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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

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Callispheres Embolic Microspheres and 8Spheres Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids.

CalliSpheres and 8Spheres Embolic Microspheres are compressible hydrogel microspheres with a regular shape, smooth surface, and calibrated size, which are formed as a result of chemical modification on polyvinyl alcohol (PVA) materials. CalliSpheres and 8Spheres Embolic Microspheres consist of a macromer derived from polyvinyl alcohol (PVA), and are hydrophilic, non-resorbable, and are available in a range of sizes. The preservation solution is 0.9% sodium chloride solution. The water content of fully polymerized microsphere is 91% ~ 94%. Microspheres can tolerate compression of 30%. CalliSpheres Embolic Microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. 8Spheres Embolic Microspheres are undyed and with natural color. CalliSpheres and 8Spheres Embolic Microspheres are supplied sterile and packaged in sealed glass vials.

CalliSpheres Embolic Microspheres and 8Spheres Embolic Microspheres are intended to be used for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors, including uterine fibroids. By blocking the blood supply to the target area, the tumor or malformation is starved of nutrients and shrinks in size.

CalliSpheres and 8Spheres Embolic Microspheres can be delivered through typical microcatheters in the 1.7- 4 Fr range. At the time of use, CalliSpheres and 8Spheres Embolic Microspheres are mixed with a nonionic contrast agent to form a suspension solution. CalliSpheres and 8Spheres Embolic Microspheres are intended for single use and are supplied sterile and non-pyrogenic.

The provided text describes the acceptance criteria and a study validating the performance of CalliSpheres Embolic Microspheres and 8Spheres Embolic Microspheres, which are vascular embolization devices.

Here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance

The document primarily focuses on non-clinical performance testing (in-vitro bench testing, packaging, shelf-life, sterilization, chemical characterization, and biocompatibility) and an animal study. The "acceptance criteria" are generally implied to be "met predefined acceptance criteria" or "met specifications" for the bench tests, and comparability to a predicate device for the animal study.

2. Sample sized used for the test set and the data provenance

• In-vitro Bench Testing: The specific sample sizes for each bench test are not explicitly provided, but it's stated that for Packaging Integrity and Shelf Life, "3 batches of each tested for all device specifications."
• Animal Performance Testing:
  • Sample Size: 24 swine (12 for CalliSpheres Embolic Microspheres, 12 for Embosphere microspheres).
  • Data Provenance: The study was an "animal study... intended to simulate the clinical application... A pig model was chosen." This indicates prospective animal data, conducted to support the device's substantial equivalence. The country of origin for the study is not explicitly stated in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This document describes a pre-market notification (510(k)) for a medical device (embolic microspheres). It does not describe a study involving human experts establishing ground truth for AI model testing. The ground truth for the non-clinical tests is based on established laboratory standards, and for the animal study, it's based on clinical observations, histopathological results, and standard measurements.

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

Not applicable, as this is not a human expert-based ground truth adjudication for an AI device.

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

Not applicable. This document is for a medical device (embolic microspheres), not an AI-assisted diagnostic or triaging tool.

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

Not applicable. This document is for a medical device, not a software algorithm.

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

• In-vitro Bench Testing: Ground truth is based on established international and national standards (e.g., USP, ISO, ASTM guidelines) and predefined acceptance criteria for physical, chemical, and biological properties.
• Animal Performance Testing: Ground truth was established through:
  • Direct observation and measurement: Ease of delivery, presence of rupture/perforation, non-target embolization.
  • Clinical tests: Blood routine, coagulation function, renal function, liver function.
  • Imaging: DSA angiography.
  • Pathology/Histopathology: Evaluation of local and systemic foreign body reactions, and assessment of embolization effectiveness after necropsy.

8. The sample size for the training set

Not applicable. This document describes the validation of a physical medical device (embolic microspheres), not an AI model requiring a training data set.

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

Not applicable, as there is no training set for an AI model.

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Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, including symptomatic uterine fibroids, and prostatic arteries for symptomatic benign prostatic hyperplasia (BPH).

Embosphere Microspheres are small, compressible, hydrophilic spheres of acrylic polymer and porcine-derived gelatin, provided sterile, non-pyrogenic in 10 saline. They are available in six size ranges (40 um - 1200 um), in svringes (Figure 1) or vials. The syringes contain 1 mL or 2 mL of microspheres in 6 or 7 mL of saline, respectively, in a single unit packaging. Vials contain 1 mL or 2 mL of microspheres in 3 or 4 mL of saline, respectively, in a single unit packaging.

The microspheres are delivered to the target site via catheter under fluoroscopic control. The technological characteristics of the subject devices are identical to the legally marketed Embosphere Microspheres (K991549. K021397).

