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When applied by a trained health care professional, the TZ Medical ARC™ device is indicated to assist in controlled compression hemostasis of the radial artery after a transradial procedure; the device is indicated to compress the radial artery access puncture site in order to achieve hemostasis and maintain patency of the radial artery (patent hemostasis).

The TZ Medial ARC Adjustable Radial Cuff "ARC" compression device is used at the end of a Transradial catheterization procedures to provide hemostasis of the radial artery at the access site. The ridged brace designed radial compression device consisting of a rigid polycarbonate "C" shaped brace, a flexible strap containing a PVC backing, hook and loop fasteners, and two buckles which attach to the ends of the brace, a collapsible bubble fixed to an adjustable slider with an air fill tube and universal luer lock, as well as back pad opposite of the bubble for patient comfort. Each device also includes a standard 20cc male luer locking syringe.

The Cuff is positioned around the patient's wrist and secured in place by fastening and tightening the Back Hook and Strap Assembly. As the introducer sheath is removed from the patient's wrist, pressure is applied to the access site by inflating the compression bubble of the ARC device. The bubble is inflated when air is injected through a luer lock air injection port which assures the desired air volume/pressure remains in the compression bubble. The volume/pressure in the bubble can be titrated by the physician to meet the hemodynamic needs of the patient by increasing or decreasing the volume in the ARC device bubble.

The ARC devices is intended for a single use only with a Functional life is less than 24 hours. This device is individually packaged and sterilized by ethylene oxide gas.

The provided text describes a 510(k) premarket notification for the "ARC Adjustable Radial Cuff Compression Device." This document outlines the device's indications for use, its comparison to a predicate device (Terumo TR Band), and mentions performance testing conducted to verify conformity to applicable standards. However, it does not describe a study that involves an AI/ML device, nor does it contain information related to acceptance criteria or performance metrics such as those typically found in clinical trials for diagnostic or AI-assisted devices (e.g., sensitivity, specificity, AUC).

The document primarily focuses on demonstrating substantial equivalence to a predicate device for a physical medical device (a vascular clamp/compression device). The "Performance Testing" section (M) refers to verification of conformity to external and internal standards (e.g., ISO standards for biological evaluation, risk management, sterilization, quality management, packaging). It also mentions Design Verification (DV) functional performance testing which included in-vitro engineering and bench testing on components.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI device meets those criteria, as the provided text does not pertain to such a device or study.

If you have a different document or context related to an AI/ML medical device, please provide it, and I will do my best to answer your detailed questions.

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The TZ Medical skull pin is placed in a clamp and is applied to the patient's skull to hold their head and neck securely in a particular position when rigid fixation is desired. The clamp is indicated for use in open and percutaneous craniotomies as well as spinal surgery when rigid fixation is necessary.

The TZ Skull Pin is a sterile cervical traction skull pin manufactured from implant grade 316L stainless steel alloy. The TZ Skull Pin is used during neurosurgical procedures to immobilize the head in reference to the torso and to provide cervical immobilization.

Here's a breakdown of the acceptance criteria and study information for the TZ Skull Pin Adult device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact sample sizes (number of pins or animals) for each specific test in the "Summary of Performance Testing" section. It refers to testing being conducted but provides general results rather than specific numerical data for each test condition. The studies are laboratory-based and use animal models for biocompatibility tests (guinea pigs, rabbits, mice) and mechanical testing of the pins. Data provenance is implied to be from the manufacturer's internal testing as part of their 510(k) submission.

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

This information is not applicable and not provided in the document. The tests performed are primarily mechanical and biological (biocompatibility) evaluations based on established international standards (ASTM and ISO), not human reader evaluations or clinical trials. The "ground truth" for these tests is defined by the specific parameters and outcomes outlined in the referenced standards (e.g., absence of cell lysis, holding a load without failure).

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for human reader studies to establish a consensus ground truth. The tests described are objective, laboratory-based evaluations against predetermined criteria.

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 information is not applicable. The TZ Skull Pin is a physical medical device (neurosurgical skull pin), not an AI algorithm or an imaging device to be read by human experts. Therefore, no MRMC study or AI-related comparative effectiveness study was performed or is relevant to this device's submission.

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

This information is not applicable. As explained above, this device is a physical skull pin, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests (Skull Pin System Testing, Max Load Test, Creep Test) is defined by the pass/fail criteria of established engineering standards, specifically ASTM F1831-97 (implicitly referenced for performance) and the general requirement that the device performs safely and effectively without material failure or slipping.

For the biocompatibility studies (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity), the ground truth is defined by the objective criteria and endpoints specified in the relevant international ISO standards (ISO 10993-5, ISO 10993-10, ISO 10993-11), such as the absence of cell lysis, dermal contact sensitization, irritation, or systemic toxicity.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this physical medical device. Training sets are relevant for machine learning algorithms.

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

This information is not applicable, as there is no training set for this device.

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