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The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System is intended to obstruct or reduce rate of blood flow in the peripheral vasculature. This device is not intended for coronary or neurovascular use.

The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System consists of a delivery wire, removable introducer sheath, and permanent implantable non-fibered embolic coil. The EMBOLD™ Soft coil can be delivered to challenging peripheral anatomy, and the EMBOLD™ Packing coil is highly conformable to enable dense packing. The device is compatible with 0.027-inch microcatheters. In addition, the device features a mechanical detachment mechanism consisting of an inner pull wire connecting the coil and delivery wire coupler arms, activated by the user through a proximal laser-etched outer wire perforation. The delivery wire design allows the coil to be fully advanced, retracted, and deployed prior to final placement. The EMBOLD™ Soft and EMBOLD™ Packing Detachable Coil System is provided sterile, using 100% ethylene oxide (EO) gas sterilization, and is intended for hospital and single use only.

Here's an analysis of the provided FDA 510(k) summary for the EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System, focusing on the requested information regarding acceptance criteria and the supporting study:

The provided document is a 510(k) summary, which is a regulatory submission to the FDA demonstrating substantial equivalence to a legally marketed predicate device. It does not describe acceptance criteria for a diagnostic algorithm or a study proving that a device meets such criteria in terms of accuracy or clinical performance (e.g., sensitivity, specificity). Instead, it focuses on the performance of a medical device (embolic coils) in terms of its physical and functional characteristics.

Therefore, many of the requested fields cannot be directly answered from this document, as they pertain to clinical performance studies for diagnostic or AI-driven devices, which is not the subject of this 510(k).

However, I can extract the relevant information regarding the performance data and equivalence testing for this specific type of device.

Acceptance Criteria and Device Performance (as interpreted for a physical medical device)

1. Table of Acceptance Criteria and Reported Device Performance

For an embolic coil system, "acceptance criteria" and "reported device performance" are geared towards physical and functional specifications to ensure safety and effectiveness, rather than diagnostic accuracy metrics.

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

• Test Set Sample Size: Not explicitly stated as a "test set" in the context of clinical images or patient data. For physical device testing (bench, animal), specific numbers of coils, devices, or animals tested are not provided in this summary.
• Data Provenance: Not applicable in the context of image data. The testing is for the physical device itself.

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

• Number of Experts & Qualifications: Not applicable. This is not a study assessing diagnostic performance against a "ground truth" established by experts.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable for this type of device and study.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a physical device, not an AI-driven diagnostic tool where human reader performance would be a factor.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• Type of Ground Truth: For this type of device, the "ground truth" for performance is generally defined by engineering specifications, validated test methods (e.g., ISO standards), and a comparison to the established performance of a predicate device. It's not a clinical "ground truth" like pathology or outcomes data in the usual sense for a diagnostic device.

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a physical device, not an AI/ML model that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable. There is no training set for this device.

Summary of Device and its Assessment - As per the K230706 Document:

The EMBOLD™ Soft Detachable Coil System and EMBOLD™ Packing Detachable Coil System are physical vascular embolization devices. The FDA clearance (K230706) is based on demonstrating substantial equivalence to a previously cleared predicate device (EMBOLD™ Fibered Detachable Coil System, K213398).

The evidence provided to the FDA for this substantial equivalence included:

• Bench Testing: To assess mechanical properties, design, and material characteristics.
• Animal Testing: Likely to evaluate in-vivo performance, deliverability, and deployment.
• Biocompatibility Testing: In accordance with ISO 10993 standards to ensure the materials are safe for human contact.

The conclusion of the submission states that the proposed device is "as safe and effective as the predicate" because:

• It has the same intended use.
• It incorporates "substantially equivalent device materials and design, fundamental technology, manufacturing processes, sterilization process."
• Differences in technological characteristics (packing coil shape, non-fibered coil) do not raise new questions of safety and effectiveness, supported by the results of the aforementioned testing.

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