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The Concerto Versa™ Detachable Coil is indicated for arterial and venous embolization in the peripheral vasculature.

The Concerto Versa™ Detachable Coil is an embolization coil that consists of a platinum embolization coil attached to a composite delivery pusher, and a hand-held Instant Detacher (I.D.) which, when activated, detaches the coil from the delivery pusher tip. The Instant Detacher is an accessory sold separately and was most recently cleared in K162704. The Concerto Versa™ Detachable Coil is supplied sterile and is intended for single-use only.

The provided document is a 510(k) summary for the Concerto Versa™ Detachable Coil. This document pertains to a medical device (an embolization coil) and does not describe a study involving an AI/Machine Learning device or a diagnostic device. Therefore, many of the requested categories, such as "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Training set," and "Ground truth for training set," are not applicable to this submission.

The document primarily focuses on demonstrating the substantial equivalence of the new device (Concerto Versa™ Detachable Coil) to a legally marketed predicate device (Concerto Detachable Coil System) through a series of bench tests and leveraging existing data from the predicate. The "acceptance criteria" are implicitly the passing results of these non-clinical tests.

Here's the information that can be extracted and how it relates to the request:

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are generally "Pass" for each test, indicating that the device met the specified performance requirements. The document does not provide specific numerical criteria for each test beyond stating they "meet specification."

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

• Sample Size: The document does not explicitly state the specific number of coils or test replicates used for each bench test conducted on the Concerto Versa™ Detachable Coil. It states that "A subset of design verification testing was conducted."
• Data Provenance: The tests were "non-clinical bench testing." The document mentions "clinically relevant tortuosity model of the splenic and gastroduodenal arteries" which implies in-vitro testing. It also states that "GLP acute animal data was also leveraged from the predicate device," indicating some previous animal study data was used, but not for the subject device's new testing.
• Retrospective or Prospective: The testing performed for this submission would be considered prospective for the subject device, as it was specifically done for this 510(k) submission.

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

Not applicable. This is a medical device submission based on physical and mechanical performance testing, not a diagnostic device requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

Not applicable. No expert adjudication process is described as it's not a diagnostic study.

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

No, this was not an MRMC comparative effectiveness study. It is a 510(k) submission for a non-diagnostic medical device.

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

Not applicable. This is a medical device, not an algorithm. The performance evaluation is based on mechanical and physical characteristics.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance tests is the defined engineering and material specifications for the device. For example, a coil's length must meet a certain specification, or its detachment time must be below a certain threshold. There's no "ground truth" derived from patient outcomes or expert consensus in the typical sense for a diagnostic device. Biocompatibility was evaluated against ISO 10993 standards.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

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The Spartan eCoil™ System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The System is also indicated for arterial and venous embolizations in the peripheral vasculature.

The Spartan eCoil™ System is a mechanically detachable embolic coil system that consists of an embolic coil (the Spartan eCoil™) attached to a delivery wire with a fluoroscopic marker band and the system is housed in an introducer sheath. The system is provided sterile and requires no additional equipment to be employed by the user.

The Spartan Micro, Inc. Spartan eCoil™ System is a neurovascular embolization device. The provided text from the 510(k) summary indicates that no clinical or animal testing was performed for this device to prove its acceptance criteria because it was deemed substantially equivalent to a predicate device (Micro Therapeutics Inc. Axium Prime Detachable Coil System - K162704). Therefore, the acceptance criteria are met through bench testing and assessments that confirm its performance is similar to or better than the predicate device, and through biocompatibility and sterilization testing.

Here's a breakdown of the requested information based on the provided document:

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

Since no specific numerical acceptance criteria are explicitly stated for each test (e.g., "tensile strength must be >X Newtons"), the performance is generally reported as "Pass" or "Equivalent" when compared to the predicate device or a minimum acceptable specification limit.

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

The document does not explicitly state the specific sample sizes used for each bench test. For the animal study (implantation in rabbits, sub-acute/sub-chronic toxicity in mice), the sample sizes are not provided either.
The data provenance is not mentioned. Given it's a 510(k) submission to the FDA, it is expected that the studies adhered to relevant US regulations and standards, but the country of origin of the actual testing is not specified. All tests were non-clinical (bench and animal, where specified) and are essentially prospective studies conducted specifically for this submission.

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 section is not applicable as there was no clinical study involving human patients to establish a medical ground truth (e.g., disease presence). The "ground truth" for the performance and biocompatibility tests was based on established engineering specifications, ASTM standards, ISO standards (for biocompatibility), and comparison to the predicate device's known performance.

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

This is not applicable as there were no subjective clinical assessments requiring adjudication. The tests conducted were objective physical, mechanical, and biological evaluations against defined standards or comparisons.

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

This is not applicable. The Spartan eCoil™ System is a physical medical device (an embolization coil), not an AI/software device. There were no human readers or AI involved in evaluating its performance in the context of effectiveness against a disease or condition.

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

This is not applicable, as the device is not an algorithm or AI system.

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

The "ground truth" for the evaluation of this device was established based on:

• Engineering specifications and standards: Many bench tests refer to "minimum acceptable specification limit" or comparison to "accepted values."
• ASTM and ISO standards: For material properties, corrosion, MRI compatibility, and biocompatibility testing.
• Predicate device comparison: Performance parity or superiority to the legally marketed predicate device (Micro Therapeutics Inc. Axium Prime Detachable Coil System - K162704) was a primary "ground truth" for substantial equivalence.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning model that requires a training set.

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

This is not applicable as the device is not an AI/machine learning model.

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