of the laboratory tests against established scientific and regulatory standards (e.g., ISO standards for biocompatibility). There's no involvement of clinical experts establishing ground truth for a diagnostic outcome.

4. Adjudication Method for the Test Set:

• Not applicable. This pertains to clinical studies often involving expert interpretation of images or patient data. Laboratory testing results are generally objective measurements directly from the test.

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

• No. An MRMC study is a clinical study design used to evaluate diagnostic systems involving multiple readers interpreting multiple cases, often with and without AI assistance. This submission relies on bench and biocompatibility testing for a device, not a diagnostic algorithm.

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

• Not applicable. This device is a physical medical device (embolization coil), not an algorithm or AI software. The performance testing is for the device itself, not a separate algorithm. The closest equivalent is the standalone "in-vitro performance tests" and "biocompatibility tests."

7. Type of Ground Truth Used:

• For biocompatibility, the ground truth is established by recognized international standards (e.g., ISO 10993 series) for evaluating biological effects of medical devices.
• For in-vitro performance, the ground truth is established by engineering specifications and functional requirements derived from the device's intended use and comparison to predicate devices, verified through direct physical measurements and observations in a controlled lab setting.

8. Sample Size for the Training Set:

• Not applicable. This submission is for a physical medical device and its manufacturing/material characteristics, not a machine learning algorithm that requires a "training set."

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

• Not applicable. As above, there is no training set for this type of device submission.

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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.

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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.

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The Interlock™ Fibered IDC™ Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.

The Interlock 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 Fibered IDC Occlusion Coil is designed to be delivered under fluoroscopy with a 0.0 21 in (0.53 mm) inner diameter (I.D.) microcatheter (e.g. Renegade™ Microcatheter) with one or two radiopaque (RO) tip markers. 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 document describes a medical device, the "Interlock™ Fibered IDC™ Occlusion System," and its premarket notification (510(k)) to the FDA. It details device characteristics, intended use, and non-clinical testing performed to establish its safety and substantial equivalence to a predicate device for regulatory clearance.

Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving performance:

The provided text is a 510(k) summary and FDA clearance letter for a medical device (Interlock™ Fibered IDC™ Occlusion System). It focuses on demonstrating substantial equivalence for regulatory clearance, not on providing a study that proves specific acceptance criteria for device performance in the way you've outlined for AI/diagnostic systems.

Therefore, I will extract the information available and explicitly state where information is not present in the provided document, as it pertains to a different type of evaluation.

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

• Acceptance Criteria: The document does not explicitly present a table of acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, the "acceptance criteria" were implied by the regulatory standard of demonstrating substantial equivalence to a predicate device (Fibered IDC™ Occlusion System, K060078) and meeting safety standards for its intended use, particularly regarding MRI compatibility.

  • For MRI compatibility, the acceptance criteria are implicit in the ASTM standards cited:
    • 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 Evaluation of MR Image Artifacts from Passive Implants.
  • The overall acceptance criterion for the 510(k) submission is that the new device presents "no additional risk to a patient" compared to gravitational and normal daily activities, or a feverish condition, in an MRI environment, and can be "scanned safely under a static magnetic field of 1.5 Tesla or 3.0 Tesla."

• Reported Device Performance:

  Performance Metric (Implied)	Reported Performance (Non-Clinical)
  MRI Safety (Heating)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2182-02a)
  MRI Safety (Displacement)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2052-06e1)
  MRI Safety (Torque)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2213-06)
  MRI Safety (Image Artifacts)	Demonstrated safe under 1.5T or 3.0T MRI (ASTM F2119-07)
  Overall Risk Profile	"will not present additional risk to a patient during a MRI procedure"

Note: This is a physical medical device, not an AI/diagnostic software. The "performance" being evaluated here relates to mechanical and material safety under specific conditions, not diagnostic accuracy, sensitivity, or specificity.

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

• Sample Size: The document refers to "non-clinical testing" and does not specify a "sample size" in the context of patients or data points characteristic of diagnostic studies. The "test set" here would refer to the physical coils themselves that underwent MRI compatibility testing. The number of physical coils tested is not provided, and there is no patient data involved in this type of non-clinical testing.
• Data Provenance: Not applicable in the context of sensor data or patient data. The "tests" were conducted in a laboratory setting. No country of origin for data or retrospective/prospective nature is relevant.

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

• Not applicable. This is not a study requiring expert consensus or ground truth establishment for diagnostic purposes. The ground truth for MRI compatibility is established by the physical properties of the device and its interaction with magnetic fields, measured according to established ASTM standards by engineering/physics experts, not medical experts for diagnostic tasks.

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

• Not applicable. There is no adjudication method described as it's not a diagnostic study involving human interpretation or subjective assessment. The ASTM test methods likely have predefined pass/fail criteria that are objectively measured.

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 medical device, not an AI or diagnostic tool. No MRMC study was performed, nor is there any AI component involved to assist human readers.

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

• Not applicable. This is a physical medical device. There is no "algorithm only" performance to evaluate. The device functions as an embolization coil.

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

• The "ground truth" for the non-clinical MRI compatibility testing is defined by the physical performance measurements against established ASTM standards. For example, the maximum temperature rise measured must be below a certain threshold according to ASTM F2182-02a to be considered safe for MRI. This is an objective, quantitative ground truth.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable, as there is no training set.

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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.

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The Fibered IDC Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for neurovascular use.

The Fibered IDC Occlusion System is a modified interlocking detachable coil indicated to obstruct or reduce rate of blood flow in the peripheral vasculature.

The provided text details a 510(k) premarket notification for a medical device and describes its intended use and regulatory status but does not contain information about specific acceptance criteria or a study proving that the device meets such criteria.

Specifically:

• Acceptance Criteria and Reported Device Performance: This information is not present in the provided text. The document states that "All data gathered demonstrate this device as substantially equivalent" to predicate devices, but it does not specify what performance metrics were evaluated or what the acceptance thresholds for those metrics were.
• Sample size for the test set and data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
• Adjudication method: Not mentioned.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
• Standalone (algorithm only without human-in-the-loop performance) study: Not applicable as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable as this is a physical medical device, not an AI algorithm requiring ground truth for training or evaluation.
• Sample size for the training set: Not applicable as this is a physical medical device, not an AI algorithm with a training set.
• How the ground truth for the training set was established: Not applicable.

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