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Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments are designed to transmit cutting, clamping, grasping, suturing and dissecting force to working tips in minimally invasive surgeries such as plastic and general laparoscopic procedures.

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments consists of a handle, shaft and insert. The insert contains an end-effector (jaw pattern). There are several device models that encompass various lengths, diameters and jaw patterns based on the surgeon's needs.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments:

Based on the provided 510(k) Summary (K151036), this document describes a medical device modification (design change from single-piece to take-apart) rather than an AI/algorithm-based product. Therefore, many of the requested points related to AI/algorithm studies (like human-in-the-loop performance, training sets, etc.) are not applicable to this submission.

The acceptance criteria and supporting study are focused on ensuring the modified physical device maintains its safety and effectiveness compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes (e.g., number of instruments tested) for each non-clinical performance test. It only states that the tests were conducted and the device "PASSED" the criteria.

Data provenance: Not explicitly stated, but these are typically retrospective non-clinical engineering and laboratory tests conducted by the manufacturer, CareFusion 2200 Inc. The country of origin of the data would likely be the location where CareFusion performs its product testing, which can be global, but typically for FDA submissions, the testing adheres to international (ISO) and US (AAMI, ANSI) standards.

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

This question is not applicable. The "ground truth" for physical device performance tests like strength, pull, force, reliability, cleaning validation, and biocompatibility is established by engineering specifications, recognized national and international standards (e.g., AAMI, ANSI, ISO), and regulatory requirements, not by expert medical opinion in the same way an AI model's diagnostic accuracy might be judged. These tests are objective measurements against defined thresholds.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's ambiguity in classifying clinical data for ground truth establishment. For the objective non-clinical performance tests mentioned, the results are typically quantitative measurements that either meet or fail pre-defined acceptance limits based on standards and engineering requirements.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "N/A - No clinical tests were conducted for this submission." MRMC studies are typically for evaluating diagnostic accuracy or clinical effectiveness, often involving human readers and AI assistance, neither of which is present in this submission.

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

No, a standalone study (referring to an algorithm's performance) was not done. This submission is for a physical surgical instrument, not an AI or algorithm-based device.

7. Type of Ground Truth Used

The "ground truth" for the performance tests undertaken are:

• Engineering Specifications and Design Requirements: For parameters like instrument strength, inadvertent disassembly, ease of disassembly/reassembly, handle reusability, and handle compatibility. These are defined by the manufacturer based on expected operational loads and user interaction.
• National and International Standards: For aspects like cleanability and sterilizability (e.g., AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ANSI AAMI ST81, ISO 11138, ISO 17664, ISO 17665) and biocompatibility (ISO 10993). These standards provide objective criteria and methodologies for testing.

8. Sample Size for the Training Set

This question is not applicable. There is no AI/algorithm, so there is no training set for an algorithm.

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

This question is not applicable, as there is no AI/algorithm and thus no training set.

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