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1. The XTRASOFT™ ORBIT GALAXY™ Detachable Coil is indicated for embolizing intracranial aneurysms.
2. The Fill ORBIT GALAXY™ Detachable Coil and the Frame ORBIT GALAXY™ Detachable Coil are indicated for embolizing intracranial aneurysms and other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The Fill ORBIT GALAXY™ Detachable Coil and the Frame ORBIT GALAXY™ Detachable Coil are also intended for arterial and venous embolization in the peripheral vasculature.

The ORBIT GALAXY™ Detachable Coil System consists of a delivery system (delivery tube and coil introducer) and a stretch resistant embolic coil. The delivery tube and coil introducer of the ORBIT GALAXY™ Detachable Coil System are identical to the delivery tube and coil introducer of the TRUFILL DCS ORBIT™ Detachable Coil System. The delivery tube is the body of the device and functions as a guidewire and a mini infusion catheter. The coil introducer is designed to protect the coil in the packaging dispenser and to provide support for introducing the coil into the infusion catheter. The coil is the implantable segment of the device. It is comprised of a platinum alloy wire and integrates a stretch resistant polymer monofilament through the inner diameter of the coil.

The TRUFILL® DCS Syringe II (sold separately) is required to properly purge and detach the coil. The coil is detached from the delivery tube by a proprietary hydraulic release mechanism.

The ORBIT GALAXY™ Detachable Coil System is packaged inside a protective dispenser tube. The product is held in place by means of a hub-to-dispenser tube clip. The entire system is packaged inside a sealed protective pouch. A luer valve is provided with the system if the user prefers to remove the syringe from the hub of the delivery tube after purging and prior to detaching the coil. The luer valve is attached to the packaging dispenser with a clip.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes a medical device, the ORBIT GALAXY™ Detachable Coil System, seeking 510(k) clearance. For this type of device, acceptance criteria are primarily demonstrated through equivalence to a predicate device and a series of bench, in-vivo, and in-vitro tests rather than a single, overarching performance metric like accuracy or sensitivity often seen in AI/diagnostic devices. The key "acceptance criteria" here relate to meeting the same specifications and safety profiles as the predicate.

2. Sample Sizes and Data Provenance:

• Bench Tests: The document lists "Coils Tested" for each bench test, including "Xtrasoft," "Fill," and "Frame." It doesn't specify the number of coils tested for each type for each criterion.
• In-vivo Simulated Use Test: Conducted in an "in-vivo porcine model." The number of animals is not specified.
• In-vitro Simulated Use Test: Conducted in an "in-vitro aneurysm model." The number of models or tests is not specified.
• Biocompatibility Tests: Sample sizes are not explicitly stated for individual tests (e.g., number of guinea pigs, mice, or rabbit implants), but the conclusion is that the requirements were met.
• Data Provenance: The document does not specify country of origin for the data. All studies are described as "in-vitro laboratory bench top testing," "in-vivo and in-vitro simulated use test," and "biocompatibility testing," implying prospective studies conducted for this submission.

3. Number of Experts and Qualifications:

The document does not mention the involvement of experts to establish ground truth or review data in the context of diagnostic performance, as this device is an embolization coil and not a diagnostic AI device. The evaluation is based on engineering specifications, biocompatibility standards, and simulated use.

4. Adjudication Method:

Not applicable. This is not a diagnostic device involving expert adjudication of results.

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

No MRMC study was done, as this is an embolization coil, not an AI-assisted diagnostic tool for human readers. There is no "human readers improve with AI vs without AI assistance" effect size to report.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's acceptance is based on:

• Pre-defined engineering specifications and manufacturing tolerances.
• Compliance with established biocompatibility standards (ISO 10993 Part 1, G95-1).
• Demonstration of performance in simulated use environments (in-vitro aneurysm models, in-vivo porcine models) against expected functional outcomes.
• Substantial equivalence to a legally marketed predicate device (TRUFILL® DCS ORBIT™ Detachable Coil System) as the primary benchmark.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable for the same reason as above.

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The TRUFILL® DCS Syringe II is indicated for use with the TRUFILL® family of Detachable Coils.

The TRUFILL® DCS Syringe II consists of a 14-cc barrel with a pressure gauge, a threaded plunger assembly with a locking mechanism, and a flexible high-pressure extension tube with a male luer connector. The gauge faceplate is calibrated for use with the TRUFILL DCS ORBIT™ Detachable Coil and the TRUFILL® DCS Detachable Coil; i.e., the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe II is used to generate controllable pressure for preparation and coil detachment of the TRUFILL™ family of Detachable Coils.

The provided document describes the TRUFILL® DCS Syringe II, an artificial embolization device, and its substantial equivalence to a predicate device. The information details the performance and safety testing, as well as design validation, conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Performance and Safety Testing" and "Design Validation Testing" conducted. The reported device performance is that these tests were conducted and the device performed as intended and met specifications.

