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.

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Torpedo Gelatin Foam is indicated for use in embolization of:
· Hypervascular tumors
· Blood vessels to occlude blood flow to control bleeding / hemorrhaging in the peripheral vasculature

Torpedo Gelatin Foam is a hydrophilic medical device which consists of resorbable dry gelatin foam that is compressed into a cylindrical shape and preloaded into a cartridge with a standard female and male luer fittings. The device is available in two sizes (0.9 mm and 1.7 mm) and two lengths configurations (10 mm and 20 mm).
Once rehydrated, the deformable torpedoes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

This document is a 510(k) summary for the Torpedo Gelatin Foam device. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the information requested in your prompt regarding acceptance criteria and the detailed study results that prove the device meets these criteria in the context of an AI-driven medical device.

The provided text does not describe an AI medical device or its performance criteria. It is a traditional medical device 510(k) submission for an embolization device (gelatin foam).

Therefore, I cannot provide the requested information about acceptance criteria and study details for an AI medical device based on the given text. The document refers to:

• Bench testing: Leveraged from a previously cleared device (K183578) with no changes in material, design, or processing.
• Animal testing: Leveraged from the predicate device (K183120) to support new indications for use. An animal study (7 test, 8 control sheep) evaluated vascular occlusion, local tissue effects, and in-vivo degradation over 4 weeks using angiography and histopathology. The outcome was successful embolization and no significant difference in artery patency between devices.

None of this relates to AI performance metrics, sample sizes for AI model testing, expert labeling, MRMC studies, or training set details that would be pertinent to an AI medical device.

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EmboCube Embolization Gelatin is indicated for use in embolization of:

• Hypervascular tumors
• Blood vessels to occlude blood flow to control bleeding / hemorrhaging in the peripheral vasculature

EmboCube Embolization Gelatin is a hydrophilic, medical device which consists of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. The device is available in 2 cube sizes and 3 weight configurations. Once rehydrated, the deformable cubes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

The provided text is a 510(k) summary for the EmboCube Embolization Gelatin and does not contain information about the acceptance criteria and study proving a device meets these criteria for an AI/ML-based medical device.

This document is for a physical medical device, an embolization gelatin, and details its substantial equivalence to a predicate device. Therefore, it discusses performance attributes relevant to a physical medical implant (e.g., macroscopic appearance, digestibility, size range, density, moisture content, sterility, pyrogenicity, shelf-life, deliverability) and includes details about an animal study to evaluate its performance (immediate control of bleeding, complications, re-bleeding rate).

The request, however, asks for information typically associated with the validation of an AI/ML medical device, such as:

• Acceptance criteria and reported device performance (in an AI/ML context, this would involve metrics like sensitivity, specificity, AUC).
• Sample sizes for test sets, data provenance (retrospective/prospective, country of origin).
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• MRMC studies and human reader improvement with AI assistance.
• Standalone algorithm performance.
• Types of ground truth (expert consensus, pathology, outcomes data).
• Training set sample size and ground truth establishment for training.

Since the provided document is about a physical medical device and not an AI/ML device, it does not contain any of the information necessary to address the specific points in the prompt related to AI/ML device validation.

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Intended Use: Torpedo Gelatin Foam is indicated for use in embolization of hypervascular tumors.

Torpedo Gelatin Foam is a hydrophilic medical device which consists of resorbable dry gelatin foam that is compressed into a cylindrical shape and preloaded into a cartridge with a standard female and male luer fittings. The device is available in two sizes (0.9 mm and 1.7 mm) and two lengths configurations (10 mm and 20 mm).

Once rehydrated, the deformable torpedoes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

The provided text is a 510(k) summary for the Torpedo Gelatin Foam, a vascular embolization device. It details the device's characteristics, intended use, and substantial equivalence to a predicate device (EmboCube Embolization Gelatin).

However, the text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/ML device performance. The document is a traditional 510(k) submission for a physical medical device, not a software-as-a-medical-device (SaMD) or an AI-powered diagnostic/therapeutic device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document focuses on demonstrating substantial equivalence through physical and chemical properties, sterilization, and animal studies for an embolization device, not on AI/ML performance metrics like sensitivity, specificity, or AUC.
2. Sample size used for the test set and the data provenance: There is no "test set" in the context of AI/ML. The document mentions an animal study with 7 test and 8 control animals.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an embolization device involves successful occlusion of vessels and tissue necrosis, assessed through angiography and histopathology in animal models.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the animal study, ground truth was established through angiography (imaging of blood vessels) and histopathology (microscopic examination of tissue), confirming the embolic effect and tissue necrosis. Outcomes data (normal flow not recovered, necrotized renal tissue, clinically normal animals) also served as evidence.
8. The sample size for the training set: Not applicable. There is no training set for an AI/ML model.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes the regulatory submission for a physical medical device, not an AI/ML driven device, and thus does not contain the specific information requested about acceptance criteria and study design for AI/ML performance.

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EmboCube Embolization Gelatin is indicated for use in embolization of hypervascular tumors.

