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Embosphere Microspheres are indicated for use in the embolization of:
• Hypervascular tumors, including symptomatic uterine fibroids
• Prostatic arteries for symptomatic benign prostatic hyperplasia (BPH)
• Arteriovenous malformations
• Blood vessels to occlude blood flow to control bleeding/hemorrhaging in the peripheral vasculature (subject of this Traditional 510(k))

Embosphere Microspheres are small, compressible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin. The microspheres are packaged in 0.9% saline and are provided sterile and non-pyrogenic in a vial or in a syringe.
The product is provided in seven size ranges to allow physicians to choose the calibration necessary for the vessel being embolized. The size ranges available are:

• 50-100 microns
• 40-120 microns
• 100-300 microns
• 300-500 microns
• 500-700 microns
• 700-900 microns
• 900-1200 microns .
  The principles of operation for the subject device Embosphere Microspheres are the same as the predicate device Embosphere Microspheres (K021397) and reference devices Embosphere Microspheres (K991549, DEN160040). Embosphere Microspheres are permanent implantable devices and are designed for controlled, targeted embolizations for Embosphere Microsphere Microspheres involve arterial embolization; embolization of uterine fibroids, arteriovenous malformations, hypervascular tumors and benign prostatic hyperplasia involve an embolization of the arteries supplying those areas. The procedure of arterial embolization is similar for all arteries. Appropriately sized microspheres for target vessel occlusion are chosen by the trained interventional radiologist. The delivery procedure involves arterial access through an artery, using a quidewire and microcatheter under fluoroscopic guidance. Once the catheter tip is placed in the artery(ies) supplying the targeted tissue Embosphere Microspheres mixed with a non-ionic contrast agent are delivered in a controlled manner under visualization to occlude the feeding vessel(s) to stop blood flow to the targeted area. The device is intended for single use.

The provided document is a 510(k) Summary for Embosphere Microspheres, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study to prove a device meets those criteria directly.

Given the context of a 510(k) submission, the "acceptance criteria" and "device performance" are framed in terms of substantial equivalence to a previously cleared predicate device. The primary "study" is a literature review of clinical data to support the safety and effectiveness of the existing device for a new indication.

Here's an attempt to extract and synthesize the information based on your request, understanding that the document is not an efficacy study report in the traditional sense for a novel AI device:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for the subject device (Embosphere Microspheres with an expanded indication) are effectively demonstrating substantial equivalence to the predicate Embosphere Microspheres (K021397) and reference devices (K991549, DEN160040) in terms of intended use, design, technological characteristics, and safety/performance. The new indication itself needed to be supported by existing safety and effectiveness data.

Table of Acceptance Criteria (Implied by Substantial Equivalence) and Reported Device Performance:

• Shelf Life (single use): Three years (36 months)
• Material (spheres): Acrylic polymer and porcine-derived gelatin
• Physical Characteristics: Biocompatible, hydrophilic, compressible, non-resorbable
• Microspheres Size: Seven size ranges (50-100 to 900-1200 microns)
• Sterilization: Steam sterilized
• Pyrogenicity: Non-pyrogenic
• Performance: Designed for controlled, targeted embolization at the desired level of vessel occlusion
• Principle of Operation: Microspheres administered with contrast medium into artery via catheter
• Volume of microspheres per container: 1ml or 2ml in 0.9% saline
• Packaging: 8-mL glass vial or 20-mL plastic syringe |
  | Safety and Effectiveness: Demonstrate safety and effectiveness for the proposed indication, not raising new safety/effectiveness issues. | Safety and Effectiveness: Extensive clinical data from 40 publications (8 prospective, 32 retrospective, 2000-2018) with 662+ patients reviewed. Embolization with Embosphere was found to be an effective method to control bleeding/hemorrhaging in the peripheral vasculature, with a low complication rate. Adverse events (catheterization complications, post-embolization syndrome, non-targeted embolization) are known and addressed in the predicate device's IFU. No new safety/effectiveness issues were identified with the expanded indication. |

Study Details: Clinical Literature Review (Not a direct device performance study)

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size (Patients): At least 662 patients in the reviewed literature.
   • Data Provenance: Clinical data from 40 publications (2000-2018). These included 8 prospective trials and 32 retrospective trials. The document does not specify the country of origin for the data, but it's reasonable to assume a mix of international and potentially US-based studies given the FDA review. The data consists of both retrospective and prospective studies.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • This section is not applicable in the traditional sense of an AI device's test set. The "ground truth" here is the clinical outcomes reported in published literature regarding the safety and effectiveness of Embosphere Microspheres for embolization. The ground truth was established by the clinical judgment and findings of the physicians and researchers who conducted the studies included in the literature review. The qualifications of these clinicians would implicitly be interventional radiologists or other specialists performing embolization procedures. The FDA, through its review process, acts as the ultimate body verifying the acceptability of the evidence presented.

3. Adjudication Method for the Test Set:

   • Not applicable for a literature review. The clinical outcomes were observed and reported in the individual studies. The FDA's review process then evaluated the aggregated evidence.

4. 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 (microspheres for embolization), not an AI/CADe device that assists human readers.

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

   • Not applicable. This is a medical device, not an algorithm.

6. The type of ground truth used:

   • Clinical Outcomes Data: The ground truth used was the reported clinical outcomes, safety profiles, and effectiveness data derived from published clinical studies (prospective and retrospective trials) on the use of Embosphere Microspheres for embolization procedures, specifically for controlling bleeding/hemorrhaging in the peripheral vasculature.

7. The Sample Size for the Training Set:

   • Not applicable. This is not an AI/machine learning device. The "training data" in a conceptual sense would be the cumulative clinical experience and data that formed the basis for previous clearances of Embosphere Microspheres and the general understanding of embolization procedures.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As above, not an AI device with a distinct training set.

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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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