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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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Arterial and venous embolization in the peripheral vasculature

This embolization coil system is supplied sterile and is intended for one time use. The device is comprised of an introducer system with a premounted detachable embolization coil. The embolization coil is deployed when the interlocking threads between the coil and the delivery wire are "unscrewed" by turning the delivery wire counterclockwise approximately 25 times.

The introducer system consists of a delivery wire and a delivery wire inserter. The delivery wire inserter consists of a plastic delivery wire holder with the delivery wire and a cannula inserter containing the coil. A Detach Locking Device is also needed to use the set. This part is sold separately because several coils can be delivered through one Detach Locking Device. These components are further described below.

• Coil: The coil is constructed of platinum and is available in the following shapes: curled, straight, Tornado™, J-Coil Shape and Multiple J-Coil Shape. The coil is also available in three degrees of softness: Detach 18® standard, Detach 18® soft, and Detach 110.
• Delivery Wire: The delivery wire is comprised of four components: a handle, the delivery wire, a marker band and a detach tip. These are constructed of platinum and PTFE coated stainless steel. The delivery wires for Detach 11® and Detach 18® are available in a length of 200 cm. The diameter of the Detach 11@ delivery wire is 0.011 inches. The diameter of the Detach 18® delivery wire is 0.018 inches.
• Delivery Wire Inserter: The delivery wire inserter is also comprised of four components. These include a stainless steel tip, a polycarbonate tip fitting, polyethylene tubing and a nylon fitting.
• Detach Locking Device: The Detach Locking Device is basically a pin vise which ensures that the delivery wire does not move forward during coil detachment. This device does not contact the skin or the blood.

The Embolization Coil System (Detach 11® and Detach 18®) was evaluated for safety and effectiveness through a series of tests. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing specific acceptance criteria with numerical targets. However, the tests performed serve to assure reliable design and performance, and successful completion of these tests implies that the device meets the implied acceptance criteria for its intended use.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each test (Tensile tests, Performance Test). It simply states that Detach 11®/18® "was subjected to the following tests."

• Test Set Sample Size: Not specified.
• Data Provenance: The tests were conducted internally by COOK INCORPORATED ("COOK INCORPORATED was subjected to the following tests"). The country of origin of the data is therefore likely the USA, where Cook Incorporated is based. The nature of the tests (tensile tests, phantom performance tests) indicates they are prospective experimental tests conducted on the device prototypes or production samples.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

It is common for such internal engineering tests to be evaluated by qualified engineers and technical personnel within the company, but specific details are not provided in this regulatory submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

For the types of mechanical and performance tests described, "adjudication" in the sense of a consensus among multiple human reviewers for subjective outcomes is not typically applicable. The results are usually quantitative (e.g., force measurements for tensile tests) or observable functional outcomes (e.g., successful deployment in a phantom). The interpretation of these results against predefined engineering specifications would be handled by the testing personnel.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done.

This submission is for a medical device (embolization coil), not an AI or imaging diagnostic tool. MRMC studies are primarily relevant for evaluating the performance of diagnostic imaging devices or AI algorithms where human readers interpret medical images.

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

• Standalone Performance Study: No, a standalone performance study was not done, as this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the specific tests mentioned:

• Tensile Tests: The "ground truth" would be established by predefined engineering specifications for strength and durability. The device's performance (e.g., ultimate tensile strength, elongation at break) would be measured and compared against these specifications.
• Performance Test in a Microferret™ Catheter Mounted in a Phantom: The "ground truth" would be the successful, unhindered deployment and detachment of the coil within the simulated anatomy. This is a functional assessment against expected operational parameters.

In essence, the ground truth is based on engineering specifications and functional performance criteria for the device.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable.

This is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. Design and development are based on engineering principles and iterative testing, not by training a model on data.

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

• Ground Truth for Training Set: Not applicable.

As mentioned above, there is no training set for this type of device. The design specifications and performance requirements that guide the device's development are established through engineering analysis, clinical needs assessment, and regulatory standards.

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The DSB is intended for artificial embolization of symptomatic carotid cavernous fistulae in patients for whom, in the judgment of the neurosurgical management team, other medical or neurosurgical means would not be indicated.

The DSB consists of a silicone balloon which is inflated with contrast agent and detached via catheter at the desired site of embolization.

The provided document describes the FDA 510(k) submission for the Detachable Silicone Balloon (DSB) Artificial Embolization Device. The submission focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for AI/software devices. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth for an AI-like device is not applicable to this 1998 medical device submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device testing mentioned in the document is primarily bench testing and biocompatibility testing, not performance metrics based on clinical outcomes relevant to AI. Acceptance criteria are implied by successful completion of these tests to demonstrate safety and functional validity for its intended use and substantial equivalence to predicate devices. Specific quantitative acceptance criteria or reported device performance in a clinical context were not provided in detail.

2. Sample Size for the Test Set and Data Provenance

Not applicable. The submission describes bench testing and biocompatibility testing, not a clinical study with a "test set" of patient data in the context of an AI device.

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

Not applicable. This is not a study involving expert review of images or data for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable.

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

Not applicable. This is not an AI device, and no MRMC study was conducted.

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

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

7. Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness relies on successful completion of biocompatibility and functional bench tests, and the demonstration of substantial equivalence to existing predicate devices. This is a regulatory pathway, not a data-driven ground truth for an AI algorithm.

