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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.

Device Description

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.

AI/ML Overview

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.

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K Number

K101805

Device Name

HYDROFIX VASO SHIELD

Manufacturer

MIMEDX GROUP, INC

Date Cleared

2011-04-08

(284 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

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

Device Description

The MiMedx HydroFix™ Vaso Shield is a flexible sheet of polyvinyl alcohol (PVA) material provided in various dimensions. It is a slippery, clear pliable, conformable, nanoporous provided in valled over 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.

AI/ML Overview

Acceptance Criteria and Study for HydroFix™ Vaso Shield (K101805)

The provided document describes the 510(k) premarket notification for the HydroFix™ Vaso Shield. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a new study with predefined acceptance criteria. Instead, the "acceptance criteria" are implied by the demonstration of comparable performance to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Technological Characteristics and Functionality comparable to predicate devices.	The device is a flexible sheet of polyvinyl alcohol (PVA). It is described as slippery, clear, pliable, conformable, and nanoporous, designed to minimize tissue contact between vessels and the spine. It has no holes or perforations, no markings, and is provided sterile and hydrated. This aligns with the basic function of a "vessel guard."
Similar Indications for Use as predicate devices.	Indicated as a cover for vessels during anterior vertebral surgery. This is directly comparable to the stated intended use of the Paradis Vaso Shield™ (K090022 and K093551) and Gore PRECLUDE® Vessel Guard (K061727).
Demonstrated reduction in risk of potential vessel damage in vivo.	A sheep model (animal study) was conducted to demonstrate the reduction in the risk of potential vessel damage during anterior vertebral revision surgery. The implanted devices (HydroFix™ Vaso Shield) allowed a separation of the soft tissue adjacent to the study site from the study site. This provides evidence for the device's protective function.
Safety profile comparable to predicate devices.	While not explicitly detailed, the 510(k) process inherently requires a demonstration that the new device does not introduce new or different questions of safety or effectiveness compared to predicate devices. The absence of adverse findings in the animal study and the comparison to established predicate devices serve as the basis for this.
Materials comparable to predicate devices or acceptable for medical use.	The device is made of polyvinyl alcohol (PVA). The overall assessment of substantial equivalence suggests this material is acceptable for the intended purpose, aligning with the materials of predicate devices (polypropylene, polyethylene terephthalate, or polytetrafluoroethylene for the general class, though specific predicate materials are not detailed for comparison).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document mentions a "Large Animal Implantation A sheep model (animal study)." It does not specify the exact number of sheep used in the study.
Data Provenance: The study was an in vivo animal study conducted on sheep. The country of origin for the data is not specified. It is a prospective study as an experiment was conducted to generate the data for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number or qualifications of experts used to establish ground truth for the animal study. Veterinary surgeons or researchers would likely have been involved in the implantation and assessment of the devices in the sheep model.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the animal study data. The results would likely have been analyzed and interpreted by the research team involved.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic devices involving human interpretation of images or other data, which is not applicable to this physical implantable device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not
applicable. The HydroFix™ Vaso Shield is a physical implantable device, not an algorithm or software. Its performance is assessed through its physical interaction with tissues in vivo.

7. Type of Ground Truth Used

The ground truth for the in vivo testing was established through direct observation and assessment of the implanted devices in the animal model. This would likely involve:

Direct observation/histology: Assessing the physical separation of soft tissue, the presence or absence of vessel damage, and tissue responses at the implant site.
Pathology: Likely the most definitive ground truth, involving histological examination of tissues around the implant to confirm device presence, tissue separation, and absence of adverse reactions or damage.

8. Sample Size for the Training Set

No training set is mentioned or applicable. This device's performance was evaluated through an in vivo study, not through a machine learning or algorithm-based approach that requires training data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.