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The MiMedx HydroFix™ Surgical Sheet is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The surgical sheet minimizes tissue attachment to the device in case of direct contact with the tissues.

The HydroFix™ Surgical Sheet is a flexible sheet of 30 Wt.% polyvinyl alcohol (PVA) material with dimensions 60 ±6 mm X 50 ±5 mm and 60 ±6 mm X 100 ±10 mm with a thickness of 1.0 ±0.2 mm. The comers of the sheet are rounded. 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 in saline solution.

The HydroFix™ Surgical Sheet will be provided in other shapes and sizes as needed for particular surgical procedures.

This document describes the 510(k) submission for the HydroFix™ Surgical Sheet, which aims to demonstrate its substantial equivalence to previously cleared devices. It primarily focuses on comparing the new device's performance and characteristics to those of predicate devices rather than establishing specific acceptance criteria for standalone performance.

Here's an analysis of the provided information based on your requested points:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria with pass/fail thresholds for the HydroFix™ Surgical Sheet. Instead, it states that the device's performance was judged as "comparable to the predicate devices."

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not specified for in vitro tests. For in vivo tests, it mentions studies conducted in "both sheep and rabbit models," implying a sample size of at least two different animal types, but the number of individual animals within each model is not provided.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, in vivo studies typically imply prospective animal studies conducted in a controlled environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document refers to "in vitro" and "in vivo" testing, implying laboratory and animal model evaluations, not expert-based ground truth for interpretation as might be found in diagnostic imaging studies.

4. Adjudication method for the test set

This information is not provided, as the evaluation type doesn't involve human interpretation that would require an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical sheet, not an AI-assisted diagnostic tool, so such a study would not be applicable.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is not applicable. The device is a surgical sheet, not an algorithm. The testing performed was to evaluate the physical and biological characteristics of the sheet.

7. The type of ground truth used

• For In Vitro Testing: The ground truth is inherent in the physical properties and mechanical measurements themselves (e.g., actual tensile strength, burst strength, etc., measured according to established material testing standards).
• For In Vivo Testing: The ground truth is the observed biological response and mechanical performance within the animal models as assessed by researchers (e.g., visual assessment of tissue attachment, successful suturing, etc.). This would likely involve histological examination and gross observations post-sacrifice.

8. The sample size for the training set

This concept is not applicable. The device is a physical product (surgical sheet), not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

This concept is not applicable, as there is no training set for a physical surgical sheet.

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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.

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.

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