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The GuardDOG™ Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion.

The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.

The GuardDOG System consists of two components: an Occlusion Guide Wire and a carbon dioxide (CO2) Inflation Device. The GuardDOG Inflation Device is used to inflate the occlusion balloon and seal the guide Wire once it is in position.

The GuardDOG Guide wire is 0.035" in size; 300cm in length (260cm working length); is compatible with a 0.038, or larger, guide catheter; has a shapeable tip; a radiopaque marker proximal and distal to the inflatable balloon; and a crimp zone that can be sealed to maintain balloon inflation on the proximal end.

The GuardDOG Inflation device is used to inflate the occlusion balloon and seal the guide wire once it is in position. The GuardDOG Inflation device is a disposable CO2 delivery device with two integrated syringes and a gauge. One syringe contains 20cc of CO2 and the second syringe is used to evacuate air from the Occlusion Guide Wire. The gauge is used to measure pressure of CO2 delivered. The GuardDOG Inflation device is packaged in Tyvek pouch for sterilization and then into a sealable can to maintain the CO2 environment.

The provided text describes a 510(k) submission for the GuardDOG® Occlusion System (K062220). This submission focuses on demonstrating substantial equivalence to a predicate device (K031357), rather than proving device performance against specific acceptance criteria through a clinical study or a standalone algorithm study.

Therefore, the requested details regarding acceptance criteria, study findings against those criteria, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not present in this document. The submission relies on non-clinical testing and comparison to a previously cleared device.

However, I can extract the information that is available:

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

This information is not available in the provided document. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing (mechanical, biocompatibility, sterility) and animal testing for performance characteristics, rather than reporting against specific, quantified acceptance criteria for overall 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):

This information is not available in the provided document. The document mentions "Representative samples of the device underwent testing," but does not specify sample sizes or data provenance for a "test set" in the context of clinical or algorithm performance. The animal testing was for "performance characteristics only."

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):

This information is not available in the provided document. The submission does not describe a study involving expert-established ground truth for a test set.

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

This information is not available in the provided document. No such adjudication method is mentioned.

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:

This information is not available in the provided document. The device is a physical medical device (occlusion system), not an AI-assisted diagnostic tool.

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

This information is not available in the provided document. The device is a physical medical device, not an algorithm.

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

This information is not available in the provided document. The submission discusses "bench testing" and "animal testing" to demonstrate "safety and effectiveness and appropriate functional and performance characteristics" and "performance characteristics only," respectively. This suggests engineering and pre-clinical data, not ground truth in the context of clinical outcomes or expert labels.

8. The sample size for the training set:

This information is not available in the provided document. The device is not an AI algorithm requiring a training set.

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

This information is not available in the provided document. The device is not an AI algorithm requiring a training set with established ground truth.

Summary of available information from the document related to substantiation:

The GardDOG Occlusion System (K062220) establishes substantial equivalence to its predicate device (K031357) based on:

• Technology Characteristics: Representative samples underwent bench testing, including mechanical testing, biocompatibility, and sterility.
• Animal Testing: Conducted to demonstrate performance characteristics only.
• Conclusion Basis: Similarities in functional design, materials, indications for use, and principles of operation between the proposed device and the predicate device.

The document is a 510(k) summary for a physical medical device and therefore does not contain the types of studies or data points typically associated with AI/algorithm-based devices.

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