(179 days)
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:
- 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.
- 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.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 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.
- The sample size for the training set: Not applicable. There is no training set for an AI/ML model.
- 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.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).