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To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
To facilitate the placement of equipment such as compatible stent devices during other diagnostic or therapeutic intravascular procedures.

The ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire with Microglide® Coating is a steerable guide wire with a nominal diameter of 0.014″ and two lengths: a 190 cm extendable length and a 300 cm exchange length. The proximal end of the 190 cm models is tapered to fit into the hypotube portion of the ACS DOC® Guide Wire Extension (K902755, cleared September 4, 1990). The proximal shaft of this guide wire is coated with polytetrafluoroethylene (PTFE) and the distal working end is coated with Microglide® Coating, a silicon based material. The distal end has a 3 cm, flexible, radiopaque tip that is provided either as a straight, shapeable configuration or as a preshaped J configuration. These guide wires have proximal markers at 90 and 100 cm from the distal tip.
Two features distinguish the new guide wire from the predicate guide wire: the addition of a segment of tetrafluoroethylene (TFE) shrink tubing around the distal portion of the guide wire proximal to the 3 cm tip and a more flexible 3 cm tip.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACS HI-TORQUE ALL STAR™ 0.014" Guide Wire:

The provided document describes a 510(k) submission for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials with detailed statistical analysis as might be seen for novel devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists performance tests conducted, but unfortunately, it does not explicitly state the specific quantitative acceptance criteria for each test. Instead, it states that the device "met acceptance criteria" and "performed similar to the predicate" or "performed in a manner equivalent to the ACS HI-TORQUE EXTRA S'PORT™ 0.014″ Guide Wire."

• Distal Tip Pull Test
• Distal Tip Turns-to-Failure Test
• Rotational Accuracy Test
• Tip Flexibility Test |
  | Not explicitly stated (implied to be parity/non-inferiority to predicate) | In vivo animal testing: Performed in a manner equivalent to the predicate guide wire in a canine model with healthy coronary arteries. |

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

• Bench Tests: The specific sample sizes for each of the four bench tests (Distal Tip Pull, Distal Tip Turns-to-Failure, Rotational Accuracy, Tip Flexibility) are not provided in the summary.
• Animal Testing: The sample size (number of animals) for the canine model testing is not provided.
• Data Provenance:
  • Bench Tests: Performed in a laboratory setting. No country of origin is specified, but given the submitter's address in Temecula, CA, USA, it's highly likely to be U.S.-based. This would be considered a controlled prospective test.
  • Animal Testing: Conducted in a canine model with healthy coronary arteries. This is an in vivo animal study, not human data. The specific location and whether it was retrospective or prospective is not stated, but animal studies are typically prospective by design.

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

• This information is not applicable and therefore not provided in the context of this device submission. The tests performed are engineering/performance-based (bench tests) and animal studies, which do not typically involve human experts establishing clinical "ground truth" in the way a diagnostic AI device would. The "ground truth" in this context would be the objective measurements from the bench tests and observations from the animal study.

4. Adjudication Method for the Test Set

• This information is not applicable and therefore not provided. As explained above, for engineering performance tests and animal studies, there isn't a need for expert adjudication in the same way there would be for a clinical diagnostic study involving subjective interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret images or data, and AI assistance is being evaluated. This device is a guide wire, which is an interventional tool, not a diagnostic AI device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This information is not applicable. The device is a physical medical instrument (guide wire), not an algorithm or AI software. All performance tests are inherently standalone in the sense that they evaluate the physical properties and performance of the guide wire itself, without human-in-the-loop interaction as a performance variable.

7. Type of Ground Truth Used

• Bench Tests: The ground truth for the bench tests would be the established engineering specifications and measurement standards for guide wire performance (e.g., specific force required for pull, number of turns to failure, degree of rotational accuracy, flexibility measurements).
• Animal Testing: The ground truth for the animal testing would be direct observation of the guide wire's performance in vivo within the canine coronary anatomy, assessed through methods like fluoroscopy or necropsy, and compared against the control (predicate device).

8. Sample Size for the Training Set

• This information is not applicable and therefore not provided. This device is a physical medical product, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• This information is not applicable as there is no training set for a physical medical device.

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