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Gel-Bead embolization spheres are intended for use in embolization of hypervascular tumors.

The Gel-Bead embolization spheres product consists of biodegradable gelatin spheres pre-filled in a 20 ml syringe. The syringe contains either 1 ml or 2 ml of spheres suspended in 5 ml or 4 ml of saline, respectively. Offered in five nominal size ranges (100-300 µm, 500-700 µm, 600-800 µm, and 700-1000 um), the spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.

This document describes the acceptance criteria and supporting study for the Gel-Bead Embolization Spheres (600-800um - 1 ml and 2 ml sphere volumes) device.

The study presented focuses on demonstrating the substantial equivalence of the new 600-800 µm sphere size and new 1ml sphere volume, to previously cleared Gel-Bead embolization spheres (K133237 and K171946). This is primarily achieved through bench testing of key device characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Information on the Study:

The provided document describes a bench test study rather than a clinical study involving human or animal subjects for evaluating performance in a biological context. The primary goal of this submission is to demonstrate substantial equivalence to previously cleared predicate devices through direct comparison of technological characteristics and performance in a controlled laboratory environment.

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

   • The document does not specify the exact sample sizes used for each of the bench tests (Deliverability, Sphere Diameter, Sphericity).
   • Data Provenance: The study appears to be an in-vitro (bench) study conducted by the manufacturer, Vascular Solutions. There is no indication of country of origin for the data in the context of clinical trials, as this is a laboratory-based evaluation.

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

   • This information is not applicable to this type of study. Bench tests rely on objective measurement and predefined specifications (acceptance criteria) rather than expert interpretation of data points to establish a "ground truth." The "ground truth" for these tests is the physical measurement itself against the defined thresholds.

4. Adjudication Method for the Test Set:

   • This information is not applicable to this type of study. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers independently assess data and discrepancies need to be resolved. Bench tests involve direct measurements against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (embolization spheres), not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

   • Not applicable. This device is not an algorithm or AI. The performance tested is the inherent physical and functional characteristics of the embolization spheres themselves.

7. Type of Ground Truth Used:

   • The "ground truth" for this study is based on pre-defined engineering specifications and measurable physical properties of the device (e.g., specific diameter ranges, mechanical properties related to deliverability, and optical properties related to sphericity). These are verified through direct measurement and laboratory testing, rather than expert consensus, pathology, or outcomes data which are typical for clinical performance evaluation.

8. Sample Size for the Training Set:

   • This concept is not applicable to this study. "Training set" refers to data used to train machine learning models. This study is a bench test verification of a physical device against engineering specifications.

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

   • Not applicable, as there is no training set for this type of device and study.

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Gel-Bead embolization spheres are intended for use in embolization of hypervascular tumors.

The Gel-Bead embolization spheres (Gel-Bead) consists of biodegradable gelatin spheres prefilled in a 20 ml syringe. The syringe contains 2 ml of spheres suspended in 4 ml of saline. Gel-Bead is offered in four nominal size ranges: 100-300 um, 300-500 um, 500-700 um and 700-1000 um. The spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Gel-Bead device, based on the requested information:

This device is a medical device (embolization spheres), not an AI/ML device. Therefore, many of the requested fields pertinent to AI/ML device studies (like those related to AI effectiveness, ground truth for training sets, etc.) are not applicable in this context and will be marked as such.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample sizes used for each of the bench tests (sphere suspension, pepsin digestion, supplied volume, deliverability, glutaraldehyde residuals). It also does not explicitly mention the data provenance in terms of country of origin or whether it was retrospective or prospective, as these are bench tests rather than clinical studies with patient data.

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

Not applicable. These are bench tests measuring physical and chemical properties of the device, not diagnostic interpretations requiring expert ground truth in the context of AI/ML.

4. Adjudication Method for the Test Set

Not applicable, as ground truth establishment by experts is not relevant for these bench tests. The acceptance criteria were likely objective measurements defined by the manufacturer based on regulatory guidelines and validated methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used

The "ground truth" for these bench tests would be the established scientific and engineering principles, regulatory standards, and internal specifications for the physical and chemical properties of the embolization spheres. For example, for "supplied volume," the ground truth would be the expected nominal volume (2 ml) and acceptable deviation from that volume. For "glutaraldehyde residuals," the ground truth would be the acceptable safe limit for residuals.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device, "Gel-Bead" embolization spheres (2 ml fill), underwent a series of bench tests to demonstrate substantial equivalence to its predicate device (Gel-Bead, K133237). The studies focused on evaluating the device's functionality and technological characteristics.

