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The CAOW Hemostasis System can be used to provide hemostasis for femoral arterial and venous punctures associated with an angiogram, angioplasty, coronary stent placement or other invasive cardiac or radiological procedures.

The CAOW Hemostasis System consists of a pole-mounted C-clamp with movable upper and lower arms. A single-use, sterile acrylic plastic pad attached to the upper arm provides hemostasis by controlled compression of the arterial puncture site.

Here's an analysis of the acceptance criteria and study information for the CAOW Hemostasis System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device submitted to the FDA in 1998. It is a regulatory document, not a scientific publication detailing a clinical trial with specific methodologies for determining device performance statistically. Therefore, much of the requested information (like specific acceptance criteria values, extensive detail on study design for performance, MRMC studies, or detailed ground truth establishment for training sets) is not present in this type of summary. The summary focuses on demonstrating substantial equivalence to predicate devices, which often involves comparing safety and effectiveness, but not necessarily defining and proving performance against pre-specified numerical acceptance criteria in the same way a modern clinical trial report would.

The document states that a "clinical study demonstrated the safety and proper performance of the CAOW Hemostasis System." However, it does not provide the specific details of this study, nor does it list numerical acceptance criteria with corresponding performance metrics from that study in the way typically requested.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, the document does not explicitly state numerical acceptance criteria for its performance or success in terms of hemostasis, nor does it report specific quantified performance metrics from a clinical study within the provided text. The statement is broad: "a clinical study demonstrated the safety and proper performance of the CAOW Hemostasis System."

Therefore, a table cannot be accurately constructed with specific numerical values for acceptance criteria and reported performance based solely on the provided text. The "acceptance" is implied by the FDA's
510(k) clearance, which means the device was found to be "substantially equivalent" to legally marketed predicate devices in terms of safety and effectiveness.

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

• Sample Size for Test Set: Not specified in the provided text. The document only states "a clinical study."
• Data Provenance: Not specified. It's unclear if the study was conducted in Canada (where the applicant is located) or elsewhere. The document doesn't mention if it was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
• Role in Ground Truth: The document does not describe how "ground truth" was established for a clinical performance study. For a hemostasis device, ground truth would typically relate to successful cessation of bleeding, complication rates, time to hemostasis, etc., which would be assessed by clinical staff involved in the procedure and patient care. Details on the methodology for this assessment are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The summary does not provide details on the study's design or how outcomes were assessed or adjudicated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, this type of study is not applicable. MRMC studies are typically used for diagnostic or screening devices where multiple human readers interpret images or data, and their performance with and without an AI algorithm is compared. The CAOW Hemostasis System is a mechanical therapeutic device, not a diagnostic imaging system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: No, this is not applicable. The CAOW Hemostasis System is a mechanical device that requires human application and monitoring. It does not have an "algorithm" in the sense of AI or software that operates independently.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated or detailed. For a hemostasis device, "ground truth" would generally refer to observed clinical outcomes such as:
  • Successful achievement of hemostasis (defined by absence of bleeding or oozing).
  • Time to hemostasis.
  • Absence of complications (e.g., hematoma formation, pseudoaneurysm, nerve damage, infection related to the device application).
    These would be assessed by medical professionals. The specific methodologies for defining and collecting these outcomes as "ground truth" are not provided.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The CAOW Hemostasis System is a mechanical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The clinical study mentioned would be for validation of the device's performance, not for "training" an algorithm.

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

• Ground Truth for Training Set: Not applicable, as there is no "training set" for a mechanical device.

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