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MReye Flipper Detachable Embolization Coils are intended for arterial and venous embolization in the peripheral vasculature.

The MReye® Flipper® Detachable Embolization Coil and Delivery System consists of a fibered detachable embolization coil and a delivery system. The MReye Flipper Detachable Embolization Coils are constructed from coiled Inconel (nickel chromium alloy) wire and synthetic fibers. The wire forms primary coil diameters from 0.035 inch. Upon exiting from the catheter, the embolization coil forms a secondary curl in vasculature, ranging from 3 to 8 mm.

The provided document is a 510(k) premarket notification for the Cook Incorporated MReye Flipper Detachable Embolization Coil and Delivery System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through extensive clinical studies as might be seen for novel technologies or PMAs.

Therefore, the document does not contain the information requested in points 1-9 regarding specific acceptance criteria, detailed study designs, sample sizes, ground truth establishment, or multi-reader multi-case studies for demonstrating clinical performance.

Instead, the document highlights the following:

1. Comparison to Predicate Device:
The submission asserts that the MReye® Flipper® Detachable Embolization Coil and Delivery System is "substantially equivalent" to its predicate device, the Flipper® Detachable Embolization Coil (K063619). The key argument for equivalence is that the new device is "identical to the predicate device in terms of intended use, principle of operation, materials of construction, and basic technological characteristics." The primary modification mentioned is related to MRI compatibility.

2. Performance Data (Limited):
The only performance testing mentioned is "MRI Testing."

• Acceptance Criteria (Implied): To verify that the implant can be labeled as "MR Conditional."
• Reported Device Performance: The MRI testing verifies that the implant "will be labeled as MR Conditional 0 with the applicable parameters described in the Instructions for Use."

This indicates that the focus of this particular submission was to ensure the device's compatibility with Magnetic Resonance Imaging, rather than re-proving its embolization efficacy, which is inferred to be equivalent to the predicate device.

In summary, none of the specific items requested in points 1-9 can be extracted from this document, as it pertains to a 510(k) submission based on substantial equivalence, with a primary focus on MRI compatibility for the modification.

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Used for arterial and venous embolization in the peripheral vasculature.

The Flipper® Detachable Embolization Coil (Inconel) is used for arterial and venous embolization procedures in the peripheral vasculature. The device is supplied sterile and intended for one-time use. The embolization coil is pre-loaded in a shipping cannula. The coil is constructed of Inconel and has a coil wire diameter of 0.035 inches. It is available in a curled shape. The emboli size range is 3 to 8 mm. The embolization coil includes synthetic fibers evenly placed down the length of the coil. The device is introduced to the target vessel using an angiographic catheter (sold separately) and deployment is achieved when the threads between the coil and the Flipper® Detachable Coil Delivery Wire are unscrewed.

The acceptance criteria and study detailed in the provided text for the Flipper Detachable Embolization Coil (Inconel) are focused on the device's physical performance characteristics rather than diagnostic accuracy or human-in-the-loop performance. Therefore, many of the requested fields related to AI/ML or diagnostic performance studies cannot be fully addressed.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "Testing data are presented to demonstrate that the Flipper® Detachable Embolization Coil (Inconel) meets applicable design and performance requirements." but does not provide specific quantitative acceptance limits or detailed test results within this summary.

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

The document does not specify the sample sizes (number of coils/tests) used for each of the performance tests. The data provenance is Cook Incorporated's internal testing. The tests are "retrospective" in the sense that they were performed on manufactured devices prior to submission for clearance, but not in the context of analyzing existing clinical data.

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

Not applicable. The "ground truth" for these performance tests is determined by engineering specifications and objective measurements, not expert consensus as would be typical for diagnostic devices.

4. Adjudication Method for the Test Set

Not applicable. The tests involve objective measurements against predefined engineering standards, not subjective assessments requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is an embolization coil, and the provided documentation focuses on its physical and functional performance, not diagnostic imaging or human interpretation.

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

No, a standalone (algorithm only) performance study was not done. This is a medical device (embolization coil), not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests (e.g., Coil Deformation, Wire Tensile Strength) would be defined by the pre-established engineering specifications and physical characteristics of the device deemed safe and effective for its intended use. This is based on engineering specifications and objective physical measurements, not expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm, so there is no training set.

