Search Results

Bearing nsPVA Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).

Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

Bearing nsPVA particles are irregularly-shaped, hydrophilic, non-resorbable particles made of 100% crosslinked poly(vinyl alcohol). These embolization particles are intended to provide vascular occlusion or reduction of blood flow within target vessels upon placement through a catheter.

The particles of the subject device, the Bearing nsPVA Express, are provided sterile and for single use in a 20 mL polycarbonate syringe with a luer-lock connector, individually packaged in a sterile foil peel pouch.

Bearing nsPVA particles are calibrated and available in 7 size ranges (see table below) to enable the physician to choose depending on the diameter of the vessel to be embolized. Each syringe contains 100 mg of Bearing nsPVA particles.

The provided text describes testing conducted for the Bearing nsPVA Express™ device, which is an embolization particle packaged in a syringe. The majority of the testing relates to hardware and packaging, and does not describe a clinical study for establishing performance against specific acceptance criteria in a human population, nor does it involve AI or human readers.

Therefore, many of the requested categories are not applicable to the information provided in this document.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document details various engineering and biological testing with associated acceptance criteria. Instead of "device performance" in a clinical sense, these refer to the manufacturing quality, sterility, packaging integrity, and biocompatibility of the physical product.

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

The document does not specify general "test set" sample sizes or data provenance in terms of patient data. The tests are primarily laboratory-based and follow established standards for medical device testing. For example:

• Sterilization Validation: Involves testing a certain number of units to establish a sterility assurance level. The exact number of units is not specified but would follow ISO 11137-2.
• Pyrogenicity: "routine pyrogen testing for each lot"
• Biocompatibility: Involves animal models for certain tests (e.g., acute systemic toxicity, intracutaneous irritation, sensitization) and in vitro tests (e.g., cytotoxicity, hemocompatibility). The specific number of animals or repetitions is not provided but would be dictated by the ISO 10993 standards cited.

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

Not applicable. This document describes physical and biological testing of a medical device, not a diagnostic or AI-assisted clinical study requiring expert human interpretation or ground truth establishment.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication is mentioned.

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 is not an AI-assisted diagnostic device, and no MRMC study was mentioned.

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

Not applicable. This is not an algorithm-based device.

7. The type of ground truth used

For the biological and physical performance testing described:

• Sterility: Achieved through rigorous validation adhering to ISO standards and verified by microbiological methods.
• Pyrogenicity: Verified by the Limulus Amebocyte Lysate (LAL) test against a quantitative limit.
• Biocompatibility: Established through standardized in vitro and in vivo biological tests according to ISO 10993 guidelines, measuring specific biological endpoints (e.g., cell viability, immune response, blood compatibility).
• Design Verification (Product/Packaging): Established through visual inspections and mechanical integrity tests against internal specifications and relevant ASTM/ISO packaging standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or a training set.

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

Not applicable. This device does not involve machine learning or a training set.

Ask a specific question about this device

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.

Ask a specific question about this device

Embozene® Microspheres are intended for embolization of arteriovenous malformations, and hypervascular tumors, including uterine fibroids.

Embozene® Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as a hypervascular tumor (HVT) or arteriovenous malformation (AVM). Embozene® Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are color coded by size to allow easy identification of the different sizes. Embozene® Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes or vials are available in 1 ml or 2 ml microsphere volume.

The acceptance criteria for the Embozene® Microspheres and the study demonstrating its performance are detailed below.
It's important to note that this submission relies heavily on substantial equivalence to previously cleared predicate devices, rather than establishing entirely new performance criteria through a de novo study.