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

The document does not specify the sample sizes used for each specific test or the data provenance (e.g., country of origin of the data, retrospective or prospective). It generally states that "in-vitro laboratory performance testing" and "in-vitro testing" were conducted.

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

This information is not provided in the document. The studies described are in-vitro laboratory tests, which typically rely on measurement instruments and adherence to technical specifications rather than human expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and is not provided. Given the nature of in-vitro engineering and performance testing, there's no mention of human adjudication methods like 2+1 or 3+1.

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

No, an MRMC comparative effectiveness study was not done. The studies described are in-vitro performance and design validation tests of the device itself, not studies comparing human reader performance with or without AI assistance.

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

The device is a physical medical instrument (a syringe) used to manipulate medical coils. It does not involve an "algorithm" or "AI" in the context of image analysis or diagnostic support. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The tests performed are standalone in the sense that they assess the device's technical specifications and functionality independent of a human operator, but it's not an AI or algorithm.

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

The ground truth for the in-vitro tests would have been established by engineering specifications, validated measurement techniques, and established industry standards for device performance, material compatibility, and sterile processing. For example, gauge accuracy would be compared against a known standard, and dimensional verification against engineering drawings.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical instrument, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable for the same reason as above; there is no training set for a physical medical device like the TRUFILL® DCS Syringe II.

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The TRUFILL DCS ORBIT™ Detachable Coil is indicated for embolizing certain intracranial ancurysms that. because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:

very high-risk for management by traditional operative techniques l )

inoperable 2)

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulac of the neurovasculature.

The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.

The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details for the Trufil! DCS Orbit Detachable Coil System Line Extension. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices and outlines its indications for use. It does not include data from performance studies or clinical trials that would provide the specific information requested about acceptance criteria and how they were met.

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The TRUFILL® DCS Detachable Coil is indicated for embolizing certain intracranial aneurysms that, because of their morphology, location, or the patient's general medical condition, are considered by the treating neurosurgical team to be:

1. very high-risk for management by traditional operative techniques
2. inoperable

and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature.

The TRUFILL® DCS Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature.

The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

Not Found

Here's a breakdown of the requested information, assuming the provided text relates to a medical device approval and not an AI-driven diagnostic or treatment tool. The document is an FDA 510(k) clearance letter for a TRUFILL DCS ORBIT™ Detachable Coil System. Therefore, the acceptance criteria and study described will pertain to the safety and effectiveness of this physical device, not an AI's performance.

Based on the provided text, there is no information related to an AI/Machine Learning device or its performance criteria, studies, or ground truth establishment. The document is a standard FDA 510(k) clearance letter for a physical medical device (detachable coil system) and its indications for use.

Therefore, many of the specific questions regarding AI performance criteria, test sets, ground truth, experts, and MRMC studies are not applicable to this document. The information that can be extracted relates to the device itself and the regulatory process.

Re-interpretation of "Acceptance Criteria" for a Physical Medical Device 510(k):

For a 510(k) clearance, the "acceptance criteria" are not reported as specific performance metrics in the same way an AI algorithm's accuracy would be. Instead, acceptance criteria are generally met by demonstrating substantial equivalence to a previously legally marketed predicate device. This involves showing that the new device is as safe and effective as the predicate. This demonstration typically relies on bench testing, biocompatibility testing, sterilization validation, and potentially limited clinical data, all compared against established standards and the predicate's performance.

Based on the provided document, here's what can be inferred and what aspects are not present:

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

• Acceptance Criteria (Implicit for 510(k) Submission):
  • Demonstrate substantial equivalence in intended use, technological characteristics, and performance to a predicate device.
  • Safety and effectiveness comparable to the predicate.
  • Compliance with relevant performance standards and regulations (e.g., biocompatibility, sterility, mechanical integrity).
• Reported Device Performance:
  • The document states that the FDA "determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "reported performance" from a regulatory standpoint—it meets the criteria for market clearance.
  • Specific quantitative performance metrics (e.g., rates of successful embolization, complication rates) are NOT detailed in this letter. These would typically be found in the actual 510(k) submission, including summaries of non-clinical and, if applicable, clinical testing.