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

Not applicable. This device is not an AI/ML algorithm, so there is no training set or ground truth to establish for it.

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Used for arterial and venous embolization in the peripheral vasculature.

The Flipper™ Detachable Embolization Coil is used for arterial and venous embolization for the peripheral vasculature. This device is used in conjunction with the Flipper Detachable Coil Delivery Wire. The detachable coil delivery system provides safe delivery of embolization coils where the size of embolization coil is difficult to predetermine. A handle facilitates manipulation and provides safe and easy detachment of embolization coils. This device is provided sterile and is intended for one-time use.

The Flipper™ Detachable Embolization Coil consists of the embolization coils and the delivery wire. The embolization coils are manufactured using stainless steel wire with synthetic fibers. The delivery wire is manufactured using stainless steel with TFE coating. The device will be available in the following sizes and is compatible with catheters of 80 and 110 cm lengths.

Delivery Wire Diameter: 0.035"
Extended Embolus Diameter: 0.035"
Coil Length: 3cm, 4cm, 5cm, 6cm, 8cm, 10cm, 12cm
Coil Embolus Diameter: 3mm, 5mm, 6.5mm, 8mm

The provided document describes a medical device, the Flipper™ Detachable Embolization Coil, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way a typical AI/software device would.

This document is a 510(k) premarket notification for a traditional medical device (an embolization coil). For such devices, "acceptance criteria" and "performance studies" are typically related to engineering and material testing, not statistical performance metrics like sensitivity, specificity, or reader agreement that are common for AI/software devices.

Here's an analysis based on the provided text, indicating what information is present and what is notably absent for an AI-focused request:

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

• Acceptance Criteria: Not explicitly stated in the format expected for a statistical performance study (e.g., "sensitivity must be > X%"). The document refers to "requirements of the design plan" but doesn't detail these as specific, quantifiable acceptance criteria for clinical performance.
• Reported Device Performance: The document lists "Performance Data" as:
  • In-Vitro Performance Test: Loading, Passage and Deployment
  • Tensile Test: Coil Thread/Delivery System
  • Tensile Test: Torque Wire to Braid Solder
  • Performance Results: The document generally states, "The results of these tests provide reasonable at the device has been designed and tested to assure conformance to the requirer to its use for arterial and venous embolization in the peripheral vasculature." However, no specific numerical results or metrics of these tests are provided.

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

• Not Applicable / Not Provided: The document does not describe a clinical test set in the context of diagnostic or AI performance evaluation. The "tests" mentioned are in-vitro performance and tensile tests, which would apply to the device components themselves, not to patient data. Therefore, concepts like data provenance or retrospective/prospective studies do not apply here.

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 / Not Provided: There is no mention of human experts establishing ground truth, as the document concerns the mechanical and functional aspects of an embolization coil, not the interpretation of medical images or data.

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

• Not Applicable / Not Provided: No adjudication method is mentioned, as there is no human interpretation or expert panel involved in the described testing.

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 / Not Provided: No MRMC study was conducted. This device is an embolization coil, not an AI diagnostic tool.

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

• Not Applicable / Not Provided: This question is for AI algorithms. The device is a physical medical implant.

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

• Not Applicable / Not Provided: The ground truth for the "Performance Data" cited would relate to engineering specifications (e.g., coil integrity under tension, successful deployment in an in-vitro model) rather than clinical "ground truth" derived from patient outcomes or expert pathological review. The document does not specify how conformance to design requirements was definitively "ground-truthed."

8. The sample size for the training set

• Not Applicable / Not Provided: Training sets are relevant for AI/machine learning models. This document describes a physical medical device.

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

• Not Applicable / Not Provided: As above, this is not relevant to the described device.

In summary: The provided 510(k) notification focuses on demonstrating "substantial equivalence" of a mechanical embolization coil to existing predicate devices based on design, materials, intended use, and general performance testing (in-vitro and tensile). It does not present information relevant to the statistical performance evaluation criteria or study design typically associated with AI/software devices as outlined in your request.

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