EmboCube Embolization Gelatin is a hydrophilic medical device which consists of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. The device is available in 2 cube sizes and 3 weight configurations. Once rehydrated, the deformable cubes can be injected into the target vessel with an intravascular catheter or a micro-catheter (depending on the size range) to provide a mechanical barrier to blood flow. Contrast enhancement may be used to monitor the embolization procedure using fluoroscopy. The device is intended for single use and is provided sterile.

The provided text is a 510(k) summary for the EmboCube Embolization Gelatin and does not contain information about the acceptance criteria and study proving a device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case (MRMC) studies, or ground truth establishment for a test or training set.

The document describes a medical device, EmboCube Embolization Gelatin, and its substantial equivalence to a predicate device based on various non-AI performance tests and an animal study. Therefore, I cannot address most of the points in your request based on the provided text.

However, I can extract information related to the device itself and the general summary of testing:

Device Information:

• Trade/Device Name: EmboCube Embolization Gelatin
• Regulation Name: Vascular Embolization Device
• Regulatory Class: Class II
• Product Code: KRD
• Intended Use: For use in embolization of hypervascular tumors.
• Device Description: Hydrophilic medical device consisting of pre-cut, dry cubes of resorbable gelatin sponge packaged in a syringe. Available in 2 cube sizes and 3 weight configurations. Once rehydrated, deformable cubes can be injected to provide a mechanical barrier to blood flow.

Study Information (Non-AI related):

1. A table of acceptance criteria and the reported device performance:
   The document lists the types of tests performed to demonstrate that the device meets "critical design specifications" and "clinical performance attributes," but it does not provide a table of
   specific quantitative acceptance criteria (e.g., "rehydration time must be

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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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QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.

QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, nonresorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres are packaged in a vial containing 25 mg of dry microspheres. The expansion rate is dependent on ionic concentration. When in contact with blood, non-ionic contrast media, or normal saline (NaCl 0.9%), QuadraSphere Microspheres expand to approximately 4 times their dry state diameter; equal to 64x volume. They are available in a range of sizes.

This document describes the QuadraSphere Microspheres, a vascular embolization device. The main change in this submission is the extension of the product line to include a 20-40 µm size, in addition to existing sizes.

Here's the information regarding the acceptance criteria and study as requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a precise "acceptance criteria" table with numerical targets, but it lists performance parameters tested and states that the device met the pre-determined acceptance criteria for each.

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

The document does not explicitly state the sample sizes for each specific test (e.g., number of microsphere batches for appearance, number of animals for in-vivo testing).

• Provenance: The studies were conducted by Biosphere Medical, S.A. No specific country of origin for the data is mentioned beyond the company's location in France. The document describes "design verification and validation testing," implying this was prospective testing directly supporting the device's clearance.

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

Not applicable. This is not a study requiring expert readers to establish ground truth for image interpretation or diagnosis. The tests are focused on physical and biological properties of the microspheres themselves.

4. Adjudication Method for the Test Set:

Not applicable. This is a technical performance study, not one requiring adjudication of diagnostic interpretations.

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

No. This document does not describe an MRMC study. The device is a physical product (microspheres), not an AI algorithm for diagnostic assistance.

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

Not applicable. This device is not an AI algorithm.

7. The Type of Ground Truth Used:

The ground truth for the performance tests was based on established engineering and biological specifications for medical device manufacturing and safety. For example:

• Physical properties (appearance, microscopic features, swelling) are typically compared against pre-defined specifications for the material and design.
• Biocompatibility is assessed against ISO 10993-1 standards.
• Bacterial endotoxin levels are measured against established safety limits.
• Catheter compatibility is tested against functional requirements for delivery.
• Animal testing would have pre-defined endpoints to evaluate safety and function in a biological system.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. This device is not an AI algorithm.

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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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QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA to Biosphere Medical, S.A. regarding their Quadrasphere Microspheres. This document largely focuses on regulatory approval and indications for use, and therefore does not contain information about acceptance criteria or a study proving the device meets said criteria.

The typical content of such a study would include:

1. Acceptance Criteria Table and Device Performance: A table outlining specific performance metrics (e.g., size distribution, mechanical strength, biocompatibility, embolization efficiency, clinical success rates, complication rates) with pre-defined acceptance limits and the observed performance of the Quadrasphere Microspheres.
2. Sample Size and Data Provenance: Details about the number of patients or samples included in the test set, as well as the geographical origin of the data (e.g., USA, France, multi-national) and whether the data was collected retrospectively (from existing records) or prospectively (specifically for the study).
3. Ground Truth Experts: Information on the number of medical experts (e.g., interventional radiologists, pathologists) who established the ground truth for the test set, along with their qualifications (e.g., years of experience, board certifications).
4. Adjudication Method: If applicable, how discrepancies among experts were resolved to establish the ground truth (e.g., 2+1 means two experts agree, and a third is consulted if they disagree; 3+1 implies a similar consensus-based approach).
5. MRMC Comparative Effectiveness Study: If a multi-reader, multi-case study was conducted, the document would describe its design and report the effect size quantifying how much human readers' performance (e.g., accuracy, diagnostic confidence) improved when using Quadrasphere Microspheres compared to a control or alternative treatment.
6. Standalone Performance Study: Whether a study evaluating the device's performance in isolation (without human intervention, if applicable to the device type) was performed. For an embolic agent, this might relate to its physical properties and in-vitro performance.
7. Ground Truth Type: The specific method used to establish the "true" clinical outcome or characteristic against which the device's performance was measured (e.g., confirmation by pathology after embolization, long-term patient outcomes, expert consensus on imaging results).
8. Training Set Sample Size: If a machine learning component were involved (which is not the case for this physical medical device), the size of the dataset used to train the algorithm would be specified.
9. Training Set Ground Truth: How the ground truth for any training set was established.

