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The CQ ENCE Circular Staplers have application throughout the alimentary tract for the creation of end-to-end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries.

The REACH™ and SeCQure CO'ENCE™ Circular Staplers (CO'ENCE™ Circular Staplers) are sterile, single-use, hand-held, non-powered stapling devices used during general surgical procedures for the creation of end-to-end, side-to-side and end-to-side anastomoses in both open and laparoscopic surgeries. The Circular Staplers place a double-staggered, circular row of titanium staples while simultaneously resecting tissue when the device is manually activated. The device is provided in five head diameter sizes: 34mm, 31mm, 28mm, 25mm, and 21mm (product codes CS34, CS31, CS28, CS25, and CS21 respectively). Each size device can be purchased with a standard 27cm length shaft. The CS21 and SC25 can also be purchased with a longer, 35cm shaft (product codes CS21L, CS25L) to facilitate surgeon access to desired tissues. The CQ 'ENCE™ Circular Stapler allows the surgeon to control tissue compression by varying the closed staple height. The CQ ENCE Circular Stapler forms traditional B-shaped staples that are comprised of titanium. Safe removal of the device is facilitated by opening the instrument one full the Audible Indicator makes a clicking sound.

The provided document is a 510(k) summary for the Reach™ and CQ'ENCE™ Circular Staplers, seeking to demonstrate their substantial equivalence (SE) to a predicate device. The document primarily focuses on establishing SE based on comparison of technological characteristics and performance bench testing, rather than a clinical study with human subjects for efficacy or diagnostic performance. Therefore, many of the typical elements of an AI/ML device study (like MRMC studies, expert adjudication for ground truth of an imaging dataset, training set details) are not applicable or described in this document.

However, based on the information provided, here's an attempt to extract and interpret the relevant details regarding acceptance criteria and performance, as they relate to the mechanical device testing presented:

Table of Acceptance Criteria and Reported Device Performance (as inferred from the document):

Study Details (Bench Testing):

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: The document states "Reach™ Circular Stapler performance bench testing was provided in K120179. Testing for the Reach™ and CQ 'ENCE™ Circular Stapler is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Reach™ Circular Stapler previously provided in K120179." It does not specify the exact number of devices or test repetitions used for the bench testing.
   • Data Provenance: The testing was conducted as part of the submission process, presumably by the manufacturer (Reach Surgical, Inc. / SeCQure Surgical). The location of the testing is not explicitly stated, but the company is based in China with a US contact. This would be considered prospective internal testing.

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

   • Not Applicable. This is a mechanical device, and the "ground truth" is established by engineering specifications, physical measurements, and functional performance tests (e.g., measuring staple form, activation of safety mechanisms). "Experts" in the sense of radiologists interpreting images are not involved.

3. Adjudication Method for the Test Set:

   • Not Applicable. As this is mechanical testing against engineering specifications, there is no need for human adjudication of subjective interpretations. Measurements and functional checks are performed against defined criteria.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This document describes a surgical stapler, a mechanical device.

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

   • No. This is not an AI/ML algorithm. The performance of the stapler itself is the focus, without an "algorithm-only" or "human-in-the-loop" distinction typical of AI medical devices. The device's operation is purely mechanical, and performance relates directly to its physical characteristics and activation.

6. The Type of Ground Truth Used:

   • The "ground truth" for this medical device is based on engineering specifications, design requirements, and established functional performance metrics for surgical staplers. This includes parameters like staple formation, dimensions, safety mechanism activation, material properties (biocompatibility, endotoxin limits), and sterilization effectiveness.

7. The Sample Size for the Training Set:

   • Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."

8. How the Ground Truth for the Training Set was Established:

   • Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for one.

Summary of the Study Proving Acceptance Criteria were Met:

The study proving the device meets the acceptance criteria was primarily a performance bench testing program. The document explicitly states:

• "Performance bench testing was provided in K120179 [for the predicate device]."
• "Testing for the Reach™ and CQ 'ENCE™ Circular Stapler is provided in Section 018 - Performance Testing - Bench of this submission to the same specifications as the Reach™ Circular Stapler previously provided in K120179."
• "The data demonstrates that the Reach™ and CQ ENCE™ Circular Stapler meets the same specifications for visual inspection, dimensional analysis, staple form and safety mechanism performance."

This indicates that the manufacturer conducted a series of laboratory tests to assure that the new device's physical characteristics and functional performance matched those of the predicate device and met predefined engineering and quality specifications. The comparison table of technological characteristics further supports the demonstration of substantial equivalence by highlighting design similarities and explaining minor differences.

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