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EmboCube Embolization Gelatin is indicated for use in embolization of:

• Hypervascular tumors
• Blood vessels to occlude blood flow to control bleeding / hemorrhaging in the peripheral vasculature

EmboCube Embolization Gelatin is a hydrophilic, medical device which consists of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. The device is available in 2 cube sizes and 3 weight configurations. Once rehydrated, the deformable cubes 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 EmboCube Embolization Gelatin and does not contain information about the acceptance criteria and study proving a device meets these criteria for an AI/ML-based medical device.

This document is for a physical medical device, an embolization gelatin, and details its substantial equivalence to a predicate device. Therefore, it discusses performance attributes relevant to a physical medical implant (e.g., macroscopic appearance, digestibility, size range, density, moisture content, sterility, pyrogenicity, shelf-life, deliverability) and includes details about an animal study to evaluate its performance (immediate control of bleeding, complications, re-bleeding rate).

The request, however, asks for information typically associated with the validation of an AI/ML medical device, such as:

• Acceptance criteria and reported device performance (in an AI/ML context, this would involve metrics like sensitivity, specificity, AUC).
• Sample sizes for test sets, data provenance (retrospective/prospective, country of origin).
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC studies and human reader improvement with AI assistance.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size and ground truth establishment for training.

Since the provided document is about a physical medical device and not an AI/ML device, it does not contain any of the information necessary to address the specific points in the prompt related to AI/ML device validation.

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EmboCube Embolization Gelatin is indicated for use in embolization of hypervascular tumors.

EmboCube Embolization Gelatin is a hydrophilic medical device which consists of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. The device is available in 2 cube sizes and 3 weight configurations. Once rehydrated, the deformable cubes 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 EmboCube Embolization Gelatin and does not contain information about the acceptance criteria and study proving a device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) studies, or ground truth establishment for a test or training set.

The document describes a medical device, EmboCube Embolization Gelatin, and its substantial equivalence to a predicate device based on various non-AI performance tests and an animal study. Therefore, I cannot address most of the points in your request based on the provided text.

However, I can extract information related to the device itself and the general summary of testing:

Device Information:

• Trade/Device Name: EmboCube Embolization Gelatin
• Regulation Name: Vascular Embolization Device
• Regulatory Class: Class II
• Product Code: KRD
• Intended Use: For use in embolization of hypervascular tumors.
• Device Description: Hydrophilic medical device consisting of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. Available in 2 cube sizes and 3 weight configurations. Once rehydrated, deformable cubes can be injected to provide a mechanical barrier to blood flow.

Study Information (Non-AI related):

1. A table of acceptance criteria and the reported device performance:
   The document lists the types of tests performed to demonstrate that the device meets "critical design specifications" and "clinical performance attributes," but it does not provide a table of
   specific quantitative acceptance criteria (e.g., "rehydration time must be < X minutes") nor the specific reported performance values for each test. Instead, it states that these tests were "successfully completed."

   Types of Performance Attributes Tested:

   • Macroscopic appearance (visual inspection)
   • Pepsin digestibility
   • Size range
   • Density
   • Moisture content (H2O analysis)
   • Hydration test
   • Effect on pH variation
   • Sterility
   • Pyrogenicity (Bacterial endotoxins)
   • Deliverability with the recommended catheters and radiopaque contrast agents
   • Flush test

   Biocompatibility Testing:

   • Cytotoxicity
   • Sensitization
   • Irritation
   • Acute Systemic Toxicity
   • Material-Mediated Pyrogenicity
   • Genotoxicity
   • Hemolysis
   • Complement Activation
   • Chemical characterization and toxicological risk assessment for Subacute/Subchronic Systemic Toxicity, Chronic Systemic Toxicity, and Carcinogenicity.

2. Sample size used for the test set and the data provenance:

   • Animal Study: "An animal study was conducted on eight test (EmboCube Embolization Gelatin) and four control (Gel-Block 10x Embolization Pledgets, K143038) adult female sheep in the renal arteries over a period of 4 weeks."
   • Data Provenance: Conducted in sheep (animal study). No information on country of origin or retrospective/prospective nature. (Animal studies for device approval are typically prospective).

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 (N/A) as this is not an AI/algorithm study involving human expert review for ground truth. The animal study evaluated "vascular safety, local tissue effects, and in vivo degradation."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   N/A, as this is not an AI/algorithm study that would involve expert interpretation requiring 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:
   N/A. This document describes a physical medical device, not an AI/algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   N/A. This document describes a physical medical device, not an AI/algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For the animal study, the "ground truth" was established by the observed "vascular safety, local tissue effects, and in vivo degradation" in the sheep. These are direct biological and physiological outcomes, not expert consensus on images or pathology as typically understood in AI studies.

8. The sample size for the training set:
   N/A. This document describes a physical medical device, not an AI/algorithm with a training set.

9. How the ground truth for the training set was established:
   N/A. This document describes a physical medical device, not an AI/algorithm with a training set.

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