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CODMAN Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is also intended for arterial and venous embolizations in the peripheral vasculature.

The DELTAMAXX Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.

The Fill ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and is also intended for arterial and venous embolizations in the peripheral vasculature.

The Xtrasoft ORBIT GALAXY G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The CODMAN® Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, and ORBIT GALAXY® G2 Microcoil Delivery System consist of three components, a Microcoil System, a connecting cable, and a Detachment Control Box (DCB). Each component is sold separately. As shown in Figure 1, the Microcoil System consists of an microcoil attached to a Device Positioning Unit (DPU).

The Microcoil System is packaged in an introducer sheath designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the infusion catheter. The microcoil is the implantable segment of the device, and is detached from the Device Positioning Unit (DPU) using the Detachment Control System (Detachment Control Box and connecting cable).

The microcoil is fabricated from a platinum alloy wire. The wire is wound into a primary coil which may contain either a polypropylene suture (SR) or an absorbable polymer suture (Cerecyte®) and then formed into a secondary shape. The secondary shape may be straight, spherical, complex, or helical. The DPU is a variable stiffness wire and has a radiopaque marker band located three (3) cm from its distal end. The introducer sheath has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool.
The Detachment Control Box (DCB) provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU. The connecting cable delivers the energy necessary to detach the embolic coil from the Microcoil System's detachment zone. The connecting cable is connected between the Microcoil System's hub connector on the DPU and the output connector on the DCB.

The detachment control box may be one of two types: the blue EnPower Detachment Control Box or the black Detachment Control Box.
The connecting cables may be one of two types: one with a remote detach button (the EnPower Control Cable) catalog no. ECB000182-00, or one without a detach button (standard connecting cable) catalog no. CCB00157-00.
The EnPower Detachment Control Box works with the EnPower Control Cable and with the standard connecting cable. The black Detachment Control Box works only with the standard connecting cable. Both cables and Detachment Control Box are sold separately.

The provided document is a 510(k) premarket notification for a medical device focusing on a packaging change. It does not contain information about the performance of the neurovascular embolization devices themselves, but rather the performance of the packaging.

Here's an analysis based on the provided text regarding the packaging acceptance criteria and study:

1. Table of Acceptance Criteria and Reported Device Performance (Packaging):

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

• Test Set Sample Size: The document does not explicitly state the specific number of units or pouches tested for each packaging integrity and shelf-life test. It mentions testing "representative products" and "each time interval" for shelf-life, implying multiple samples were used.
• Data Provenance: The studies were conducted internally by Codman & Shurtleff, Inc. This is a retrospective analysis of the modified packaging, comparing it to the predicate device's packaging characteristics and ensuring the new packaging maintains similar performance.

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

• Not Applicable. For packaging integrity and sterilization validation, "ground truth" is established through standardized physical, chemical, and microbiological testing methods (e.g., visual inspection, seal strength measurement, dye leak tests, bioburden assays) and comparison against pre-defined engineering and regulatory specifications, rather than expert consensus on a clinical outcome.

4. Adjudication Method for the Test Set:

• Not Applicable. As the tests are objective physical and microbiological measurements of packaging performance, an adjudication method for conflicting expert opinions is not relevant. The results would be interpreted against established acceptance criteria for each test.

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. This is a packaging modification submission for an existing neurovascular embolization device. It does not involve AI, image analysis, or human readers.

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

• No. This submission is about medical device packaging, not an algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• For the packaging validation, the "ground truth" is defined by established engineering standards, regulatory guidelines (e.g., ISO 11137 for sterilization), and predefined acceptance criteria for physical (e.g., seal strength, visual integrity) and microbiological (e.g., bioburden levels) properties of the sterile barrier system.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

• Not Applicable. As there is no training set.

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The Fill Orbit Galaxy G2 Microdelivery System is intended for endovascular embolization of intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, and is intended for arterial and venous embolizations in the peripheral vasculature.