Acceptance Criteria and Reported Device Performance

• Same method of delivery, Rx status.
• Same mechanism of action (mechanical occlusion).
• Same material class, design, and composition (Crosslinked polyacrylate hydrogel with Polyzene-F).
• Same size ranges, biocompatibility, microsphere volume, sterility assurance level ($10^{-6}$), pyrogen-free status, packaging, and shelf-life (3 years). | All technological characteristics are identical to the primary predicate device (Embozene® Microspheres, K073417 and K132675). The only difference is the broadened indication for use to explicitly include uterine fibroids, which is supported by clinical data. | Non-Clinical Performance Testing (bench testing) and comparison to predicate device. |
  | Safety | No unique safety concerns regarding use for uterine fibroid embolization. | Review of published and unpublished data regarding adverse events did not identify any unique safety concerns. Adverse events observed in the Smeets et al. study (hysterectomy due to incomplete fibroid expulsion or persistent pain) are documented, but not deemed "unique safety concerns" for the device itself. | Clinical Experience (Smeets et al.) |
  | Clinical Effectiveness (for Uterine Fibroids) | Improvement in fibroid symptoms and/or reduction in fibroid/uterine volume, successful infarction. (Implicitly comparable to predicate device performance) | - UFS-QOL Symptom Severity Scores: Mean score dropped from 64 at baseline to 23 at 3 months (n=85), and to 16 at 12.8 months (n=81).
• Fibroid/Uterine Volume Reduction: Mean dominant fibroid volume reduction of 45% at 3 months. Mean total uterine volume reduction of 42% at 3 months.
• Fibroid Infarction: 94% rate of >90% infarction of dominant fibroid at 3 months. 91% rate of >90% infarction of total fibroid load at 3 months. | Clinical Experience (Smeets et al.) |

Study Details

The submission's primary evidence for meeting acceptance criteria for the expanded indication (uterine fibroids) comes from a review of clinical information, specifically a published study by Smeets et al., and a comparison to predicate devices. No new, prospective, de novo clinical trial was conducted for this 510(k) submission.

1. A table of acceptance criteria and the reported device performance:
See table above.

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

• Sample Size for Clinical Data:
  • Smeets et al. study: n=85 patients for initial 3-month follow-up on UFS-QOL scores. n=81 patients for extended 12.8-month follow-up on UFS-QOL scores.
• Data Provenance:
  • Smeets et al. study: Published data, conducted outside the United States. The document states "published and unpublished data on the use of use of Embozene® for the treatment of uterine fibroids (outside the United States)". This indicates a retrospective or prospective observational study conducted previously.

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

• This information is not provided in the summary. The clinical study (Smeets et al.) relied on patient-reported outcomes (UFS-QOL) and objective measurements from MRI (uterine and fibroid volume, fibroid infarction). The interpretation of MRI results would have been by medical professionals (radiologists), but their number and specific qualifications are not specified in this 510(k) summary.

4. Adjudication method for the test set:

• This information is not provided in the summary. For the Smeets et al. study, it doesn't mention any specific adjudication method for patient-reported outcomes or MRI interpretations.

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, an MRMC comparative effectiveness study was not done. This device is a vascular embolization device, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improve with AI assistance" is not applicable.

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

• No, this is not an algorithm or AI-based device. It is a physical device (microspheres) for embolization. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used:

• For the clinical effectiveness concerning uterine fibroids, the ground truth was established through:
  • Patient-reported outcomes: Uterine Fibroid Symptom Quality of Life (UFS-QOL) instrument.
  • Imaging-based objective measures: Uterine and fibroid volume reduction and percent fibroid infarction as determined by MRI.

8. The sample size for the training set:

• Not applicable / Not explicitly stated. This is not an AI/machine learning device that involves a training set in the conventional sense. The "training" for the device's effectiveness is based on the general understanding of embolization therapy and the established performance of predicate devices. The clinical data from Smeets et al. serves as evidence for effectiveness, not as a training set for an algorithm.

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

• Not applicable. As mentioned, there isn't a "training set" in the context of an algorithm. The evidence base relies on existing medical knowledge, predicate device performance, and clinical study outcomes.

Ask a specific question about this device

Bearing ™ nsPVA Embolization Particles are used for the embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs). Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

The Bearing™ nsPVA Embolization Particles are particles of They are noncross-linked polyvinyl alcohol (PVA). resorbable (permanent), hydrophilic and deformable particles that can be injected through a variety of catheters, depending on the size range, and are generally mixed with radiopaque contrast agent prior to their injection.

