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The Echelon Endoscopic Cutters, Staplers and Reloads are intended for transection, resection, and/or anastomoses. The instruments have application in multiplesopen of minimally invasive general, gynecologic, urologic, thoracic, and pediative surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.

The Echelon devices are sterile, single-use instruments that deliver staples while simultaneously dividing tissue between rows. Thesc devices may be used in either open or Endoscopic procedures, depending upon the design. The device is intended for use in transection and resection of tissue for various open or minimally invasive surgical procedures. They arc intended for use in the creation of anastomoses in these procedures. The instruments are reloadable and, as such, they may be reloaded with various cartridges depending on the thickness of tissue that is to be transected or resected.

The Echclon Gray cartridge is a storage case that contains implantable staples. The cartridge is loaded into an Echelon instrument. When the instrument is deployed, it cuts a surgical wound while simultaneously delivering the staples into the tissuc. As in the predicate ETS Gray cartridge, the Echelon Gray cartridges will be available in 45mm lengths. There are 70 staples in the 45mm length cartridge.

Cartridges deliver the staples in a predetermined staple row configuration or pattern in rclation to the cut line. The staple row configurations of both the predicate and the new device have 6 staples, 3 staples on either side of the cut line. The staple row configuration (or pattern) of the predicate device and the new device is straight. That is to say, all 6 staples are of the same height and formation.

The provided text describes a 510(k) summary for the Echelon™ Gray Cartridge-45mm, a medical device. However, it does not contain the specific details about acceptance criteria or a study proving that the device meets such criteria in the format requested. The document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and indications for use.

Here's an analysis of what can be extracted and what is missing from the provided text, structured according to your request:

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

The provided document does not contain a table of acceptance criteria or specific reported device performance metrics. It states: "Performance Data. Bench testing was performed to demonstrate that the new device will perform as intended." However, the results of this bench testing and the specific criteria it aimed to meet are not detailed.

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

The document mentions "Bench testing," which implies physical testing of the device. However, it does not specify the sample size used for this test set, nor does it provide any information on data provenance (e.g., country of origin, retrospective or prospective nature of data, as this pertains more to clinical or observational studies).

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 section is not applicable to the type of device and testing described. The device is a surgical stapler cartridge, and the "bench testing" would likely involve mechanical and functional evaluations rather than expert assessment for ground truth.

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

This section is not applicable for the same reasons as point 3.

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 section is not applicable. The device is a surgical stapler cartridge, not an AI or imaging diagnostic tool. Therefore, MRMC studies are irrelevant here.

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

This section is not applicable. The device is a physical surgical instrument, not an algorithm.

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

As mentioned, the testing described is "bench testing." The "ground truth" for such testing would typically be engineering specifications, material properties, and functional requirements (e.g., staple formation, cutting ability, staple height, tissue thickness range). The document does not explicitly state the type of ground truth used beyond implying it relates to the device performing "as intended."

8. The sample size for the training set

This section is not applicable. The document describes a physical medical device, not a machine learning algorithm that requires a training set.

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

This section is not applicable for the same reasons as point 8.

In summary:

The provided 510(k) summary focuses on establishing substantial equivalence for a surgical stapler cartridge by detailing its technological characteristics and intended use in comparison to predicate devices. It states that "bench testing was performed to demonstrate that the new device will perform as intended," but it does not provide any specifics regarding acceptance criteria, the results of this testing, the sample size, or any other details typically found in a clinical or performance study report. The questions posed in your request are largely geared towards evaluating diagnostic or AI-driven medical devices, which are not relevant to this particular submission.

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