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

The QuadraSphere Microspheres are sterile, biocompatible, hydrophilic, non-resorbable, expandable, acrylic copolymer microspheres. QuadraSphere Microspheres size is: 30 to 60µm in containers (vials) containing 25 mg of dry microspheres, which can absorb aqueous media up to 64 times their dry state volume. 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.

The QuadraSphere Microspheres have the following properties:

• Retains 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 absorbs contrast media and 0.9% saline solution. The spheres are positively charged, which allows them to bond ionically with negatively charged aqueous based solutions.
• Compresses in the vessel lumen, providing more surface contact with vessel intima.
• Expands 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 device. 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 BioSphere Medical QuadraSphere® Microspheres 30 to 60µm is a medical device for embolization and is substantially equivalent to the predicate device, QuadraSphere Microspheres (K052742). The main difference is the additional size offering of 30 to 60µm.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document doesn't explicitly list specific quantitative "acceptance criteria" with numerical targets for the new 30-60µm size. Instead, the acceptance is based on demonstrating that the new size performs similarly to the predicate device and meets established design and performance specifications. The table below summarizes the key evaluations and their outcomes.

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

• Test Set Description: The primary test set mentioned for the 30-60µm device is an animal study.
• Sample Size: The document refers to "healthy mini-pigs" and states that "Embolization was successful for all animals," implying a small, but sufficient, number of animals for this pre-clinical feasibility and safety study when coupled with the in-vitro data. The exact number of animals is not explicitly stated.
• Data Provenance: The data is from a prospective animal study conducted to evaluate the safety and product performance of the new 30-60µm QuadraSphere Microspheres. The origin is not specified by country, but it's a pre-clinical study.

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 given text. For an animal study, "ground truth" would typically come from veterinary pathologists or other trained animal researchers/clinicians.

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

This information is not provided in the given text. Given it's an animal study focusing on objective measurements (histopathology, granulometry), a formal adjudication process as seen in multi-reader human image interpretation studies is unlikely or not explicitly detailed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This is a device modification for an embolization microsphere, not an AI-assisted diagnostic tool. Therefore, the concept of "human readers improving with AI assistance" does not apply.

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

Not applicable. This device is a physical embolization microsphere, not a software algorithm. Its performance is evaluated through its physical and biological effects, both in vitro and in vivo.

7. The type of ground truth used:

The ground truth for the animal study (in-vivo testing) was established using:

• Histopathology: Microscopic examination of tissue samples to evaluate vessel occlusion, tissue response (e.g., presence of macrophages), and confirms the location of the microspheres.
• Animal behavior and blood tests: To assess overall safety and well-being.
• In-vitro granulometry: Objective measurement of microsphere size distribution.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI algorithm, so there is no "training set" in the context of machine learning. The device's design and manufacturing processes are refined through engineering and material science, not data training.

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

Not applicable. As stated above, there is no "training set" for this type of device. The "ground truth" for its development would be based on established engineering principles, material science, and prior knowledge from the predicate device.

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The BioSphere QuadraSphere™ Microspheres are intended for embolization of hypervascularized tumors and peripheral vascular arteriovenous malformations (AVMs).

QuadraSphere Microspheres are indicated for embolization of hypervascularized arteriovenous malformations.

BioSphere Medical, Inc., QuadraSphere™ Microspheres are sterile, biocompatible, hydrophilic (absorbent), non-resorbable, acrylic copolymer microspheres. They are provided in three (nominal) microsphere sizes: 50 to 100 um, 100 to 150 um, and 150 to 200 um in containers (vials) containing 50 mg of the dry spheres.

The provided text is a 510(k) summary for a medical device (QuadraSphere™ Microspheres), which focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results as one might find in a clinical trial report.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and study designs are not present in this type of regulatory submission. The document states that "In-vitro and in-vivo design verification and validation testing demonstrates that the BioSphere Medical, Inc. QuadraSphere™ Microspheres fulfill design and performance specifications," but it does not elaborate on what those specifications or the detailed results were.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the 510(k) summary. A 510(k) summary typically focuses on demonstrating substantial equivalence to existing devices rather than detailing specific numerical acceptance criteria and performance outcomes from a statistically powered study. It states that "In-vitro and in-vivo design verification and validation testing demonstrates that the BioSphere Medical, Inc. QuadraSphere™ Microspheres fulfill design and performance specifications," but doesn't list the specifications or the results.

