Search Results

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.

Ask a specific question about this device

Embozene Color-Advanced Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). The device is not intended for neurovascular use.

Embozene Color-Advanced Microspheres (hereafter may be referenced as Embozene Microspheres or Embozene) are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer shell (Polyzene-F). The microspheres are suspended in liquid and then injected into the bloodstream to permanently occlude blood vessels. They are used to stop bleeding when the underlying lesion is not likely to heal or block arteries supplying a tumor to cause tumor necrosis and/or shrinkage. Embozene Color-Advanced Microspheres are sterile, single use devices and are supplied in pre-filled 20 ml syringes containing 2ml of microspheres in approximately 7 ml of transport solution. The Embozene Microspheres are available in 40-1300 µm sizes.

The provided text is a 510(k) Premarket Notification from the FDA regarding "Embozene Color-Advanced Microspheres". This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing efficacy study data with acceptance criteria for a new device.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The submission confirms that:

• The device is "substantially equivalent" to a legally marketed predicate device (K180102).
• The substantial equivalence is based on the devices having "the same indications for use and the same technological characteristics."
• The only change in the subject device is an "updated syringe due to end of life of the previously used syringe."
• Non-clinical testing (mechanical performance, biocompatibility, sterility, packaging, and shelf-life) was conducted to ensure the updated device meets the specifications of the predicate device.

Ask a specific question about this device

Bead Block microspheres are intended to be used for the embolization of hypervascular tumours, including uterine fibroids (UFE) and arteriovenous malformations (AVMs). Bead Block microspheres are also intended for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Bead Block, a permanent intravascular implant, is made up of preformed soft, compressible, biocompatible, hydrophilic, non-resorbable and precisely calibrated microspheres that occlude vessels for the purpose of blocking the blood flow to a target tissue. Bead Block compressible microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90-95% water and is compressible to approximately 30% by diameter. Bead Block microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be suspended in contrast agents and delivered through microcatheters to the target location. Bead Block is available in bead sizes from 100 – 1200µm and supplied sterile in 20ml syringes which contain 1 or 2 ml of beads suspended in 6 or 5 ml of phosphate buffered saline, respectively. The different bead sizes of the product are differentiated by differently colored labels and syringe end caps. Bead Block is provided as a single use, non-pyrogenic, sterile (steam sterilized) device.

This document is a 510(k) Premarket Notification from the FDA regarding the "Bead Block" device. It attests to the device's substantial equivalence to previously marketed predicate devices for the specified indications for use.

Based on the provided text, the Acceptance Criteria and Device Performance for this medical device (Bead Block) are not defined in terms of typical AI/ML-based image analysis performance metrics (e.g., sensitivity, specificity, AUC). Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on safety and effectiveness for its intended use, which is embolization.

The "study" described is a retrospective data review of the clinical outcomes of patients treated with Bead Block for prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH). This is a clinical effectiveness study, not a study of an AI/ML device's diagnostic or analytical performance.

Therefore, many of the requested points related to AI/ML device study parameters (e.g., test set, ground truth experts, MRMC studies, standalone performance) are not applicable to this document.

Here's an attempt to answer the prompt based on the provided text, reinterpreting the "acceptance criteria" and "study" in the context of a medical device submission for substantial equivalence:

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

The "acceptance criteria" for this 510(k) submission are not explicitly stated as quantitative thresholds for clinical performance but rather are implicitly tied to demonstrating safety and effectiveness comparable to predicate devices. The "reported device performance" refers to the clinical outcomes observed in the retrospective study.

• 85% of patients: decrease in total IPSS by at least 3 points.
• 62% of patients: dropped at least 1 symptom category (severe to moderate to mild).
• Statistically significant and clinically relevant improvements in total IPSS, QoL, PSA, and prostate volume (p

Ask a specific question about this device

The HydroPearl® Microspheres are intended for the embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

The HydroPearl TM Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The HydroPearl TM Microspheres are offered in a variety of diameters ranging from 75-1100µm and are provided in a sterile syringe pre-filled with microspheres in phosphate buffered saline. The pre- filled syringe is packaged in a sealed sterile dispenser tray. The HydroPearl TM Microspheres are delivered to the treatment site through a delivery catheter.

The provided document describes the acceptance criteria and study for the HydroPearl Microspheres, specifically for the expanded indication of prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds (e.g., "IPSS score reduction must be X%"). Instead, it reports the observed clinical outcomes and concludes that these results support safe and effective use. The "acceptance criteria" here are implied through the positive clinical outcomes and the comparison to established understanding of PAE effectiveness.

Ask a specific question about this device

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.

Ask a specific question about this device

Embozene Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benien prostatic hyperplasia (BPH).

This device is not intended for neurovascular use.

