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The Disposable circular staplers have application throughout the alimentary tract for end to side, and side to side anastomoses.

The Disposable Endoscopic Staplers and Reload Unit have applications in general, gynecologic, pediatric and thoracic surgery for resection, transection, and creation of anastomoses.

The Disposable Hemorrhoidal Cutter Staplers have application for general treatment of hemorrhoids.

Disposable Linear Cutter Staplers have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.

Disposable circular staplers place a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 23mm, 32mm and 34mm four specifications. The staple height is 4.8mm.

Disposable Endoscopic Staplers and Reload Unit place two, triple-staggered rows of progressive titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in 2.5mm, 4.0mm, 4.8mm four staple sizes and 3.04.0, 4.05.0 two progressive staple sizes to accommodate various tissue thicknesses. The device may be reloaded and fired up to 10 times in a single procedure.

Disposable Hemorrhoidal Cutter Staplers are a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The stapler is available in 32mm two specifications. The staple size is 4.0mm. It cannot be reloaded.

Disposable Linear Cutter Staplers place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 60mm, 80mm and 100mm lengths. Reloads are available in two staple sizes to accommodate various tissue thicknesses: 3.8mm and 4.8mm. It may be reloaded and fired up to 5 times in a single procedure.

The provided text describes a 510(k) premarket notification for disposable endoscopic staplers and reload units, disposable hemorrhoidal cutter staplers, disposable linear cutter staplers, and disposable circular staplers. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

Missing Information: It's critical to note that this document is a 510(k) summary, not a full study report. As such, it primarily focuses on demonstrating substantial equivalence based on non-clinical performance testing against predicate devices and adherence to relevant standards. It explicitly states "No clinical study is included in this submission," which means the questions regarding human reader studies (MRMC), standalone algorithm performance, and training/test set details for AI/ML models are not applicable to this submission. The "device" in question refers to medical staplers, a physical medical device, not a software algorithm.

Therefore, the answers below will focus on the information relevant to the provided document, specifically the non-clinical performance and substantial equivalence.

1. A table of acceptance criteria and the reported device performance

The document doesn't present a single, consolidated table of acceptance criteria and reported performance in a pass/fail format typical for each specific test item. Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards."

The implied acceptance criteria are compliance with the listed standards and demonstrating performance comparable to predicate devices in specific ex-vivo tissue and in-vivo animal model tests.

Here's a summary of the performance claims based on the described non-clinical tests:

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

• Sample Size: The document does not specify the exact sample sizes for each non-clinical test (e.g., number of porcine tissues, number of jugular veins, number of stapler firings). It only mentions that tests were "conducted on porcine stomach and intestine tissue" and "jugular vein test was conducted on a porcine model."
• Data Provenance: The tests were non-clinical (ex-vivo tissue, in-vivo animal model), not human data. The company is Wuxi Beien Surgery Device Co., Ltd. in China, so the testing was likely performed in China or by a lab contracted by them. The data is prospective for these tests, as they were specifically performed to support the 510(k) submission.

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 as the device is a physical medical stapler, not an AI/ML diagnostic or image interpretation device. "Ground truth" in this context would be objective measurements from physical testing, not expert consensus on medical images.

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

This is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used in consensus reading of medical images, which is not relevant to the non-clinical testing of a 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. The document explicitly states: "No clinical study is included in this submission." Furthermore, the device is a surgical stapler, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a surgical stapler, not a standalone algorithm.

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

For the non-clinical performance tests, the "ground truth" was established by objective physical measurements and observations in the ex-vivo tissue and in-vivo animal model tests. For example:

• Pressure Resistance: Measurement of burst pressure.
• Closed Staple Dimension: Measurement of the physical dimensions of the formed staples.
• Staple Formation: Visual and/or microscopic assessment of the formed staples.
• Force Required to Fire: Measurement of the mechanical force.
• Burst Pressure (Jugular Vein Test): Measurement of pressure the anastomoses could withstand.

For biocompatibility, the "ground truth" was derived from standard biological and chemical testing methods as per ISO and USP guidelines.

8. The sample size for the training set

This is not applicable. This device is not an AI/ML algorithm requiring a training set.

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

This is not applicable. This device is not an AI/ML algorithm requiring a training set.

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