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The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

The CanGaroo Envelope is constructed from two to four perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM (extracellular matrix) 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 violet 5-0 polydioxanone suture (PDS). The device design is identical to the device cleared under K192616.

The provided text is a 510(k) summary for the CanGaroo Envelope, a surgical mesh device intended to securely hold implantable electronic devices. This document describes a "Special 510(k)" application, which means it addresses changes to a previously cleared device (K192616), specifically regarding its packaging.

Crucially, this document does not describe a study related to acceptance criteria for an AI/algorithm-based medical device. It focuses on demonstrating that changes in the product's packaging do not alter its fundamental scientific technology, intended use, or performance. Therefore, most of the information requested in your prompt regarding AI/algorithm performance, ground truth, expert consensus, and multi-reader studies is not applicable to this document.

However, I can extract information related to the device's validation for the packaging changes:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated in the document. The text mentions "packaging testing and sterilization adoption testing of product manufactured with the new packaging was repeated," implying a test set was used, but the number of units tested is not provided.
• Data Provenance: Not applicable. The testing is described as non-clinical, likely internal testing performed by Aziyo Biologics, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is a non-clinical, packaging-focused submission, not an AI/algorithm study requiring expert ground truth in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This is not an AI/algorithm study requiring clinical adjudication.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document is about a physical medical device (surgical mesh envelope) and packaging changes, not an AI/algorithm.

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

• No, a standalone algorithm performance study was not done. This document is about a physical medical device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For the packaging validation, the "ground truth" would be the pre-defined design input requirements for packaging and sterilization performance (e.g., maintaining sterility, physical integrity). These are engineering and quality control standards, not clinical ground truth.

8. The sample size for the training set

• Not applicable. This is not an AI/algorithm study requiring a training set.

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

• Not applicable. This is not an AI/algorithm study.

In summary: The provided text is a regulatory submission for a physical medical device (a surgical mesh envelope) specifically addressing changes to its packaging. It does not contain information about an AI/algorithm-based device, its performance, or associated studies like those you've inquired about.

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The CanGaroo Envelope is intended to securely hold a cardiac implantable neurostimulator to create a stable environment when implanted in the cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator to create a stable environment when implanted in the cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

The CanGaroo Envelope is constructed from two to four perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM (extracellular matrix) 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 violet 5-0 polydioxanone suture (PDS). The device design is identical to the device cleared under K182255.

The provided text describes a 510(k) submission for the CanGaroo Envelope, which is a surgical mesh envelope intended to securely hold cardiac implantable electronic devices or implantable neurostimulators. This submission (K192616) is a Special 510(k) application based on a change in the labeled shelf life of the device, rather than a new device or significant modification to its design or indications for use.

Therefore, the document does not contain information typically found in a clinical study report for an AI/ML device, such as:

• Acceptance criteria related to AI performance (e.g., sensitivity, specificity, AUC)
• A test set of medical images or patient data
• Information on expert readers, ground truth establishment, or adjudication methods
• Details of a multi-reader, multi-case (MRMC) study or standalone algorithm performance
• Training set details for an AI model

Instead, the "testing" mentioned in this document refers to non-clinical testing (specifically, shelf-life testing and seam strength testing of aged products) to support the extended shelf life.

Based on the provided text, it is not possible to fill out the requested table or answer the questions related to AI device performance evaluation. The device described is a physical medical device (surgical mesh), not an AI/ML software device.

However, if we were to interpret the "device" as a product undergoing a 510(k) pathway, and map the available information to the request (even if it doesn't perfectly fit), here's what could be inferred, focusing on the concept of 'acceptance criteria' for the shelf-life change:

Simulated "Acceptance Criteria" for Shelf Life Extension (based on inference):

Given the context of a Special 510(k) for shelf-life extension, the "acceptance criteria" and "study" would relate to the physical properties of the device over its proposed new shelf life.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated, but for shelf-life testing of physical products, samples from specific manufacturing lots would have been used for real-time aging studies. This would typically be a pre-defined statistical sample size based on relevant standards (e.g., ISO, ASTM) and risk assessment.
• Data Provenance: The testing was "real-time aged product," implying the device was stored for the full 30-month period under specified conditions, then tested. This is prospective testing for the shelf-life study itself. The country of origin of the data/testing is not specified but would typically be performed at the manufacturer's facility or a contract testing lab.

3. Number of Experts Used and Qualifications:

• Not Applicable. This is a physical product shelf-life test, not an AI/ML diagnostic performance study involving human readers or expert consensus on medical images. The "experts" would be analytical chemists or material scientists performing laboratory tests.

