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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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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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