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The Chex Family of Staplers and there intended uses are as follows:

1. Single Use Curved Intraluminal Circular Stapler
   The CHEX™ Single Use Curved Intraluminal Circular Stapler is used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic techniques.

2. Circular Stapler for Rectal Prolapse and Hemorrhoid
   The CHEX™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids is a Circular Stapler product, with accessories, that has application for general surgical treatment of haemorrhoids and anorectal wall defects by means of transanal stapling and resection of mucosal and musculo-mucosal tissue resulting in occlusion of haemorrhoidal inflow, restoring the haemorrhoidal tissue to its normal physiological position.

3. Single Use Reloadable Linear Stapler
   The CHEX™ Single Use Reloadable Linear Stapler is used in the resection or transaction of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.

4. Single Use Reloadable Linear Cutter Stapler
   The CHEX™ Single Use Reloadable Linear Cutter Stapler has application in abdominal, gynecological, thoracic and pediatric surgery transaction, resection, and the creation of anastomoses.

The Chex™ Staplers were designed in reference to the general principles of surgical staplers. Each stapler/ instrument is activated by squeezing the handle firmly as far as it will go. Specifics for each stapler include:

The Chex™ Single Use Curved Intraluminal Circular Stapler places a circular, double staqqered row of titanium staples. Immediately after staple formation, the instrument's knife blade resects the excess tissue, creating a circular anastomosis. The diameter of the staple line is determined by the selection of the 21mm, 25mm, 28mm, or 32mm stapler.

The Chex™ Single Use Circular Stapler for Rectal Prolapse and Hemorrhoids places two circular peripheral lines of alternating and overlapping staples, thereby sealing off the rectal mucosa above the anal canal. The central circular cutting blade cuts the surplus tissue after the sealing to reconstruct the rectal mucosa. The diameter of the staple line is determined by the selection of the 32mm or 34mm stapler.

The Chex™ Disposable Reloadable Linear Stapler places a double staggered row of titanium staples used for mechanical suturing and closure of tissue, prior to the removal of excess tissue. The Linear Stapler is available in 30mm, 45mm, 60mm, and 90mm line lengths for use in various applications. The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument.

The Chex™ Linear Cutter Disposable Reloadable Stapler delivers two doubled staggered rows of titanium staples and anastomoses the internal tissues and incisions during surgical procedures. The Linear Cutter stapler is available in three staple line lengths (61mm, 81mm, or 100mm). The instrument may be reloaded during a single procedure but cannot be reloaded more than seven times for a maximum of eight firings per instrument. The use of the instrument with stable buttressing materials, or across a previous staple line, may reduce the number of firings.

This FDA 510(k) summary (K090821) is for surgical staplers, which are mechanical devices. The acceptance criteria and "device performance" in this context refer to the physical and mechanical properties of the staplers, not to performance metrics like sensitivity, specificity, or accuracy that would be associated with AI/software devices. Therefore, the questions related to AI/software performance (e.g., sample size for test/training sets, expert ground truth, MRMC studies) are not applicable.

Here's an analysis of the provided information regarding the acceptance criteria and performance:

1. Table of Acceptance Criteria and Reported Device Performance

The submission doesn't provide a specific table of "acceptance criteria" with numerical targets in the way an AI/software device submission would. Instead, it states that the devices were tested and "passed all required" testing, and in some cases, "produced superior results." The acceptance criteria are implicitly defined by compliance with a set of international standards and by demonstrating substantial equivalence to predicate devices, and sometimes superior clinical outcomes compared to manual suturing.

Regarding AI/Software specific questions:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • This is not applicable as the submission is for a physical surgical stapler, not an AI/software device. The "test set" in this context would refer to tested units of the stapler.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • This is not applicable for a physical surgical stapler. "Ground truth" in this context could refer to accurate measurements of physical properties or expert assessment of clinical outcomes, but the submission does not detail the number or qualifications of individuals involved in these aspects beyond generic statements about "clinical testing."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • This is not applicable for a physical surgical stapler.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

   • This is not applicable for a physical surgical stapler. The closest equivalent is the comparison of the staplers' clinical performance to manual suturing and competitors' devices, which is not an MRMC study for AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

   • This is not applicable for a physical surgical stapler. The "standalone" performance here refers to the stapler's mechanical and clinical function without human intervention in its design or manufacturing, but its use inherently involves a surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For the physical/mechanical tests, the "ground truth" would be established by validated measurement techniques and adherence to international standards (e.g., ISO 10993 for biocompatibility, ISO 11737 and EN 552 for sterility).
   • For the clinical performance, the "ground truth" was based on "post-operative healing, pain management, anastomotic leakage, and bleeding" outcomes, which are typical clinical outcome measures derived from patient data.

8. The sample size for the training set

   • This is not applicable for a physical surgical stapler.

9. How the ground truth for the training set was established

   • This is not applicable for a physical surgical stapler.

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