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

This information is not provided. The summary mentions "in-vitro and in-vivo" testing but does not specify the sample sizes or the origin of any data (e.g., country of origin, retrospective/prospective). This is common for 510(k) submissions, which often rely on bench testing and animal studies rather than large-scale human clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided. As no clinical study is described with a ground truth establishment process, there is no mention of experts, their number, or qualifications.

4. Adjudication Method for the Test Set:

This information is not provided, as no clinical test set adjudication process is described.

5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:

This information is not provided. The document makes no mention of an MRMC study or any comparison of human readers with and without AI assistance. The device is an embolization agent, not an AI-powered diagnostic tool.

6. Standalone Performance (Algorithm Only):

This information is not applicable/not provided. The device is a physical medical implant (microspheres) for embolization, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant.

7. Type of Ground Truth Used:

This information is not provided. Since no specific human clinical study with a defined ground truth for efficacy or safety is outlined, the type of ground truth is not detailed. The "performance testing" likely refers to engineering, biocompatibility, and animal studies.

8. Sample Size for the Training Set:

This information is not provided. As the device is not an AI algorithm, there is no concept of a "training set" in the context of machine learning.

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

This information is not applicable/not provided for the same reason as point 8.

Summary of Provided Information Relevant to Performance:

• Performance Testing: The summary states that "In-vitro and in-vivo design verification and validation testing demonstrates that the BioSphere Medical, Inc. QuadraSphere™ Microspheres fulfill design and performance specifications."
• Intended Use: Embolization of hypervascularized tumors and peripheral vascular arteriovenous malformations (AVMs).
• Technological Characteristics: Sterile, biocompatible, hydrophilic (absorbent), non-resorbable, acrylic copolymer microspheres, available in three nominal sizes (50 to 100 um, 100 to 150 um, and 150 to 200 um). Delivered via catheters, mixed with contrast media for visualization.
• Substantial Equivalence: The claim is based on intended use, indications for use, fundamental technological characteristics, and fundamental operational characteristics being similar to predicate devices (GelSpheres, BeadBlock Compressible Microspheres, Contour SE, Contour Emboli, Embospheres). This implies that the performance is considered acceptable because it is similar to already legally marketed devices.

This 510(k) summary serves to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not to independently prove its efficacy and safety against a set of predefined, quantifiable acceptance criteria in a detailed clinical study.

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The EmboCath® Plus Infusion Microcatheter is intended for: infusion of various diagnostic, embolic and therapeutic agents into the body's peripheral vascular systems, guidewire exchange/support; and superselective angiography of the peripheral vasculatures.

The EmboCath® Plus Infusion Microcatheter, same as its predicate device EmboCath Hydrophilic Catheter (K003105) is sterile, biocompatible, single use, peripheral vascular catheter constructed of a tapered reinforced shaft, inner lubricious lined lumen, hydrophilic outer surface, radiopaque marker and a standard luer adapter at the proximal end.

The device will be provided in the following configurations:

• Inner Diameter: 0.028 in.
• Outer Diameters: 3 F proximally to 2.8 F distally
• Lengths: 100 cm and 135 cm as indicated on product label .

The EmboCath® Plus Infusion Microcatheter is a tapered 3.0-2.8F single lumen catheter designed to facilitate the access of distal vasculature over a guidewire. The catheter has a semi-rigid proximal shaft and becomes progressively more flexible toward the distal end. The shaft is reinforced, which provides improved torque transmission. The inner lumen is lined with a lubricious material to facilitate the movement of guidewires or other devices. The outer diameter of the catheter is coated with a hydrophilic surface to enhance the ability to navigate tortuous anatomy. The distal tip of the catheter has a single radiopaque marker to facilitate fluoroscopic visualization. The hub at the proximal end incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter lumen is 0.028 inches and guidewires measuring up to 0.025 inches (0.635 mm) in diameter are recommended.