The provided text does not describe a study involving a device that uses AI or machine learning, nor does it provide acceptance criteria and proof of meeting those criteria in the context of such a device. The device described, Embosphere Microspheres, is a physical medical device used for prostatic artery embolization.

Therefore, I cannot fulfill the request as it asks for information related to AI/ML device performance and studies demonstrating its adherence to acceptance criteria, which is not present in the provided text.

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The Occlusin® 500 Artificial Embolization Device is intended to be used as an artificial embolization device in the treatment of unresectable/inoperable hypervascularized tumors.

The Occlusin® 500 Artificial Embolization Device is a collagen-coated polymeric embolization microparticle. It is provided sterile and non-pyrogenic.

The provided document describes the Occlusin® 500 Artificial Embolization Device and its premarket notification (510(k)) for substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML performance. Instead, it focuses on non-clinical and animal model testing to demonstrate safety and effectiveness compared to a predicate device.

Therefore, many of the requested sections (Table of acceptance criteria, Sample size for test set, Number of experts, Adjudication method, MRMC study, Standalone performance, Type of ground truth, Sample size for training set, How ground truth for training set was established) cannot be filled as they are not present in the provided text.

Here's a summary of the information that is available based on your request:

1. A table of acceptance criteria and the reported device performance
Not applicable. The submission is for a physical medical device (embolization microparticles), not an AI/ML device, and thus does not present performance metrics in the same way an AI/ML study would (e.g., sensitivity, specificity, AUC). Instead, it relies on demonstrating compliance with design specifications and comparable performance to a predicate device in non-clinical and animal models.

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

• Test Set Description: Two animal models were used for "in vivo testing."
  • Short-term testing: Porcine model (acute and 1 month).
  • Long-term testing: Ovine model (3 months, 6 months, and 12 months).
• Sample Size: Not explicitly stated (e.g., number of pigs, number of sheep).
• Data Provenance: The studies were "prospectively defined verification and validation testing." The country of origin of the data is not specified, but the applicant's address is Edmonton, AB, Canada.
• Retrospective/Prospective: 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. Ground truth was established through animal model observations and measurements of device performance, not expert consensus for diagnostic tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to human expert review for establishing ground truth, which was not the method used here.

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 MRMC study was not done. This type of study is relevant for AI/ML diagnostic tools, not for a physical embolization device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this refers to AI/ML algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or standard for evaluation in this context was based on:

• Biocompatibility testing against ISO 10993-1
• Stability testing
• Catheter compatibility testing
• Characterization of finished product against release specifications (visual appearance, packaging integrity, mass per vial, density, particle count per gram, particle size distribution, residual PVA, molecular weight, collagen content, sterility, endotoxin, melting range)
• In vivo performance in animal models (porcine and ovine) compared to a predicate device, presumably assessing parameters like embolization efficacy, tissue response, and degradation over time.

8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is a physical medical device, not an AI/ML algorithm.

9. How the ground truth for the training set was established
Not applicable.

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The Contour® Emboli PVA are used for the embolization of hypervascular tumors, leiomyoma uteri, and arteriovenous malformations.

The FasTracker-325® Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast, and therapeutic agents, to the peripheral and coronary vasculature. This includes the delivery of the Contour® Emboli PVA to the uterine arteries for the purpose of occluding blood flow to leiomyoma uteri.

The Contour® Emboli PVA are used for the embolization of hypervascular tumors, leiomyoma uteri, and arteriovenous malformations.

The FasTracker-325® Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast, and therapeutic agents, to the peripheral and coronary vasculature. This includes the delivery of the Contour® Emboli PVA to the uterine arteries for the purpose of occluding blood flow to leiomyoma uteri.

The provided text details the submission of the Contour® Emboli PVA and FasTracker®-325 Infusion Catheter for 510(k) clearance, asserting substantial equivalence to predicate devices. However, the document does not explicitly describe acceptance criteria, nor does it provide a study report detailing specific performance metrics against such criteria. It mentions a prospective clinical study, but no performance data from that study is included within the provided sections.

Therefore, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance
• If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

What is present in the document is the following:

• Clinical Data Source: Clinical data were collected in a prospective clinical study to support the safety and effectiveness of these devices for treatment of uterine fibroids. This indicates that a clinical study was performed, but the results and details of this study are not within the provided text.
• Biocompatibility Testing: The devices were tested for biocompatibility per ISO 10993, and all data demonstrated biocompatibility for their intended use. This is a form of acceptance criteria (biocompatibility) with a positive outcome, but it's not related to diagnostic or therapeutic efficacy performance.
• Substantial Equivalence: The submission asserts that the devices have been tested and compared to predicate devices, and "All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised." This is the primary "proof" for 510(k) clearance, but it refers to a comparison with existing devices rather than a detailed performance study against specific, pre-defined acceptance criteria for the new device.

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