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The OTW Takeru PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion in the coronary artery or bypass graft stenosis for the purpose of myocardial perfusion.

This product (balloon models 2.0 – 5.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents.

OTW Takeru PTCA Balloon Dilatation Catheter (OTW Takeru) is an over-the-wire balloon dilation catheter, which consists of a distal tube, mid tube, proximal tube, balloon, guidewire transition tube, radiopaque marker(s), manifold, and strain relief. A balloon is attached to the distal end of the catheter, and it can be inflated and deflated using the inflation device connected to the manifold at the proximal end. OTW Takeru has a lumen at the distal end of the catheter through which a guidewire can be inserted. This lumen extends from the distal end of the catheter to the guidewire port on the manifold for the guidewire.

The maximum compatible diameter of a guidewire used together with OTW Takeru in a PTCA procedure is 0.014 inches. Additionally, guiding catheters with a diameter of 5 or 6 Fr have been deemed to be compatible with OTW Takeru. The nominal inflated balloon diameters range from 1.5 mm to 5.0 mm with balloon working lengths of 6 mm to 30 mm. The catheter working length is 1450 mm.

This document is a 510(k) premarket notification for the OTW Takeru PTCA Balloon Dilatation Catheter. It describes the device, its indications for use, and its comparison to predicate devices, along with performance and biocompatibility testing. The document states that the device met all predetermined acceptance criteria, but it does not provide specific acceptance criteria or detailed study results for a device that involves AI (artificial intelligence) or includes human-in-the-loop performance. This device is a physical medical device (catheter) and the testing described is related to its physical properties and biocompatibility.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details related to AI or human-in-the-loop performance, as this information is not present in the provided text.

Based on the provided text, here is the information related to the device's acceptance criteria and the studies conducted:

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

The document broadly states: "The OTW Takeru met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, specific numerical acceptance criteria and their corresponding reported device performance values are not provided in this summary.

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

The document describes "in vitro tests" and "biocompatibility testing." These are laboratory, bench-top, and biological tests, not clinical studies involving data from patients or human subjects in the typical sense of AI studies. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) as they apply to clinical data or AI model evaluation are not applicable to the testing described here. No specific sample sizes for these bench tests are mentioned in the summary.

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 question is related to establishing ground truth for clinical data, usually in the context of AI model development or evaluation where human experts annotate or interpret data. This is not applicable to the performance testing described for this physical medical device.

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

This question is related to how discrepancies in expert ground truth assessment are resolved in clinical data annotation for AI. This is not applicable to the performance testing described for this physical medical device.

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

The document does not describe an MRMC comparative effectiveness study. This type of study is relevant for evaluating the impact of AI assistance on human performance in diagnostic tasks, which is not applicable to the evaluation of this balloon dilatation catheter.

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

The device is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not applicable.

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

For the performance testing mentioned (e.g., "Balloon Rated Burst Pressure"), the "ground truth" would be established by validated measurement methods and engineering standards, not through expert consensus or pathology in a clinical data context. For biocompatibility, the ground truth is established by the results of standardized biological tests.

8. The sample size for the training set

This question is relevant for AI model development. This is not applicable as the device is a physical medical device, not an AI system.

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

This question is relevant for AI model development. This is not applicable as the device is a physical medical device, not an AI system.

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