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The Onocor ONO Retrieval device is indicated for use in the cardiovascular system to retrieve objects using minimally invasive surgical procedures include retrieval of intravascular foreign objects such as coils, balloons, catheters, guidewires and/or filters within the cardiovascular system. This device is not intended for use in the coronary arteries or neurovasculature.

The ONO Retrieval device is constructed of 12 Fr stainless steel reinforced catheter, a series of braided nitinol loops forming a basket, a peel away sheath, inner catheter and stop-cocks. The peel away sheath is advanced to compress the nitinol basket for introduction and then removed. The ONO is compatible with up to a 7 Fr manipulation device or snare and with 12Fr to 26 Fr retrieval sheaths. The ONO has a working length of 86 cm.

The provided text is a 510(k) summary for the ONO Retrieval Device and does not contain information related to software or AI performance metrics. Therefore, it is not possible to describe acceptance criteria or a study proving device performance in the context of an AI/software device using the provided input.

The document discusses performance tests for a physical medical device (a retrieval catheter), including:

• Dimensional Testing
• Tensile Strength
• Corrosion Resistance
• Catheter Kink Testing
• Torque Strength
• Simulated Use
• Radiopacity
• Design Validation Testing and Summative Usability Testing
• Distribution Testing
• Fatigue
• Biocompatibility Testing (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, Thrombogenicity, Complement Activation)
• Pre-clinical study in a porcine model comparing subject and predicate devices for retrieval of foreign objects and assessment of histology and thrombogenicity.

The document states that these tests were conducted "to meet the acceptance criteria that were determined to demonstrate substantial equivalence," but it does not explicitly list the acceptance criteria values or the reported device performance for these tests. It only makes a general statement that the device was shown to meet them and is substantially equivalent to the predicate device.

To answer the requested points, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: The document lists types of tests but does not provide specific criteria values or performance results.
2. Sample size used for the test set and the data provenance: For the pre-clinical study, it mentions "a porcine model" but not the number of animals or the origin of the data. For other performance tests, no sample sizes are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a physical device and not an AI/software testing scenario for ground truth against expert interpretation.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI/software device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth in the context of AI/software performance is not relevant here. For the physical device, performance was assessed through engineering tests and an animal study.
8. The sample size for the training set: Not applicable, as this is not an AI/software device using a training set.
9. How the ground truth for the training set was established: Not applicable.

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