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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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