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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

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 appropriate size 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 (K181300). Embosphere Microspheres are permanent implantable devices and are designed for controlled, targeted embolization. All indications for Embosphere Microspheres; uterine arteries, arteriovenous malformations, hypervascular tumors and prostate arteries all involve arterial embolization. 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 guidewire 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 interrupt artery blood flow to the targeted area. The device is intended for single use.

I am sorry, but the provided text is an FDA 510(k) Clearance Letter for a medical device (Embosphere Microspheres). It details the regulatory clearance process, the device's intended use, and its equivalence to a predicate device.

This document does NOT contain information about any AI/ML model, its acceptance criteria, or a study proving that an AI/ML device meets those criteria.

Therefore, I cannot extract the information required to answer your request regarding the acceptance criteria and the study proving the device meets them, as it pertains to an AI model. The provided text describes a physical medical device and its regulatory review, not a software or AI-driven diagnostic tool.

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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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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.

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EMBOSPHERE® Microspheres are indicated for embolization of hypervascular tumors and arteriovenous malformations.

EMBOSPHERE® Microspheres are spherical microbeads for arterial embolization, made of acrylic polymer impregnated with gelatin. They are delivered with the help of a microcatheter in an amount appropriate to the area to be embolized. Six ranges of EMBOSPHERE® Microspheres are available in order to allow the physician to choose the calibration necessary for the vessel being embolized:

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

The provided text describes a 510(k) summary for Biosphere Medical, Inc. EMBOSPHERE® Microspheres, an artificial embolization device. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study design with acceptance criteria and device performance metrics in the typical format of a clinical trial for a standalone AI device.

Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them, especially those pertaining to AI/ML device evaluation (like sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details), are not applicable or cannot be extracted from this document.

However, I can extract information related to the performance testing employed to demonstrate substantial equivalence for the EMBOSPHERE® Microspheres.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative acceptance criteria or a direct comparison of device performance against such criteria in a table format. Instead, it lists types of performance testing that support substantial equivalence. The "performance" in this context refers to the device's characteristics and its comparable behavior to predicate devices and established clinical practice, rather than specific performance metrics (e.g., accuracy, sensitivity, specificity) typically associated with AI/ML device evaluations.

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

• Sample Size:
  • Animal Testing: The document does not specify the sample size (number of animals) used.
  • Clinical Data (European experience): The specific sample size for the European clinical data (referenced as "clinical data describing the European experience") is not provided in this summary.
  • Comparative Clinical Study: The specific sample size for the "clinical study comparing EMBOSPHERE® Microspheres to PVA for preoperative embolization of meningiomas" is not provided in this summary.
• Data Provenance:
  • Animal Testing: Implied to be laboratory-based (likely in a controlled research setting).
  • Clinical Data: "European experience." This is retrospective in the sense that it relies on past clinical use.
  • Comparative Clinical Study: The citation indicates a study by Bendszus M, Klein R, Burger R, et al.: "Efficacy of trisacryl gelatin microspheres versus polyvinyl alcohol particles in the prooperative embolization of meningiomas." This was published in AJNR in Feb 2000, suggesting a prospective clinical trial.

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 document. For device evaluations like this (medical products, not AI), the concept of "ground truth" and expert consensus as used in AI/ML performance testing is not directly applicable in the same way. Clinical outcomes and imaging results would be assessed by medical professionals, but their number and specific qualifications for establishing a "ground truth" for a test set are not detailed.

4. Adjudication method

This information is not provided and is not typically relevant for the type of device evaluation described in this 510(k) summary. Adjudication methods (like 2+1 or 3+1) are common in AI/ML studies where multiple human readers' interpretations need to be reconciled to establish a ground truth.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers with and without AI assistance was not done. This is not an AI/ML device.
• The document mentions a "clinical study comparing EMBOSPHERE® Microspheres to PVA for preoperative embolization of meningiomas." This is a comparative effectiveness study between two embolization materials, not an MRMC study related to AI. Therefore, there is no effect size related to AI assistance.

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

This is not applicable as the EMBOSPHERE® Microspheres are a medical device (microspheres for embolization), not an algorithm or AI system. Their performance is inherently tied to their physical and biological interaction within the patient and their delivery by a physician.

7. The type of ground truth used

For the clinical and animal studies, the "ground truth" would implicitly be derived from:

• Clinical Outcomes Data: Observed patient outcomes (e.g., successful embolization, tumor reduction, AVM occlusion, complications, tissue reaction) as assessed by clinicians and confirmed through imaging or other diagnostic methods.
• Pathology: Potentially from tissue samples in animal studies to assess tissue reaction and depth of penetration.
• Imaging Data: Radiographic imaging results (e.g., visualization of embolization process, extent of embolization).

8. The sample size for the training set

This is not applicable as the EMBOSPHERE® Microspheres are a physical medical device, not an AI/ML model that requires a training set. The development of the device involved bench testing and iterative design, but not "training data" in the AI sense.

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

This is not applicable for the reason stated above (not an AI/ML model requiring a training set).

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