The provided text describes Merit Medical Systems, Inc.'s Bearing™ nsPVA Embolization Particles and their substantial equivalence to a predicate device, Boston Scientific's Contour™ Embolization Particles. The submission centers around demonstrating that the new device has characteristics that are substantially equivalent to a device already on the market, rather than proving performance against specific acceptance criteria through a full-scale clinical study with a detailed test set, ground truth, and statistical analysis as would be done for novel devices or AI systems.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not directly applicable or explicitly stated in the context of this 510(k) summary, which relies on the concept of "substantial equivalence."

Here's an attempt to extract and interpret the information based on the provided document, addressing each point as much as possible:

1. A table of acceptance criteria and the reported device performance

The document does not present a formal table of "acceptance criteria" for clinical performance with specific metrics like sensitivity, specificity, or accuracy that would be typical for an AI/diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to an existing predicate device based on various non-clinical tests and a literature review.

The "reported device performance" is essentially that the Bearing™ nsPVA Embolization Particles perform equivalently to the predicate device, Contour™ Embolization Particles, in achieving vascular occlusion for the indicated uses.

Here's a summary of the types of performance aspects assessed:

• Polyvinyl Alcohol (PVA) Particle Testing
• Particle Size Ranges (granulometry)
• Assessment of Particle Size Compatibility with Recommended Delivery Catheter(s)
• Evaluation of the Uniform Dispersion and Suspension of Particles within a Catheter.
  The principle of operation is stated as the same. |
  | Intended Use (Embolization of peripheral hypervascularized tumors, including leiomyoma uteri and peripheral AVMs) | Same indications for use as the predicate device. |
  | Safety & Biocompatibility (Non-toxic, non-pyrogenic, sterile, no adverse biological reactions) | Biocompatibility: Conforms to ISO 10993 standards (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, implantation effects).
  Sterilization: Conforms to ISO and NF EN standards for sterility assurance (SAL 10-6).
  Endotoxins: Tested on each batch, limit per device 20 EU, labeled nonpyrogenic. |
  | Shelf Life & Packaging (Maintains integrity and sterility over time) | Packaging Performance: Visual inspection, bubble emission, peel strength, sterile barrier maintenance after simulated transportation/storage.
  Accelerated Aging: Product (visual inspection, granulometric, residual formaldehyde, IR analysis) and Primary Packaging (visual inspection, seal width, label inspection, burst test, seal strength test). |

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

• Sample Size for Test Set: Not applicable in the traditional sense of a clinical trial test set. The validation was primarily based on non-clinical bench testing and a literature review.
• Data Provenance: The literature review analyzed existing clinical data on PVA particles. The document does not specify the country of origin of this data but refers to "medical/scientific databases, PubMed, and Cochrane Database of Systematic Reviews (CDSR)." This implies a broad, international scope of retrospective clinical evidence.

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. There was no specific "test set" requiring expert ground truth establishment for this 510(k) submission, as it relied on non-clinical testing and a review of existing clinical literature for similar devices.

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

Not applicable. No clinical test set requiring adjudication was performed.

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 device is an embolization particle, not an AI-assisted diagnostic tool.

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

Not applicable. This device is an embolization particle, not an algorithm.

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

For the literature review, the "ground truth" would be the clinical outcomes and safety profiles reported in previously conducted clinical trials and applications of similar PVA embolic devices. The document states that "the absence of materovigilance reports concerning similar PVA embolic devices are sufficient to establish the efficacy and safety." This points towards real-world outcomes data and safety surveillance as the basis.

For the non-clinical tests, the "ground truth" was established by standard laboratory testing methods (e.g., chemical analysis, granulometry, biocompatibility assays) comparing the subject device's properties to established norms or the predicate device's characteristics.

8. The sample size for the training set

Not applicable. This device is an embolization particle, not a machine learning model, so there is no "training set."

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

Not applicable. No training set was used.

