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The Haskal™ Torque Device is intended to facilitate steering of guidewires during interventional procedures.

The Haskal™ Torque Device is a one-piece molded unit with rows of interlocking "teeth". When the sides of the device are squeezed, the "teeth" line up and a groove is exposed in the center. The device is then positioned with the guidewire in the groove. When the sides are released, the device "teeth" close onto the guidewire to secure it firmly. The Haskal™ accommodates guidewires with diameters between 0.010 inches to 0.038 inches.

The Haskal™ is designed to be mounted onto the guidewire from the side with one hand, eliminating the need for threading along the wire starting from the distal end. It can also be released from the guide wire or repositioned as the guide wire advances by squeezing it on both sides to release the wire.

The Haskal™ is a sterile, non-pyrogenic single use device. It is manufactured in several colors.

The provided text describes the Haskal™ Torque Device, a medical device intended to facilitate steering of guidewires during interventional procedures. The text primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval (510(k) K100425).

Here’s an analysis of the acceptance criteria and the study information based on the provided text, while explicitly noting what information is not available:

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

The document does not explicitly present specific numerical acceptance criteria (e.g., minimum torque force, maximum operational force thresholds) or corresponding reported performance values in a table. It states that "Results of nonclinical testing demonstrated that the device is as safe, as effective, and performs as well as the legally marketed devices identified in paragraph 5 of this section," implying that the device met internal or regulatory expectations for each test.

The studies performed are listed as:

• Packaging Environmental Endurance
• Dimensions Verification
• Device and Guidewire Axial Force
• Torque Force
• Device Operational Force
• Performance During Exposure to Fluids
• Usability
• Sterility Integrity and Shelf life
• Biocompatibility (Cytotoxicity, Systemic toxicity, Sensitization, Irritation, Subchronic toxicity, Genotoxicity, Haemocompatibility- Hemolysis)

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

• Sample size for test set: Not specified. The document repeatedly refers to "in-vitro/bench studies," which typically involve a certain number of units or measurements, but these numbers are not provided.
• Data provenance: Not specified, other than being "in-vitro/bench studies." It does not mention country of origin, nor whether the studies were retrospective or prospective.

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 information is not applicable to the type of studies described. The "Haskal™ Torque Device" is a mechanical tool used to manipulate guidewires. Its performance is evaluated through bench testing (e.g., force measurements, usability assessment), not by interpretation of images or patient data requiring expert clinical judgment as "ground truth." Therefore, there were no experts establishing ground truth in the sense of clinical diagnoses or interpretations.

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

Not applicable. Adjudication methods are typically used in studies where human readers or experts are disagreeing on interpretations (e.g., image readings). Since this device underwent bench testing, not a reader study, no adjudication method was relevant or performed.

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

• MRMC study: No. The document describes laboratory bench testing and mechanical performance evaluation for a physical medical device (a torque device), not an AI algorithm or an imaging diagnostic tool. Therefore, an MRMC study was not conducted.
• Effect size of human reader improvement: Not applicable, as no MRMC study was performed.

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

• Standalone performance: Not applicable. The Haskal™ Torque Device is a physical, hand-operated tool. It is not an algorithm, and it always functions with human interaction to "steer guidewires." The "performance" described refers to the mechanical and physical characteristics of the device itself (e.g., torque force, operational force, biocompatibility), which are inherently "standalone" in the sense that they are properties of the device, not an algorithm's output.

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

The concept of "ground truth" as clinical diagnosis or outcomes data is not applicable to this device's evaluation. For mechanical device testing, the "ground truth" would be established by:

• Reference standards for dimensions and material properties.
• Calibrated instruments for measuring forces (axial, torque, operational).
• Standardized protocols for evaluating usability.
• Laboratory tests (e.g., ISO standards) for biocompatibility and sterility.
  Essentially, the ground truth is derived from objective, quantifiable measurements against established engineering and safety standards.

8. The sample size for the training set

Not applicable. The Haskal™ Torque Device is a physical medical device. It does not involve any artificial intelligence or machine learning component, therefore there are no "training sets" in the context of an algorithm.

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

Not applicable, as there is no training set for this device.

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