2. Sample size used for the test set and the data provenance

• Not explicitly stated in this document. For a 510(k), test sets would likely include:
  • Bench Testing: Often involves hundreds or thousands of cycles for mechanical durability, often dozens of samples for burst pressure, tensile strength, etc. The sample size depends on the specific test and statistical justification.
  • Biocompatibility Testing: Typically uses a small number of samples, following ISO 10993 guidelines.
  • Limited Clinical Data (if any): While not always required for 510(k), if clinical data were submitted, the sample size would vary.
• Data Provenance: Not stated. For a 510(k), data provenance would typically be from the manufacturer's internal testing labs, contract research organizations (CROs), or possibly clinical sites (if clinical data was part of the submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• N/A (Not Applicable to this type of device and document). Ground truth, in the context of an AI device, implies an independent, verified determination that the AI is trying to predict. For a medical device like an embolization coil, the "ground truth" for its safety and effectiveness is established through validated scientific and engineering tests, and potentially clinical outcomes, rather than expert consensus on an interpretation task like with AI.
• Experts involved would be those conducting the bench tests (engineers, materials scientists) and potentially clinicians for any clinical studies (neurointerventionalists, neurosurgeons). Their qualifications would be expertise in their respective fields, but they wouldn't be "establishing ground truth" for an AI.

4. Adjudication method for the test set

• N/A (Not Applicable). Adjudication methods (like 2+1, 3+1) are common in clinical trials or for establishing ground truth from expert readings (e.g., for AI training/testing data). This document does not describe such a process for the coil system's testing. Testing for a physical device typically follows pre-defined protocols and acceptance limits without "adjudication" in this sense.

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

• N/A (Not Applicable). This document refers to a physical embolization device, not an AI system that assists human readers. Therefore, an MRMC study and effects of AI assistance are irrelevant to this FDA clearance.

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

• N/A (Not Applicable). This is a physical medical device, not an algorithm.

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

• N/A (Not Applicable in the AI sense). For a physical device, "ground truth" for safety and effectiveness is established by:
  • Bench Testing Standards: e.g., device integrity under stress, embolization effectiveness in a simulated vessel model.
  • Biocompatibility Data: Demonstrating non-toxicity, non-immunogenicity.
  • Sterilization Validation: Proving the device is sterile.
  • Clinical Outcomes Data (if applicable for 510(k), or more extensively for PMA): Patient outcomes (e.g., aneurysm occlusion rates, complication rates, long-term stability) would be the ultimate "ground truth" for effectiveness and safety. However, the 510(k) pathway often relies heavily on non-clinical data and comparison to a predicate, not always requiring extensive new clinical trials.

8. The sample size for the training set

• N/A (Not Applicable). This device is not an AI algorithm, so there is no "training set."

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

• N/A (Not Applicable). As there's no AI, there's no training set or ground truth in this context.

In summary: The provided document is an FDA 510(k) clearance letter for a physical medical device, the TRUFILL DCS ORBIT™ Detachable Coil System. It confirms the device's substantial equivalence to a predicate, allowing it to be marketed. The concepts of AI acceptance criteria, training/test sets, ground truth, experts for AI evaluation, and MRMC studies are not relevant to this document.

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The TRUFILL DCS ORBIT™ Detachable Coil is intended for embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be: very high risk for management by traditional operative techniques, or, 1. inoperable, 2. and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL DCS ORBIT™ Detachable Coil is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Syringe is indicated for use with the TRUFILL® family of Detachable Coils.

The TRUFILL DCS ORBIT™ Detachable Coil System is comprised of the TRUFILL DCS ORBIT™ Detachable Coil and TRUFILL® DCS Syringe.

• The TRUFILL DCS ORBIT™ Detachable Coil consists of a delivery system . (delivery tube and coil introducer) and an embolic coil. The delivery tube segment comprises the body of the device and has the combined functionality of a guidewire and a mini infusion catheter. The coil introducer is a tube designed to protect the detachable embolic coil in the packaging dispenser and provide support for introducing the embolic coil into the infusion catheter. The embolic coil is the implantable segment of the device.
• The TRUFILL® DCS Syringe is used to generate a controlled pressure for . preparation and detachment of the TRUFILL® family of Detachable Coils. The TRUFILL® DCS Syringe consists of a 25-cc barrel with a pressure gauge, a threaded plunger assembly with a locking wing mechanism, and a flexible high-pressure extension tube. The gauge faceplate is calibrated for three settings for use with the TRUFILL® family of Detachable Coils.

The provided text is a 510(k) summary for the TRUFILL DCS ORBIT™ Detachable Coil System. It details the device's intended use, comparison to a predicate device, and summaries of non-clinical performance data.

However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in a format applicable to AI/ML device evaluations. The document describes a traditional medical device submission for substantial equivalence based on in-vitro and animal testing and comparison to a predicate device, not an AI/ML algorithm.

Therefore, I cannot populate the requested table and information points. The information about sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance is not present in this type of submission.

The document discusses "Performance Standards" but states "There are no performance standards applicable under Section 514 of the Food, Drug and Cosmetic Act for Artificial Embolization Devices." This further indicates that the requested type of acceptance criteria and performance study (as would be typical for AI/ML) is not a component of this submission.

In summary, this document is not a study proving an AI/ML device meets acceptance criteria, but rather a 510(k) summary for a physical medical device.

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