(62 days)
The MiMedx Group, Inc. HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.
The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. 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 describes a 510(k) summary for the MiMedx HydroFix™ Vaso Shield, focusing on demonstrating its substantial equivalence to predicate devices rather than establishing novel acceptance criteria for device performance as an AI device. Therefore, a direct table of "acceptance criteria" and "reported device performance" in the context of an AI device's metrics (like sensitivity, specificity, etc.) is not applicable here.
However, I can extract the performance criteria that were evaluated to show substantial equivalence and explain the study conducted.
Here's a breakdown of the requested information based on the provided text, interpreted for a medical device (not an AI device):
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative "acceptance criteria" with numerical thresholds for performance metrics. Instead, it describes comparative performance against predicate devices to demonstrate "comparable" or "equivalent" performance.
| Performance Criteria (Evaluated Attributes) | Device Performance (Reported Outcome) |
|---|---|
| In Vitro Testing: | |
| Suture pull out | Results demonstrate comparable technological characteristics and performance to predicate devices. |
| In Vivo Testing: | |
| Reflectivity of light from the surgical sheet | Results show the MiMedx HydroFix™ Vaso Shield is comparable to predicate devices and can perform equivalently for the intended use. |
| Edge sharpness | Results show the MiMedx HydroFix™ Vaso Shield is comparable to predicate devices and can perform equivalently for the intended use. |
| Ability to suture to tissue | Results show the MiMedx HydroFix™ Vaso Shield is comparable to predicate devices and can perform equivalently for the intended use. |
| Ability to secure to tissue | Results show the MiMedx HydroFix™ Vaso Shield is comparable to predicate devices and can perform equivalently for the intended use. |
| Ability to cut the sheet | Results show the MiMedx HydroFix™ Vaso Shield is comparable to predicate devices and can perform equivalently for the intended use. |
2. Sample size used for the test set and the data provenance
- Sample size for in vitro testing: Not specified.
- Sample size for in vivo testing: Not specified, only mentions "a porcine model," implying one or more animals were used.
- Data provenance: The in vivo study was conducted in a "porcine model," indicating animal data. The location or specific details of where the in vitro testing occurred are not provided. Both types of studies appear to be prospective, as they were conducted to demonstrate substantial equivalence for this specific 510(k) application.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The studies conducted (in vitro and in vivo animal studies) do not involve human expert interpretation for "ground truth" in the way an AI device study would. The performance was likely assessed by researchers and possibly veterinary professionals in the case of the porcine model.
4. Adjudication method for the test set
Not applicable and not provided. This concept is typically relevant for human-interpreted diagnostic findings, not for the physical performance testing of a medical device described here.
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. This is a medical device, not an AI device. No MRMC study involving human readers or AI assistance was conducted or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI.
7. The type of ground truth used
For the in vitro and in vivo studies, the "ground truth" would be objective measurements and observations of the device's physical and functional characteristics (e.g., how well it holds a suture, its light reflectivity) under controlled experimental conditions. It is not based on expert consensus, pathology, or outcomes data in the typical sense of diagnostic ground truth.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device, not an AI model.
§ 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).