This 510(k) summary describes a medical device, the EmboCath® Plus Infusion Microcatheter, and its substantial equivalence to a predicate device, the EmboCath Hydrophilic Catheter (K003105). The submission primarily focuses on functional equivalence rather than clinical performance or AI-driven diagnostic accuracy. Therefore, several of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not applicable or not provided in this document as they pertain to clinical or AI performance studies which were not conducted for this type of device submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide explicit quantitative "acceptance criteria" for clinical performance. Instead, it relies on demonstrating that the EmboCath® Plus Infusion Microcatheter performs equivalently to its predicate device through in-vitro design verification and validation testing, ensuring it meets its design and performance specifications. The "reported device performance" is essentially the successful completion of these tests.

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

Not applicable. This submission describes in-vitro engineering tests (e.g., trackability, kink resistance, patency) rather than a clinical study involving a test set of patient data. The tests are benchtop evaluations of device characteristics. No data provenance in terms of country of origin or retrospective/prospective collection is relevant here.

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

Not applicable. Ground truth, in the context of expert consensus, is not relevant for in-vitro engineering tests. The "ground truth" for these tests would be established by validated test methodologies and measurement equipment against engineering specifications.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring expert 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 device is a microcatheter, not an AI-driven diagnostic tool. No MRMC study was performed as no human reader interpretation of AI output is involved.

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

Not applicable. This device does not involve an algorithm or AI.

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

The "ground truth" for the performance claims is derived from engineering specifications and established test methods for material properties and functional device performance during the in-vitro design verification and validation testing. For example, a "kink resistance test" would have predetermined acceptance criteria for the force or angle at which kinking occurs, and the device's performance is measured against these criteria.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI models, so there is no training set.

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

Not applicable. As there is no training set for an AI model, no ground truth needed to be established for it.

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The Sequitor™ Steerable Guidewire is intended to facilitate the placement of catheters within the peripheral vasculature for various diagnostic and interventional procedures.

The Sequitor™ Steerable Guidewire (.014" or .018") is a stainless steel guidewire with a polymer distal tip and a radiopaque distal tip that is shapeable. The distal 50 cm is coated with a hydrophilic coating. The guidewire length is depicted on the product label.

The provided text is a 510(k) summary for the BioSphere Medical, Inc. Sequitor™ Steerable Guidewire. It describes the device, its intended use, predicate devices, and a general statement about performance testing. However, it does not include detailed information regarding specific acceptance criteria, study methodologies, sample sizes for test or training sets, expert qualifications, or ground truth establishment.

Therefore, most of the requested information cannot be extracted directly from the provided document.

Here's a breakdown of what can and cannot be provided based on the input:

1. Table of acceptance criteria and reported device performance:

• Cannot be provided. The document states, "In-vitro and in-vivo design verification and validation testing demonstrates that the Sequitor™ Steerable Guidewire fulfills design and performance specifications." However, it does not specify what those specifications are (i.e., the acceptance criteria) or what the quantitative performance results were against those criteria.

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

• Cannot be provided. The document mentions "in-vitro and in-vivo design verification and validation testing" but does not provide any details about the sample sizes used in these tests or the provenance of any data (e.g., country of origin, retrospective/prospective).

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

• Cannot be provided. This information is typically relevant for studies involving human interpretation (e.g., imaging devices with AI assistance). This document describes a guidewire, which is a physical device, and its testing would likely involve engineering and clinical performance evaluations, not expert-established ground truth in the context of diagnostic interpretation.

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

• Cannot be provided. Similar to point 3, adjudication methods are usually for resolving discrepancies in expert interpretations, which is not applicable to the type of device and testing described here.

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

• Cannot be provided. An MRMC study is relevant for AI-assisted diagnostic tools. The Sequitor™ Steerable Guidewire is a physical medical device (a guidewire), not an AI diagnostic tool. Therefore, this type of study is not applicable.

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

• Cannot be provided. This question is also relevant for AI algorithms. The device described is a physical guidewire, so the concept of an "algorithm only" performance doesn't apply.

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

• Cannot be provided. As a physical guidewire, its performance would be assessed against engineering specifications (e.g., flexibility, torque transmission, coating integrity, tensile strength) and possibly clinical outcomes related to its safe and effective use (e.g., successful catheter placement, lack of vessel damage). The document only vaguely refers to "design and performance specifications" without detailing them or the ground truth against which they were measured.

8. The sample size for the training set:

• Cannot be provided. This concept is specific to machine learning/AI models. The guidewire is a physical device and doesn't involve a "training set."

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

• Cannot be provided. As explained in point 8, this is not applicable to the described device.

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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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