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The MTI Reinforced Infusion Catheter is intended to be used for the controlled selective infusion of physician-specified pharmacologic agents or radiopaque contrast media into the general vasculature.

The MTI TruLine™ Reinforced Infusion Catheter is a single-lumen plastic catheter designed to be introduced over a guidewire into the vasculature. Once positioned, various pharmacological agents may be delivered through a standard luer lock adapter at the proximal end. The infusion area is indicated by distal and proximal radiopaque markers to facilitate fluoroscopic visualization. The reinforced Infusion catheters are available in a variety of infusion lengths.

The provided text describes a Special 510(k) submission for the Micro Therapeutics, Inc. TruLine™ Reinforced Valved Infusion Catheter (K021139). This submission focuses on establishing substantial equivalence to a predicate device, which usually involves a different type of testing than what would be described for an AI/ML powered device, and therefore does not include detailed information on acceptance criteria and a study design in the way an AI/ML device would.

Based on the information provided, here's what can be extracted and what is not applicable:

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

The document does not provide a table with specific, quantifiable acceptance criteria and corresponding performance metrics in the way an AI/ML device submission would. Instead, it states that "All testing yielded acceptable results" for a range of physical and biocompatibility tests.

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 specify sample sizes for any of the performance tests. It also does not mention data provenance as it pertains to a clinical test set. The testing described is in-vitro performance testing and biocompatibility testing, not clinical trials with human participant data.

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)

Not applicable. The ground truth for this type of device (an infusion catheter) is established through standardized engineering and biocompatibility testing, not expert interpretation of clinical data.

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

Not applicable. This concept applies to human interpretation of data, typically in clinical studies, which is not described here.

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

Not applicable. This device is not an AI/ML product for interpretation or diagnostic assistance.

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

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

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

For the biocompatibility testing, the ground truth is established by adherence to ISO 10993-1 standards and the specific endpoints defined within those tests (e.g., cytotoxicity, sensitization, irritation).

For the in-vitro performance testing (dimensional, tensile, burst, flow rate, cyclic fatigue), the "ground truth" is defined by pre-established engineering specifications and performance limits for the device. The device's performance is compared against these engineering standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML product and does not involve a "training set" in that context.

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

Not applicable.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided information indicates that the device's acceptable performance and substantial equivalence were established through:

• Biocompatibility Testing: Conducted in accordance with ISO 10993-1, Biological Evaluation of Medical Devices. This testing confirmed the biocompatibility of the catheter for its intended use as an external communicating, blood contact, limited exposure (<24 hrs) device.
• In-vitro Performance Testing: Included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, cyclic fatigue tests, and performance under simulated conditions. The submission states that "All testing yielded acceptable results," implying that the device met pre-defined engineering specifications and performance criteria for each of these physical and functional characteristics.

The document emphasizes that this testing verified the device's performance and confirmed its substantial equivalence to the predicate device in terms of intended use and principles of operation, rather than detailing a clinical study with quantifiable metrics often found in AI/ML device submissions.

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