Embozene™ Color-Advanced Microspheres (hereafter referenced as Embozene or Embozene Microspheres) are spherical, tightly calibrated, biocompatible, hydrogel microspheres coated with proprietary polymer (Polyzene®-F). The microspheres are compressible to enable smooth delivery through the indicated delivery catheter and color-coded by size to allow for easy identification.

Microspheres are supplied sterile and packaged in 20 ml syringes with an approximate 7ml fill volume across the range. Embozene microspheres syringes are available in 2 ml microsphere volume for 40 -1300 µm.

Acceptance Criteria and Device Performance for Embozene Color-Advanced Microspheres

This information is extracted from the provided 510(k) Summary for Embozene Color-Advanced Microspheres (K180102).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Embozene Color-Advanced Microspheres for the expanded indication of prostatic artery embolization (PAE) for symptomatic benign prostatic hyperplasia (BPH) are implicitly derived from the primary endpoints of the prospective clinical study, which focused on safety and symptomatic improvement. Specific quantitative acceptance criteria are not explicitly stated in the provided document, but the results demonstrate successful outcomes relative to baseline.

• No device-related events reported.
• No post-prostatic artery embolization syndrome events reported.
• Total adverse events in 39.5% of subjects, none of which were serious or device-related. |
  | Symptomatic Improvement of BPH (at 6 and 12 months) as measured by IPSS:
• Improvement in average IPSS score over baseline.
• Proportion of subjects with at least 3 IPSS points improvement. | IPSS:
• Average 6-month IPSS score demonstrated 46% improvement over baseline.
• Average 12-month IPSS score demonstrated 47% improvement over baseline.
• 81.8% of subjects improved at least 3 IPSS points at 12 months. |
  | Improvement in Quality of Life (QoL):
• Improvement in average QoL score over baseline. | QoL:
• Baseline QoL score of 4.4 (mostly dissatisfied) improved to 2.3 (mostly satisfied) at 3 months, maintained through 12 months. |
  | Physiological Improvements:
• Prostate volume reduction.
• Increase in peak flow rates (Qmax). | Physiological Parameters:
• Prostate volume reduction maintained through follow-up.
• Increase of peak flow rates (Qmax) maintained through follow-up. |
  | Procedural Success:
• High success rate of embolization procedures.
• No non-targeted embolization. | Procedural Success:
• 100% (38/38) successful embolization procedures.
• No cases of non-targeted embolization. |

The document also refers to non-clinical tests for biocompatibility and performance for the Embozene Microspheres (which were previously cleared). The acceptance criteria for these tests were "All tests passed, indicating that the device materials are biocompatible for its intended use" and "All tests passed demonstrating the device meets the predetermined performance requirements." These include:

• Biocompatibility: Cytotoxicity, Sensitization, Sub-Acute and Sub-Chronic Systemic Toxicity, Systemic Toxicity- Material Mediated Pyrogenicity, Genotoxicity (Bacterial Mutagenicity, In-vitro Chromosome Aberration, In-Vivo Micronucleous Assay), Implantation, Hemocompatibility (hemolysis, partial thromboplastin time, platelet/leukocyte counts).
• Performance: Microsphere size distribution, visual inspection, pH of transport solution, Osmolality of transport solution, Microsphere suspension, Catheter compatibility, and Elution Test: Determination of leachable substances by UV-Vis, HPLC, and ICP-MS.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 38 patients (male evaluable subjects).
• Data Provenance: Prospective clinical study at a single center. The country of origin is not explicitly stated, but the submission is to the U.S. FDA by a U.S.-based company (Boston Scientific Corporation).

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

The document does not specify the number or qualifications of experts used to establish a "ground truth" for the test set. The clinical study collected patient-reported outcomes (IPSS, QoL, IIEF) and objective clinical measurements (Qmax, PVR, PV, PSA) which serve as the primary evaluation metrics for efficacy and safety. These are standard clinical assessments rather than expert-adjudicated ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The data presented are reported clinical outcomes and adverse events collected directly from patients and clinical assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study is a prospective single-arm study evaluating the device's performance directly in patients, not assessing human reader performance with or without AI assistance.

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

This question is not applicable. The device, Embozene Color-Advanced Microspheres, is a medical device (embolization microspheres) used in a medical procedure performed by a physician, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the clinical study's primary endpoints was based on:

• Patient-reported outcomes: International Prostate Symptom Score (IPSS), Quality of Life (QoL) questionnaires, and International Index of Erectile Function (IIEF).
• Objective clinical measurements: Peak flow rate (Qmax), Post Void Residual (PVR), Prostate Volume (PV), and Prostate Specific Antigen (PSA) levels.
• Safety assessment: Reported adverse events.
• Procedural success: Radiographic evidence.

8. The Sample Size for the Training Set

No training set is mentioned as this is a medical device and not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used for an AI/ML algorithm.

Ask a specific question about this device

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.

Ask a specific question about this device