4. Adjudication Method for the Test Set:

• Not Applicable. This is a laboratory test with objective, measurable outcomes (e.g., force measured for seam strength). There is no "adjudication" in the sense of reconciling subjective expert opinions.

5. MRMC Comparative Effectiveness Study:

• Not Applicable. This is a physical medical device, not an AI/ML software.

6. Standalone Algorithm Performance:

• Not Applicable. This is a physical medical device, not an AI/ML algorithm.

7. Type of Ground Truth Used:

• For shelf-life testing, the "ground truth" is the measured physical properties of the aged device (e.g., measured seam strength, visual inspection for degradation, etc.) compared against pre-defined specifications. This is an objective, laboratory-derived "truth."

8. Sample Size for the Training Set:

• Not Applicable. This device does not involve a "training set" in the context of AI/ML.

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

• Not Applicable.

In summary, the provided document is a 510(k) clearance letter and summary for a physical medical device, focusing on a shelf-life extension. It does not provide the information requested about AI/ML device performance or associated clinical studies.

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The CanGaroo® Envelope is intended to securely hold a cardiac implantable neurostimulator to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

The CanGaroo Envelope is a sterile device intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator device to create a stable environment when implanted in the body. It is for single use in a single patient. The cardiac devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices; the implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

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

The provided text is a 510(k) premarket notification letter and summary for a medical device called the CanGaroo® Envelope. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about an AI/ML-driven medical device, nor does it describe an acceptance criterion or a study that proves a device meets an acceptance criterion related to AI/ML performance.

The document details the device's physical properties (decellularized porcine small intestinal submucosa, polydioxanone suture), its purpose (securely holding implanted cardiac or neurostimulator devices), and the non-clinical testing performed (seam strength testing) to demonstrate its biomechanical properties.

Therefore, I cannot answer your request based on the provided input. The request asks for details about acceptance criteria and a study proving an AI/ML device meets those criteria, including specifics like sample sizes for test/training sets, expert qualifications for ground truth establishment, MRMC studies, and standalone algorithm performance. This information is completely absent from the provided text, which pertains to a physical surgical mesh envelope.

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

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

The CanGaroo Envelope is constructed from two perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM (extracellular matrix) 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 violet 5-0 polydioxanone suture (PDS).

The device design is identical to the device cleared under K140306.

This document is a 510(k) submission for the CanGaroo Envelope, a surgical mesh device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device due to a change in suture supplier. As such, it does not detail a study involving AI or complex performance metrics typically associated with medical device software.

Based on the provided text, the device itself is a "Surgical Mesh Envelope" designed to hold cardiac implantable electronic devices. The clinical performance aspects discussed relate to the physical integrity of the envelope rather than diagnostic accuracy or AI-driven insights.

Here's an analysis of the provided information, addressing your questions where applicable, and noting when information is not present:

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for seam strength testing. Given the nature of the test (material property), data provenance in terms of country of origin or retrospective/prospective is not directly relevant. It's a non-clinical, in-vitro test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a non-clinical, in-vitro material test, not a study involving human experts establishing ground truth for diagnostic or prognostic purposes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is a non-clinical, in-vitro material test, not a study requiring adjudication of expert opinions.

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. This document does not pertain to an AI/ML-driven device or a study involving human readers.

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

No. This document does not pertain to an AI/ML-driven device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical testing was defined by the "design input requirements for seam strength," which represent pre-defined engineering specifications for the device's physical integrity.

8. The sample size for the training set

Not applicable. There is no AI/ML component described in this submission, so no training set is relevant.

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

Not applicable. There is no AI/ML component described in this submission, so no training set or its ground truth establishment is relevant.

Additional Information from the document:

• Device Name: CanGaroo® Envelope (Common Name: Surgical Mesh Envelope)
• Intended Use: To securely hold a cardiac implantable electronic device (pacemaker pulse generators, defibrillators, or other CIEDs) to create a stable environment when implanted in the body.
• Device Description: Constructed from two perforated, multilaminate sheets (4-ply) of decellularized, non-crosslinked, lyophilized ECM (extracellular matrix) derived from porcine small intestinal submucosa. Assembled into a pouch form using violet 5-0 polydioxanone suture (PDS).
• Predicate Device: CorMatrix PROTECT ECM Envelope (K140306).
• Reason for 510(k): Alternate supplier for the suture used to manufacture the device. The device design, materials (other than suture supplier), intended use, and labeling are not changing.
• Conclusion: The CanGaroo Envelope manufactured with an alternate, equivalent suture from a new supplier is substantially equivalent to the predicate device based on meeting design input requirements for seam strength.

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