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The Inno-Pathwire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).

The Inno-Pathwire is a steerable guidewire available in a diameter of 0.014" (0.36 mm) and an effective length of 190 cm. The distal tip is shapeable. Before use, the tip can be shaped "J". The wire construction includes a stainless steel proximal shaft and a distal super-elastic nitinol shaft for flexibility and performance. The two shafts are connected by a super-elastic nitinol hypotube. The distal shaft is soldered with the tip coil or the tip coil and proximal coil both. For IW-14-190-EXS model, the distal shaft is soldered to the tip coil only but for IW-14-190-STS and IW-14-190-MDS, their distal shafts are soldered to the tip coil and proximal coil both. The tip coil is visible under Xray to assist the physician with the movement of the guidewire. The distal segment of the guidewire, up to the hypotube, is coated with hydrophilic coating to reduce friction for improved guidewire movement within the catheter and arteries. The proximal end of the guidewire is coated with PTFE coating which reduces friction of the wire within a catheter.

The guidewire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire for twisting and controlling the guidewire. The guidewires are packaged within a cardboard box which contains five individual guidewires.

The provided text describes the acceptance criteria and study for the Inno-Pathwire, a medical device, in its 510(k) summary. However, this is a medical device submission for a guidewire, not a software or AI-based device. Therefore, many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable (N/A) for this type of submission.

Here is the information that can be extracted from the provided text, modified to acknowledge the product type:

1. Table of Acceptance Criteria and Reported Device Performance

The following fields are N/A because the Inno-Pathwire is a physical medical device (guidewire), not an AI or software device. The studies described are bench tests and biocompatibility tests, not evaluations of algorithmic performance.

2. Sample size used for the test set and the data provenance: N/A (Not an AI/software device; testing involved physical device samples and materials)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (Ground truth is based on engineering specifications, material science, and biological testing standards)
4. Adjudication method for the test set: N/A (Not an AI/software device evaluation)
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 an AI/software device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI/software device)
7. The type of ground truth used: For physical performance tests, the "ground truth" is defined by established engineering and medical device standards (e.g., ISO, ASTM) and the expected physical and chemical properties of the materials. For biocompatibility, it's the biological response measured against toxicity, irritation, and other harmful effects as defined by ISO 10993 standards.
8. The sample size for the training set: N/A (Not an AI/software device; no "training set" in the AI sense)
9. How the ground truth for the training set was established: N/A (Not an AI/software device)

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The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. This device is not intended for neurovascular or coronary use.

The Inno-Hydrowire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures. It is provided sterile and is intended for single use only. It consists of a Nickel-Titanium alloy core wire; a polymer coating (Pebax containing BaSO4 for X-Ray visibility); and a hydrophilic coating applied to the entire wire. There are two shaft configurations: standard and stiff. There are two distal tip shapes: straight and angled. The Inno-Hydrowire includes a 3cm flexible tip. The Inno-Hydrowire is packaged in a plastic dispenser that is contained within an individual package. A Torquer is included which connects to the proximal end of the guidewire utilized for rotating and controlling the guidewire. The Hydrowires are packaged within a cardboard box which contains five individual guidewires.

The provided text describes a 510(k) summary for the Inno-Hydrowire, a catheter guide wire. The purpose of a 510(k) submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process typically relies on non-clinical performance testing and biocompatibility testing, rather than studies involving expert readers, AI assistance, or complex ground truth establishment as seen in diagnostic AI devices.

Therefore, many of the requested categories are not applicable to this type of device submission.

Here's an analysis based on the provided document:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a directly comparable format for each test. Instead, it lists the performance tests conducted and then states that "The results of the following performance tests have demonstrated substantial equivalence to the predicate device" and that "Test results for all biocompatibility testing met the applicable test requirements."

Inferred Acceptance Criteria (Based on tested parameters): The acceptance criteria are implicitly defined by compliance with established medical device standards and the substantial equivalence to the predicate device for each performance characteristic.

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

The document describes non-clinical performance testing and biocompatibility testing. These tests are typically conducted on a specific number of device samples or using specific biological models (e.g., rabbits for pyrogenicity, dogs for thrombogenicity). The document does not specify the exact sample sizes for each individual test, nor does it refer to a "test set" in the context of human data or image data. Data provenance (country of origin, retrospective/prospective) is not relevant for these types of non-clinical tests.

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

This is not applicable. The device is a physical guidewire; there is no "ground truth" established by human experts in the context of diagnostic performance or image interpretation. The "ground truth" for its performance is instead defined by objective physical and chemical properties measured according to international standards (e.g., tensile strength, biocompatibility profiles).

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

This is not applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, often in diagnostic contexts. The tests performed for this guidewire are objective and standardized, not requiring human adjudication of results.

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. This document describes the substantial equivalence evaluation for a medical device (a guidewire), not an AI-powered diagnostic tool. Therefore, MRMC studies, human reader improvement with AI, or effect sizes are not relevant.

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

This is not applicable. The Inno-Hydrowire is a manually operated physical medical device, not an algorithm or AI system.

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

The "ground truth" for evaluating the Inno-Hydrowire is defined by:

• International Standards: Compliance with ISO 11070:2014 for physical performance and ISO 10993 series for biocompatibility, and ISO 11135 for sterilization.
• Predicate Device Performance: The primary method of demonstrating safety and effectiveness for a 510(k) device is by showing substantial equivalence to a legally marketed predicate device (Terumo Radifocus® Guidewire, K863138). This means the Inno-Hydrowire's performance characteristics must fall within acceptable ranges similar to the predicate under the specified test conditions.

8. The sample size for the training set

This is not applicable. The Inno-Hydrowire is a physical medical device, not a machine learning model; therefore, there is no "training set."

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

This is not applicable for the same reason as point 8.

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