(70 days)
The Medtronic Graft Delivery Syringe is intended to provide the surgeon with a means to mix autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic bone graft materials and to deliver these materials to all orthopaedic surgical sites.
The purpose of this application is to notify the FDA of our intent to market the Medtronic Graft Delivery Syringe as a means to deliver graft material to an orthopedic surgical site.
The provided text is a 510(k) summary for the Medtronic Graft Delivery Syringe. This document focuses on demonstrating substantial equivalence to existing devices, a regulatory pathway that typically does not involve clinical performance studies or the establishment of novel acceptance criteria based on device performance metrics like sensitivity and specificity.
Therefore, the information required to populate the table and answer questions 2-9 is not present in the provided text. The submission is based on a comparison to predicate devices, implying that if the new device is sufficiently similar to previously approved devices, it is considered safe and effective without needing to re-demonstrate its performance against specific acceptance criteria through new studies.
Here's a breakdown of why the information is unavailable in this document:
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Acceptance Criteria and Reported Device Performance: This type of information is typically found in submissions for novel devices or devices undergoing performance trials. For a 510(k) submission based on substantial equivalence, the "performance" is primarily judged by its similarity to predicate devices, not by meeting new, pre-defined performance metrics.
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Sample Size for Test Set and Data Provenance: As no new performance study is described, there's no "test set" in the context of clinical or diagnostic accuracy.
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Number of Experts and Qualifications: Experts are not mentioned as being used to establish a "ground truth" for a performance study.
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Adjudication Method: Not applicable as there's no performance study described that would require adjudication.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is a type of clinical study, and no such study is described.
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Standalone Performance Study: No standalone clinical performance study is described. The equivalency is based on design and intended use, not on new performance data demonstrating accuracy, sensitivity, or specificity.
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Type of Ground Truth: No ground truth is established as no performance study is detailed.
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Sample Size for Training Set: Not applicable as this is a medical device, not an AI/ML diagnostic tool requiring a "training set" in the computational sense.
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How Ground Truth for Training Set was Established: Not applicable for the same reason as above.
Conclusion:
The provided 510(k) summary for the Medtronic Graft Delivery Syringe does not contain the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, or ground truth establishment. This is consistent with a 510(k) pathway that relies on demonstrating substantial equivalence to predicate devices rather than proving de novo performance against new criteria.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).