8. Sample Size for the Training Set

Not applicable. There is no AI model or "training set" for this physical device.

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

Not applicable.

Summary of Relevant Information from the Document:

• Device Name: Detachable Silicone Balloon (DSB) Artificial Embolization Device
• Intended Use: Artificial embolization of symptomatic carotid cavernous fistulae in patients for whom other medical or neurosurgical means would not be indicated.
• Testing Performed:
  • Biocompatibility testing
  • Functional bench testing: cycle testing, rupture testing, pressure volume testing, detachment force testing, inflation-deflation cycle rate testing, and catheter insertion valve testing.
• Outcome of Testing: Demonstrated the device to be safe for its intended use.
• Regulatory Pathway: 510(k) premarket notification, where the primary focus is demonstrating substantial equivalence to legally marketed predicate devices.
• Predicate Devices:
  • Target Therapeutics Detachable Platinum Coil (GDC)
  • Target Therapeutics (ITC) Radiopaque Spherical Emboli (RSE)
  • Target Therapeutics (ITC) Contour Emboli (CE)
  • Target Therapeutics (ITC) Occlusion Balloon Catheter (mentioned conceptually, but not in the detailed comparison)
• Substantial Equivalence: Claimed based on equivalence/identity in intended use, materials, manufacturing, design parameters, method of delivery, and method of deployment to the predicate devices. The comparison chart specifically details similarities in general description, indications, device function, material (though DSB is silicone, GDC is platinum/tungsten, RSE is silicone, CE is Polyvinyl Alcohol), delivery, and deployment methods.

This document clearly outlines a 510(k) submission for a physical medical device, not a software or AI-driven device. Therefore, the questions tailored for AI/software performance studies do not directly apply.

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The Patient Return Electrode is indicated for use only with Target Therapeutics GDC System as the patient return electrode.

Target Therapeutics' Patient Return Electrode (PRE) is a single use, disposable, non-sterile electrode. The PRE is intended to be used as an alternative patient return electrode for Target Therapeutics GDC system (K951256 & K960705). A hypodermic needle is currently used as the patient return electrode. The PRE is applied to the skin on the patient's upper arm (deltoid). The PRE is being made available for patient comfort and has no effect on the safety or efficacy of the GDC system as functional testing indicates.

A small Prep pad is included with the PRE to exfoliate the skin prior to applying the PRE.

This is a 510(k) premarket notification for a medical device (Patient Return Electrode). This type of submission generally does not contain detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies as would be expected for AI/ML device evaluations. The focus of a 510(k) is to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested fields cannot be directly answered from the provided text. I will extract the information that is available and note when information is not present.

Here's a breakdown based on your request:

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

Based on the provided text, specific quantitative acceptance criteria and their corresponding reported device performance values (like sensitivity, specificity, AUC) are not explicitly stated as they would be for an AI/ML device. The document mentions "functional testing" and "bench testing" but does not provide specific metrics or thresholds.

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

• Sample size for the test set: Not specified. The document mentions "bench testing," "animal studies," and "biocompatibility testing" but does not give sample sizes for these tests.
• Data provenance: Not specified. (e.g., country of origin, retrospective/prospective).

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

• Number of experts: Not applicable/Not specified. For this type of device (Patient Return Electrode), ground truth is established through physical/electrical measurements and biological responses, not expert interpretation of data.
• Qualifications of experts: Not applicable/Not specified.

4. Adjudication method for the test set

• Adjudication method: Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used when human interpretation of data (e.g., medical images) is involved in establishing ground truth. This is not pertinent to the evaluation of a Patient Return Electrode.

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

• MRMC study: No. An MRMC study is relevant for AI/ML diagnostic devices where human readers interpret medical images or data. This is not applicable to a Patient Return Electrode.
• Effect size of human reader improvement: Not applicable.

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

• Standalone performance: Not applicable in the context of AI/ML algorithms. The device itself (Patient Return Electrode) is a standalone component; its performance is evaluated in direct physical/electrical tests and biological studies, not as an algorithm.

7. The type of ground truth used

For this device, the "ground truth" would be established by:

• Physical/Electrical measurements: For the Tensile Test and Impedance Test, ground truth is based on engineering specifications and physics.
• Biological responses: For animal studies and biocompatibility testing, ground truth is based on observed physiological reactions and histological analyses against established safety standards.

8. The sample size for the training set

• Sample size for the training set: Not applicable. This document does not describe the development or evaluation of an AI/ML algorithm, so there is no concept of a "training set" in the sense of machine learning.

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

• How ground truth was established for the training set: Not applicable (as there is no training set for an AI/ML algorithm).

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The Guglielmi Detachable Coil (GDC) is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: a)very high risk for management by traditional operative techniques, or, b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.

The GDC system consists of a remote power supply and an occlusion coil attached to a delivery wire. The occlusion coil is detached by electrolytically dissolving a small portion of the delivery wire upon desired placement of the coil in the anatomy. The occlusion coils are manufactured from a platinum wire which is wound into a primary coil, and formed into a secondary helical or curved shape. The delivery wire consists of a stainless steel core wire with a stainless steel coil soldered on at the distal end and a Teflon outer jacket proximal to the detachment zone.

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The provided text describes a medical device (Guglielmi Detachable Coil - GDC) and its intended use, as well as compares its indications for use with predicate devices. It is a summary of safety and effectiveness, likely from a regulatory submission, but it lacks the specific details requested regarding performance studies.

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