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The CO2 Pneumo-Dissector is used to gently dissect planes of soft tissue using short, pressure regulated, trigger-controlled pulses of CO2 gas. The device may be used in both open and laparoscopic procedures in which gentle, blunt dissection of soft tissue planes is desired.

The CO, Pneumo-Dissector is used to gently dissect planes of soft tissue using short, pressure regulated, triggercontrolled pulses of CO, gas. The device may be used in both open and laparoscopic procedures. The primary materials used in this device are stainless steel, acetal, polyvinylchloride. These materials are widely used in the medical field and biocompatibility is assured. Testing to evaluate performance characteristics showed the CO, Pneumo-Dissector to meet device specifications, and accomplish safe and effective blunt tissue dissection.

The provided document is a 510(k) Premarket Notification for the CO2 Pneumo-Dissector, a surgical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance characteristics or clinical study results as one might find for a more complex diagnostic or AI-driven device.

Therefore, much of the requested information about acceptance criteria, specific performance metrics, sample sizes for testing sets, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this type of regulatory submission.

However, I can extract the information that is available and indicate where the requested details are absent.

Acceptance Criteria and Study for CO2 Pneumo-Dissector

This 510(k) Premarket Notification for the CO2 Pneumo-Dissector primarily relies on demonstrating substantial equivalence to existing predicate devices based on design, construction, materials, and intended use, rather than presenting a detailed study with specific acceptance criteria in the manner one would for a novel diagnostic or AI-based device.

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criterion	Reported Device Performance
   Device specifications	"Testing to evaluate performance characteristics showed the CO2 Pneumo-Dissector to meet device specifications..."
   Safe and effective blunt tissue dissection	"...and accomplish safe and effective blunt tissue dissection."
   Biocompatibility	"Biocompatibility is assured."
   Substantial Equivalence to Predicate Devices	"This device meets the requirements for section 510(k) substantial equivalence" based on "indications for use, materials and physical construction to predicate devices."

   Note: The specific numerical or qualitative "specifications" for the device are not detailed in this document. The assessment mentioned is qualitative.

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

   • Sample Size: Not specified. The document mentions "Testing to evaluate performance characteristics" but does not detail the size or nature of this testing (e.g., in-vitro bench testing, animal studies, or human clinical cases).
   • Data Provenance: Not specified.

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

   • Not applicable/Not specified. This type of submission for a surgical instrument does not typically involve ground truth established by experts in the context of diagnostic performance. The focus is on functionality and safety.

4. Adjudication Method for the Test Set:

   • Not applicable/Not specified.

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

   • No, a MRMC comparative effectiveness study was not done or reported. This type of study is relevant for assessing human performance (e.g., radiologists) with and without AI assistance, which is not pertinent to a CO2 surgical dissector.

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

   • No, a standalone algorithm performance study was not done or reported. This device is a physical surgical instrument and does not involve an algorithm. The "performance characteristics" testing would refer to the mechanical and functional aspects of the dissector itself.

7. Type of Ground Truth Used:

   • Not applicable in the context of diagnostic performance. For this device, the "ground truth" implicitly refers to the expected functional performance of a surgical dissector (e.g., successful dissection, controlled pressure, biocompatibility). These are assessed against internal device specifications and general surgical requirements.

8. Sample Size for the Training Set:

   • Not applicable. This device does not use machine learning or require a "training set."

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

   • Not applicable.

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