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.

AI/ML Overview

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.

Summary

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KIUOTOS

Image /page/0/Picture/1 description: The image shows the logo for MiMedx Group. The logo is black and white and features the company name in a bold, sans-serif font. There are two curved lines above the "edx" portion of the name. The word "GROUP" is below the "edx" portion of the name.

JUN - 2 2010

May 27, 2010

510(k) Summary as required by section 807.92

Proprietary Name:	HydroFix ™ Vaso Shield
Common Name:	Vessel Guard or Cover
Classification Name:	Intracardiac patch or pledget made of polypropylene, polyethyleneterephthalate, or polytetrafluoroethylene. (per 21 CFR 870.3470)
Device Class:	Class II
Product Code:	OMR
Classification Panel:	Cardiovascular Devices
Establishment Registration:	3006731846
Contact Person:	Sally ThorsenMiMedx Group, Inc.811 Livingston Court SE, Suite BMarietta, GA 30067(678) 384-6720Fax 678-384-6741sthorsen@mimedx.com

Performance Standards:

Performance standards do not currently exist for these devices.

Device Description:

Indications for Use:

The MiMedx HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.

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Image /page/1/Picture/0 description: The image shows the logo for MiMedx Group. The logo is black and white and features the company name in a bold, sans-serif font. The word "MiMedx" is on the top line, and the word "GROUP" is on the bottom line. There is a curved line above the word "MiMedx".

May 5, 2010

Substantially Equivalent Devices:

The following devices as substantially equivalent predicate devices listed below.

K090022 Paradís Vaso ShieldTM K093551 Paradis Vaso ShieldTM

The MiMedx HydroFix™ Vaso Shield was shown to be substantially equivalent to previously cleared device and has the same indications for use, design, function, and/or materials.

Brief Comparison Summary:

To demonstrate substantial equivalence of the MiMedx HydroFix™ Vaso Shield to the predicate devices, technological characteristics and performance criterion were evaluated using in vitro and in vivo testing as indicated below:

In Vitro Testing

Suture pull out .
The results from this test demonstrate that the technological characteristics and performance criteria of the MiMedx HydroFix™ Vaso Shield are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

In Vivo Testing

To assess the performance of the MiMedx HydroFix™ Vaso Shield, an in vivo study was conducted in a porcine model to evaluate the following attributes:

reflectivity of light from the surgical sheet �
edge sharpness .
. ability to suture to tissue
ability to secure to tissue .
. ability to cut the sheet

The results of this study show that the MiMedx HydroFix™ Vaso Shield are comparable to the predicate devices and that it can perform in a manner equivalent to devices currently on the market for the same intended use.

Conclusion:

The sponsor believes that the data and information presented in this 510(k) application, including in vitro and in vivo testing, and numerous device similarities support a determination of substantial equivalence, and therefore market clearance of the MiMedx HydroFix™ Vaso Shield through this 510(k) Premarket Notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like shapes, representing care and protection. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the circumference of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN = 2 2010

MiMedx Group, Inc. c/o Ms. Sally Thorsen Director, Regulatory Affairs and Quality Assurance 811 Livingston Court SE, Suite B Marietta, GA 30067

Re: K100905

MiMedx HydroFix™ Vaso Shield Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate or polytetrafluoroethylene

Regulatory Class: Class II Product Code: OMR Dated: May 5, 2010 Received: May 6, 2010

Dear Ms. Thorsen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Sally Thorsen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K100905

Device Name: HydroFix™ Vaso Shield

The MiMedx Group, Inc. HydroFix™ Vaso Shield is indicated as a cover for vessels during anterior vertebral surgery.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division/Sign-Off) Di son of Cardlovascular Devices 510(k) Number K (00965

Regulation Number and Section

§ 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).