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The CorMatrix PROTECT ECM Envelope is intended to securely hold an implantable electronic device to create a stable environment when implanted in the body. The devices that may be used with the CorMatrix PROTECT ECM Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.

The CorMatrix PROTECT ECM Envelope is intended to securely hold a cardiac implantable electronic device (CIED) in order to create a stable environment when implanted in the body. The devices that may be used with the CorMatrix PROTECT ECM Envelope include pacemaker pulse generators, defibrillators, or other CIEDs.

The CorMatrix PROTECT ECM (extracellular matrix) Envelope is constructed from two perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM derived from porcine small intestinal submucosa. The 3 mm perforations are spaced evenly at 10 mm apart to allow exit of any exudate. The ECM is assembled into pouch form using with violet 5-0 polydioxanone (PDS) suture.

The provided text describes a 510(k) premarket notification for a medical device called the CorMatrix PROTECT ECM Envelope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a comprehensive study with acceptance criteria and device performance in the way a clinical trial or a novel AI device study would.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, expert involvement, and ground truth establishment, which are typical for an AI/ML device or a novel clinical device, is not directly applicable or available in this document.

What is available is information about non-clinical testing (an animal study) to support the substantial equivalence claim.

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, explicit "acceptance criteria" for specific performance metrics (like sensitivity, specificity, accuracy, etc.) for a human-in-the-loop or standalone AI device are not defined or reported in the document. The "performance" assessment is primarily focused on demonstrating biocompatibility and functional equivalence to predicate devices in a non-clinical setting.

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

• Sample Size: Not explicitly stated as a number of subjects. The study was conducted on a "New Zealand White rabbit." The number of rabbits or implants used is not specified.
• Data Provenance: The study was an animal study conducted on a New Zealand White rabbit model. No country of origin is specified. It is a prospective study as it involves implanting the device into the animal for assessment.

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

Not applicable/mentioned. This type of study (animal model for biocompatibility and device stabilization) would typically involve veterinary expertise and histopathological assessment, but the document does not detail the number or qualifications of experts involved in establishing a "ground truth" in the way it's understood for diagnostic AI.

4. Adjudication Method for the Test Set

Not applicable/mentioned. Adjudication methods (like 2+1, 3+1) are common in clinical studies where multiple human readers interpret data, often for diagnostic accuracy. This animal study doesn't involve such a human reader assessment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation and would assess the impact of the device on human reader performance. The CorMatrix PROTECT ECM Envelope is a surgical mesh envelope designed to hold implanted electronic devices, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense. The "performance" described relates to the physical characteristics and biological interaction of the device itself (stabilization, isolation, biocompatibility) without direct human intervention in its function subsequent to implantation. However, it's not "standalone" in the context of an AI algorithm performing a task without human involvement.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on the outcome and tissue response observed in the animal model, likely through methods such as:

• Visual inspection of the implanted site.
• Histopathological examination of surrounding tissues for biocompatibility assessment.
• Observation of the stability of the pacemaker.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant.

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