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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 Detachable Coil System 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, a) b) inoperable, and for embolizing other vascular malformations such as arteriovenous malformations and arteriovenous fistulae of the neurovasculature. The TRUFILL® DCS Detachable Coil System is also intended for arterial and venous embolizations in the peripheral vasculature. The TRUFILL® DCS Detachable Syringe is indicated for use with the TRUFILL® DCS TRUFILL® DCS Syringe Intended Detachable Coil. Use

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

• The TRUFILL® DCS Detachable Coil consists of a delivery system (delivery tube and . coil introducer) and an embolic coil. The delivery tube is comprised of a hub, a strain relief, a stiff proximal section, and a floppy distal section. 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 microcatheter. The embolic coil is the implantable segment of the device. It is comprised of a vasocclusion coil wound from a platinum alloy wire (92% Platinum / 8% Tungsten) into a primary coil and then formed into a secondary helical or complex shape.
• 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 with a male luer connector.

The provided text is a 510(k) Summary of Safety and Effectiveness for a medical device (TRUFILL® DCS Detachable Coil System). It focuses on demonstrating substantial equivalence to a predicate device rather than establishing novel acceptance criteria or presenting a standalone study for the device's performance against specific metrics.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth establishment are not present in this document.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

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

This information is not explicitly provided in terms of numerical acceptance criteria or performance metrics. The document instead focuses on comparative characteristics and "comparable safety and effectiveness" to a predicate device.

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

This information is not provided. The document broadly mentions "clinical testing" but does not detail the size or nature of the test set, nor its provenance or study design (retrospective/prospective).

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)

This information is not provided. The concept of "ground truth" establishment by experts for a test set is not discussed in the context of this 510(k) summary.

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

This information is not provided. Adjudication methods are not discussed.

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

An MRMC study is not mentioned and is not relevant for this type of device (an embolization coil, not an AI diagnostic tool).

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

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

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

This information is not explicitly stated as the framework of "ground truth" against specific criteria is not detailed. The study's "clinical testing" likely refers to patient outcomes or clinical observations, but specifics are missing.

8. The sample size for the training set

This information is not provided. A "training set" in the context of machine learning is not applicable here. While there were "animal studies" and "in-vitro" testing, their sample sizes are not specified.

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

This information is not applicable/provided. The concept of "ground truth for a training set" is for AI models, not for a physical medical device's testing directly.

Summary of Study and Device Performance (Based on provided text):

The study described is a comparative study aiming to demonstrate "substantial equivalence" of the TRUFILL® DCS Detachable Coil System to a predicate device, Target's Guglielmi Detachable Coil (GDC).

Acceptance Criteria (Implied by Substantial Equivalence):

The acceptance criteria are implicitly that the TRUFILL® DCS Detachable Coil System performs as safely and effectively as the predicate device (Target's GDC) across various characteristics and biological interactions. This is assessed through:

• Comparative Characteristics: Matching or being comparable in design, materials, and functional aspects to the predicate device.
• Non-Clinical Performance Data: Showing acceptable performance in in-vitro and animal tests.
• Clinical Data: Demonstrating comparable safety and effectiveness in human use.

Table of Performance (Based on Comparative Characteristics):

The Study:

The study proving the device meets the acceptance criteria (of substantial equivalence) consisted of:

• In-vitro testing:
  • Embolic coil radiopacity
  • Markerband radiopacity
  • Embolic coil softness
  • Force exerted on the wall of a simulated aneurysm
  • Force required to push the device through a microcatheter
  • Migration in a simulated worst-case fistula model
  • Distal tip softness
  • Distal tip angular displacement
• Animal studies
• Biocompatibility tests
• Clinical testing: Demonstrated "comparable safety and effectiveness to the predicate device."

Conclusion: Results of in-vitro, animal, and clinical testing demonstrated that the TRUFILL® DCS Detachable Coil System is substantially equivalent to the predicate device, Target's GDC.

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