(90 days)
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.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).