Ask a specific question about this device

The Contour Embolization Particles are used for the embolization of peripheral hypervascular tumors, including leiomyoma uteri and peripheral arteriovenous malformations (AVMs).

Do not use particles smaller than 355 microns for the treatment of leiomyoma uteri.

Contour Embolization Particles are artificial embolization devices. These devices are intended to provide vascular occlusion upon selective.placement via an angiographic catheter. Contour Embolization Particles are packaged sterile by gamma irradiation. Each vial is intended for single patient use only. The Contour™ Embolization particles are packaged in 1 cc dry volume per vial. The vials (glass with screw cap closure) are contained within a poly/Tyvek® pouch. The pouches are placed in boxes, in either a 2 vial/box or 5 vial/box configurations. All vials and boxes are appropriately labeled. The labels are color coded to differentiate between the different size ranges. The device is sterilized by gamma irradiation and labeled with a 26 month shelf life. The Contour Embolization Particles are available in a range of sizes as tabulated below:

The Contour Embolization Particles are made of polyvinyl alcohol, which has been used for embolization procedures since 1972.

This document is a 510(k) summary for the Contour™ Embolization Particles. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

The provided text details the submission of a medical device (Contour™ Embolization Particles) for clearance by the FDA based on substantial equivalence to a predicate device. This type of submission (510(k)) generally focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance metrics from clinical trials, especially for a non-AI/ML device.

Here's why the requested information cannot be extracted from the provided text:

• Non-AI/ML Device: The device described is "Contour™ Embolization Particles," which are physical artificial embolization devices made of polyvinyl alcohol. This is not an Artificial Intelligence or Machine Learning (AI/ML) device. Therefore, questions 1-9, which pertain to AI/ML device validation (acceptance criteria, test sets, ground truth, expert adjudication, MRMC studies, standalone performance, training sets), are not applicable to this document.
• Substantial Equivalence: The core of this 510(k) submission is to demonstrate "substantial equivalence" to a previously cleared device (K030966). This means the manufacturer is asserting that the new device has the same intended use, technological characteristics, and safety/effectiveness profile as the predicate device. The only change mentioned is to the labeling (contraindications).
• Lack of Performance Study Details: The document explicitly states: "This assessment is based upon identical device materials and design characteristics." It does not describe any new performance study, clinical trial, or data analysis to establish specific numerical performance metrics for the device itself against predefined acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about studies for an AI/ML device, as the provided text describes a non-AI/ML embolization particle device and focuses on substantial equivalence rather than new performance studies with specific metrics.

Ask a specific question about this device

The Cook Polyvinyl Alcohol Foam Embolization Particles are intended for cmbolization of the blood supply to symptomatic utcrine fibroids.

Cook Incorporated Polyvinyl Alcohol Foam Embolization Particles are small, flexible, particles made of cross-linked polyvinyl alcohol. The particles are packaged dry and are provided sterile in sealed vials. They are intended for delivery to the target site by a catheter under fluoroscopic control.

Embolization particle sizes appropriate for use in symptomatic uterine fibroid treatment are 300-500 microns and 500-710 microns.

There have been no changes in the design, dimensions, or materials of the device.

This document is a 510(k) summary for Cook Incorporated's Polyvinyl Alcohol (PVA) Foam Embolization Particles. It details the device information, predicate devices, and intended use. However, it does not contain the acceptance criteria or a study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to pre-existing devices.

Therefore, I cannot provide the requested information. The provided text explicitly states:

• "Clinical data was leveraged to support the substantial equivalence of this proposed device to predicate devices."
• "Clinical data from Cook Incorporated's Polyvinyl Alcohol Foam Embolization Particles were obtained from published studies and from data generated by the FIBROID clinical registry."

This indicates that the submission relies on existing clinical data for established devices to argue for substantial equivalence, rather than presenting a new study with specific acceptance criteria for a new device.

If you have a document that describes the acceptance criteria and the results of a new study for this device, please provide that text.

Ask a specific question about this device

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.

Ask a specific question about this device

Embosphere® and EmboGold™ Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including and uterine fibroids.

Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular turnors, and symptomatic uterine fibroids.

Embosphere® and EmboGold™ Microspheres are small, flexible, hydrophilic, biocompatible spheres made of acrylic polymer and porcine-derived gelatin. The microspheres are packaged in 0.9% saline and are provided sterile and nonpyrogenic. They are delivered to the target site by a catheter under fluoroscopic control.

Both products are provided in six size ranges in order to allow physicians to choose the calibration necessary for the vessel being embolized. The size ranges available are:

• 40-120 microns
• 100-300 microns
• 300-500 microns
• 500-700 microns
• 700-900 microns
• 900-1200 microns

Only microspheres of 500 microns or greater should be used for the embolization of uterine fibroids.

The only difference between Embosphere® and EmboGold™ Microspheres is the colorization of the EmboGold™ Microspheres. Embosphere® Microspheres are translucent, although they are visible to the naked eye when in suspension. EmboGold™ Microspheres are purple/red in color for improved visibility during preparation and handling by the physician.

The provided text describes the 510(k) submission for Embosphere® Microspheres and EmboGold™ Microspheres for use in Uterine Fibroid Embolization. Since this is an embolization device and not a diagnostic AI device, many of the requested criteria (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text.

However, I can extract information related to the clinical study performed to support the device's safety and effectiveness for its intended use in uterine fibroid embolization.

Acceptance Criteria and Device Performance (Not directly applicable as this is not a diagnostic device with performance metrics like sensitivity/specificity):

The acceptance criteria for this type of device typically revolve around demonstrating safety and effectiveness for the intended use, often compared to an existing predicate device. The text states: "Clinical data was collected in a prospective clinical study to support the safety and effectiveness of Embosphere® Microspheres for uterine fibroid embolization." Specific quantitative acceptance criteria or detailed device performance metrics (e.g., success rates, complication rates, fibroid reduction) are not provided in this 510(k) summary.

Study Type and Design:

• Study Name: Not explicitly named, but referred to as a "prospective clinical study."
• Purpose: To support the safety and effectiveness of Embosphere® Microspheres for uterine fibroid embolization.

Missing Information (and why it's missing from this type of document):

Many of the questions are geared towards diagnostic AI models, which have different evaluation methodologies than medical devices like embolization microspheres. Therefore, much of the requested information cannot be found in this 510(k) summary for a medical device.

Here's a breakdown of the requested information based on the provided text, and an explanation for the missing parts:

Acceptance Criteria and Device Performance

Detailed Study Information

1. Sample Size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text.
   • Data Provenance: "Clinical data was collected in a prospective clinical study". The country of origin is not specified but is implicitly within the scope of FDA approval requirements, likely U.S. or international studies following regulatory guidelines.

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

   • Not Applicable. For a therapeutic device like embolization microspheres, "ground truth" as it applies to diagnostic image interpretation by experts is not a relevant concept. The "truth" would be clinical outcomes (e.g., fibroid reduction, symptom improvement), not interpretations of images.

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

   • Not Applicable. Adjudication methods like 2+1 are used for resolving discrepancies in expert interpretations of images or data, which is not relevant for evaluating the performance of an embolization device in a clinical study.

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:

   • No. This is not a diagnostic AI device, so MRMC studies involving human readers and AI assistance are not relevant.

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

   • Not Applicable. This is a physical medical device, not a standalone algorithm. Its performance inherently involves human intervention (physician delivery).

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

   • Clinical Outcomes Data. While not explicitly stated with detail, for a device used to treat uterine fibroids, the "ground truth" for effectiveness would be based on measured clinical outcomes such as reduction in fibroid volume, improvement in symptoms, and patient quality of life, alongside safety parameters.

7. The sample size for the training set:

   • Not Applicable. As a medical device rather than a machine learning model, there is no "training set" in the AI sense. Performance is established through preclinical testing and clinical studies.

8. How the ground truth for the training set was established:

   • Not Applicable. See point 7.

Ask a specific question about this device