(28 days)
The MiMedx HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.
Fusion surgery, Adjacent level surgery, Artificial Disc Implantation, Implant or Hardware Removal, Trauma, Vascular Surgery in the Spine.
The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is slippery, clear, pliable, conformable, nanoporous permanent vessel cover that minimizes tissue contact between the vessels and the spine. There are no holes or perforations. There are no markings on either side of the sheet, raised (embossed) or printed. The sheet is provided sterile and hydrated.
The provided text does not describe acceptance criteria for a device, nor does it detail a study proving the device meets acceptance criteria.
This document is a 510(k) summary for the HydroFix™ Vaso Shield, which is a regulatory submission to the FDA (Food and Drug Administration) for market clearance based on substantial equivalence to existing devices. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria and performance studies in the context of AI/software devices.
Here's why the prompt's requested information is not present and what this document does describe:
- Acceptance Criteria & Device Performance (Table): This document does not establish performance criteria for an AI/software device. Instead, it compares the HydroFix™ Vaso Shield to predicate devices based on "technological characteristics and performance criterion" evaluated through in vitro testing. There's no table presenting acceptance criteria for an AI solution nor reported device performance in terms of metrics like accuracy, sensitivity, or specificity.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set: These are all concepts relevant to studies evaluating AI/software devices, often involving medical imaging, diagnosis, or risk prediction. This 510(k) pertains to a physical medical device (a vessel cover), not an AI algorithm. Therefore, such information is entirely absent.
- "Study that proves the device meets the acceptance criteria": The "study" mentioned here is in vitro testing (Simulated Use and Environmental conditioning testing) to demonstrate substantial equivalence to predicate devices, not a clinical or performance study of an AI system.
Information that is present in the document:
- Proprietary Name: HydroFix™ Vaso Shield
- Common Name: Vessel Guard or Cover
- Indications for Use: As a cover for vessels during anterior vertebral surgery.
- Device Description: Flexible sheet of polyvinyl alcohol (PVA) material, slippery, clear, pliable, conformable, nanoporous, permanent vessel cover that minimizes tissue contact between vessels and the spine. Provided sterile and hydrated.
- Substantially Equivalent Devices (Predicates): K090022 Paradis Vaso Shield™, K100905 HydroFix™ Vaso Shield, K101826 HydroFix™ Vaso Shield, K101805 HydroFix™ Vaso Shield.
- Performance Evaluation (used for substantial equivalence):
- In Vitro Testing: Simulated Use and Environmental conditioning testing for 49℃ to 54℃ high temperature exposure limit.
- Limitations/Warnings included in the FDA Letter:
- "The safety and effectiveness of this device for reducing the incidence, severity, and extent of post-operative adhesion formation have not been established."
- The indication for use "as a cover for vessels during anterior vertebral surgery" must be prominently displayed in all labeling.
In conclusion, this document describes a physical medical device and its clearance process through the FDA's 510(k) pathway, which is based on demonstrating substantial equivalence to existing devices, rather than a performance study of an AI system against specific acceptance criteria.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).