Without a detailed study report, which is not part of this 510(k) letter, I cannot provide the requested information.

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QuadraSphere Microspheres are indication of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.

QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, nonresorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres are in vials containing 25 mg of dry microspheres. The expansion rate is dependent on ionic concentration. When in contact with blood, non-ionic contrast media, or normal saline (NaCl 0.9%), QuadraSphere Microspheres expand to approximately 4 times their dry state diameter; equal to 64x volume. They are available in a range of sizes: 30-60 um, 50-100 um, 100-150 um, and 150-200 um. QuadraSphere Microspheres have the following properties: Spherical shape with consistent cross sectional diameter after reconstitution with aqueous-based solutions such as contrast media and 0.9% saline solution for predictable flow directed level of occlusion in the vasculature. Rapidly absorb contrast media and 0.9% saline solution. Conform to vessel lumen, providing more surface contact with vessel intima. Expand up to four times the stated dry diameter when hydrated with non-ionic aqueous solutions, resulting in an increase in surface area contact for a more complete vessel occlusion. The principles of operation for the QuadraSphere Microspheres are the same as the predicate devices K052742 (50-100um, 100-150um and 150-200μm) and K113822 (30-60μm). QuadraSphere Microspheres are permanent implantable devices and are designed for controlled, targeted embolization. The device is provided dry (in a vial) and must be rehydrated before use. The microspheres are injected into the target vessel with an intravascular catheter(s) to selectively occlude blood vessels. Contrast enhancement using commercially available ionic or non-ionic contrast media allows the embolization procedure to be monitored using fluoroscopy. The embolization agents are intended for single use and are provided sterile.

This document is a 510(k) Premarket Notification from BioSphere Medical S.A. for their QuadraSphere Microspheres. It states that the subject device is substantially equivalent to previously cleared predicate devices, K052742 and K113822, with the only change being an update to the indications for use. Therefore, the information provided focuses on the substantial equivalence of the device's technical characteristics and performance to its predicates, rather than presenting a de novo study with acceptance criteria and device performance for a new, unproven device.

Given that this is a 510(k) submission for substantial equivalence based on identical technological characteristics to the predicate devices, a traditional AI/medical device study with specified acceptance criteria and detailed performance reporting (as might be found for a novel AI algorithm) is not present in this document. The document explicitly states: "No new testing was performed since both predicate devices... and the QuadraSphere Microspheres have identical technological subject characteristics, manufacturing, processing and sterilization."

However, I can extract the information related to the device's fundamental attributes and the studies performed on the predicate devices that establish the overall safety and performance.

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

Since this is a 510(k) for substantial equivalence with identical technological characteristics, no new acceptance criteria or reported device performance are provided for the subject device. Instead, the document refers to studies performed on the predicate devices to demonstrate substantial equivalence. The "acceptance criteria" are effectively that the new device is identical to the predicates.

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

This document does not describe specific "test sets" for a new study, but rather relies on the equivalency to previously cleared devices. Therefore, these details are not available in this filing. The previous studies on the predicate devices would have encompassed these aspects.

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)

This information is not provided in this 510(k) submission as it relies on substantial equivalence to predicate devices, not on a new, independent clinical study requiring expert ground truth establishment.

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

Not applicable, as this document does not describe a new test set or clinical study requiring adjudication.

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 a medical device (microspheres for embolization), not an AI-based diagnostic or assistive technology.

6. 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.

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

For the predicate devices, safety and performance would have been established through a combination of:

• Physical and Chemical Testing: Evaluating material composition, size, sterility, expansion characteristics.
• Biocompatibility Studies: In vitro and in vivo tests based on ISO 10993-1:2009 (as mentioned).
• Pre-clinical Animal Studies: To assess embolization effectiveness and safety in biological systems.
• Clinical Data (if available for predicates): Though not explicitly detailed here, general clinical outcomes for embolization procedures would inform the understanding of safe and effective use.

The document implicitly uses the "ground truth" established by the prior clearance of the predicate devices, meaning their safety and effectiveness were already demonstrated.

8. The sample size for the training set

Not applicable. This document is for a physical medical device, not an AI model requiring a training set.

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

Not applicable. This document is for a physical medical device, not an AI model.

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