The specific tests conducted were:

• Sphere suspension in contrast: This likely assesses how well the spheres remain suspended in a contrast agent, which is crucial for their navigability and visualization during clinical use.
• Pepsin digestion: This test evaluates the biodegradability of the gelatin spheres, confirming they break down as intended over time after embolization.
• Supplied volume: This verifies that the actual volume of spheres provided in the syringe meets the specified amount (2 ml).
• Deliverability: This assesses the ability of the spheres to be successfully delivered through compatible catheters without clumping or clogging, which is critical for clinical efficacy.
• Glutaraldehyde residuals: This measures any residual glutaraldehyde (a cross-linking agent sometimes used in gelatin products), ensuring it is below safe limits.

The document states that "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." This indicates that for each of these measured characteristics, the device performed within the predefined acceptable ranges or thresholds. The exact numerical acceptance criteria are not provided in this document, but the overall conclusion is that they were successfully met.

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Gel-Bead embolization spheres is intended for use in embolization of hypervascular tumors.

The Gel-Bead embolization spheres (Gel-Bead) consists of biodegradable gelatin spheres pre-filled in a 20 ml syringe. The syringe contains 1 ml of spheres suspended in 5 ml of saline. Gel-Bead is offered in four size ranges: 100-300 µm, 300-500 µm, 500-700 µm and 700-1000 µm. The spheres are intended to be used with a delivery catheter with an inner diameter that is adequate for sphere delivery (not included). The finished product is sterilized by Gamma irradiation and is intended for single use only.

The provided text describes a 510(k) submission for the Gel-Bead embolization spheres device. This is a medical device submission, and the focus of the "study" and "acceptance criteria" is on demonstrating substantial equivalence to existing predicate devices, rather than a clinical trial-style study with direct performance metrics in humans.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set (Animal Study): 12 mature miniature swine.
  • 8 animals implanted with Gel-Bead.
  • 4 animals implanted with a control (Embosphere Microspheres).
• Data Provenance: Prospective animal study (GLP animal study), conducted with animals survived up to 12 weeks following implantation. The country of origin of the data is not specified, but it's typically conducted in a controlled lab environment.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth. However, given the nature of a GLP animal study, it would typically involve:

• Veterinary Pathologists: To interpret tissue examinations and identify foci of infarction.
• Veterinarians/Surgeons: For implantation procedures, clinical observation, and interpretation of clinical pathology results.
• Radiologists/Interventionalists: To interpret angiographic confirmation of arterial occlusion.

The document states "similar well-demarcated foci of infarction, indicative of successful embolization, observed in the target organs of both test article animals," which implies expert pathological assessment.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method for the animal study (e.g., 2+1 review). The findings related to successful occlusion, infarction, and clinical pathology are presented as observed outcomes of the study. GLP studies inherently have rigorous protocols for data collection and interpretation, but specific adjudication of disagreements is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This submission is for a medical device (embolization spheres), not an AI/imaging diagnostic device that would typically involve human readers interpreting cases.

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

No, a standalone (algorithm-only) performance study was not done. This device is not an algorithm; it is a physical medical device. The "study" here refers to the animal study demonstrating the physical device's function and safety.

7. The Type of Ground Truth Used

The ground truth for the animal study was established through a combination of:

• Direct Observation/Angiography: Confirmation of successful arterial occlusion at the time of implant.
• Pathology: Histopathological examination of target organs to observe "well-demarcated foci of infarction, indicative of successful embolization."
• Clinical Pathology: Blood results to assess for systemic toxicity.
• Gross Examination: Of tissues distant to implantation sites.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here because this is a physical medical device submission, not an AI/machine learning algorithm that requires training data. The animal study described is a verification and validation study for the device's performance and safety.

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

As there is no training set in the context of this device submission, this question is not applicable.

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