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GelSpheres™ Embolic Agent are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascualr tumor or arteriovenous malformations (AVM's). GelSpheres™ Embolic Agent consists of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. GelSpheres™ Embolic Agent is dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.

The product is supplied sterile and packaged in sealed glass bottles for V-Series Model numbers, and in pre-filled syringes for S- Series model numbers. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ Embolic Agent in sterile physiologic buffered saline (PBS) to a volume of 8 mL. and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 8 mL. Two quantities will be available in a pre-filled syringe: (1) 1.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL, and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL.

GelSpheres™ Embolic Agent is supplied in several units covering the range from 100um to 1200um diameter.

At the time of use, GelSpheres™ Embolic Agent is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for the GelSpheres™ Embolic Agent. It details the device's indications for use, description, similarities and differences to predicate devices, and performance standards it meets.

However, the document does not contain information about the acceptance criteria and the results of a specific study to prove the device meets those criteria. The performance standards listed are general regulatory and biological evaluation standards (e.g., ISO/EN, AAMI guidance) that the device must comply with for a 510(k) submission, not specific clinical or performance acceptance criteria for its intended use that would be evaluated in a study with stated performance metrics.

Therefore, I cannot provide the requested table and study details as they are not present in the input text.

Here’s what I can extract based on the available information:

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

Not applicable / Not found in the provided text. The document lists general performance standards (e.g., ISO for biological evaluation), but not specific acceptance criteria for "device performance" in terms of its embolization efficacy or measurable outcomes with associated performance metrics.

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

Not applicable / Not found in the provided text. The document describes the device and regulatory compliance, but not a specific study with a test set.

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)

Not applicable / Not found in the provided text. No information on establishing ground truth for a test set is provided.

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

Not applicable / Not found in the provided text. No information on an adjudication method for a test set is provided.

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 / Not found in the provided text. This device is an embolic agent, not an AI-assisted diagnostic or interpretative tool. No MRMC study is mentioned.

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

Not applicable / Not found in the provided text. This device is an embolic agent, not an algorithm.

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

Not applicable / Not found in the provided text. No study employing ground truth is detailed.

8. The sample size for the training set

Not applicable / Not found in the provided text. No training set is mentioned as this is a physical medical device, not a machine learning model.

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

Not applicable / Not found in the provided text. No training set or ground truth establishment relevant to it is discussed.

Summary of what the document does provide regarding "performance":

The document states that the GelSpheres™ Embolic Agent "meets the following Performance Standards":

Guidance For Industry: 2000: FDA Guidance for Neurological Embolization Products
ISO/EN 10993-1; 1997 Biological Evaluation of Medical Devices, Part I: Evaluation and Testing
ISO/EN 10993-3; 1993 Biological Evaluation of Medical Devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
ISO/EN 10993-4: 1993 Biological Evaluation of Medical Devices, Part 4: Selection of tests for interaction with blood.
ISO/EN 10993-6; 1995 Biological Evaluation of Medical Devices, Part 6: Test for local effects after implantation.
ISO/EN 10993-10: 1995 Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization.
ISO/EN 10993-11; 1993 Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity.
ISO/EN 10993-13: 1995 Biological Evaluation of Medical Devices, Part 13: Identification and Quantification of potential degradation products from polymers.
ISO/EN 11607; 1997 Packaging for terminally sterilized products.
AAMI TIR 22;1998 -- Guidance for application of EN 11607, Packaging for terminally sterilized products
AAMI 11134; 1993 - Sterilization of Health Care Products - Requirements for validation and routine control - Industrial moist heat sterilization 2nd edition.
ANSI/AAMI/ISO 14937; 2000 - Sterilization of Health Care Products - Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
EN 554: Sterilization of Medical Devices validation and Routine Control of Sterilization by Moist Heat

These are regulatory and manufacturing standards, not specific clinical performance metrics with acceptance criteria and corresponding study results. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, and adherence to these general standards, which implies safety and effectiveness without detailing a performance study with specific outcome measures.

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