The Xtrasoft Orbit Galaxy® G2 Microcoil Delivery System is intended for endovascular embolization of intracranial aneurysms.

The ORBIT GALAXY® G2 Microcoil Delivery System consists of a Microcoil System, a Connecting Cable (CC), and an ENPOWER Detachment Control Box (DCB). Each component is sold separately. ORBIT GALAXY® G2 Microcoil Systems are provided as Stretch Resistant, with Fill and XTRASOFT™ microcoil models, and will be offered in lengths ranging from 1.5 cm to 30 cm and diameters ranging from 2 mm to 20 mm. The ORBIT GALAXY® G2 Microcoil System is compatible with commercially available 2-tip marker microcatheters which have internal lumen diameters between 0.0165 inches and v 0.019 inches.

The Microcoil System consists of an embolic microcoil attached to a device positioning unit (DPU) which is covered by an introducer sheath. The Fill ORBIT GALAXY® G2 Microcoils are provided in complex shape, and the XTRASOFT™ ORBIT GALAXY® G2 Microcoils are provided in complex and helical shapes. The DPU is a variable stiffness pushing system and has a radiopaque marker band located three (3) cm from its distal end. The introducer sheath system has three main components: an introducer tip, a translucent introducer body, and a re-sheathing tool. The Microcoil System is packaged individually in a protective hoop and sealed in a film pouch. A Microcoil System carton contains one Microcoil System and the associated Instructions for Use, and is provided as a sterile and single-use product.

The Connecting Cable delivers the energy needed to detach the microcoil from the Microcoil System's detachment zone. The connecting cable connects the DPU to the DCB. The DCB provides the energy necessary to allow for a thermo-mechanical detachment of the microcoil from the DPU.

The provided text describes a Special 510(k) submission for the ORBIT GALAXY® G2 Microcoil System. This type of submission is typically for modifications to a previously cleared device, asserting substantial equivalence to existing predicate devices based on non-clinical testing. Therefore, the study described here is primarily a non-clinical bench testing study.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in a table format for a specific performance metric. Instead, it describes a comparative approach where the modified device (ORBIT GALAXY® G2 Microcoil System) is tested against the predicate devices (CASHMERE® SR Microcoil System and ORBIT GALAXY® Detachable Coil System) and is deemed to perform "equivalently" or "as designed." The acceptance criteria, therefore, are implied to be meeting the performance of the predicate devices for each test conducted.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample sizes (number of coils or tests) used for each bench test conducted. It states "bench testing data" and "results of verification and validation testing."
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Codman & Shurtleff, Inc. No information regarding country of origin of the data beyond the manufacturer's location in Raynham, MA (USA) is provided. It's an internal test, not a retrospective or prospective study in the typical human trials sense.

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

This section is not applicable as the study is a non-clinical bench testing study of a medical device, not a study involving human data, medical imaging, or expert interpretation for ground truth. Ground truth for device performance is typically established by engineering specifications, validated test methods, and comparison to established predicate device performance.

4. Adjudication Method for the Test Set

This section is not applicable as the study is a non-clinical bench testing study. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where opinions of multiple human reviewers or experts need to be reconciled.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers evaluating cases, often in radiology or pathology, with and without AI assistance to measure reader improvement. The described study is non-clinical bench testing.

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

No. This section is not applicable either in the sense of an "algorithm" or "AI." The device is a physical embolization microcoil system, not an AI or software algorithm that would have standalone performance. The testing performed is for the physical device's characteristics.

7. The Type of Ground Truth Used

The "ground truth" for this non-clinical bench testing is engineering specifications, validated test methods, and the established performance characteristics of the predicate devices. The new device's performance in mechanical tests (delivery force, shape retention, tensile strength, durability, detachability) and material characteristics (biocompatibility, sterilization) is measured against these established benchmarks to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

This section is not applicable for the same reason as above.

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