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Torpedo Gelatin Foam is indicated for use in embolization of:
· Hypervascular tumors
· Blood vessels to occlude blood flow to control bleeding / hemorrhaging in the peripheral vasculature

Torpedo Gelatin Foam is a hydrophilic medical device which consists of resorbable dry gelatin foam that is compressed into a cylindrical shape and preloaded into a cartridge with a standard female and male luer fittings. The device is available in two sizes (0.9 mm and 1.7 mm) and two lengths configurations (10 mm and 20 mm).
Once rehydrated, the deformable torpedoes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

This document is a 510(k) summary for the Torpedo Gelatin Foam device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the information requested in your prompt regarding acceptance criteria and the detailed study results that prove the device meets these criteria in the context of an AI-driven medical device.

The provided text does not describe an AI medical device or its performance criteria. It is a traditional medical device 510(k) submission for an embolization device (gelatin foam).

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI medical device based on the given text. The document refers to:

• Bench testing: Leveraged from a previously cleared device (K183578) with no changes in material, design, or processing.
• Animal testing: Leveraged from the predicate device (K183120) to support new indications for use. An animal study (7 test, 8 control sheep) evaluated vascular occlusion, local tissue effects, and in-vivo degradation over 4 weeks using angiography and histopathology. The outcome was successful embolization and no significant difference in artery patency between devices.

None of this relates to AI performance metrics, sample sizes for AI model testing, expert labeling, MRMC studies, or training set details that would be pertinent to an AI medical device.

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Intended Use: Torpedo Gelatin Foam is indicated for use in embolization of hypervascular tumors.

Torpedo Gelatin Foam is a hydrophilic medical device which consists of resorbable dry gelatin foam that is compressed into a cylindrical shape and preloaded into a cartridge with a standard female and male luer fittings. The device is available in two sizes (0.9 mm and 1.7 mm) and two lengths configurations (10 mm and 20 mm).

Once rehydrated, the deformable torpedoes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

The provided text is a 510(k) summary for the Torpedo Gelatin Foam, a vascular embolization device. It details the device's characteristics, intended use, and substantial equivalence to a predicate device (EmboCube Embolization Gelatin).

However, the text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/ML device performance. The document is a traditional 510(k) submission for a physical medical device, not a software-as-a-medical-device (SaMD) or an AI-powered diagnostic/therapeutic device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document focuses on demonstrating substantial equivalence through physical and chemical properties, sterilization, and animal studies for an embolization device, not on AI/ML performance metrics like sensitivity, specificity, or AUC.
2. Sample size used for the test set and the data provenance: There is no "test set" in the context of AI/ML. The document mentions an animal study with 7 test and 8 control animals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an embolization device involves successful occlusion of vessels and tissue necrosis, assessed through angiography and histopathology in animal models.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the animal study, ground truth was established through angiography (imaging of blood vessels) and histopathology (microscopic examination of tissue), confirming the embolic effect and tissue necrosis. Outcomes data (normal flow not recovered, necrotized renal tissue, clinically normal animals) also served as evidence.
8. The sample size for the training set: Not applicable. There is no training set for an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes the regulatory submission for a physical medical device, not an AI/ML driven device, and thus does not contain the specific information requested about acceptance criteria and study design for AI/ML performance.

Ask a specific question about this device