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The Andrews Introducer™ is specifically designed for the insertion of intercostal chest tubes.

The Andrews Introducer™ is a reusable surgical forceps made of surgical steel that is specifically designed for the insertion of chest tubes. The Andrews Introducer™ is a three-limbed forceps and has three major features:

1. A pivot joint at the fulcrum that opens the tips when the handles are closed using the stronger gripping force of the hand. The extent to which the tips open has been limited so as to reduce the trauma to the intercostal muscle.
2. A vertical extension on each blade that creates a circular channel which is more accurately and appropriately shaped to allow easy passage of the chest tube. The distance between the vertical blades at the fulcrum is 10.7 millimetres, sufficient-to accommodate the diameter of a 32 gauge chest tube, expanding to 22mm at the.
3. A third limb that is attached to the two main limbs through the pivot joint. It is held equidistant from the two main limbs by two leaf springs, which also close the tips when force is relieved from the handles. There is also a grip on the distal end of the third limb to hold the chest tube in position on the instrument for more rapid insertion once the channel has been created.

Here's a breakdown of the acceptance criteria and the study details for the Andrews Introducer™, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document does not explicitly state pre-defined quantitative acceptance criteria (e.g., "95% successful placement rate"). Instead, it presents the results of the feasibility study as evidence that the device meets the intended use and offers improvements over predicate devices. The "acceptance criteria" here are inferred from the study's endpoints and reported outcomes.

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

• Sample Size: 30 patients
• Data Provenance:
  • Country of Origin: Not explicitly stated, but the applicant's address is in Dublin, Ireland, which suggests the study may have been conducted there.
  • Retrospective or Prospective: Prospective. The study was a "clinical feasibility study of the use of the Andrews Introducer™ in an elective surgical setting" where tubes "were instead inserted using the Andrews Introducer™." This indicates a planned intervention for data collection.

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

• The document does not explicitly state the "number of experts" or their "qualifications" involved in establishing ground truth for the test set.
• Instead, the assessment of "successful and accurate placement" and the questionnaire ratings were completed by the "operators" who inserted the chest tubes. These operators would be medical professionals (likely surgeons or cardiothoracic surgeons) trained in chest tube insertion.
• The document doesn't specify any independent review or external expert consensus on the "ground truth" of successful placement; it implicitly relies on the operator's assessment during the procedure.

4. Adjudication Method for the Test Set

• An explicit adjudication method (e.g., 2+1, 3+1) is not described in the provided text.
• The determination of "successful and accurate placement" appears to have been made by the operating physician(s) at the time of the procedure without a described independent adjudication process.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in the traditional sense involving multiple human readers assessing cases with and without AI assistance.
• The study was a clinical feasibility study comparing the device (Andrews Introducer™) to previous experience with a different device (Roberts forceps), not an AI algorithm assisting human readers.
• The comparison was qualitative based on operator experience ("rated as significantly easier relative to experience of use of the Roberts forceps").

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

• Yes, in a manner of speaking, the study was a "standalone" performance study for the device itself.
• The Andrews Introducer™ is a surgical tool, not an AI algorithm. Therefore, the "standalone" performance here refers to its direct application in surgery by a human operator, without any AI component or "human-in-the-loop" interaction in the context of an AI algorithm. The device's performance was evaluated based on its use by the operators.

7. Type of Ground Truth Used

• The ground truth for the test set was primarily based on clinical outcome and operator assessment:
  • "Successful and accurate placement of the chest tube" as assessed by the operating physician/team.
  • Absence of complications.
  • Subjective ratings of ease of use by the operators.

8. Sample Size for the Training Set

• Not applicable / Not explicitly stated. This device is a manual surgical instrument, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The device design and refinement would have involved engineering principles and potentially pre-clinical testing, but not a data-driven "training set."

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

• Not applicable. As a manual surgical instrument, there is no "training set" for which ground truth would be established in the context of AI. The design and manufacturing would adhere to established surgical instrument standards and engineering specifications.

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